Trial Outcomes & Findings for Efficacy and Safety of GSK Biologicals HIV Vaccine in Antiretroviral Therapy (ART)-naïve HIV-1 Infected Persons (NCT NCT01218113)
NCT ID: NCT01218113
Last Updated: 2018-05-21
Results Overview
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
191 participants
Primary outcome timeframe
During the 7-day (Days 0-6) period following Dose 1
Results posted on
2018-05-21
Participant Flow
Out of 191 subjects originally enrolled in the study, only 190 subjects received vaccination and were hence included in the Total Vaccinated Cohort.
Participant milestones
| Measure |
3D_HIV Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|
|
Overall Study
STARTED
|
62
|
64
|
64
|
|
Overall Study
COMPLETED
|
57
|
63
|
58
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
6
|
Reasons for withdrawal
| Measure |
3D_HIV Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
4
|
|
Overall Study
Protocol Deviation Eligibility Criteria
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of GSK Biologicals HIV Vaccine in Antiretroviral Therapy (ART)-naïve HIV-1 Infected Persons
Baseline characteristics by cohort
| Measure |
3D_HIV Group
n=62 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.9 Years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
37.0 Years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
35.9 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
35.9 Years
STANDARD_DEVIATION 8.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African heritage/African American
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White-Arabic/North African heritage
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White-Caucasian/European heritage
|
43 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Week 48, post-Dose 3Population: The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.
Changes from baseline in HIV-1 viral load (ratio of each value over baseline value) were obtained using crude values and expressed in RNA copies/milliliter \[copies/mL\]. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic.
Outcome measures
| Measure |
3D_HIV Group
n=46 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=55 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=50 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Geometric Mean Change in Human Immunodeficiency Virus Type 1 (HIV-1) Viral Load (VL) From Baseline
|
1.0 RNA copies/mL
Standard Deviation 0.35
|
1.5 RNA copies/mL
Standard Deviation 0.38
|
1.3 RNA copies/mL
Standard Deviation 0.34
|
—
|
PRIMARY outcome
Timeframe: At Week 48, post-Dose 3Population: The analysis was performed on the Modified Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.
Changes from baseline in HIV-1 viral load (difference of each value minus baseline value) were obtained using log10-transformed values and expressed in log10-RNA copies/mL. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic.
Outcome measures
| Measure |
3D_HIV Group
n=46 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=55 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=50 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Geometric Mean Change in HIV-1 VL From Baseline
|
0.0 log10(RNA copies/mL)
Standard Deviation 0.35
|
0.2 log10(RNA copies/mL)
Standard Deviation 0.38
|
0.1 log10(RNA copies/mL)
Standard Deviation 0.34
|
—
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) period following Dose 1Population: The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in. For the purpose of the analysis, 3D\_HIV Group and 2D\_HIV Group were combined into a single group (HIV Group), since Dose 1 vaccination was identical for both groups.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.
Outcome measures
| Measure |
3D_HIV Group
n=125 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=63 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Solicited Local Symptoms
Any Pain, Dose 1
|
112 Participants
|
12 Participants
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
9 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Medically attended Pain, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Any Redness, Dose 1
|
16 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Medically attended Redness, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling, Dose 1
|
7 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Medically attended Swelling, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) period following Dose 2Population: The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in. For the purpose of the analysis, 3D\_HIV Group and 2D\_HIV Group were combined into a single group (HIV Group), since Dose 2 vaccination was identical for both groups.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.
Outcome measures
| Measure |
3D_HIV Group
n=120 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=61 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Solicited Local Symptoms
Medically Attended Swelling, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Any Pain, Dose 2
|
98 Participants
|
5 Participants
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
11 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Medically Attended Pain, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Any Redness, Dose 2
|
15 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Medically Attended Redness, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling, Dose 2
|
6 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) period following Dose 3Population: The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.
Outcome measures
| Measure |
3D_HIV Group
n=55 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=58 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=54 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Solicited Local Symptoms
Any Pain, Dose 3
|
42 Participants
|
9 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Pain, Dose 3
|
6 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Medically attended Pain, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Any Redness, Dose 3
|
10 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Redness, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Medically attended Redness, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling, Dose 3
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Swelling, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Medically attended Swelling, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period, across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.
Outcome measures
| Measure |
3D_HIV Group
n=62 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Solicited Local Symptoms
Medically Attended Swelling, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Any Pain, Across doses
|
58 Participants
|
57 Participants
|
14 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Pain, Across doses
|
15 Participants
|
6 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Medically Attended Pain, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Any Redness, Across doses
|
17 Participants
|
14 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Redness, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Medically Attended Redness, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling, Across doses
|
4 Participants
|
8 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Swelling, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) period following Dose 1Population: The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in. For the purpose of the analysis, 3D\_HIV Group and 2D\_HIV Group were combined into a single group (HIV Group), since Dose 1 vaccination was identical for both groups.
Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)\&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social\&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination
Outcome measures
| Measure |
3D_HIV Group
n=124 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=63 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Solicited General Symptoms
Any Temperature, Dose 1
|
8 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Abdominal pain, Dose 1
|
14 Participants
|
3 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Abdominal pain, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Abdominal pain, Dose 1
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Abdominal pain, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Abdominal pain, Dose 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Anorexia, Dose 1
|
7 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Anorexia, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Anorexia, Dose 1
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Anorexia, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Anorexia, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Diarrhoea, Dose 1
|
16 Participants
|
5 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Diarrhoea, Dose 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Diarrhoea, Dose 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Diarrhoea, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Diarrhoea, Dose 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Fatigue, Dose 1
|
56 Participants
|
16 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Fatigue, Dose 1
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Fatigue, Dose 1
|
24 Participants
|
7 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Fatigue, Dose 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Fatigue, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Headache, Dose 1
|
40 Participants
|
14 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Headache, Dose 1
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Headache, Dose 1
|
16 Participants
|
8 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Headache, Dose 1
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Headache, Dose 1
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Myalgia, Dose 1
|
44 Participants
|
9 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Myalgia, Dose 1
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Myalgia, Dose 1
|
26 Participants
|
4 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Myalgia, Dose 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Myalgia, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Nausea, Dose 1
|
17 Participants
|
5 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Nausea, Dose 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Nausea, Dose 1
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Nausea, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Nausea, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Sweating, Dose 1
|
16 Participants
|
6 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Sweating, Dose 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Sweating, Dose 1
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Sweating, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Sweating, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Temperature, Dose 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Temperature, Dose 1
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Temperature, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Temperature, Dose 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Vomiting, Dose 1
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Vomiting, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Vomiting, Dose 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Vomiting, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Vomiting, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) period following Dose 2Population: The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in. For the purpose of the analysis, 3D\_HIV Group and 2D\_HIV Group were combined into a single group (HIV Group), since Dose 2 vaccination was identical for both groups.
Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)\&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social\&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination
Outcome measures
| Measure |
3D_HIV Group
n=120 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=61 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Nausea, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Nausea, Dose 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Sweating, Dose 2
|
17 Participants
|
3 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Sweating, Dose 2
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Sweating, Dose 2
|
8 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Sweating, Dose 2
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Sweating, Dose 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Temperature, Dose 2
|
11 Participants
|
3 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Temperature, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Temperature, Dose 2
|
7 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Temperature, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Temperature, Dose 2
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Vomiting, Dose 2
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Vomiting, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Vomiting, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Vomiting, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Vomiting, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Abdominal pain, Dose 2
|
9 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Abdominal Pain, Dose 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Abdominal Pain, Dose 2
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Abdominal Pain, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Abdominal Pain, Dose 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Anorexia, Dose 2
|
7 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Anorexia, Dose 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Anorexia, Dose 2
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Anorexia, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Anorexia, Dose 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Diarrhoea, Dose 2
|
13 Participants
|
7 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Diarrhoea, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Diarrhoea, Dose 2
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Diarrhoea, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Diarrhoea, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Fatigue, Dose 2
|
56 Participants
|
10 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Fatigue, Dose 2
|
6 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Fatigue, Dose 2
|
25 Participants
|
4 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Fatigue, Dose 2
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Fatigue, Dose 2
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Headache, Dose 2
|
34 Participants
|
8 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Headache, Dose 2
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Headache, Dose 2
|
15 Participants
|
3 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Headache, Dose 2
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Headache, Dose 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Myalgia, Dose 2
|
42 Participants
|
6 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Myalgia, Dose 2
|
6 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Myalgia, Dose 2
|
26 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Myalgia, Dose 2
|
6 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Myalgia, Dose 2
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Nausea, Dose 2
|
11 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Nausea, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Nausea, Dose 2
|
4 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) period following Dose 3Population: The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)\&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social\&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination
Outcome measures
| Measure |
3D_HIV Group
n=56 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=58 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=54 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Solicited General Symptoms
Any Abdominal pain, Dose 3
|
4 Participants
|
4 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Abdominal pain, Dose 3
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Abdominal pain, Dose 3
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Abdominal pain, Dose 3
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attende Abdominal pain, Dose 3
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Anorexia, Dose 3
|
7 Participants
|
3 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Anorexia, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Anorexia, Dose 3
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Anorexia, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Anorexia, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Diarrhoea, Dose 3
|
8 Participants
|
12 Participants
|
5 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Diarrhoea, Dose 3
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Diarrhoea, Dose 3
|
4 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Diarrhoea, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Diarrhoea, Dose 3
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Fatigue, Dose 3
|
25 Participants
|
11 Participants
|
8 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Fatigue, Dose 3
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Fatigue, Dose 3
|
15 Participants
|
3 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Fatigue, Dose 3
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Fatigue, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Headache, Dose 3
|
16 Participants
|
17 Participants
|
7 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Headache, Dose 3
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Headache, Dose 3
|
8 Participants
|
5 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Headache, Dose 3
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Headache, Dose 3
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Myalgia, Dose 3
|
19 Participants
|
9 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Myalgia, Dose 3
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Myalgia, Dose 3
|
13 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Myalgia, Dose 3
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Myalgia, Dose 3
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Nausea, Dose 3
|
7 Participants
|
2 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Nausea, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Nausea, Dose 3
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Nausea, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Nausea, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Sweating, Dose 3
|
7 Participants
|
8 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Sweating, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Sweating, Dose 3
|
4 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Sweating, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Sweating, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Temperature, Dose 3
|
5 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Temperature, Dose 3
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Temperature, Dose 3
|
4 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Temperature, Dose 3
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Temperature, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Vomiting, Dose 3
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Vomiting, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Vomiting, Dose 3
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Vomiting, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Vomiting, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period, across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)\&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social\&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination
Outcome measures
| Measure |
3D_HIV Group
n=62 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Temperature, Across doses
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Abdominal pain, Across doses
|
13 Participants
|
10 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Abdominal pain, Across doses
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Abdominal pain, Across doses
|
3 Participants
|
3 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Abdominal pain, Across doses
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Abdominal pain, Across doses
|
3 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Anorexia, Across doses
|
11 Participants
|
10 Participants
|
7 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Anorexia, Across doses
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Anorexia, Across doses
|
5 Participants
|
4 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Anorexia, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Anorexia, Across doses
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Diarrhoea, Across doses
|
17 Participants
|
19 Participants
|
14 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Diarrhoea, Across doses
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Diarrhoea, Across doses
|
5 Participants
|
4 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Diarrhoea, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Diarrhoea, Across doses
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Fatigue, Across doses
|
43 Participants
|
38 Participants
|
20 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Fatigue, Across doses
|
8 Participants
|
4 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Fatigue, Across doses
|
24 Participants
|
24 Participants
|
9 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Fatigue, Across doses
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Fatigue, Across doses
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Headache, Across doses
|
32 Participants
|
33 Participants
|
21 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Headache, Across doses
|
4 Participants
|
4 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Headache, Across doses
|
15 Participants
|
17 Participants
|
11 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Headache, Across doses
|
3 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Headache, Across doses
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Myalgia, Across doses
|
33 Participants
|
32 Participants
|
12 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Myalgia, Across doses
|
4 Participants
|
5 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Myalgia, Across doses
|
22 Participants
|
21 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Myalgia, Across doses
|
2 Participants
|
4 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Myalgia, Across doses
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Nausea, Across doses
|
17 Participants
|
14 Participants
|
8 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Nausea, Across doses
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Nausea, Across doses
|
7 Participants
|
4 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Nausea, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Nausea, Across doses
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Sweating, Across doses
|
11 Participants
|
20 Participants
|
10 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Sweating, Across doses
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Sweating, Across doses
|
6 Participants
|
7 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Sweating, Across doses
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Sweating, Across doses
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Temperature, Across doses
|
14 Participants
|
9 Participants
|
6 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Temperature, Across doses
|
9 Participants
|
4 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Temperature, Across doses
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Temperature, Across doses
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Vomiting, Across doses
|
3 Participants
|
2 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Vomiting, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Vomiting, Across doses
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Related Vomiting, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Medically Attended Vomiting, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: During the 28-Day (Days 0-27) period following Dose 1 and Dose 2Population: The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D\_HIV Group and 2D\_HIV Group were combined into a single group (HIV Group), since Dose 1 and 2 vaccinations were identical for both groups.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 (G3) AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were tabulated following Dose 1 and Dose 2 vaccinations.
Outcome measures
| Measure |
3D_HIV Group
n=126 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Any AE(s)
|
58 Participants
|
29 Participants
|
—
|
—
|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Grade 3 AE(s)
|
9 Participants
|
3 Participants
|
—
|
—
|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Related AE(s)
|
6 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Grade 3 Related AE(s)
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Medically Attended AE(s)
|
17 Participants
|
13 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: During the 28-Day (Days 0-27) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 (G3) AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were tabulated following Dose 3 and across doses.
Outcome measures
| Measure |
3D_HIV Group
n=56 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=60 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=56 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Unsolicited AEs
Any AE(s)
|
30 Participants
|
42 Participants
|
34 Participants
|
—
|
|
Number of Subjects With Unsolicited AEs
Grade 3 AE(s)
|
3 Participants
|
7 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Unsolicited AEs
Related AE(s)
|
2 Participants
|
6 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Unsolicited AEs
Grade 3 Related AE(s)
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Unsolicited AEs
Medically Attended AE(s)
|
11 Participants
|
14 Participants
|
15 Participants
|
—
|
PRIMARY outcome
Timeframe: During the entire study period (up to Week 48)Population: The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
3D_HIV Group
n=62 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
1 Participants
|
3 Participants
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: During the entire study period (up to Week 48)Population: The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.
Potentially Immune-Mediated Diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Outcome measures
| Measure |
3D_HIV Group
n=62 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Potentially Immune-Mediated Diseases (pIMDs)
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: At ScreeningPopulation: The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D\_HIV Group and 2D\_HIV Group were combined into a single group (HIV Group), since the screening timepoint was identical for both groups.
Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase \[ALT\], albumin \[ALB\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin (total) \[BIL\], creatinine \[CRE\], eosinophils \[EOS\], eosinophils/100 leukocytes \[EOS/100LEU\], bicarbonate \[BIC\], haemoglobin \[HGB\], potassium \[PTS\], lymphocytes \[LYM\], lymphocytes/100 leukocytes \[LYM/100LEU\], sodium \[SDI\], neutrophils \[NEU\], neutrophils/100 leukocytes \[NEU/100LEU\], platelet count \[PLC\], prothrombin time-international normalized ratio \[PTT\] and white blood cell count \[WBC\]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).
Outcome measures
| Measure |
3D_HIV Group
n=126 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 1
|
11 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 0
|
124 Participants
|
64 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 0
|
115 Participants
|
63 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 1
|
9 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 2
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 0
|
126 Participants
|
64 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 0
|
125 Participants
|
64 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 0
|
120 Participants
|
63 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 1
|
6 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 0
|
123 Participants
|
63 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 1
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 2
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 0
|
124 Participants
|
62 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 1
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 2
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 0
|
124 Participants
|
64 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 0
|
124 Participants
|
64 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 0
|
118 Participants
|
59 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 1
|
8 Participants
|
5 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 0
|
126 Participants
|
64 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 0
|
126 Participants
|
64 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 0
|
124 Participants
|
64 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 0
|
115 Participants
|
63 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 0
|
119 Participants
|
64 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 1
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 2
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 0
|
124 Participants
|
64 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 0
|
122 Participants
|
63 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 1
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 2
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 0
|
116 Participants
|
59 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 1
|
10 Participants
|
4 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 0
|
126 Participants
|
64 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-vaccination, at Week 0Population: The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D\_HIV Group and 2D\_HIV Group were combined into a single group (HIV Group), since Dose 1 vaccination was identical for both groups.
Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase \[ALT\], albumin \[ALB\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin (total) \[BIL\], creatinine \[CRE\], eosinophils \[EOS\], eosinophils/100 leukocytes \[EOS/100LEU\], bicarbonate \[BIC\], haemoglobin \[HGB\], potassium \[PTS\], lymphocytes \[LYM\], lymphocytes/100 leukocytes \[LYM/100LEU\], sodium \[SDI\], neutrophils \[NEU\], neutrophils/100 leukocytes \[NEU/100LEU\], platelet count \[PLC\], prothrombin time-international normalized ratio \[PTT\] and white blood cell count \[WBC\]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).
Outcome measures
| Measure |
3D_HIV Group
n=126 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 1
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 0
|
126 Participants
|
64 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 0
|
126 Participants
|
64 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 0
|
100 Participants
|
47 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 1
|
26 Participants
|
17 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 0
|
126 Participants
|
64 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 0
|
126 Participants
|
64 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 0
|
126 Participants
|
64 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 0
|
126 Participants
|
64 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 0
|
114 Participants
|
59 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 1
|
11 Participants
|
5 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 0
|
123 Participants
|
62 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 1
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 2
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 0
|
126 Participants
|
64 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 0
|
121 Participants
|
63 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 1
|
5 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 2
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 0
|
118 Participants
|
55 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 1
|
7 Participants
|
9 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 0
|
125 Participants
|
63 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 2
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 0
|
117 Participants
|
62 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 1
|
6 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 2
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 0
|
125 Participants
|
64 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 0
|
125 Participants
|
64 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 0
|
121 Participants
|
61 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 1
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 2
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 0
|
125 Participants
|
63 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 2
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 0
|
125 Participants
|
61 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Week 4Population: The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D\_HIV Group and 2D\_HIV Group were combined into a single group (HIV Group), since Dose 1 and Dose 2 vaccinations were identical for both groups.
Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase \[ALT\], albumin \[ALB\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin (total) \[BIL\], creatinine \[CRE\], eosinophils \[EOS\], eosinophils/100 leukocytes \[EOS/100LEU\], bicarbonate \[BIC\], haemoglobin \[HGB\], potassium \[PTS\], lymphocytes \[LYM\], lymphocytes/100 leukocytes \[LYM/100LEU\], sodium \[SDI\], neutrophils \[NEU\], neutrophils/100 leukocytes \[NEU/100LEU\], platelet count \[PLC\], prothrombin time-international normalized ratio \[PTT\] and white blood cell count \[WBC\]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).
Outcome measures
| Measure |
3D_HIV Group
n=126 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 1
|
7 Participants
|
3 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 0
|
126 Participants
|
63 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 0
|
119 Participants
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 0
|
122 Participants
|
62 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 0
|
126 Participants
|
63 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 0
|
115 Participants
|
54 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 0
|
126 Participants
|
63 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 0
|
99 Participants
|
48 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 1
|
27 Participants
|
15 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 0
|
126 Participants
|
63 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 0
|
124 Participants
|
63 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 1
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 0
|
126 Participants
|
63 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 0
|
126 Participants
|
63 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 1
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 0
|
123 Participants
|
62 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 1
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 2
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 1
|
11 Participants
|
9 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 0
|
126 Participants
|
63 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 0
|
114 Participants
|
62 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 1
|
10 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 2
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 0
|
125 Participants
|
63 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 0
|
124 Participants
|
63 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 1
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 0
|
119 Participants
|
61 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 1
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 2
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 0
|
125 Participants
|
63 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 0
|
121 Participants
|
61 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 1
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Week 6Population: The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D\_HIV Group and 2D\_HIV Group were combined into a single group (HIV Group), since Dose 1 and Dose 2 vaccinations were identical for both groups.
Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase \[ALT\], albumin \[ALB\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin (total) \[BIL\], creatinine \[CRE\], eosinophils \[EOS\], eosinophils/100 leukocytes \[EOS/100LEU\], bicarbonate \[BIC\], haemoglobin \[HGB\], potassium \[PTS\], lymphocytes \[LYM\], lymphocytes/100 leukocytes \[LYM/100LEU\], sodium \[SDI\], neutrophils \[NEU\], neutrophils/100 leukocytes \[NEU/100LEU\], platelet count \[PLC\], prothrombin time-international normalized ratio \[PTT\] and white blood cell count \[WBC\]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).
Outcome measures
| Measure |
3D_HIV Group
n=126 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 0
|
119 Participants
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 1
|
33 Participants
|
23 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 1
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 0
|
125 Participants
|
62 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 0
|
125 Participants
|
62 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 0
|
117 Participants
|
58 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 0
|
121 Participants
|
62 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 0
|
125 Participants
|
62 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 1
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 0
|
118 Participants
|
51 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 1
|
7 Participants
|
11 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 0
|
117 Participants
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 1
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 2
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 0
|
124 Participants
|
62 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 0
|
123 Participants
|
62 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 1
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 0
|
118 Participants
|
61 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 1
|
6 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 0
|
121 Participants
|
62 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 1
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 1
|
6 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 0
|
125 Participants
|
62 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 0
|
125 Participants
|
62 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 0
|
92 Participants
|
39 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 0
|
125 Participants
|
62 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 0
|
124 Participants
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 1
|
7 Participants
|
4 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 1
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 0
|
122 Participants
|
61 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 3
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 0
|
125 Participants
|
62 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Week 16Population: The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D\_HIV Group and 2D\_HIV Group were combined into a single group (HIV Group), since Dose 1 and Dose 2 vaccinations were identical for both groups.
Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase \[ALT\], albumin \[ALB\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin (total) \[BIL\], creatinine \[CRE\], eosinophils \[EOS\], eosinophils/100 leukocytes \[EOS/100LEU\], bicarbonate \[BIC\], haemoglobin \[HGB\], potassium \[PTS\], lymphocytes \[LYM\], lymphocytes/100 leukocytes \[LYM/100LEU\], sodium \[SDI\], neutrophils \[NEU\], neutrophils/100 leukocytes \[NEU/100LEU\], platelet count \[PLC\], prothrombin time-international normalized ratio \[PTT\] and white blood cell count \[WBC\]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).
Outcome measures
| Measure |
3D_HIV Group
n=126 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 0
|
124 Participants
|
59 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 1
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 2
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 0
|
124 Participants
|
61 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 0
|
93 Participants
|
47 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 1
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 0
|
124 Participants
|
61 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 0
|
124 Participants
|
61 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 1
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 0
|
124 Participants
|
61 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 1
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 1
|
13 Participants
|
6 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 0
|
124 Participants
|
61 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 0
|
121 Participants
|
58 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 0
|
121 Participants
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 1
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 0
|
119 Participants
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 0
|
113 Participants
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 1
|
10 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 2
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 0
|
123 Participants
|
61 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 0
|
122 Participants
|
61 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 1
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 0
|
117 Participants
|
59 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 1
|
6 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 0
|
111 Participants
|
55 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 0
|
119 Participants
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 1
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 0
|
124 Participants
|
61 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 1
|
31 Participants
|
14 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 0
|
122 Participants
|
61 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 0
|
123 Participants
|
61 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Week 28Population: The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D\_HIV Group and 2D\_HIV Group were combined into a single group (HIV Group), since Dose 1 and Dose 2 vaccinations were identical for both groups.
Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase \[ALT\], albumin \[ALB\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin (total) \[BIL\], creatinine \[CRE\], eosinophils \[EOS\], eosinophils/100 leukocytes \[EOS/100LEU\], bicarbonate \[BIC\], haemoglobin \[HGB\], potassium \[PTS\], lymphocytes \[LYM\], lymphocytes/100 leukocytes \[LYM/100LEU\], sodium \[SDI\], neutrophils \[NEU\], neutrophils/100 leukocytes \[NEU/100LEU\], platelet count \[PLC\], prothrombin time-international normalized ratio \[PTT\] and white blood cell count \[WBC\]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).
Outcome measures
| Measure |
3D_HIV Group
n=126 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 1
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 2
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 4
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 0
|
121 Participants
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 0
|
121 Participants
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 0
|
115 Participants
|
57 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 0
|
119 Participants
|
59 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 2
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 0
|
119 Participants
|
59 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 2
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 0
|
121 Participants
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 0
|
121 Participants
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 0
|
92 Participants
|
45 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 1
|
29 Participants
|
15 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 1
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 0
|
120 Participants
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 0
|
121 Participants
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 0
|
112 Participants
|
57 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 1
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 4
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 1
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 0
|
120 Participants
|
59 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 0
|
121 Participants
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 0
|
115 Participants
|
57 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 1
|
6 Participants
|
3 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 0
|
115 Participants
|
58 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 1
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 2
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 0
|
121 Participants
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 0
|
118 Participants
|
59 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 1
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 2
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 0
|
110 Participants
|
54 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 1
|
11 Participants
|
6 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 0
|
121 Participants
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Week 30Population: The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.
Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase \[ALT\], albumin \[ALB\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin (total) \[BIL\], creatinine \[CRE\], eosinophils \[EOS\], eosinophils/100 leukocytes \[EOS/100LEU\], bicarbonate \[BIC\], haemoglobin \[HGB\], potassium \[PTS\], lymphocytes \[LYM\], lymphocytes/100 leukocytes \[LYM/100LEU\], sodium \[SDI\], neutrophils \[NEU\], neutrophils/100 leukocytes \[NEU/100LEU\], platelet count \[PLC\], prothrombin time-international normalized ratio \[PTT\] and white blood cell count \[WBC\]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).
Outcome measures
| Measure |
3D_HIV Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=62 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 0
|
57 Participants
|
57 Participants
|
60 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 0
|
55 Participants
|
54 Participants
|
58 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 0
|
57 Participants
|
56 Participants
|
60 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 0
|
58 Participants
|
56 Participants
|
60 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 0
|
51 Participants
|
55 Participants
|
59 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 1
|
7 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 1
|
5 Participants
|
6 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 0
|
58 Participants
|
57 Participants
|
60 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 0
|
58 Participants
|
57 Participants
|
60 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 0
|
58 Participants
|
56 Participants
|
59 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 0
|
53 Participants
|
51 Participants
|
56 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 0
|
53 Participants
|
54 Participants
|
57 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 1
|
5 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 2
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 0
|
58 Participants
|
56 Participants
|
60 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 1
|
3 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 0
|
55 Participants
|
57 Participants
|
59 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 1
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 0
|
57 Participants
|
55 Participants
|
59 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 1
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 0
|
58 Participants
|
57 Participants
|
60 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 0
|
58 Participants
|
57 Participants
|
60 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 0
|
43 Participants
|
45 Participants
|
45 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 1
|
15 Participants
|
12 Participants
|
15 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 0
|
58 Participants
|
57 Participants
|
60 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 0
|
58 Participants
|
57 Participants
|
60 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 0
|
55 Participants
|
53 Participants
|
58 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 1
|
3 Participants
|
4 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: At Week 38Population: The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.
Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase \[ALT\], albumin \[ALB\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin (total) \[BIL\], creatinine \[CRE\], eosinophils \[EOS\], eosinophils/100 leukocytes \[EOS/100LEU\], bicarbonate \[BIC\], haemoglobin \[HGB\], potassium \[PTS\], lymphocytes \[LYM\], lymphocytes/100 leukocytes \[LYM/100LEU\], sodium \[SDI\], neutrophils \[NEU\], neutrophils/100 leukocytes \[NEU/100LEU\], platelet count \[PLC\], prothrombin time-international normalized ratio \[PTT\] and white blood cell count \[WBC\]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).
Outcome measures
| Measure |
3D_HIV Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=62 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 1
|
4 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 0
|
53 Participants
|
52 Participants
|
61 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 2
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 0
|
55 Participants
|
52 Participants
|
61 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 1
|
2 Participants
|
4 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 2
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 1
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 0
|
56 Participants
|
54 Participants
|
61 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 1
|
2 Participants
|
3 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 0
|
58 Participants
|
57 Participants
|
63 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 0
|
57 Participants
|
56 Participants
|
63 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 0
|
57 Participants
|
57 Participants
|
61 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 1
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 0
|
54 Participants
|
54 Participants
|
61 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 1
|
4 Participants
|
3 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 0
|
56 Participants
|
54 Participants
|
59 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 1
|
2 Participants
|
2 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 2
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 0
|
58 Participants
|
57 Participants
|
63 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 0
|
58 Participants
|
55 Participants
|
59 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 1
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 0
|
51 Participants
|
52 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 1
|
7 Participants
|
5 Participants
|
7 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 0
|
57 Participants
|
57 Participants
|
63 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 0
|
58 Participants
|
55 Participants
|
63 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 1
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 0
|
56 Participants
|
57 Participants
|
61 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 2
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 0
|
58 Participants
|
57 Participants
|
63 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 0
|
46 Participants
|
47 Participants
|
51 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 1
|
11 Participants
|
10 Participants
|
12 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 0
|
58 Participants
|
57 Participants
|
63 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 0
|
58 Participants
|
57 Participants
|
63 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 0
|
58 Participants
|
56 Participants
|
63 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: At Week 48Population: The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.
Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase \[ALT\], albumin \[ALB\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin (total) \[BIL\], creatinine \[CRE\], eosinophils \[EOS\], eosinophils/100 leukocytes \[EOS/100LEU\], bicarbonate \[BIC\], haemoglobin \[HGB\], potassium \[PTS\], lymphocytes \[LYM\], lymphocytes/100 leukocytes \[LYM/100LEU\], sodium \[SDI\], neutrophils \[NEU\], neutrophils/100 leukocytes \[NEU/100LEU\], platelet count \[PLC\], prothrombin time-international normalized ratio \[PTT\] and white blood cell count \[WBC\]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).
Outcome measures
| Measure |
3D_HIV Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=62 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 1
|
3 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 0
|
58 Participants
|
56 Participants
|
63 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 0
|
57 Participants
|
55 Participants
|
63 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 1
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 0
|
55 Participants
|
54 Participants
|
62 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 0
|
58 Participants
|
57 Participants
|
63 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 0
|
49 Participants
|
43 Participants
|
51 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 1
|
9 Participants
|
14 Participants
|
12 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIC, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 0
|
58 Participants
|
56 Participants
|
63 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
HGB, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 0
|
58 Participants
|
57 Participants
|
61 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 1
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTS, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 0
|
58 Participants
|
57 Participants
|
63 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 0
|
57 Participants
|
53 Participants
|
60 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 0
|
48 Participants
|
55 Participants
|
58 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 0
|
58 Participants
|
57 Participants
|
63 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 0
|
52 Participants
|
55 Participants
|
61 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 2
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALT, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALB, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
ALP, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 0
|
54 Participants
|
56 Participants
|
63 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 1
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 2
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
AST, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 0
|
56 Participants
|
57 Participants
|
63 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
BIL, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 1
|
3 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
CRE, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 0
|
58 Participants
|
57 Participants
|
63 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
EOS/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 0
|
58 Participants
|
57 Participants
|
63 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
LYM/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 0
|
55 Participants
|
56 Participants
|
58 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 1
|
3 Participants
|
1 Participants
|
5 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
SDI, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 1
|
0 Participants
|
4 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 0
|
58 Participants
|
57 Participants
|
63 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
NEU/100LEU, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 0
|
58 Participants
|
56 Participants
|
62 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 2
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PLC, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 1
|
8 Participants
|
2 Participants
|
5 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 3
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
PTT, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Values
WBC, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At Weeks 1, 4, 6, 16, 28, 30 and 38Population: The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.
Changes from baseline in HIV-1 viral load (ratio of each value over baseline value) were obtained using crude values and expressed in RNA copies/mL. Baseline of HIV-1 viral load was defined as the geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic. Changes from baseline were measured at Week 1 to 28 for the HIV Group, Weeks 30 and 38 for the 3D\_HIV Group and 2D\_HIV Group and from Week 1 to Week 38 for the Control Group.
Outcome measures
| Measure |
3D_HIV Group
n=124 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=53 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=58 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=60 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Geometric Mean Change in HIV-1 Viral Load (LV) From Baseline
HIV-1 VL, Week 28
|
1.2 RNA copies/mL
Standard Deviation 0.35
|
—
|
—
|
1.2 RNA copies/mL
Standard Deviation 0.36
|
|
Geometric Mean Change in HIV-1 Viral Load (LV) From Baseline
HIV-1 VL, Week 30
|
—
|
1.1 RNA copies/mL
Standard Deviation 0.24
|
1.2 RNA copies/mL
Standard Deviation 0.38
|
1.2 RNA copies/mL
Standard Deviation 0.34
|
|
Geometric Mean Change in HIV-1 Viral Load (LV) From Baseline
HIV-1 VL, Week 1
|
1.0 RNA copies/mL
Standard Deviation 0.18
|
—
|
—
|
0.9 RNA copies/mL
Standard Deviation 0.18
|
|
Geometric Mean Change in HIV-1 Viral Load (LV) From Baseline
HIV-1 VL, Week 4
|
1.1 RNA copies/mL
Standard Deviation 0.28
|
—
|
—
|
1.1 RNA copies/mL
Standard Deviation 0.32
|
|
Geometric Mean Change in HIV-1 Viral Load (LV) From Baseline
HIV-1 VL, Week 6
|
1.1 RNA copies/mL
Standard Deviation 0.26
|
—
|
—
|
1.2 RNA copies/mL
Standard Deviation 0.37
|
|
Geometric Mean Change in HIV-1 Viral Load (LV) From Baseline
HIV-1 VL, Week 16
|
1.1 RNA copies/mL
Standard Deviation 0.31
|
—
|
—
|
1.1 RNA copies/mL
Standard Deviation 0.28
|
|
Geometric Mean Change in HIV-1 Viral Load (LV) From Baseline
HIV-1 VL, Week 38
|
—
|
0.9 RNA copies/mL
Standard Deviation 0.28
|
1.2 RNA copies/mL
Standard Deviation 0.32
|
1.2 RNA copies/mL
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: At Weeks 1, 4, 6, 16, 28, 30 and 38Population: The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.
Changes from baseline in HIV-1 viral load (difference of each value minus baseline value) were obtained using log10-transformed values and expressed in log10-RNA copies/mL. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic. Changes from baseline were measured at Week 1 to 29 for the HIV Group, Weeks 30 and 38 for the 3D\_HIV Group and 2D\_HIV Group and from Week 1 to Week 38 for the Control Group.
Outcome measures
| Measure |
3D_HIV Group
n=124 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=53 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=58 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=60 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Geometric Mean Change in HIV-1 VL From Baseline
HIV-1 VL, Week 4
|
0.0 log10(RNA copies/mL)
Standard Deviation 0.28
|
—
|
—
|
0.1 log10(RNA copies/mL)
Standard Deviation 0.32
|
|
Geometric Mean Change in HIV-1 VL From Baseline
HIV-1 VL, Week 30
|
—
|
0.0 log10(RNA copies/mL)
Standard Deviation 0.24
|
0.1 log10(RNA copies/mL)
Standard Deviation 0.38
|
0.1 log10(RNA copies/mL)
Standard Deviation 0.34
|
|
Geometric Mean Change in HIV-1 VL From Baseline
HIV-1 VL, Week 38
|
—
|
0.0 log10(RNA copies/mL)
Standard Deviation 0.28
|
0.1 log10(RNA copies/mL)
Standard Deviation 0.32
|
0.1 log10(RNA copies/mL)
Standard Deviation 0.43
|
|
Geometric Mean Change in HIV-1 VL From Baseline
HIV-1 VL, Week 1
|
0.0 log10(RNA copies/mL)
Standard Deviation 0.18
|
—
|
—
|
-0.1 log10(RNA copies/mL)
Standard Deviation 0.18
|
|
Geometric Mean Change in HIV-1 VL From Baseline
HIV-1 VL, Week 6
|
0.1 log10(RNA copies/mL)
Standard Deviation 0.26
|
—
|
—
|
0.1 log10(RNA copies/mL)
Standard Deviation 0.37
|
|
Geometric Mean Change in HIV-1 VL From Baseline
HIV-1 VL, Week 16
|
0.0 log10(RNA copies/mL)
Standard Deviation 0.31
|
—
|
—
|
0.0 log10(RNA copies/mL)
Standard Deviation 0.28
|
|
Geometric Mean Change in HIV-1 VL From Baseline
HIV-1 VL, Week 28
|
0.1 log10(RNA copies/mL)
Standard Deviation 0.35
|
—
|
—
|
0.1 log10(RNA copies/mL)
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48Population: The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.
HIV-1 VL, using crude values, was expressed in RNA copies/mL and measured from Screening to Week 28 for the HIV Group, Weeks 30, 38 and 48 for the 3D\_HIV Group and 2D\_HIV Group and from Screening to Week 48 for the Control Group.
Outcome measures
| Measure |
3D_HIV Group
n=125 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=53 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=58 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=60 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Levels of HIV-1 Viral Load (VL)
HIV-1 VL, Screening
|
13797 RNA Copies/mL
Interval 6823.0 to 28493.0
|
—
|
—
|
12882.5 RNA Copies/mL
Interval 6441.5 to 27468.5
|
|
Levels of HIV-1 Viral Load (VL)
HIV-1 VL, Week 38
|
—
|
12248 RNA Copies/mL
Interval 6977.0 to 23435.0
|
14739 RNA Copies/mL
Interval 8367.0 to 28182.0
|
12264.5 RNA Copies/mL
Interval 5068.0 to 27001.0
|
|
Levels of HIV-1 Viral Load (VL)
HIV-1 VL, Pre-vaccination
|
12982 RNA Copies/mL
Interval 5800.0 to 29086.0
|
—
|
—
|
12688.5 RNA Copies/mL
Interval 6882.0 to 26514.0
|
|
Levels of HIV-1 Viral Load (VL)
HIV-1 VL, Week 1
|
14939 RNA Copies/mL
Interval 5486.0 to 24432.0
|
—
|
—
|
11936 RNA Copies/mL
Interval 6142.0 to 21405.5
|
|
Levels of HIV-1 Viral Load (VL)
HIV-1 VL, Week 4
|
14242.5 RNA Copies/mL
Interval 6151.0 to 32192.5
|
—
|
—
|
11627.5 RNA Copies/mL
Interval 7010.0 to 25070.0
|
|
Levels of HIV-1 Viral Load (VL)
HIV-1 VL, Week 6
|
17019 RNA Copies/mL
Interval 6676.0 to 32848.0
|
—
|
—
|
15117.5 RNA Copies/mL
Interval 6488.5 to 35630.0
|
|
Levels of HIV-1 Viral Load (VL)
HIV-1 VL, Week 16
|
15045 RNA Copies/mL
Interval 6040.0 to 28436.0
|
—
|
—
|
14605 RNA Copies/mL
Interval 5698.5 to 33234.0
|
|
Levels of HIV-1 Viral Load (VL)
HIV-1 VL, Week 28
|
12552.5 RNA Copies/mL
Interval 6970.5 to 32604.5
|
—
|
—
|
13208 RNA Copies/mL
Interval 5910.0 to 28274.0
|
|
Levels of HIV-1 Viral Load (VL)
HIV-1 VL, Week 30
|
—
|
14703 RNA Copies/mL
Interval 7365.0 to 25970.0
|
13902 RNA Copies/mL
Interval 6977.0 to 29316.0
|
12855.5 RNA Copies/mL
Interval 5996.0 to 32574.0
|
|
Levels of HIV-1 Viral Load (VL)
HIV-1 VL, Week 48
|
—
|
11004.5 RNA Copies/mL
Interval 5910.0 to 25624.0
|
18415 RNA Copies/mL
Interval 6741.0 to 38871.0
|
15266.5 RNA Copies/mL
Interval 6000.0 to 39189.0
|
SECONDARY outcome
Timeframe: At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48Population: The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.
HIV-1 VL, using log10 transformed values, was expressed in log10-RNA copies/mL and measured from Screening to Week 28 for the HIV Group, Weeks 30, 38 and 48 for the 3D\_HIV Group and 2D\_HIV Group and from Screening to Week 48 for the Control Group.
Outcome measures
| Measure |
3D_HIV Group
n=125 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=53 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=58 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=60 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Levels of HIV-1 VL
HIV-1 VL, Week 1
|
4.174 log10 (RNA Copies/mL)
Interval 3.739 to 4.388
|
—
|
—
|
4.077 log10 (RNA Copies/mL)
Interval 3.788 to 4.331
|
|
Levels of HIV-1 VL
HIV-1 VL, Week 30
|
—
|
4.167 log10 (RNA Copies/mL)
Interval 3.867 to 4.414
|
4.143 log10 (RNA Copies/mL)
Interval 3.844 to 4.467
|
4.108 log10 (RNA Copies/mL)
Interval 3.778 to 4.513
|
|
Levels of HIV-1 VL
HIV-1 VL, Week 38
|
—
|
4.088 log10 (RNA Copies/mL)
Interval 3.844 to 4.37
|
4.168 log10 (RNA Copies/mL)
Interval 3.923 to 4.45
|
4.089 log10 (RNA Copies/mL)
Interval 3.705 to 4.429
|
|
Levels of HIV-1 VL
HIV-1 VL, Screening
|
4.14 log10 (RNA Copies/mL)
Interval 3.834 to 4.455
|
—
|
—
|
4.11 log10 (RNA Copies/mL)
Interval 3.809 to 4.438
|
|
Levels of HIV-1 VL
HIV-1 VL, Pre-vaccination
|
4.113 log10 (RNA Copies/mL)
Interval 3.763 to 4.464
|
—
|
—
|
4.103 log10 (RNA Copies/mL)
Interval 3.838 to 4.423
|
|
Levels of HIV-1 VL
HIV-1 VL, Week 4
|
4.153 log10 (RNA Copies/mL)
Interval 3.789 to 4.508
|
—
|
—
|
4.065 log10 (RNA Copies/mL)
Interval 3.846 to 4.399
|
|
Levels of HIV-1 VL
HIV-1 VL, Week 6
|
4.231 log10 (RNA Copies/mL)
Interval 3.825 to 4.517
|
—
|
—
|
4.179 log10 (RNA Copies/mL)
Interval 3.811 to 4.551
|
|
Levels of HIV-1 VL
HIV-1 VL, Week 16
|
4.177 log10 (RNA Copies/mL)
Interval 3.781 to 4.454
|
—
|
—
|
4.163 log10 (RNA Copies/mL)
Interval 3.755 to 4.52
|
|
Levels of HIV-1 VL
HIV-1 VL, Week 28
|
4.099 log10 (RNA Copies/mL)
Interval 3.843 to 4.513
|
—
|
—
|
4.12 log10 (RNA Copies/mL)
Interval 3.772 to 4.451
|
|
Levels of HIV-1 VL
HIV-1 VL, Week 48
|
—
|
4.04 log10 (RNA Copies/mL)
Interval 3.772 to 4.409
|
4.265 log10 (RNA Copies/mL)
Interval 3.829 to 4.59
|
4.184 log10 (RNA Copies/mL)
Interval 3.778 to 4.593
|
SECONDARY outcome
Timeframe: At Week 48Population: The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.
The proportion of subjects with \>1 decrease of HIV-1 VL, was determined using log10-transformed values.
Outcome measures
| Measure |
3D_HIV Group
n=46 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=55 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=50 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Percentage of Subjects With Plasmatic HIV-1 Viral Load Decrease Higher Than (>) 1
|
0.00 Percentage of participants
|
0.00 Percentage of participants
|
0.00 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48Population: The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.
Result determination, using crude values, was done from Screening to Week 28 for the HIV Group, Weeks 30, 38 and 48 for the 3D\_HIV Group and 2D\_HIV Group and from Screening (SCR) to Week (W) 48 for the Control Group.
Outcome measures
| Measure |
3D_HIV Group
n=125 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=53 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=58 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=60 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Cluster of Differentiation 4 (CD4) Absolute Cell Count
CD4, Week 48
|
—
|
636.957 CD4 cells/cubic millimeter
Standard Deviation 175.72
|
650.418 CD4 cells/cubic millimeter
Standard Deviation 206.12
|
601.9 CD4 cells/cubic millimeter
Standard Deviation 186.81
|
|
Cluster of Differentiation 4 (CD4) Absolute Cell Count
CD4, Screening
|
677.072 CD4 cells/cubic millimeter
Standard Deviation 164.31
|
—
|
—
|
688.2 CD4 cells/cubic millimeter
Standard Deviation 141.74
|
|
Cluster of Differentiation 4 (CD4) Absolute Cell Count
CD4, Pre-vaccination
|
687.566 CD4 cells/cubic millimeter
Standard Deviation 184.41
|
—
|
—
|
712.407 CD4 cells/cubic millimeter
Standard Deviation 251.98
|
|
Cluster of Differentiation 4 (CD4) Absolute Cell Count
CD4, Week 1
|
723.91 CD4 cells/cubic millimeter
Standard Deviation 228.73
|
—
|
—
|
711.905 CD4 cells/cubic millimeter
Standard Deviation 226.84
|
|
Cluster of Differentiation 4 (CD4) Absolute Cell Count
CD4, Week 4
|
676.992 CD4 cells/cubic millimeter
Standard Deviation 182.96
|
—
|
—
|
688.717 CD4 cells/cubic millimeter
Standard Deviation 186.24
|
|
Cluster of Differentiation 4 (CD4) Absolute Cell Count
CD4, Week 6
|
691.174 CD4 cells/cubic millimeter
Standard Deviation 195.35
|
—
|
—
|
687.883 CD4 cells/cubic millimeter
Standard Deviation 202.79
|
|
Cluster of Differentiation 4 (CD4) Absolute Cell Count
CD4, Week 16
|
674.215 CD4 cells/cubic millimeter
Standard Deviation 213.69
|
—
|
—
|
674.75 CD4 cells/cubic millimeter
Standard Deviation 186.63
|
|
Cluster of Differentiation 4 (CD4) Absolute Cell Count
CD4, Week 28
|
630.836 CD4 cells/cubic millimeter
Standard Deviation 172.16
|
—
|
—
|
667.981 CD4 cells/cubic millimeter
Standard Deviation 183.53
|
|
Cluster of Differentiation 4 (CD4) Absolute Cell Count
CD4, Week 30
|
—
|
649.377 CD4 cells/cubic millimeter
Standard Deviation 193.66
|
654.448 CD4 cells/cubic millimeter
Standard Deviation 202.71
|
662.481 CD4 cells/cubic millimeter
Standard Deviation 181.76
|
|
Cluster of Differentiation 4 (CD4) Absolute Cell Count
CD4, Week 38
|
—
|
660.306 CD4 cells/cubic millimeter
Standard Deviation 202.04
|
635.561 CD4 cells/cubic millimeter
Standard Deviation 174.15
|
653.154 CD4 cells/cubic millimeter
Standard Deviation 176.71
|
SECONDARY outcome
Timeframe: At Weeks 1, 4, 6, 16, 28, 30, 38 and 48Population: The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.
Baseline for CD4 cell count analysis was defined as the mean of values measured in blood taken at Screening and at pre vaccination (PRE). Result determination, using crude values, was done from week 1 to 28 for the HIV Group, weeks 30, 38 and 48 for the 3D\_HIV Group and 2D\_HIV Group and from week 1 to week 48 for the Control Group.
Outcome measures
| Measure |
3D_HIV Group
n=124 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=53 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=58 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=60 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Mean Change in CD4 Cell Count From Baseline
CD4, Week 16
|
-0.52 CD4 cells/cubic millimeter
Standard Deviation 20.82
|
—
|
—
|
-2.568 CD4 cells/cubic millimeter
Standard Deviation 19.68
|
|
Mean Change in CD4 Cell Count From Baseline
CD4, Week 30
|
—
|
-5.641 CD4 cells/cubic millimeter
Standard Deviation 19.17
|
-2.417 CD4 cells/cubic millimeter
Standard Deviation 20.31
|
-4.403 CD4 cells/cubic millimeter
Standard Deviation 19.88
|
|
Mean Change in CD4 Cell Count From Baseline
CD4, Week 38
|
—
|
-4.224 CD4 cells/cubic millimeter
Standard Deviation 22.97
|
-4.626 CD4 cells/cubic millimeter
Standard Deviation 20.01
|
-5.936 CD4 cells/cubic millimeter
Standard Deviation 16.85
|
|
Mean Change in CD4 Cell Count From Baseline
CD4, Week 48
|
—
|
-9.859 CD4 cells/cubic millimeter
Standard Deviation 18.66
|
-3.915 CD4 cells/cubic millimeter
Standard Deviation 19.56
|
-13.82 CD4 cells/cubic millimeter
Standard Deviation 18.67
|
|
Mean Change in CD4 Cell Count From Baseline
CD4, Week 1
|
4.633 CD4 cells/cubic millimeter
Standard Deviation 16.53
|
—
|
—
|
0.589 CD4 cells/cubic millimeter
Standard Deviation 17.98
|
|
Mean Change in CD4 Cell Count From Baseline
CD4, Week 4
|
-0.201 CD4 cells/cubic millimeter
Standard Deviation 17.97
|
—
|
—
|
-1.212 CD4 cells/cubic millimeter
Standard Deviation 18.58
|
|
Mean Change in CD4 Cell Count From Baseline
CD4, Week 6
|
2.066 CD4 cells/cubic millimeter
Standard Deviation 19.97
|
—
|
—
|
-1.713 CD4 cells/cubic millimeter
Standard Deviation 19.68
|
|
Mean Change in CD4 Cell Count From Baseline
CD4, Week 28
|
-5.782 CD4 cells/cubic millimeter
Standard Deviation 19.13
|
—
|
—
|
-4.421 CD4 cells/cubic millimeter
Standard Deviation 16.06
|
SECONDARY outcome
Timeframe: During the entire study period (up to Week 48)Population: The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.
Only actual ART initiations were reported under the category "ART initiation". HIV-related clinical events were defined as: clinical disease progression, or confirmed VL \> 100.000 copies/mL, or confirmed CD4 cell count \< 350 cells/ cubic millimeter (mm3).
Outcome measures
| Measure |
3D_HIV Group
n=61 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=64 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=60 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Percentage of Subjects With ART (Anti-Retroviral Therapy) Initiation and HIV-related Clinical Events
ART initiation
|
8.2 Percentage of participants
|
6.3 Percentage of participants
|
8.3 Percentage of participants
|
—
|
|
Percentage of Subjects With ART (Anti-Retroviral Therapy) Initiation and HIV-related Clinical Events
HIV related clinical events
|
9.8 Percentage of participants
|
10.9 Percentage of participants
|
10.0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.
Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD40L+CD4+ T-cells and F4co-Computed \[frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)\] CD40L+CD4+ T-cells expressing at least interleukin- 2 (IL-2), as assessed by Intracellular Cytokine Staining (ICS).
Outcome measures
| Measure |
3D_HIV Group
n=38 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=40 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=75 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=35 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
p24, Week 48
|
197.0 CD40L+CD+ T-cells/million cells
Interval 122.0 to 355.0
|
129.0 CD40L+CD+ T-cells/million cells
Interval 65.0 to 301.0
|
—
|
119.5 CD40L+CD+ T-cells/million cells
Interval 67.5 to 229.0
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
p17, Week 28
|
132.0 CD40L+CD+ T-cells/million cells
Interval 62.0 to 243.0
|
109.5 CD40L+CD+ T-cells/million cells
Interval 55.5 to 189.5
|
118.0 CD40L+CD+ T-cells/million cells
Interval 60.0 to 202.0
|
68.0 CD40L+CD+ T-cells/million cells
Interval 30.0 to 158.0
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
RT, Pre-vaccination
|
158.0 CD40L+CD+ T-cells/million cells
Interval 73.0 to 239.0
|
126.0 CD40L+CD+ T-cells/million cells
Interval 85.0 to 185.0
|
132.0 CD40L+CD+ T-cells/million cells
Interval 81.0 to 210.0
|
116.0 CD40L+CD+ T-cells/million cells
Interval 29.0 to 223.0
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
RT, Week 6
|
1160.0 CD40L+CD+ T-cells/million cells
Interval 560.0 to 2161.5
|
837.0 CD40L+CD+ T-cells/million cells
Interval 364.5 to 1689.5
|
1070.5 CD40L+CD+ T-cells/million cells
Interval 461.5 to 1890.0
|
174.0 CD40L+CD+ T-cells/million cells
Interval 82.0 to 322.0
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
RT, Week 28
|
297.0 CD40L+CD+ T-cells/million cells
Interval 205.0 to 501.0
|
279.5 CD40L+CD+ T-cells/million cells
Interval 130.5 to 540.5
|
297.0 CD40L+CD+ T-cells/million cells
Interval 185.0 to 534.0
|
101.0 CD40L+CD+ T-cells/million cells
Interval 58.0 to 153.0
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
RT, Week 30
|
1155.0 CD40L+CD+ T-cells/million cells
Interval 682.0 to 2958.0
|
245.5 CD40L+CD+ T-cells/million cells
Interval 114.0 to 465.0
|
—
|
180.5 CD40L+CD+ T-cells/million cells
Interval 92.0 to 270.0
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
RT, Week 48
|
365.5 CD40L+CD+ T-cells/million cells
Interval 122.0 to 781.5
|
170.0 CD40L+CD+ T-cells/million cells
Interval 91.0 to 469.0
|
—
|
120.0 CD40L+CD+ T-cells/million cells
Interval 37.0 to 187.0
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
F4co-Computed, Pre-vaccination
|
430.0 CD40L+CD+ T-cells/million cells
Interval 288.0 to 714.0
|
469.0 CD40L+CD+ T-cells/million cells
Interval 285.0 to 679.0
|
435.0 CD40L+CD+ T-cells/million cells
Interval 285.0 to 690.0
|
364.0 CD40L+CD+ T-cells/million cells
Interval 239.0 to 680.0
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
F4co-Computed, Week 6
|
2559.5 CD40L+CD+ T-cells/million cells
Interval 1123.5 to 3879.5
|
1686.0 CD40L+CD+ T-cells/million cells
Interval 823.5 to 2629.0
|
2014.5 CD40L+CD+ T-cells/million cells
Interval 896.5 to 3456.5
|
557.5 CD40L+CD+ T-cells/million cells
Interval 298.5 to 789.5
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
F4co-Computed, Week 28
|
818.0 CD40L+CD+ T-cells/million cells
Interval 527.0 to 1333.0
|
677.5 CD40L+CD+ T-cells/million cells
Interval 331.5 to 1179.5
|
751.0 CD40L+CD+ T-cells/million cells
Interval 454.0 to 1329.0
|
345.0 CD40L+CD+ T-cells/million cells
Interval 188.0 to 607.0
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
F4co-Computed, Week 30
|
2495.5 CD40L+CD+ T-cells/million cells
Interval 1478.0 to 5418.0
|
681.0 CD40L+CD+ T-cells/million cells
Interval 328.0 to 1387.0
|
—
|
521.0 CD40L+CD+ T-cells/million cells
Interval 278.0 to 705.0
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
F4co-Computed, Week 48
|
937.0 CD40L+CD+ T-cells/million cells
Interval 499.0 to 2490.0
|
534.5 CD40L+CD+ T-cells/million cells
Interval 280.0 to 1243.5
|
—
|
365.0 CD40L+CD+ T-cells/million cells
Interval 198.0 to 591.0
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
Nef, Pre-vaccination
|
43.0 CD40L+CD+ T-cells/million cells
Interval 28.0 to 81.0
|
42.0 CD40L+CD+ T-cells/million cells
Interval 20.0 to 86.0
|
43.0 CD40L+CD+ T-cells/million cells
Interval 21.0 to 86.0
|
46.0 CD40L+CD+ T-cells/million cells
Interval 4.0 to 93.0
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
Nef, Week 6
|
521.0 CD40L+CD+ T-cells/million cells
Interval 153.5 to 832.0
|
219.0 CD40L+CD+ T-cells/million cells
Interval 126.0 to 524.0
|
259.0 CD40L+CD+ T-cells/million cells
Interval 142.0 to 704.5
|
45.5 CD40L+CD+ T-cells/million cells
Interval 11.0 to 80.0
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
Nef, Week 28
|
157.0 CD40L+CD+ T-cells/million cells
Interval 60.0 to 361.0
|
97.5 CD40L+CD+ T-cells/million cells
Interval 50.0 to 217.5
|
122.0 CD40L+CD+ T-cells/million cells
Interval 54.0 to 243.0
|
29.0 CD40L+CD+ T-cells/million cells
Interval 17.0 to 66.0
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
Nef, Week 30
|
672.0 CD40L+CD+ T-cells/million cells
Interval 320.0 to 1340.0
|
104.0 CD40L+CD+ T-cells/million cells
Interval 40.0 to 228.0
|
—
|
42.0 CD40L+CD+ T-cells/million cells
Interval 5.0 to 90.0
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
Nef, Week 48
|
166.0 CD40L+CD+ T-cells/million cells
Interval 76.0 to 620.5
|
96.0 CD40L+CD+ T-cells/million cells
Interval 29.0 to 197.0
|
—
|
26.0 CD40L+CD+ T-cells/million cells
Interval 4.0 to 86.0
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
p17, Pre-vaccination
|
111.5 CD40L+CD+ T-cells/million cells
Interval 44.0 to 152.0
|
92.0 CD40L+CD+ T-cells/million cells
Interval 32.0 to 197.0
|
97.0 CD40L+CD+ T-cells/million cells
Interval 38.0 to 168.0
|
105.0 CD40L+CD+ T-cells/million cells
Interval 59.0 to 169.0
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
p17, Week 6
|
226.0 CD40L+CD+ T-cells/million cells
Interval 101.0 to 576.0
|
226.0 CD40L+CD+ T-cells/million cells
Interval 115.0 to 300.0
|
226.0 CD40L+CD+ T-cells/million cells
Interval 114.0 to 345.0
|
130.5 CD40L+CD+ T-cells/million cells
Interval 70.0 to 174.5
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
p17, Week 30
|
173.5 CD40L+CD+ T-cells/million cells
Interval 115.0 to 374.0
|
115.0 CD40L+CD+ T-cells/million cells
Interval 56.0 to 222.0
|
—
|
106.5 CD40L+CD+ T-cells/million cells
Interval 46.0 to 168.0
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
p17, Week 48
|
100.0 CD40L+CD+ T-cells/million cells
Interval 71.0 to 222.0
|
120.0 CD40L+CD+ T-cells/million cells
Interval 35.0 to 236.0
|
—
|
78.5 CD40L+CD+ T-cells/million cells
Interval 30.0 to 140.5
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
p24, Pre-vaccination
|
140.5 CD40L+CD+ T-cells/million cells
Interval 74.0 to 266.0
|
121.0 CD40L+CD+ T-cells/million cells
Interval 59.0 to 212.0
|
127.0 CD40L+CD+ T-cells/million cells
Interval 60.0 to 213.0
|
129.0 CD40L+CD+ T-cells/million cells
Interval 80.0 to 250.0
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
p24, Week 6
|
271.0 CD40L+CD+ T-cells/million cells
Interval 124.0 to 450.0
|
222.0 CD40L+CD+ T-cells/million cells
Interval 128.5 to 411.0
|
253.0 CD40L+CD+ T-cells/million cells
Interval 128.0 to 449.0
|
127.0 CD40L+CD+ T-cells/million cells
Interval 90.5 to 306.0
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
p24, Week 28
|
184.0 CD40L+CD+ T-cells/million cells
Interval 71.0 to 374.0
|
159.0 CD40L+CD+ T-cells/million cells
Interval 55.5 to 284.5
|
178.0 CD40L+CD+ T-cells/million cells
Interval 60.0 to 291.0
|
120.0 CD40L+CD+ T-cells/million cells
Interval 34.0 to 238.0
|
|
Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
p24, Week 30
|
256.0 CD40L+CD+ T-cells/million cells
Interval 119.0 to 542.0
|
183.5 CD40L+CD+ T-cells/million cells
Interval 94.5 to 286.5
|
—
|
155.0 CD40L+CD+ T-cells/million cells
Interval 45.0 to 205.0
|
SECONDARY outcome
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.
Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD40L+CD4+ T-cells and F4co-Computed \[frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)\] CD40L+CD4+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).
Outcome measures
| Measure |
3D_HIV Group
n=38 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=40 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=75 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=35 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
F4co-Computed, Week 28
|
1587.0 CD40L+CD4+ T-cells/million T-cells
Interval 977.0 to 2345.0
|
1253.0 CD40L+CD4+ T-cells/million T-cells
Interval 810.0 to 2402.5
|
1433.0 CD40L+CD4+ T-cells/million T-cells
Interval 876.0 to 2394.0
|
786.0 CD40L+CD4+ T-cells/million T-cells
Interval 612.0 to 1928.0
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
Nef, Pre-vaccination
|
87.0 CD40L+CD4+ T-cells/million T-cells
Interval 55.0 to 219.0
|
87.0 CD40L+CD4+ T-cells/million T-cells
Interval 57.0 to 176.0
|
87.0 CD40L+CD4+ T-cells/million T-cells
Interval 55.0 to 219.0
|
108.0 CD40L+CD4+ T-cells/million T-cells
Interval 52.0 to 172.0
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
p24, Pre-vaccination
|
459.0 CD40L+CD4+ T-cells/million T-cells
Interval 286.0 to 669.0
|
339.0 CD40L+CD4+ T-cells/million T-cells
Interval 242.0 to 532.0
|
379.0 CD40L+CD4+ T-cells/million T-cells
Interval 250.0 to 591.0
|
379.0 CD40L+CD4+ T-cells/million T-cells
Interval 191.0 to 718.0
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
F4co-Computed, Pre-vaccination
|
1135.5 CD40L+CD4+ T-cells/million T-cells
Interval 745.0 to 1666.0
|
997.0 CD40L+CD4+ T-cells/million T-cells
Interval 625.0 to 1631.0
|
1022.0 CD40L+CD4+ T-cells/million T-cells
Interval 686.0 to 1665.0
|
953.0 CD40L+CD4+ T-cells/million T-cells
Interval 550.0 to 1942.0
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
F4co-Computed, Week 6
|
3675.0 CD40L+CD4+ T-cells/million T-cells
Interval 2101.0 to 5981.0
|
2506.5 CD40L+CD4+ T-cells/million T-cells
Interval 1502.0 to 4102.5
|
2864.0 CD40L+CD4+ T-cells/million T-cells
Interval 1590.5 to 5248.0
|
1243.0 CD40L+CD4+ T-cells/million T-cells
Interval 689.5 to 1815.0
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
F4co-Computed, Week 30
|
4039.0 CD40L+CD4+ T-cells/million T-cells
Interval 2055.0 to 7632.0
|
1108.0 CD40L+CD4+ T-cells/million T-cells
Interval 744.0 to 2718.0
|
—
|
1157.0 CD40L+CD4+ T-cells/million T-cells
Interval 769.0 to 1792.0
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
F4co-Computed, Week 48
|
1947.0 CD40L+CD4+ T-cells/million T-cells
Interval 847.0 to 2914.0
|
1039.5 CD40L+CD4+ T-cells/million T-cells
Interval 663.5 to 2032.5
|
—
|
1251.0 CD40L+CD4+ T-cells/million T-cells
Interval 529.0 to 1637.0
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
Nef, Week 6
|
599.0 CD40L+CD4+ T-cells/million T-cells
Interval 323.0 to 1289.5
|
392.0 CD40L+CD4+ T-cells/million T-cells
Interval 232.0 to 692.5
|
434.0 CD40L+CD4+ T-cells/million T-cells
Interval 244.0 to 821.0
|
115.0 CD40L+CD4+ T-cells/million T-cells
Interval 39.5 to 188.5
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
Nef, Week 28
|
227.0 CD40L+CD4+ T-cells/million T-cells
Interval 134.0 to 480.0
|
179.5 CD40L+CD4+ T-cells/million T-cells
Interval 93.5 to 308.5
|
208.0 CD40L+CD4+ T-cells/million T-cells
Interval 96.0 to 382.0
|
73.0 CD40L+CD4+ T-cells/million T-cells
Interval 33.0 to 149.0
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
Nef, Week 30
|
763.0 CD40L+CD4+ T-cells/million T-cells
Interval 562.0 to 1705.0
|
204.0 CD40L+CD4+ T-cells/million T-cells
Interval 70.0 to 344.0
|
—
|
113.0 CD40L+CD4+ T-cells/million T-cells
Interval 42.0 to 230.0
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
Nef, Week 48
|
258.5 CD40L+CD4+ T-cells/million T-cells
Interval 136.5 to 717.5
|
146.0 CD40L+CD4+ T-cells/million T-cells
Interval 78.0 to 394.0
|
—
|
87.0 CD40L+CD4+ T-cells/million T-cells
Interval 45.0 to 213.5
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
p17, Pre-vaccination
|
249.5 CD40L+CD4+ T-cells/million T-cells
Interval 146.0 to 397.0
|
164.0 CD40L+CD4+ T-cells/million T-cells
Interval 106.0 to 406.0
|
228.0 CD40L+CD4+ T-cells/million T-cells
Interval 127.0 to 406.0
|
263.0 CD40L+CD4+ T-cells/million T-cells
Interval 109.0 to 468.0
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
p17, Week 6
|
517.0 CD40L+CD4+ T-cells/million T-cells
Interval 244.0 to 835.0
|
379.5 CD40L+CD4+ T-cells/million T-cells
Interval 187.0 to 600.5
|
393.0 CD40L+CD4+ T-cells/million T-cells
Interval 221.0 to 791.0
|
267.0 CD40L+CD4+ T-cells/million T-cells
Interval 199.5 to 475.0
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
p17, Week 28
|
284.0 CD40L+CD4+ T-cells/million T-cells
Interval 171.0 to 415.0
|
243.5 CD40L+CD4+ T-cells/million T-cells
Interval 101.0 to 493.0
|
281.0 CD40L+CD4+ T-cells/million T-cells
Interval 138.0 to 426.0
|
228.0 CD40L+CD4+ T-cells/million T-cells
Interval 116.0 to 406.0
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
p17, Week 30
|
413.0 CD40L+CD4+ T-cells/million T-cells
Interval 252.0 to 654.0
|
242.0 CD40L+CD4+ T-cells/million T-cells
Interval 158.5 to 540.0
|
—
|
303.0 CD40L+CD4+ T-cells/million T-cells
Interval 142.0 to 444.0
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
p17, Week 48
|
261.0 CD40L+CD4+ T-cells/million T-cells
Interval 124.0 to 455.0
|
244.0 CD40L+CD4+ T-cells/million T-cells
Interval 97.0 to 484.0
|
—
|
245.5 CD40L+CD4+ T-cells/million T-cells
Interval 146.0 to 426.0
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
p24, Week 6
|
596.0 CD40L+CD4+ T-cells/million T-cells
Interval 333.0 to 985.0
|
452.0 CD40L+CD4+ T-cells/million T-cells
Interval 330.0 to 1016.5
|
486.0 CD40L+CD4+ T-cells/million T-cells
Interval 333.0 to 989.0
|
505.5 CD40L+CD4+ T-cells/million T-cells
Interval 235.0 to 766.5
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
p24, Week 28
|
439.0 CD40L+CD4+ T-cells/million T-cells
Interval 263.0 to 806.0
|
381.5 CD40L+CD4+ T-cells/million T-cells
Interval 173.0 to 735.0
|
408.0 CD40L+CD4+ T-cells/million T-cells
Interval 205.0 to 748.0
|
277.0 CD40L+CD4+ T-cells/million T-cells
Interval 201.0 to 918.0
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
p24, Week 30
|
596.0 CD40L+CD4+ T-cells/million T-cells
Interval 413.0 to 941.0
|
424.5 CD40L+CD4+ T-cells/million T-cells
Interval 233.5 to 915.5
|
—
|
401.5 CD40L+CD4+ T-cells/million T-cells
Interval 255.0 to 688.0
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
p24, Week 48
|
486.0 CD40L+CD4+ T-cells/million T-cells
Interval 303.0 to 892.0
|
371.0 CD40L+CD4+ T-cells/million T-cells
Interval 220.0 to 638.0
|
—
|
404.5 CD40L+CD4+ T-cells/million T-cells
Interval 211.0 to 662.5
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
RT, Pre-vaccination
|
268.5 CD40L+CD4+ T-cells/million T-cells
Interval 158.0 to 412.0
|
238.0 CD40L+CD4+ T-cells/million T-cells
Interval 140.0 to 335.0
|
247.0 CD40L+CD4+ T-cells/million T-cells
Interval 158.0 to 387.0
|
204.0 CD40L+CD4+ T-cells/million T-cells
Interval 110.0 to 436.0
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
RT, Week 6
|
1588.5 CD40L+CD4+ T-cells/million T-cells
Interval 839.0 to 2806.0
|
1074.0 CD40L+CD4+ T-cells/million T-cells
Interval 622.5 to 2123.0
|
1346.0 CD40L+CD4+ T-cells/million T-cells
Interval 739.0 to 2427.5
|
296.0 CD40L+CD4+ T-cells/million T-cells
Interval 137.0 to 428.0
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
RT, Week 28
|
378.0 CD40L+CD4+ T-cells/million T-cells
Interval 299.0 to 709.0
|
379.0 CD40L+CD4+ T-cells/million T-cells
Interval 204.5 to 687.0
|
378.0 CD40L+CD4+ T-cells/million T-cells
Interval 232.0 to 709.0
|
204.0 CD40L+CD4+ T-cells/million T-cells
Interval 136.0 to 328.0
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
RT, Week 30
|
1629.0 CD40L+CD4+ T-cells/million T-cells
Interval 784.0 to 3596.0
|
327.5 CD40L+CD4+ T-cells/million T-cells
Interval 150.0 to 753.5
|
—
|
256.0 CD40L+CD4+ T-cells/million T-cells
Interval 153.0 to 471.0
|
|
Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
RT, Week 48
|
451.5 CD40L+CD4+ T-cells/million T-cells
Interval 228.0 to 911.5
|
299.0 CD40L+CD4+ T-cells/million T-cells
Interval 155.0 to 615.0
|
—
|
222.0 CD40L+CD4+ T-cells/million T-cells
Interval 127.0 to 436.0
|
SECONDARY outcome
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.
Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD40L-CD4+ T-cells and F4co-Computed \[frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)\] CD40L-CD4+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).
Outcome measures
| Measure |
3D_HIV Group
n=38 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=40 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=75 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=35 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
F4co-Computed, Week 6
|
1189.0 CD40L-CD4+ T-cells/million T-cells
Interval 707.5 to 2215.0
|
1086.5 CD40L-CD4+ T-cells/million T-cells
Interval 839.0 to 2067.5
|
1090.0 CD40L-CD4+ T-cells/million T-cells
Interval 815.0 to 2102.0
|
1227.0 CD40L-CD4+ T-cells/million T-cells
Interval 803.0 to 2323.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
F4co-Computed, Week 28
|
892.0 CD40L-CD4+ T-cells/million T-cells
Interval 605.0 to 1528.0
|
1115.5 CD40L-CD4+ T-cells/million T-cells
Interval 645.5 to 1626.5
|
986.0 CD40L-CD4+ T-cells/million T-cells
Interval 644.0 to 1577.0
|
1118.0 CD40L-CD4+ T-cells/million T-cells
Interval 659.0 to 2782.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
F4co-Computed, Week 30
|
1376.0 CD40L-CD4+ T-cells/million T-cells
Interval 1033.0 to 2230.0
|
1198.0 CD40L-CD4+ T-cells/million T-cells
Interval 650.0 to 2233.0
|
—
|
1416.0 CD40L-CD4+ T-cells/million T-cells
Interval 749.0 to 2035.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
F4co-Computed, Week 48
|
1193.0 CD40L-CD4+ T-cells/million T-cells
Interval 655.0 to 1592.0
|
1006.5 CD40L-CD4+ T-cells/million T-cells
Interval 628.0 to 1781.5
|
—
|
1419.0 CD40L-CD4+ T-cells/million T-cells
Interval 717.0 to 2659.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
Nef, Pre-vaccination
|
148.0 CD40L-CD4+ T-cells/million T-cells
Interval 89.0 to 357.0
|
239.0 CD40L-CD4+ T-cells/million T-cells
Interval 115.0 to 400.0
|
195.0 CD40L-CD4+ T-cells/million T-cells
Interval 100.0 to 400.0
|
263.0 CD40L-CD4+ T-cells/million T-cells
Interval 109.0 to 453.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
Nef, Week 6
|
302.0 CD40L-CD4+ T-cells/million T-cells
Interval 122.0 to 376.5
|
301.5 CD40L-CD4+ T-cells/million T-cells
Interval 151.0 to 882.5
|
301.5 CD40L-CD4+ T-cells/million T-cells
Interval 133.5 to 495.5
|
211.5 CD40L-CD4+ T-cells/million T-cells
Interval 78.0 to 342.5
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
Nef, Week 30
|
245.0 CD40L-CD4+ T-cells/million T-cells
Interval 191.0 to 467.0
|
273.0 CD40L-CD4+ T-cells/million T-cells
Interval 152.0 to 529.0
|
—
|
250.0 CD40L-CD4+ T-cells/million T-cells
Interval 103.0 to 495.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
Nef, Week 48
|
215.0 CD40L-CD4+ T-cells/million T-cells
Interval 111.0 to 393.5
|
174.0 CD40L-CD4+ T-cells/million T-cells
Interval 79.0 to 381.0
|
—
|
267.5 CD40L-CD4+ T-cells/million T-cells
Interval 100.5 to 576.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
RT, Week 28
|
210.0 CD40L-CD4+ T-cells/million T-cells
Interval 85.0 to 455.0
|
118.0 CD40L-CD4+ T-cells/million T-cells
Interval 64.0 to 316.0
|
148.0 CD40L-CD4+ T-cells/million T-cells
Interval 75.0 to 322.0
|
138.0 CD40L-CD4+ T-cells/million T-cells
Interval 88.0 to 340.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
RT, Week 30
|
369.0 CD40L-CD4+ T-cells/million T-cells
Interval 185.0 to 631.0
|
162.0 CD40L-CD4+ T-cells/million T-cells
Interval 96.5 to 384.0
|
—
|
162.0 CD40L-CD4+ T-cells/million T-cells
Interval 74.0 to 338.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
F4co-Computed, Pre-vaccination
|
874.0 CD40L-CD4+ T-cells/million T-cells
Interval 609.0 to 1535.0
|
973.0 CD40L-CD4+ T-cells/million T-cells
Interval 723.0 to 1480.0
|
945.0 CD40L-CD4+ T-cells/million T-cells
Interval 677.0 to 1518.0
|
1433.0 CD40L-CD4+ T-cells/million T-cells
Interval 766.0 to 2554.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
Nef, Week 28
|
169.0 CD40L-CD4+ T-cells/million T-cells
Interval 70.0 to 542.0
|
261.5 CD40L-CD4+ T-cells/million T-cells
Interval 109.0 to 409.0
|
241.0 CD40L-CD4+ T-cells/million T-cells
Interval 86.0 to 430.0
|
197.0 CD40L-CD4+ T-cells/million T-cells
Interval 102.0 to 322.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
p17, Pre-vaccination
|
204.5 CD40L-CD4+ T-cells/million T-cells
Interval 110.0 to 316.0
|
184.0 CD40L-CD4+ T-cells/million T-cells
Interval 108.0 to 337.0
|
188.0 CD40L-CD4+ T-cells/million T-cells
Interval 108.0 to 334.0
|
230.0 CD40L-CD4+ T-cells/million T-cells
Interval 101.0 to 552.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
p17, Week 6
|
229.0 CD40L-CD4+ T-cells/million T-cells
Interval 103.0 to 382.0
|
231.5 CD40L-CD4+ T-cells/million T-cells
Interval 100.0 to 333.5
|
230.0 CD40L-CD4+ T-cells/million T-cells
Interval 103.0 to 365.0
|
293.5 CD40L-CD4+ T-cells/million T-cells
Interval 126.5 to 444.5
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
p17, Week 28
|
164.0 CD40L-CD4+ T-cells/million T-cells
Interval 103.0 to 334.0
|
238.0 CD40L-CD4+ T-cells/million T-cells
Interval 112.5 to 395.5
|
210.0 CD40L-CD4+ T-cells/million T-cells
Interval 106.0 to 361.0
|
203.0 CD40L-CD4+ T-cells/million T-cells
Interval 101.0 to 405.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
p17, Week 30
|
279.5 CD40L-CD4+ T-cells/million T-cells
Interval 188.0 to 378.0
|
166.0 CD40L-CD4+ T-cells/million T-cells
Interval 101.0 to 336.5
|
—
|
229.0 CD40L-CD4+ T-cells/million T-cells
Interval 71.0 to 513.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
p17, Week 48
|
210.0 CD40L-CD4+ T-cells/million T-cells
Interval 82.0 to 292.0
|
177.0 CD40L-CD4+ T-cells/million T-cells
Interval 104.0 to 403.0
|
—
|
224.5 CD40L-CD4+ T-cells/million T-cells
Interval 108.0 to 461.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
p24, Pre-vaccination
|
297.5 CD40L-CD4+ T-cells/million T-cells
Interval 189.0 to 568.0
|
287.0 CD40L-CD4+ T-cells/million T-cells
Interval 169.0 to 593.0
|
294.0 CD40L-CD4+ T-cells/million T-cells
Interval 174.0 to 593.0
|
377.0 CD40L-CD4+ T-cells/million T-cells
Interval 200.0 to 819.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
p24, Week 6
|
287.0 CD40L-CD4+ T-cells/million T-cells
Interval 177.0 to 481.0
|
344.5 CD40L-CD4+ T-cells/million T-cells
Interval 173.5 to 594.0
|
288.0 CD40L-CD4+ T-cells/million T-cells
Interval 175.0 to 587.0
|
428.5 CD40L-CD4+ T-cells/million T-cells
Interval 272.5 to 900.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
p24, Week 28
|
296.0 CD40L-CD4+ T-cells/million T-cells
Interval 141.0 to 521.0
|
340.0 CD40L-CD4+ T-cells/million T-cells
Interval 108.5 to 512.0
|
313.0 CD40L-CD4+ T-cells/million T-cells
Interval 116.0 to 521.0
|
487.0 CD40L-CD4+ T-cells/million T-cells
Interval 236.0 to 836.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
p24, Week 30
|
389.0 CD40L-CD4+ T-cells/million T-cells
Interval 220.0 to 749.0
|
298.0 CD40L-CD4+ T-cells/million T-cells
Interval 163.0 to 674.0
|
—
|
492.5 CD40L-CD4+ T-cells/million T-cells
Interval 237.0 to 862.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
p24, Week 48
|
341.0 CD40L-CD4+ T-cells/million T-cells
Interval 150.0 to 580.0
|
369.0 CD40L-CD4+ T-cells/million T-cells
Interval 228.0 to 695.0
|
—
|
396.5 CD40L-CD4+ T-cells/million T-cells
Interval 218.5 to 1082.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
RT, Pre-vaccination
|
175.5 CD40L-CD4+ T-cells/million T-cells
Interval 101.0 to 292.0
|
194.0 CD40L-CD4+ T-cells/million T-cells
Interval 63.0 to 339.0
|
194.0 CD40L-CD4+ T-cells/million T-cells
Interval 73.0 to 310.0
|
235.0 CD40L-CD4+ T-cells/million T-cells
Interval 84.0 to 432.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
RT, Week 6
|
369.0 CD40L-CD4+ T-cells/million T-cells
Interval 159.0 to 666.5
|
258.5 CD40L-CD4+ T-cells/million T-cells
Interval 142.0 to 513.0
|
304.0 CD40L-CD4+ T-cells/million T-cells
Interval 148.5 to 637.5
|
144.0 CD40L-CD4+ T-cells/million T-cells
Interval 78.0 to 298.0
|
|
Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
RT, Week 48
|
270.5 CD40L-CD4+ T-cells/million T-cells
Interval 119.0 to 493.0
|
132.5 CD40L-CD4+ T-cells/million T-cells
Interval 77.0 to 428.0
|
—
|
158.0 CD40L-CD4+ T-cells/million T-cells
Interval 99.0 to 300.0
|
SECONDARY outcome
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.
Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD4+ T-cells and F4co-Computed \[frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)\] CD4+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).
Outcome measures
| Measure |
3D_HIV Group
n=38 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=40 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=75 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=35 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
F4co-Computed, Week 28
|
2885.0 CD4+ T-cells/million cells
Interval 1932.0 to 3632.0
|
2374.0 CD4+ T-cells/million cells
Interval 1710.0 to 3617.5
|
2459.0 CD4+ T-cells/million cells
Interval 1806.0 to 3632.0
|
2052.0 CD4+ T-cells/million cells
Interval 1413.0 to 5226.0
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
Nef, Pre-vaccination
|
284.5 CD4+ T-cells/million cells
Interval 175.0 to 524.0
|
390.0 CD4+ T-cells/million cells
Interval 186.0 to 706.0
|
337.0 CD4+ T-cells/million cells
Interval 175.0 to 594.0
|
386.0 CD4+ T-cells/million cells
Interval 218.0 to 545.0
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
Nef, Week 28
|
494.0 CD4+ T-cells/million cells
Interval 288.0 to 1002.0
|
444.0 CD4+ T-cells/million cells
Interval 308.0 to 786.0
|
455.0 CD4+ T-cells/million cells
Interval 288.0 to 942.0
|
283.0 CD4+ T-cells/million cells
Interval 162.0 to 434.0
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
p24, Week 28
|
784.0 CD4+ T-cells/million cells
Interval 459.0 to 1223.0
|
670.5 CD4+ T-cells/million cells
Interval 499.0 to 1158.5
|
726.0 CD4+ T-cells/million cells
Interval 461.0 to 1201.0
|
883.0 CD4+ T-cells/million cells
Interval 502.0 to 1885.0
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
F4co-Computed, Pre-vaccination
|
2360.5 CD4+ T-cells/million cells
Interval 1515.0 to 3354.0
|
1998.0 CD4+ T-cells/million cells
Interval 1549.0 to 3083.0
|
2068.0 CD4+ T-cells/million cells
Interval 1515.0 to 3354.0
|
2420.0 CD4+ T-cells/million cells
Interval 1334.0 to 3993.0
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
F4co-Computed, Week 6
|
5024.5 CD4+ T-cells/million cells
Interval 3128.0 to 7808.5
|
4146.5 CD4+ T-cells/million cells
Interval 2389.0 to 7608.0
|
4432.0 CD4+ T-cells/million cells
Interval 2623.5 to 7663.5
|
2711.5 CD4+ T-cells/million cells
Interval 1518.0 to 3755.0
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
F4co-Computed, Week 30
|
5376.5 CD4+ T-cells/million cells
Interval 4123.0 to 9609.0
|
2538.0 CD4+ T-cells/million cells
Interval 1587.0 to 4652.0
|
—
|
2593.0 CD4+ T-cells/million cells
Interval 1415.0 to 3718.0
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
F4co-Computed, Week 48
|
3266.0 CD4+ T-cells/million cells
Interval 1851.0 to 4297.0
|
2544.5 CD4+ T-cells/million cells
Interval 1301.0 to 3816.0
|
—
|
2398.0 CD4+ T-cells/million cells
Interval 1866.0 to 3805.0
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
Nef, Week 6
|
983.5 CD4+ T-cells/million cells
Interval 502.5 to 1533.5
|
805.0 CD4+ T-cells/million cells
Interval 553.0 to 1474.5
|
813.0 CD4+ T-cells/million cells
Interval 508.5 to 1474.5
|
323.5 CD4+ T-cells/million cells
Interval 171.5 to 644.0
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
Nef, Week 30
|
1220.0 CD4+ T-cells/million cells
Interval 824.0 to 2059.0
|
512.0 CD4+ T-cells/million cells
Interval 263.0 to 1132.0
|
—
|
357.0 CD4+ T-cells/million cells
Interval 177.0 to 673.0
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
Nef, Week 48
|
568.0 CD4+ T-cells/million cells
Interval 320.0 to 888.0
|
356.0 CD4+ T-cells/million cells
Interval 233.0 to 721.0
|
—
|
377.5 CD4+ T-cells/million cells
Interval 173.0 to 772.5
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
p17, Pre-vaccination
|
463.0 CD4+ T-cells/million cells
Interval 305.0 to 733.0
|
434.0 CD4+ T-cells/million cells
Interval 256.0 to 980.0
|
457.0 CD4+ T-cells/million cells
Interval 256.0 to 809.0
|
578.0 CD4+ T-cells/million cells
Interval 316.0 to 815.0
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
p17, Week 6
|
797.0 CD4+ T-cells/million cells
Interval 434.0 to 1198.0
|
561.5 CD4+ T-cells/million cells
Interval 356.0 to 1252.0
|
682.0 CD4+ T-cells/million cells
Interval 386.0 to 1198.0
|
562.0 CD4+ T-cells/million cells
Interval 370.0 to 949.0
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
p17, Week 28
|
494.0 CD4+ T-cells/million cells
Interval 364.0 to 687.0
|
527.5 CD4+ T-cells/million cells
Interval 330.5 to 866.0
|
494.0 CD4+ T-cells/million cells
Interval 344.0 to 819.0
|
433.0 CD4+ T-cells/million cells
Interval 281.0 to 823.0
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
p17, Week 30
|
798.0 CD4+ T-cells/million cells
Interval 519.0 to 1041.0
|
473.0 CD4+ T-cells/million cells
Interval 308.5 to 930.0
|
—
|
536.0 CD4+ T-cells/million cells
Interval 324.0 to 925.0
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
p17, Week 48
|
525.0 CD4+ T-cells/million cells
Interval 293.0 to 749.0
|
580.0 CD4+ T-cells/million cells
Interval 230.0 to 962.0
|
—
|
498.5 CD4+ T-cells/million cells
Interval 264.5 to 812.5
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
p24, Pre-vaccination
|
794.5 CD4+ T-cells/million cells
Interval 533.0 to 1280.0
|
699.0 CD4+ T-cells/million cells
Interval 400.0 to 1112.0
|
759.0 CD4+ T-cells/million cells
Interval 471.0 to 1237.0
|
733.0 CD4+ T-cells/million cells
Interval 526.0 to 1658.0
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
p24, Week 6
|
902.0 CD4+ T-cells/million cells
Interval 608.0 to 1291.0
|
1033.0 CD4+ T-cells/million cells
Interval 529.0 to 1847.0
|
977.0 CD4+ T-cells/million cells
Interval 533.0 to 1363.0
|
943.0 CD4+ T-cells/million cells
Interval 605.5 to 1772.5
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
p24, Week 30
|
988.0 CD4+ T-cells/million cells
Interval 682.0 to 1504.0
|
708.0 CD4+ T-cells/million cells
Interval 470.0 to 1535.0
|
—
|
944.5 CD4+ T-cells/million cells
Interval 606.0 to 1383.0
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
p24, Week 48
|
856.0 CD4+ T-cells/million cells
Interval 590.0 to 1194.0
|
831.0 CD4+ T-cells/million cells
Interval 471.0 to 1393.0
|
—
|
891.0 CD4+ T-cells/million cells
Interval 547.5 to 1562.0
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
RT, Pre-vaccination
|
494.5 CD4+ T-cells/million cells
Interval 293.0 to 757.0
|
442.0 CD4+ T-cells/million cells
Interval 298.0 to 677.0
|
455.0 CD4+ T-cells/million cells
Interval 293.0 to 757.0
|
474.0 CD4+ T-cells/million cells
Interval 308.0 to 734.0
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
RT, Week 6
|
1916.5 CD4+ T-cells/million cells
Interval 1208.5 to 3465.0
|
1426.5 CD4+ T-cells/million cells
Interval 839.0 to 2496.5
|
1680.0 CD4+ T-cells/million cells
Interval 1011.5 to 2837.5
|
416.0 CD4+ T-cells/million cells
Interval 284.0 to 653.0
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
RT, Week 28
|
599.0 CD4+ T-cells/million cells
Interval 450.0 to 1206.0
|
667.5 CD4+ T-cells/million cells
Interval 347.0 to 1015.5
|
634.0 CD4+ T-cells/million cells
Interval 403.0 to 1081.0
|
384.0 CD4+ T-cells/million cells
Interval 269.0 to 686.0
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
RT, Week 30
|
2138.0 CD4+ T-cells/million cells
Interval 1186.0 to 3878.0
|
540.0 CD4+ T-cells/million cells
Interval 330.5 to 1299.0
|
—
|
477.0 CD4+ T-cells/million cells
Interval 339.0 to 720.0
|
|
Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
RT, Week 48
|
797.5 CD4+ T-cells/million cells
Interval 433.5 to 1666.0
|
573.0 CD4+ T-cells/million cells
Interval 373.0 to 791.0
|
—
|
470.0 CD4+ T-cells/million cells
Interval 274.0 to 838.0
|
SECONDARY outcome
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.
Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD8+ T-cells and F4co-Computed \[frequency of CD8+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD8+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)\] CD8+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).
Outcome measures
| Measure |
3D_HIV Group
n=38 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=40 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=75 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=35 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
RT, Week 6
|
3699.5 CD8+ T-cells/million cells
Interval 1575.0 to 8150.5
|
3418.0 CD8+ T-cells/million cells
Interval 2058.5 to 7416.0
|
3490.0 CD8+ T-cells/million cells
Interval 1856.0 to 7732.0
|
4715.0 CD8+ T-cells/million cells
Interval 2605.0 to 9441.0
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
F4co-Computed, Pre-vaccination
|
15895.5 CD8+ T-cells/million cells
Interval 10567.0 to 28650.0
|
19633.0 CD8+ T-cells/million cells
Interval 13938.0 to 37746.0
|
17609.0 CD8+ T-cells/million cells
Interval 11299.0 to 30838.0
|
25819.0 CD8+ T-cells/million cells
Interval 13977.0 to 41349.0
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
F4co-Computed, Week 6
|
16727.0 CD8+ T-cells/million cells
Interval 9665.5 to 23222.5
|
19340.0 CD8+ T-cells/million cells
Interval 13082.0 to 37413.5
|
17839.5 CD8+ T-cells/million cells
Interval 12295.0 to 25795.5
|
29786.5 CD8+ T-cells/million cells
Interval 17947.0 to 46398.0
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
F4co-Computed, Week 28
|
17526.0 CD8+ T-cells/million cells
Interval 11559.0 to 29760.0
|
17186.5 CD8+ T-cells/million cells
Interval 11078.5 to 33554.0
|
17344.0 CD8+ T-cells/million cells
Interval 11179.0 to 30317.0
|
25798.0 CD8+ T-cells/million cells
Interval 17168.0 to 36067.0
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
F4co-Computed, Week 30
|
15659.5 CD8+ T-cells/million cells
Interval 9940.0 to 23406.0
|
19210.0 CD8+ T-cells/million cells
Interval 12487.0 to 33548.0
|
—
|
29064.0 CD8+ T-cells/million cells
Interval 16232.0 to 37335.0
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
F4co-Computed, Week 48
|
16143.0 CD8+ T-cells/million cells
Interval 8304.0 to 26733.0
|
21063.0 CD8+ T-cells/million cells
Interval 10921.0 to 33207.0
|
—
|
25564.0 CD8+ T-cells/million cells
Interval 14771.0 to 35420.0
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
Nef, Pre-vaccination
|
3187.0 CD8+ T-cells/million cells
Interval 1413.0 to 6646.0
|
2453.0 CD8+ T-cells/million cells
Interval 1447.0 to 8829.0
|
3174.0 CD8+ T-cells/million cells
Interval 1413.0 to 7329.0
|
3796.0 CD8+ T-cells/million cells
Interval 1772.0 to 10330.0
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
Nef, Week 6
|
3141.0 CD8+ T-cells/million cells
Interval 1060.0 to 6597.5
|
3497.5 CD8+ T-cells/million cells
Interval 1341.5 to 8698.5
|
3141.0 CD8+ T-cells/million cells
Interval 1178.5 to 6856.0
|
5174.0 CD8+ T-cells/million cells
Interval 2343.5 to 9489.5
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
Nef, Week 28
|
2641.0 CD8+ T-cells/million cells
Interval 1087.0 to 6218.0
|
3655.0 CD8+ T-cells/million cells
Interval 1110.5 to 8598.5
|
3054.0 CD8+ T-cells/million cells
Interval 1087.0 to 7235.0
|
4332.0 CD8+ T-cells/million cells
Interval 2158.0 to 8647.0
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
Nef, Week 30
|
2790.0 CD8+ T-cells/million cells
Interval 1156.0 to 4828.0
|
3387.0 CD8+ T-cells/million cells
Interval 1497.0 to 8670.0
|
—
|
3970.5 CD8+ T-cells/million cells
Interval 2122.0 to 9214.0
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
Nef, Week 48
|
2444.5 CD8+ T-cells/million cells
Interval 1032.5 to 5241.5
|
2478.0 CD8+ T-cells/million cells
Interval 1521.0 to 7197.0
|
—
|
4014.5 CD8+ T-cells/million cells
Interval 2288.5 to 7700.0
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
p17, Pre-vaccination
|
858.0 CD8+ T-cells/million cells
Interval 185.0 to 1995.0
|
1212.0 CD8+ T-cells/million cells
Interval 385.0 to 2891.0
|
991.0 CD8+ T-cells/million cells
Interval 275.0 to 2670.0
|
2246.0 CD8+ T-cells/million cells
Interval 648.0 to 7255.0
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
p17, Week 6
|
829.0 CD8+ T-cells/million cells
Interval 231.0 to 2702.0
|
1478.5 CD8+ T-cells/million cells
Interval 275.5 to 3688.5
|
1085.0 CD8+ T-cells/million cells
Interval 260.0 to 3435.0
|
1681.5 CD8+ T-cells/million cells
Interval 621.0 to 6251.5
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
p17, Week 28
|
707.0 CD8+ T-cells/million cells
Interval 217.0 to 2386.0
|
1419.0 CD8+ T-cells/million cells
Interval 334.5 to 3422.5
|
1055.0 CD8+ T-cells/million cells
Interval 271.0 to 2756.0
|
1613.0 CD8+ T-cells/million cells
Interval 566.0 to 3702.0
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
p17, Week 30
|
510.0 CD8+ T-cells/million cells
Interval 142.0 to 2861.0
|
1467.0 CD8+ T-cells/million cells
Interval 378.0 to 3265.0
|
—
|
1524.0 CD8+ T-cells/million cells
Interval 447.0 to 4659.0
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
p17, Week 48
|
818.0 CD8+ T-cells/million cells
Interval 217.0 to 1890.0
|
1669.0 CD8+ T-cells/million cells
Interval 301.0 to 3477.0
|
—
|
1494.0 CD8+ T-cells/million cells
Interval 623.0 to 5155.0
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
p24, Pre-vaccination
|
5364.0 CD8+ T-cells/million cells
Interval 2266.0 to 8040.0
|
8630.0 CD8+ T-cells/million cells
Interval 1356.0 to 12207.0
|
6248.0 CD8+ T-cells/million cells
Interval 1787.0 to 11204.0
|
8435.0 CD8+ T-cells/million cells
Interval 2567.0 to 20399.0
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
p24, Week 6
|
4972.0 CD8+ T-cells/million cells
Interval 2291.0 to 8391.0
|
6826.0 CD8+ T-cells/million cells
Interval 1924.0 to 14308.5
|
5610.0 CD8+ T-cells/million cells
Interval 2221.0 to 10269.0
|
10328.0 CD8+ T-cells/million cells
Interval 2723.5 to 23641.5
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
p24, Week 28
|
6273.0 CD8+ T-cells/million cells
Interval 2195.0 to 8487.0
|
5465.5 CD8+ T-cells/million cells
Interval 1629.0 to 12415.5
|
6181.0 CD8+ T-cells/million cells
Interval 1654.0 to 11338.0
|
8207.0 CD8+ T-cells/million cells
Interval 2303.0 to 19305.0
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
p24, Week 30
|
5525.0 CD8+ T-cells/million cells
Interval 1903.0 to 8346.0
|
5064.0 CD8+ T-cells/million cells
Interval 1472.0 to 13693.0
|
—
|
8923.5 CD8+ T-cells/million cells
Interval 3217.0 to 21785.0
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
p24, Week 48
|
5900.0 CD8+ T-cells/million cells
Interval 2042.0 to 8511.0
|
6371.0 CD8+ T-cells/million cells
Interval 2135.0 to 12114.0
|
—
|
7410.0 CD8+ T-cells/million cells
Interval 2127.5 to 18982.5
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
RT, Pre-vaccination
|
3724.5 CD8+ T-cells/million cells
Interval 1740.0 to 7216.0
|
3073.0 CD8+ T-cells/million cells
Interval 1953.0 to 7529.0
|
3556.0 CD8+ T-cells/million cells
Interval 1826.0 to 7529.0
|
4395.0 CD8+ T-cells/million cells
Interval 2124.0 to 7654.0
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
RT, Week 28
|
6187.0 CD8+ T-cells/million cells
Interval 1597.0 to 9131.0
|
2860.5 CD8+ T-cells/million cells
Interval 1817.5 to 7713.0
|
3663.0 CD8+ T-cells/million cells
Interval 1778.0 to 8986.0
|
4292.0 CD8+ T-cells/million cells
Interval 1921.0 to 7171.0
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
RT, Week 30
|
3262.0 CD8+ T-cells/million cells
Interval 1577.0 to 8040.0
|
3747.5 CD8+ T-cells/million cells
Interval 2134.5 to 7150.5
|
—
|
4538.0 CD8+ T-cells/million cells
Interval 2198.0 to 8225.0
|
|
Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
RT, Week 48
|
3299.5 CD8+ T-cells/million cells
Interval 1737.5 to 7638.0
|
3462.5 CD8+ T-cells/million cells
Interval 1950.0 to 8127.0
|
—
|
4565.0 CD8+ T-cells/million cells
Interval 2477.0 to 7347.0
|
SECONDARY outcome
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.
Breadth was assessed only for the CD4+ T-cells and was measured by evaluating response to at least 1, 2, 3 or all 4 antigens: proteins 17, 24, Nef, reverse transcriptase (RT).
Outcome measures
| Measure |
3D_HIV Group
n=38 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=40 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=75 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=35 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens
4 antigens, Week 28
|
2 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens
1 antigen, Week 48
|
23 Participants
|
19 Participants
|
—
|
13 Participants
|
|
Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens
4 antigens, Week 48
|
4 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens
1 antigen, Week 30
|
30 Participants
|
20 Participants
|
—
|
14 Participants
|
|
Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens
2 antigens, Week 30
|
24 Participants
|
11 Participants
|
—
|
5 Participants
|
|
Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens
3 antigens, Week 30
|
15 Participants
|
6 Participants
|
—
|
3 Participants
|
|
Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens
1 antigen, Pre-vaccination
|
30 Participants
|
25 Participants
|
55 Participants
|
25 Participants
|
|
Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens
2 antigens, Pre-vaccination
|
19 Participants
|
16 Participants
|
35 Participants
|
18 Participants
|
|
Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens
3 antigens, Pre-vaccination
|
11 Participants
|
8 Participants
|
19 Participants
|
8 Participants
|
|
Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens
4 antigens, Pre-vaccination
|
4 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
|
Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens
1 antigen, Week 6
|
28 Participants
|
32 Participants
|
60 Participants
|
9 Participants
|
|
Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens
2 antigens, Week 6
|
24 Participants
|
24 Participants
|
48 Participants
|
2 Participants
|
|
Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens
3 antigens, Week 6
|
12 Participants
|
12 Participants
|
24 Participants
|
1 Participants
|
|
Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens
4 antigens, Week 6
|
6 Participants
|
6 Participants
|
12 Participants
|
0 Participants
|
|
Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens
1 antigen, Week 28
|
19 Participants
|
22 Participants
|
41 Participants
|
7 Participants
|
|
Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens
2 antigens, Week 28
|
13 Participants
|
11 Participants
|
24 Participants
|
4 Participants
|
|
Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens
3 antigens, Week 28
|
4 Participants
|
4 Participants
|
8 Participants
|
2 Participants
|
|
Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens
4 antigens, Week 30
|
8 Participants
|
2 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens
2 antigens, Week 48
|
17 Participants
|
7 Participants
|
—
|
3 Participants
|
|
Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens
3 antigens, Week 48
|
5 Participants
|
4 Participants
|
—
|
2 Participants
|
SECONDARY outcome
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.
The cytokine co-expression profile was defined by the frequency of F4co-Computed CD4+ T-cells \[frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)\] expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).
Outcome measures
| Measure |
3D_HIV Group
n=41 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=42 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=79 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=37 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L, Week 28
|
560.5 F4co-computed CD4+ T-cells/million cells
Interval 133.0 to 1163.0
|
453.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 938.0
|
506.5 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 988.0
|
442.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 848.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
TNF-α, Pre-vaccination
|
250.0 F4co-computed CD4+ T-cells/million cells
Interval 103.0 to 528.0
|
251.5 F4co-computed CD4+ T-cells/million cells
Interval 46.0 to 610.0
|
250.0 F4co-computed CD4+ T-cells/million cells
Interval 67.0 to 610.0
|
178.5 F4co-computed CD4+ T-cells/million cells
Interval 82.0 to 639.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
TNF-α, Week 6
|
346.0 F4co-computed CD4+ T-cells/million cells
Interval 112.0 to 664.0
|
251.0 F4co-computed CD4+ T-cells/million cells
Interval 130.0 to 528.0
|
277.5 F4co-computed CD4+ T-cells/million cells
Interval 129.0 to 644.5
|
166.5 F4co-computed CD4+ T-cells/million cells
Interval 21.0 to 477.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
TNF-α, Week 48
|
341.0 F4co-computed CD4+ T-cells/million cells
Interval 70.0 to 901.0
|
192.5 F4co-computed CD4+ T-cells/million cells
Interval 20.0 to 317.0
|
—
|
182.0 F4co-computed CD4+ T-cells/million cells
Interval 25.0 to 668.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
IFN- γ, Week 48
|
329.0 F4co-computed CD4+ T-cells/million cells
Interval 158.0 to 553.0
|
418.5 F4co-computed CD4+ T-cells/million cells
Interval 179.0 to 772.5
|
—
|
487.0 F4co-computed CD4+ T-cells/million cells
Interval 325.0 to 1223.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_TNF-α, Week 6
|
416.0 F4co-computed CD4+ T-cells/million cells
Interval 212.0 to 683.0
|
275.0 F4co-computed CD4+ T-cells/million cells
Interval 132.0 to 456.0
|
374.5 F4co-computed CD4+ T-cells/million cells
Interval 165.5 to 481.5
|
110.0 F4co-computed CD4+ T-cells/million cells
Interval 63.0 to 256.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_TNF-α, Week 28
|
152.5 F4co-computed CD4+ T-cells/million cells
Interval 95.0 to 276.0
|
101.0 F4co-computed CD4+ T-cells/million cells
Interval 57.0 to 236.0
|
129.5 F4co-computed CD4+ T-cells/million cells
Interval 70.0 to 255.0
|
130.0 F4co-computed CD4+ T-cells/million cells
Interval 82.0 to 234.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_IFN- γ, Week 6
|
375.0 F4co-computed CD4+ T-cells/million cells
Interval 201.0 to 619.0
|
233.0 F4co-computed CD4+ T-cells/million cells
Interval 118.0 to 608.0
|
280.5 F4co-computed CD4+ T-cells/million cells
Interval 163.5 to 613.5
|
307.0 F4co-computed CD4+ T-cells/million cells
Interval 178.0 to 532.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_IFN- γ, Week 28
|
180.5 F4co-computed CD4+ T-cells/million cells
Interval 89.0 to 447.0
|
186.5 F4co-computed CD4+ T-cells/million cells
Interval 94.0 to 412.0
|
181.5 F4co-computed CD4+ T-cells/million cells
Interval 91.5 to 437.0
|
239.0 F4co-computed CD4+ T-cells/million cells
Interval 126.0 to 450.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
IFN- γ_IL-2, Pre-vaccination
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 28.5
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
IFN- γ_IL-2, Week 30
|
28.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 67.0
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 30.5
|
—
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 10.5
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_TNF-α_IFN- γ, Week 30
|
291.0 F4co-computed CD4+ T-cells/million cells
Interval 201.0 to 509.0
|
149.5 F4co-computed CD4+ T-cells/million cells
Interval 86.0 to 283.0
|
—
|
142.0 F4co-computed CD4+ T-cells/million cells
Interval 86.5 to 326.5
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_TNF-α_IFN- γ_IL-2, Pre-vaccination
|
106.0 F4co-computed CD4+ T-cells/million cells
Interval 31.0 to 191.0
|
93.0 F4co-computed CD4+ T-cells/million cells
Interval 22.0 to 181.0
|
95.0 F4co-computed CD4+ T-cells/million cells
Interval 25.0 to 191.0
|
131.5 F4co-computed CD4+ T-cells/million cells
Interval 24.5 to 196.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L, Pre-vaccination
|
772.0 F4co-computed CD4+ T-cells/million cells
Interval 183.0 to 1601.0
|
299.5 F4co-computed CD4+ T-cells/million cells
Interval 73.0 to 1332.0
|
453.0 F4co-computed CD4+ T-cells/million cells
Interval 130.0 to 1451.0
|
493.0 F4co-computed CD4+ T-cells/million cells
Interval 33.0 to 1376.5
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L, Week 6
|
355.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 1290.0
|
472.0 F4co-computed CD4+ T-cells/million cells
Interval 172.0 to 1091.0
|
427.0 F4co-computed CD4+ T-cells/million cells
Interval 33.0 to 1100.5
|
153.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 931.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L, Week 30
|
452.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 1211.0
|
760.5 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 1575.0
|
—
|
716.5 F4co-computed CD4+ T-cells/million cells
Interval 103.0 to 1666.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L, Week 48
|
383.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 831.0
|
481.5 F4co-computed CD4+ T-cells/million cells
Interval 28.0 to 1966.0
|
—
|
653.0 F4co-computed CD4+ T-cells/million cells
Interval 143.0 to 1520.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
IL-2, Pre-vaccination
|
118.0 F4co-computed CD4+ T-cells/million cells
Interval 18.0 to 237.0
|
45.5 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 108.0
|
70.0 F4co-computed CD4+ T-cells/million cells
Interval 10.0 to 193.0
|
93.5 F4co-computed CD4+ T-cells/million cells
Interval 29.5 to 149.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
IL-2, Week 6
|
127.0 F4co-computed CD4+ T-cells/million cells
Interval 25.0 to 222.0
|
72.0 F4co-computed CD4+ T-cells/million cells
Interval 31.0 to 171.0
|
91.5 F4co-computed CD4+ T-cells/million cells
Interval 25.0 to 206.5
|
58.0 F4co-computed CD4+ T-cells/million cells
Interval 20.0 to 126.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
IL-2, Week 28
|
63.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 126.0
|
59.0 F4co-computed CD4+ T-cells/million cells
Interval 8.0 to 245.0
|
63.0 F4co-computed CD4+ T-cells/million cells
Interval 6.5 to 206.5
|
34.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 115.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
IL-2, Week 30
|
103.0 F4co-computed CD4+ T-cells/million cells
Interval 25.0 to 273.0
|
92.5 F4co-computed CD4+ T-cells/million cells
Interval 9.0 to 155.0
|
—
|
46.5 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 137.5
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
IL-2, Week 48
|
74.0 F4co-computed CD4+ T-cells/million cells
Interval 5.0 to 165.0
|
58.0 F4co-computed CD4+ T-cells/million cells
Interval 18.0 to 114.0
|
—
|
86.0 F4co-computed CD4+ T-cells/million cells
Interval 6.0 to 139.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
TNF-α, Week 28
|
242.0 F4co-computed CD4+ T-cells/million cells
Interval 79.0 to 423.0
|
135.5 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 272.0
|
163.0 F4co-computed CD4+ T-cells/million cells
Interval 6.5 to 329.5
|
216.0 F4co-computed CD4+ T-cells/million cells
Interval 83.0 to 392.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
TNF-α, Week 30
|
389.0 F4co-computed CD4+ T-cells/million cells
Interval 113.0 to 749.0
|
101.5 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 422.5
|
—
|
223.0 F4co-computed CD4+ T-cells/million cells
Interval 43.5 to 686.5
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
IFN- γ, Pre-vaccination
|
352.0 F4co-computed CD4+ T-cells/million cells
Interval 192.0 to 640.0
|
396.5 F4co-computed CD4+ T-cells/million cells
Interval 193.0 to 779.0
|
383.0 F4co-computed CD4+ T-cells/million cells
Interval 192.0 to 654.0
|
446.0 F4co-computed CD4+ T-cells/million cells
Interval 262.5 to 850.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
IFN- γ, Week 6
|
411.0 F4co-computed CD4+ T-cells/million cells
Interval 242.0 to 808.0
|
448.0 F4co-computed CD4+ T-cells/million cells
Interval 193.0 to 696.0
|
426.0 F4co-computed CD4+ T-cells/million cells
Interval 212.0 to 697.5
|
563.5 F4co-computed CD4+ T-cells/million cells
Interval 301.0 to 999.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
IFN- γ, Week 28
|
289.5 F4co-computed CD4+ T-cells/million cells
Interval 167.0 to 419.0
|
454.0 F4co-computed CD4+ T-cells/million cells
Interval 218.0 to 642.0
|
377.5 F4co-computed CD4+ T-cells/million cells
Interval 197.0 to 557.0
|
536.0 F4co-computed CD4+ T-cells/million cells
Interval 275.0 to 995.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
IFN- γ, Week 30
|
439.0 F4co-computed CD4+ T-cells/million cells
Interval 226.0 to 720.0
|
432.5 F4co-computed CD4+ T-cells/million cells
Interval 235.0 to 935.0
|
—
|
479.0 F4co-computed CD4+ T-cells/million cells
Interval 310.5 to 892.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_IL-2, Pre-vaccination
|
149.0 F4co-computed CD4+ T-cells/million cells
Interval 105.0 to 227.0
|
149.5 F4co-computed CD4+ T-cells/million cells
Interval 48.0 to 244.0
|
149.0 F4co-computed CD4+ T-cells/million cells
Interval 67.0 to 244.0
|
77.5 F4co-computed CD4+ T-cells/million cells
Interval 20.5 to 138.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_IL-2, Week 6
|
499.0 F4co-computed CD4+ T-cells/million cells
Interval 189.0 to 1192.0
|
320.0 F4co-computed CD4+ T-cells/million cells
Interval 198.0 to 616.0
|
430.5 F4co-computed CD4+ T-cells/million cells
Interval 193.5 to 890.0
|
127.5 F4co-computed CD4+ T-cells/million cells
Interval 8.0 to 208.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_IL-2, Week 28
|
199.0 F4co-computed CD4+ T-cells/million cells
Interval 120.0 to 473.0
|
196.0 F4co-computed CD4+ T-cells/million cells
Interval 91.0 to 325.0
|
198.0 F4co-computed CD4+ T-cells/million cells
Interval 108.0 to 360.5
|
56.0 F4co-computed CD4+ T-cells/million cells
Interval 27.0 to 97.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_IL-2, Week 30
|
377.0 F4co-computed CD4+ T-cells/million cells
Interval 175.0 to 865.0
|
142.5 F4co-computed CD4+ T-cells/million cells
Interval 108.5 to 299.0
|
—
|
96.0 F4co-computed CD4+ T-cells/million cells
Interval 46.0 to 180.5
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_IL-2, Week 48
|
172.0 F4co-computed CD4+ T-cells/million cells
Interval 52.0 to 335.0
|
218.0 F4co-computed CD4+ T-cells/million cells
Interval 68.0 to 342.0
|
—
|
102.0 F4co-computed CD4+ T-cells/million cells
Interval 17.0 to 166.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_TNF-α, Pre-vaccination
|
201.0 F4co-computed CD4+ T-cells/million cells
Interval 90.0 to 270.0
|
116.0 F4co-computed CD4+ T-cells/million cells
Interval 10.0 to 290.0
|
154.0 F4co-computed CD4+ T-cells/million cells
Interval 63.0 to 283.0
|
88.5 F4co-computed CD4+ T-cells/million cells
Interval 41.0 to 254.5
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_TNF-α, Week 30
|
413.0 F4co-computed CD4+ T-cells/million cells
Interval 261.0 to 868.0
|
144.5 F4co-computed CD4+ T-cells/million cells
Interval 48.5 to 268.5
|
—
|
195.5 F4co-computed CD4+ T-cells/million cells
Interval 42.5 to 360.5
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_TNF-α, Week 48
|
164.0 F4co-computed CD4+ T-cells/million cells
Interval 43.0 to 321.0
|
160.5 F4co-computed CD4+ T-cells/million cells
Interval 29.5 to 321.0
|
—
|
201.0 F4co-computed CD4+ T-cells/million cells
Interval 71.0 to 382.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_IFN- γ, Pre-vaccination
|
229.0 F4co-computed CD4+ T-cells/million cells
Interval 133.0 to 392.0
|
208.5 F4co-computed CD4+ T-cells/million cells
Interval 80.0 to 383.0
|
224.0 F4co-computed CD4+ T-cells/million cells
Interval 99.0 to 392.0
|
209.0 F4co-computed CD4+ T-cells/million cells
Interval 115.5 to 609.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_IFN- γ, Week 30
|
325.0 F4co-computed CD4+ T-cells/million cells
Interval 230.0 to 593.0
|
195.5 F4co-computed CD4+ T-cells/million cells
Interval 136.0 to 489.0
|
—
|
254.5 F4co-computed CD4+ T-cells/million cells
Interval 162.0 to 470.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_IFN- γ, Week 48
|
202.0 F4co-computed CD4+ T-cells/million cells
Interval 129.0 to 447.0
|
202.0 F4co-computed CD4+ T-cells/million cells
Interval 82.5 to 371.5
|
—
|
227.0 F4co-computed CD4+ T-cells/million cells
Interval 115.0 to 466.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
TNF-α_IL-2, Pre-vaccination
|
23.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 54.0
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 38.0
|
20.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 43.0
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 31.5
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
TNF-α_IL-2, Week 6
|
54.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 167.0
|
65.0 F4co-computed CD4+ T-cells/million cells
Interval 29.0 to 112.0
|
60.0 F4co-computed CD4+ T-cells/million cells
Interval 16.5 to 138.5
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 28.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
TNF-α_IL-2, Week 28
|
45.5 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 103.0
|
20.5 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 75.0
|
27.5 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 98.5
|
24.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 36.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
TNF-α_IL-2, Week 30
|
76.0 F4co-computed CD4+ T-cells/million cells
Interval 23.0 to 208.0
|
17.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 59.0
|
—
|
10.5 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 45.5
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
TNF-α_IL-2, Week 48
|
36.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 128.0
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 31.5
|
—
|
6.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 38.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
IFN- γ_IL-2, Week 6
|
19.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 45.0
|
27.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 57.0
|
21.5 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 49.0
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
IFN- γ_IL-2, Week 28
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 24.0
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 24.0
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 17.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
IFN- γ_IL-2, Week 48
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 24.0
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 46.5
|
—
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 14.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
TNF-α_IFN- γ, Pre-vaccination
|
94.0 F4co-computed CD4+ T-cells/million cells
Interval 55.0 to 156.0
|
92.0 F4co-computed CD4+ T-cells/million cells
Interval 60.0 to 194.0
|
93.0 F4co-computed CD4+ T-cells/million cells
Interval 56.0 to 184.0
|
149.5 F4co-computed CD4+ T-cells/million cells
Interval 97.0 to 331.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
TNF-α_IFN- γ, Week 6
|
132.0 F4co-computed CD4+ T-cells/million cells
Interval 53.0 to 246.0
|
123.0 F4co-computed CD4+ T-cells/million cells
Interval 66.0 to 253.0
|
127.0 F4co-computed CD4+ T-cells/million cells
Interval 59.0 to 247.5
|
165.0 F4co-computed CD4+ T-cells/million cells
Interval 66.0 to 413.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
TNF-α_IFN- γ, Week 28
|
111.5 F4co-computed CD4+ T-cells/million cells
Interval 54.0 to 155.0
|
141.5 F4co-computed CD4+ T-cells/million cells
Interval 36.0 to 253.0
|
129.5 F4co-computed CD4+ T-cells/million cells
Interval 40.5 to 216.0
|
90.0 F4co-computed CD4+ T-cells/million cells
Interval 46.0 to 349.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
TNF-α_IFN- γ, Week 30
|
110.0 F4co-computed CD4+ T-cells/million cells
Interval 50.0 to 195.0
|
127.0 F4co-computed CD4+ T-cells/million cells
Interval 68.5 to 268.5
|
—
|
153.5 F4co-computed CD4+ T-cells/million cells
Interval 46.0 to 355.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
TNF-α_IFN- γ, Week 48
|
72.0 F4co-computed CD4+ T-cells/million cells
Interval 44.0 to 171.0
|
98.5 F4co-computed CD4+ T-cells/million cells
Interval 41.5 to 263.0
|
—
|
143.0 F4co-computed CD4+ T-cells/million cells
Interval 74.0 to 334.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_TNF-α_IL-2, Pre-vaccination
|
110.0 F4co-computed CD4+ T-cells/million cells
Interval 31.0 to 193.0
|
109.5 F4co-computed CD4+ T-cells/million cells
Interval 40.0 to 203.0
|
110.0 F4co-computed CD4+ T-cells/million cells
Interval 31.0 to 195.0
|
126.0 F4co-computed CD4+ T-cells/million cells
Interval 46.5 to 239.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_TNF-α_IL-2, Week 6
|
889.0 F4co-computed CD4+ T-cells/million cells
Interval 498.0 to 1600.0
|
529.0 F4co-computed CD4+ T-cells/million cells
Interval 307.0 to 1187.0
|
730.5 F4co-computed CD4+ T-cells/million cells
Interval 316.5 to 1340.5
|
134.0 F4co-computed CD4+ T-cells/million cells
Interval 57.0 to 234.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_TNF-α_IL-2, Week 28
|
312.0 F4co-computed CD4+ T-cells/million cells
Interval 178.0 to 765.0
|
247.0 F4co-computed CD4+ T-cells/million cells
Interval 88.0 to 470.0
|
286.5 F4co-computed CD4+ T-cells/million cells
Interval 138.0 to 576.5
|
114.0 F4co-computed CD4+ T-cells/million cells
Interval 60.0 to 215.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_TNF-α_IL-2, Week 30
|
953.0 F4co-computed CD4+ T-cells/million cells
Interval 466.0 to 2115.0
|
244.5 F4co-computed CD4+ T-cells/million cells
Interval 101.5 to 410.0
|
—
|
182.5 F4co-computed CD4+ T-cells/million cells
Interval 60.0 to 266.5
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_TNF-α_IL-2, Week 48
|
367.0 F4co-computed CD4+ T-cells/million cells
Interval 125.0 to 1226.0
|
174.0 F4co-computed CD4+ T-cells/million cells
Interval 60.5 to 384.0
|
—
|
81.0 F4co-computed CD4+ T-cells/million cells
Interval 24.0 to 131.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_IFN- γ_IL-2, Pre-vaccination
|
46.0 F4co-computed CD4+ T-cells/million cells
Interval 19.0 to 72.0
|
45.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 104.0
|
46.0 F4co-computed CD4+ T-cells/million cells
Interval 18.0 to 79.0
|
43.0 F4co-computed CD4+ T-cells/million cells
Interval 23.0 to 110.5
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_IFN- γ_IL-2, Week 6
|
331.0 F4co-computed CD4+ T-cells/million cells
Interval 109.0 to 533.0
|
208.0 F4co-computed CD4+ T-cells/million cells
Interval 88.0 to 462.0
|
253.0 F4co-computed CD4+ T-cells/million cells
Interval 89.5 to 500.5
|
68.5 F4co-computed CD4+ T-cells/million cells
Interval 26.0 to 129.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_IFN- γ_IL-2, Week 28
|
88.0 F4co-computed CD4+ T-cells/million cells
Interval 27.0 to 129.0
|
87.5 F4co-computed CD4+ T-cells/million cells
Interval 33.0 to 163.0
|
87.5 F4co-computed CD4+ T-cells/million cells
Interval 32.5 to 137.5
|
37.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 83.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_IFN- γ_IL-2, Week 30
|
336.0 F4co-computed CD4+ T-cells/million cells
Interval 131.0 to 462.0
|
77.5 F4co-computed CD4+ T-cells/million cells
Interval 18.5 to 218.0
|
—
|
55.0 F4co-computed CD4+ T-cells/million cells
Interval 24.0 to 101.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_IFN- γ_IL-2, Week 48
|
92.0 F4co-computed CD4+ T-cells/million cells
Interval 26.0 to 170.0
|
58.0 F4co-computed CD4+ T-cells/million cells
Interval 10.5 to 156.5
|
—
|
53.0 F4co-computed CD4+ T-cells/million cells
Interval 6.0 to 112.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_TNF-α_IFN- γ, Pre-vaccination
|
149.0 F4co-computed CD4+ T-cells/million cells
Interval 40.0 to 304.0
|
152.5 F4co-computed CD4+ T-cells/million cells
Interval 44.0 to 248.0
|
150.0 F4co-computed CD4+ T-cells/million cells
Interval 40.0 to 297.0
|
154.5 F4co-computed CD4+ T-cells/million cells
Interval 96.5 to 349.5
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_TNF-α_IFN- γ, Week 6
|
341.0 F4co-computed CD4+ T-cells/million cells
Interval 132.0 to 596.0
|
264.0 F4co-computed CD4+ T-cells/million cells
Interval 112.0 to 433.0
|
289.0 F4co-computed CD4+ T-cells/million cells
Interval 125.5 to 521.5
|
172.5 F4co-computed CD4+ T-cells/million cells
Interval 62.0 to 324.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_TNF-α_IFN- γ, Week 28
|
123.5 F4co-computed CD4+ T-cells/million cells
Interval 87.0 to 253.0
|
131.0 F4co-computed CD4+ T-cells/million cells
Interval 69.0 to 268.0
|
131.0 F4co-computed CD4+ T-cells/million cells
Interval 79.0 to 267.5
|
154.0 F4co-computed CD4+ T-cells/million cells
Interval 48.0 to 265.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_TNF-α_IFN- γ, Week 48
|
187.0 F4co-computed CD4+ T-cells/million cells
Interval 76.0 to 323.0
|
129.5 F4co-computed CD4+ T-cells/million cells
Interval 42.0 to 290.5
|
—
|
121.0 F4co-computed CD4+ T-cells/million cells
Interval 60.0 to 378.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
TNF-α_IFN- γ_IL-2, Pre-vaccination
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 27.0
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 22.0
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 24.0
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 21.5
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
TNF-α_IFN- γ_IL-2, Week 6
|
40.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 70.0
|
21.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 66.0
|
32.5 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 69.5
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 35.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
TNF-α_IFN- γ_IL-2, Week 28
|
13.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 40.0
|
10.5 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 53.0
|
12.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 42.0
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 27.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
TNF-α_IFN- γ_IL-2, Week 30
|
36.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 83.0
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 25.0
|
—
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 10.5
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
TNF-α_IFN- γ_IL-2, Week 48
|
18.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 63.0
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 29.0
|
—
|
4.0 F4co-computed CD4+ T-cells/million cells
Interval 4.0 to 30.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_TNF-α_IFN- γ_IL-2, Week 6
|
624.0 F4co-computed CD4+ T-cells/million cells
Interval 349.0 to 1399.0
|
441.0 F4co-computed CD4+ T-cells/million cells
Interval 206.0 to 1044.0
|
532.0 F4co-computed CD4+ T-cells/million cells
Interval 239.5 to 1079.5
|
146.5 F4co-computed CD4+ T-cells/million cells
Interval 90.0 to 317.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_TNF-α_IFN- γ_IL-2, Week 28
|
235.5 F4co-computed CD4+ T-cells/million cells
Interval 121.0 to 400.0
|
147.0 F4co-computed CD4+ T-cells/million cells
Interval 61.0 to 347.0
|
205.5 F4co-computed CD4+ T-cells/million cells
Interval 85.0 to 396.0
|
91.0 F4co-computed CD4+ T-cells/million cells
Interval 31.0 to 186.0
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_TNF-α_IFN- γ_IL-2, Week 30
|
747.0 F4co-computed CD4+ T-cells/million cells
Interval 479.0 to 2069.0
|
110.5 F4co-computed CD4+ T-cells/million cells
Interval 55.0 to 502.0
|
—
|
108.0 F4co-computed CD4+ T-cells/million cells
Interval 35.5 to 189.5
|
|
Cytokine Expression Profile of F4co-Computed CD4+ T Cells
CD40L_TNF-α_IFN- γ_IL-2, Week 48
|
367.0 F4co-computed CD4+ T-cells/million cells
Interval 80.0 to 657.0
|
132.0 F4co-computed CD4+ T-cells/million cells
Interval 55.5 to 332.0
|
—
|
72.0 F4co-computed CD4+ T-cells/million cells
Interval 44.0 to 232.0
|
SECONDARY outcome
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.
The cytokine co-expression profile was defined by the frequency of Nef-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).
Outcome measures
| Measure |
3D_HIV Group
n=41 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=42 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=79 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=37 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
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|---|---|---|---|---|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
TNF-α_IFN- γ, Week 48
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 44.0
|
13.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 61.0
|
—
|
16.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 74.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_TNF-α_IL-2, Pre-vaccination
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 37.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 28.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 30.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 29.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_TNF-α_IL-2, Week 28
|
74.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 244.0
|
57.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 123.0
|
67.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 166.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 19.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
IL-2, Week 48
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 25.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 26.0
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 15.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
TNF-α_IL-2, Pre-vaccination
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
TNF-α_IL-2, Week 28
|
15.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 36.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 15.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 27.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 14.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
TNF-α_IFN- γ, Pre-vaccination
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 34.0
|
21.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 63.0
|
15.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 46.0
|
20.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 64.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
TNF-α_IFN- γ, Week 6
|
26.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 44.0
|
8.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 65.0
|
19.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 49.0
|
14.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 54.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
TNF-α_IFN- γ, Week 30
|
14.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 38.0
|
45.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 77.5
|
—
|
17.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 53.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_TNF-α_IL-2, Week 6
|
207.0 Nef-specific CD4+ T-cells/million cells
Interval 62.0 to 394.0
|
110.5 Nef-specific CD4+ T-cells/million cells
Interval 13.0 to 234.0
|
137.0 Nef-specific CD4+ T-cells/million cells
Interval 37.0 to 305.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 18.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_IFN- γ_IL-2, Week 48
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 29.5
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 21.0
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ, Week 6
|
17.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 111.0
|
16.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 57.0
|
17.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 65.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 32.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ, Week 28
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 26.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 22.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 25.5
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 27.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
TNF-α_IFN- γ_IL-2, Week 6
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 17.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
TNF-α_IFN- γ_IL-2, Week 28
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
TNF-α_IFN- γ_IL-2, Week 30
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 23.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
TNF-α_IFN- γ_IL-2, Week 48
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Pre-vaccination
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 16.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 6
|
77.0 Nef-specific CD4+ T-cells/million cells
Interval 13.0 to 222.0
|
53.0 Nef-specific CD4+ T-cells/million cells
Interval 22.0 to 103.0
|
66.0 Nef-specific CD4+ T-cells/million cells
Interval 22.0 to 149.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 28
|
26.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 97.0
|
7.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 42.0
|
20.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 53.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 21.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 30
|
142.5 Nef-specific CD4+ T-cells/million cells
Interval 48.0 to 478.0
|
14.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 51.5
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 48
|
43.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 150.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 39.0
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_TNF-α_IL-2, Week 30
|
327.0 Nef-specific CD4+ T-cells/million cells
Interval 113.0 to 572.0
|
38.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 107.0
|
—
|
1.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 37.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_TNF-α_IL-2, Week 48
|
78.5 Nef-specific CD4+ T-cells/million cells
Interval 6.5 to 329.0
|
32.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 98.0
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 19.5
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L, Pre-vaccination
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 331.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 230.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 280.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 390.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L, Week 6
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 194.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 280.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 194.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 34.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L, Week 28
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 113.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 210.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 158.5
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 90.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L, Week 30
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 50.0
|
98.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 357.5
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 185.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L, Week 48
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 75.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 420.0
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 218.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
IL-2, Pre-vaccination
|
14.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 32.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 23.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 32.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 30.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
IL-2, Week 6
|
22.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 59.0
|
7.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 43.0
|
14.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 45.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 27.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
IL-2, Week 28
|
4.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 45.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 46.0
|
1.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 45.5
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 28.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
IL-2, Week 30
|
19.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 108.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 44.5
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 30.5
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
TNF-α, Pre-vaccination
|
18.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 94.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 104.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 104.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 149.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
TNF-α, Week 6
|
31.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 135.0
|
37.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 164.0
|
32.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 137.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 43.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
TNF-α, Week 28
|
5.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 58.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 50.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 53.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 52.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
TNF-α, Week 30
|
43.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 181.0
|
7.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 109.0
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 120.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
TNF-α, Week 48
|
82.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 203.5
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 63.0
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 187.5
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
IFN- γ, Pre-vaccination
|
84.0 Nef-specific CD4+ T-cells/million cells
Interval 38.0 to 124.0
|
62.5 Nef-specific CD4+ T-cells/million cells
Interval 11.0 to 323.0
|
83.0 Nef-specific CD4+ T-cells/million cells
Interval 22.0 to 178.0
|
87.0 Nef-specific CD4+ T-cells/million cells
Interval 21.0 to 229.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
IFN- γ, Week 6
|
101.0 Nef-specific CD4+ T-cells/million cells
Interval 31.0 to 216.0
|
105.5 Nef-specific CD4+ T-cells/million cells
Interval 41.0 to 182.0
|
103.0 Nef-specific CD4+ T-cells/million cells
Interval 31.0 to 195.0
|
81.0 Nef-specific CD4+ T-cells/million cells
Interval 31.0 to 202.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
IFN- γ, Week 28
|
24.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 174.0
|
114.5 Nef-specific CD4+ T-cells/million cells
Interval 24.0 to 197.0
|
67.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 179.5
|
101.0 Nef-specific CD4+ T-cells/million cells
Interval 49.0 to 161.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
IFN- γ, Week 30
|
83.0 Nef-specific CD4+ T-cells/million cells
Interval 31.0 to 144.0
|
118.5 Nef-specific CD4+ T-cells/million cells
Interval 31.5 to 201.0
|
—
|
99.5 Nef-specific CD4+ T-cells/million cells
Interval 50.0 to 238.5
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
IFN- γ, Week 48
|
61.5 Nef-specific CD4+ T-cells/million cells
Interval 15.0 to 107.0
|
69.0 Nef-specific CD4+ T-cells/million cells
Interval 24.0 to 160.0
|
—
|
79.0 Nef-specific CD4+ T-cells/million cells
Interval 6.0 to 180.5
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_IL-2, Pre-vaccination
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 44.0
|
2.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 39.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 40.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 24.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_IL-2, Week 6
|
111.0 Nef-specific CD4+ T-cells/million cells
Interval 19.0 to 262.0
|
65.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 190.0
|
78.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 244.0
|
16.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 41.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_IL-2, Week 28
|
25.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 104.0
|
9.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 60.0
|
21.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 73.5
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_IL-2, Week 30
|
112.5 Nef-specific CD4+ T-cells/million cells
Interval 57.0 to 259.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 70.0
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 10.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_IL-2, Week 48
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 84.5
|
15.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 78.0
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 33.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_TNF-α, Pre-vaccination
|
6.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 43.0
|
7.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 57.0
|
6.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 50.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 7.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_TNF-α, Week 6
|
75.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 155.0
|
42.0 Nef-specific CD4+ T-cells/million cells
Interval 4.0 to 82.0
|
46.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 127.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 32.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_TNF-α, Week 28
|
2.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 38.0
|
3.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 41.0
|
3.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 39.5
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 26.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_TNF-α, Week 30
|
141.0 Nef-specific CD4+ T-cells/million cells
Interval 20.0 to 218.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 39.5
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 50.5
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_TNF-α, Week 48
|
22.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 63.5
|
11.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 49.0
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 32.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_IFN- γ, Pre-vaccination
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 28.0
|
7.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 36.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 31.0
|
20.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 43.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_IFN- γ, Week 6
|
31.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 89.0
|
31.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 55.0
|
31.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 79.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 22.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_IFN- γ, Week 28
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 36.0
|
12.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 31.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 35.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 48.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_IFN- γ, Week 30
|
59.0 Nef-specific CD4+ T-cells/million cells
Interval 23.0 to 133.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 36.5
|
—
|
7.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 42.5
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_IFN- γ, Week 48
|
10.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 46.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 31.0
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 32.5
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
TNF-α_IL-2, Week 6
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 27.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 23.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 26.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
TNF-α_IL-2, Week 30
|
7.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 55.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
TNF-α_IL-2, Week 48
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 20.5
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
IFN- γ_IL-2, Pre-vaccination
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
IFN- γ_IL-2, Week 6
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 14.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 12.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
IFN- γ_IL-2, Week 28
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
IFN- γ_IL-2, Week 30
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
IFN- γ_IL-2, Week 48
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
TNF-α_IFN- γ, Week 28
|
18.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 43.0
|
3.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 96.0
|
15.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 59.5
|
24.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 60.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_IFN- γ_IL-2, Pre-vaccination
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_IFN- γ_IL-2, Week 6
|
44.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 111.0
|
6.5 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 93.0
|
22.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 102.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_IFN- γ_IL-2, Week 28
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 21.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 26.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 22.5
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_IFN- γ_IL-2, Week 30
|
74.5 Nef-specific CD4+ T-cells/million cells
Interval 18.0 to 169.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 12.0
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ, Pre-vaccination
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 15.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 23.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 16.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 37.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ, Week 30
|
43.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 120.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 23.0
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 33.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ, Week 48
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 37.5
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 33.0
|
—
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 40.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
TNF-α_IFN- γ_IL-2, Pre-vaccination
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.
The cytokine co-expression profile was defined by the frequency of P17-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).
Outcome measures
| Measure |
3D_HIV Group
n=41 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=42 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=79 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=37 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L, Week 6
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 152.5
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 340.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 212.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 123.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
IL-2, Pre-vaccination
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 72.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 23.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 43.0
|
9.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 34.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
TNF-α, Week 6
|
26.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 147.0
|
41.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 99.0
|
36.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 130.0
|
31.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 175.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
IFN- γ_IL-2, Week 30
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
TNF-α_IFN- γ, Week 6
|
7.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 35.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 28.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 33.0
|
22.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 61.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
TNF-α_IFN- γ, Week 48
|
2.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 25.0
|
11.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 28.0
|
—
|
24.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 57.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_IFN- γ_IL-2, Week 6
|
26.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 68.5
|
25.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 54.0
|
25.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 61.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 18.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_IFN- γ_IL-2, Week 48
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 29.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 17.0
|
—
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 21.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ, Week 6
|
54.5 P17-specific CD4+ T-cells/million T-cell
Interval 10.5 to 131.5
|
35.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 86.0
|
42.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 118.0
|
37.5 P17-specific CD4+ T-cells/million T-cell
Interval 17.0 to 87.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ, Week 30
|
59.0 P17-specific CD4+ T-cells/million T-cell
Interval 38.0 to 95.0
|
40.0 P17-specific CD4+ T-cells/million T-cell
Interval 13.0 to 94.0
|
—
|
39.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 88.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_IFN- γ_IL-2, Week 28
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 22.0
|
18.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 34.0
|
12.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 28.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 20.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_IFN- γ_IL-2, Week 30
|
20.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 45.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 35.0
|
—
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 24.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ, Pre-vaccination
|
37.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 96.0
|
35.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 64.0
|
35.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 85.0
|
37.0 P17-specific CD4+ T-cells/million T-cell
Interval 7.0 to 86.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
IFN- γ, Pre-vaccination
|
51.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 123.0
|
71.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 131.0
|
55.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 127.0
|
76.0 P17-specific CD4+ T-cells/million T-cell
Interval 5.0 to 215.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
IFN- γ, Week 6
|
88.5 P17-specific CD4+ T-cells/million T-cell
Interval 7.0 to 135.0
|
75.5 P17-specific CD4+ T-cells/million T-cell
Interval 19.0 to 147.0
|
83.0 P17-specific CD4+ T-cells/million T-cell
Interval 15.0 to 142.0
|
88.0 P17-specific CD4+ T-cells/million T-cell
Interval 28.0 to 255.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
IFN- γ, Week 28
|
44.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 92.0
|
82.0 P17-specific CD4+ T-cells/million T-cell
Interval 22.0 to 158.0
|
65.5 P17-specific CD4+ T-cells/million T-cell
Interval 11.0 to 121.0
|
73.0 P17-specific CD4+ T-cells/million T-cell
Interval 10.0 to 199.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L, Pre-vaccination
|
180.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 440.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 240.0
|
68.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 380.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 311.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L, Week 28
|
100.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 270.0
|
60.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 200.0
|
80.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 257.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 230.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L, Week 30
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 440.0
|
133.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 420.0
|
—
|
198.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 415.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L, Week 48
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 390.0
|
72.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 370.0
|
—
|
150.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 385.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
IFN- γ, Week 30
|
77.0 P17-specific CD4+ T-cells/million T-cell
Interval 12.0 to 132.0
|
54.0 P17-specific CD4+ T-cells/million T-cell
Interval 14.0 to 179.0
|
—
|
57.5 P17-specific CD4+ T-cells/million T-cell
Interval 36.0 to 146.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
IFN- γ, Week 48
|
72.0 P17-specific CD4+ T-cells/million T-cell
Interval 6.0 to 123.0
|
74.0 P17-specific CD4+ T-cells/million T-cell
Interval 15.0 to 134.0
|
—
|
84.5 P17-specific CD4+ T-cells/million T-cell
Interval 22.0 to 180.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_IL-2, Pre-vaccination
|
31.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 63.0
|
6.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 44.0
|
23.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 63.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 25.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
IL-2, Week 6
|
1.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 34.5
|
20.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 85.0
|
6.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 43.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 45.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
IL-2, Week 28
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 16.0
|
27.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 63.0
|
1.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 39.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 23.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
IFN- γ_IL-2, Pre-vaccination
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
IFN- γ_IL-2, Week 6
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
IFN- γ_IL-2, Week 28
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
IFN- γ_IL-2, Week 48
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
TNF-α_IFN- γ, Pre-vaccination
|
19.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 40.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 41.0
|
16.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 41.0
|
26.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 61.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
TNF-α_IFN- γ, Week 28
|
22.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 34.0
|
23.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 64.0
|
22.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 42.5
|
1.00 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 44.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
TNF-α_IFN- γ, Week 30
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 40.0
|
20.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 45.0
|
—
|
14.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 80.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IL-2, Pre-vaccination
|
4.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 42.0
|
16.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 43.0
|
10.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 43.0
|
26.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 56.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IL-2, Week 6
|
88.0 P17-specific CD4+ T-cells/million T-cell
Interval 3.0 to 124.5
|
64.5 P17-specific CD4+ T-cells/million T-cell
Interval 33.0 to 118.0
|
73.5 P17-specific CD4+ T-cells/million T-cell
Interval 24.0 to 122.0
|
25.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 47.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IL-2, Week 28
|
51.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 72.0
|
25.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 66.0
|
31.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 71.5
|
6.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 40.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IL-2, Week 30
|
44.0 P17-specific CD4+ T-cells/million T-cell
Interval 2.0 to 156.0
|
33.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 63.0
|
—
|
17.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 50.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IL-2, Week 48
|
33.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 67.0
|
15.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 68.0
|
—
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 38.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_IFN- γ_IL-2, Pre-vaccination
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 30.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 30.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 30.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 29.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ, Week 28
|
32.5 P17-specific CD4+ T-cells/million T-cell
Interval 4.0 to 45.0
|
28.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 92.0
|
30.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 54.5
|
26.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 99.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_IL-2, Week 6
|
58.5 P17-specific CD4+ T-cells/million T-cell
Interval 3.0 to 107.0
|
21.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 65.0
|
33.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 101.0
|
19.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 62.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_IL-2, Week 28
|
34.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 69.0
|
20.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 54.0
|
28.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 62.5
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 27.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_IL-2, Week 30
|
56.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 101.0
|
14.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 60.0
|
—
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 38.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_IL-2, Week 48
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 37.0
|
42.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 88.0
|
—
|
34.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 63.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_TNF-α, Pre-vaccination
|
24.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 74.0
|
16.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 74.0
|
21.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 74.0
|
6.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 38.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_TNF-α, Week 6
|
58.5 P17-specific CD4+ T-cells/million T-cell
Interval 3.0 to 145.0
|
34.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 88.0
|
45.0 P17-specific CD4+ T-cells/million T-cell
Interval 2.0 to 118.0
|
30.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 67.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_TNF-α, Week 28
|
39.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 102.0
|
6.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 57.0
|
23.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 64.5
|
26.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 47.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_TNF-α, Week 30
|
26.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 68.0
|
22.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 66.0
|
—
|
21.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 85.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_TNF-α, Week 48
|
11.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 51.0
|
20.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 78.0
|
—
|
32.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 91.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_IFN- γ, Pre-vaccination
|
41.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 94.0
|
42.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 80.0
|
41.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 94.0
|
48.0 P17-specific CD4+ T-cells/million T-cell
Interval 29.0 to 149.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_IFN- γ, Week 6
|
76.0 P17-specific CD4+ T-cells/million T-cell
Interval 28.0 to 126.5
|
42.0 P17-specific CD4+ T-cells/million T-cell
Interval 17.0 to 96.0
|
56.0 P17-specific CD4+ T-cells/million T-cell
Interval 25.0 to 113.0
|
70.0 P17-specific CD4+ T-cells/million T-cell
Interval 44.0 to 149.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_IFN- γ, Week 28
|
33.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 93.0
|
49.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 132.0
|
41.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 117.5
|
64.0 P17-specific CD4+ T-cells/million T-cell
Interval 40.0 to 125.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_IFN- γ, Week 30
|
79.0 P17-specific CD4+ T-cells/million T-cell
Interval 39.0 to 169.0
|
35.0 P17-specific CD4+ T-cells/million T-cell
Interval 22.0 to 84.0
|
—
|
56.0 P17-specific CD4+ T-cells/million T-cell
Interval 22.5 to 146.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_IFN- γ, Week 48
|
44.0 P17-specific CD4+ T-cells/million T-cell
Interval 21.0 to 101.0
|
43.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 108.0
|
—
|
49.0 P17-specific CD4+ T-cells/million T-cell
Interval 22.5 to 95.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
TNF-α_IL-2, Pre-vaccination
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 16.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 16.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
TNF-α_IL-2, Week 6
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 14.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 25.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 20.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
TNF-α_IL-2, Week 28
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 14.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 18.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 16.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
TNF-α_IL-2, Week 30
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 30.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
TNF-α_IL-2, Week 48
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 22.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 19.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
IL-2, Week 30
|
12.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 44.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 33.0
|
—
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 26.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
IL-2, Week 48
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 33.0
|
9.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 43.0
|
—
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 29.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
TNF-α, Pre-vaccination
|
24.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 93.0
|
25.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 166.0
|
25.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 130.0
|
13.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 165.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
TNF-α, Week 28
|
57.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 155.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 101.0
|
26.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 122.5
|
27.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 89.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
TNF-α, Week 30
|
51.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 162.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 82.0
|
—
|
1.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 171.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
TNF-α, Week 48
|
4.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 110.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 88.0
|
—
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 155.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ, Week 48
|
26.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 100.0
|
16.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 55.0
|
—
|
22.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 90.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
TNF-α_IFN- γ_IL-2, Pre-vaccination
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
TNF-α_IFN- γ_IL-2, Week 6
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
TNF-α_IFN- γ_IL-2, Week 28
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
TNF-α_IFN- γ_IL-2, Week 30
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
TNF-α_IFN- γ_IL-2, Week 48
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Pre-vaccination
|
22.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 41.0
|
8.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 50.0
|
20.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 43.0
|
12.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 56.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 6
|
50.0 P17-specific CD4+ T-cells/million T-cell
Interval 2.5 to 121.5
|
71.5 P17-specific CD4+ T-cells/million T-cell
Interval 31.0 to 123.0
|
64.0 P17-specific CD4+ T-cells/million T-cell
Interval 23.0 to 123.0
|
30.5 P17-specific CD4+ T-cells/million T-cell
Interval 3.0 to 63.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 28
|
22.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 34.0
|
8.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 69.0
|
21.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 57.5
|
25.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 45.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 30
|
46.0 P17-specific CD4+ T-cells/million T-cell
Interval 21.0 to 125.0
|
13.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 105.0
|
—
|
27.5 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 60.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 48
|
42.0 P17-specific CD4+ T-cells/million T-cell
Interval 22.0 to 74.0
|
25.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 51.0
|
—
|
14.0 P17-specific CD4+ T-cells/million T-cell
Interval 1.0 to 41.0
|
SECONDARY outcome
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.
The cytokine co-expression profile was defined by the frequency of P24-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).
Outcome measures
| Measure |
3D_HIV Group
n=41 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=42 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=79 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=37 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L, Week 28
|
125.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 380.0
|
194.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 408.0
|
165.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 394.0
|
15.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 380.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L, Week 48
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 282.0
|
160.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 569.0
|
—
|
125.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 490.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
IL-2, Week 30
|
22.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 74.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 37.0
|
—
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 32.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
IL-2, Week 48
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 25.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 32.0
|
—
|
19.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 60.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
TNF-α, Pre-vaccination
|
79.0 P24-specific CD4+ T-cells/million cells
Interval 13.0 to 172.0
|
11.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 134.0
|
58.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 168.0
|
21.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 153.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
TNF-α, Week 48
|
67.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 258.0
|
40.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 89.0
|
—
|
12.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 182.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
IFN- γ, Week 48
|
96.0 P24-specific CD4+ T-cells/million cells
Interval 47.0 to 235.0
|
171.0 P24-specific CD4+ T-cells/million cells
Interval 74.0 to 323.0
|
—
|
266.0 P24-specific CD4+ T-cells/million cells
Interval 89.5 to 621.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_IL-2, Week 6
|
45.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 163.0
|
36.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 119.0
|
41.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 129.0
|
17.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 61.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_IL-2, Week 28
|
31.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 79.0
|
31.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 86.0
|
31.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 84.0
|
13.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 46.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_TNF-α, Pre-vaccination
|
68.0 P24-specific CD4+ T-cells/million cells
Interval 39.0 to 104.0
|
30.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 73.0
|
58.0 P24-specific CD4+ T-cells/million cells
Interval 2.0 to 95.0
|
38.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 92.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
TNF-α_IFN- γ, Pre-vaccination
|
22.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 61.0
|
42.0 P24-specific CD4+ T-cells/million cells
Interval 19.0 to 86.0
|
35.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 80.0
|
53.0 P24-specific CD4+ T-cells/million cells
Interval 26.0 to 173.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
TNF-α_IFN- γ, Week 6
|
34.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 82.0
|
34.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 64.0
|
34.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 70.0
|
56.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 254.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
TNF-α_IFN- γ, Week 28
|
28.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 65.0
|
41.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 107.0
|
33.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 87.5
|
29.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 223.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
TNF-α_IFN- γ, Week 48
|
24.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 59.0
|
40.0 P24-specific CD4+ T-cells/million cells
Interval 20.0 to 76.0
|
—
|
46.0 P24-specific CD4+ T-cells/million cells
Interval 3.5 to 101.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IL-2, Week 6
|
98.0 P24-specific CD4+ T-cells/million cells
Interval 22.5 to 185.0
|
80.0 P24-specific CD4+ T-cells/million cells
Interval 51.0 to 162.0
|
87.0 P24-specific CD4+ T-cells/million cells
Interval 25.0 to 170.0
|
29.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 87.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IL-2, Week 30
|
79.5 P24-specific CD4+ T-cells/million cells
Interval 29.0 to 172.0
|
44.0 P24-specific CD4+ T-cells/million cells
Interval 13.0 to 97.0
|
—
|
32.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 98.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IL-2, Week 48
|
78.0 P24-specific CD4+ T-cells/million cells
Interval 10.0 to 112.0
|
31.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 103.0
|
—
|
45.0 P24-specific CD4+ T-cells/million cells
Interval 4.0 to 78.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_IFN- γ_IL-2, Pre-vaccination
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 24.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 44.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 30.0
|
16.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 32.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_IFN- γ_IL-2, Week 6
|
30.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 59.5
|
30.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 63.0
|
30.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 60.0
|
29.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 57.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_IFN- γ_IL-2, Week 28
|
19.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 39.0
|
21.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 58.0
|
21.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 43.0
|
2.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 27.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_IFN- γ_IL-2, Week 30
|
41.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 91.0
|
14.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 69.0
|
—
|
17.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 41.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_IFN- γ_IL-2, Week 48
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 55.0
|
21.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 54.0
|
—
|
16.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 55.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ, Pre-vaccination
|
59.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 161.0
|
85.5 P24-specific CD4+ T-cells/million cells
Interval 15.0 to 149.0
|
72.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 150.0
|
71.0 P24-specific CD4+ T-cells/million cells
Interval 33.0 to 212.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ, Week 6
|
68.0 P24-specific CD4+ T-cells/million cells
Interval 34.0 to 159.5
|
84.5 P24-specific CD4+ T-cells/million cells
Interval 30.0 to 147.0
|
74.5 P24-specific CD4+ T-cells/million cells
Interval 31.0 to 147.0
|
62.5 P24-specific CD4+ T-cells/million cells
Interval 20.0 to 158.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ, Week 28
|
70.0 P24-specific CD4+ T-cells/million cells
Interval 24.0 to 121.0
|
54.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 173.0
|
58.5 P24-specific CD4+ T-cells/million cells
Interval 10.5 to 125.5
|
59.0 P24-specific CD4+ T-cells/million cells
Interval 7.0 to 138.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
TNF-α_IFN- γ_IL-2, Pre-vaccination
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
TNF-α_IFN- γ_IL-2, Week 6
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 16.5
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 22.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 20.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
TNF-α_IFN- γ_IL-2, Week 30
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 6
|
62.5 P24-specific CD4+ T-cells/million cells
Interval 3.5 to 128.5
|
58.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 120.0
|
59.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 120.0
|
52.5 P24-specific CD4+ T-cells/million cells
Interval 17.0 to 85.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L, Pre-vaccination
|
115.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 384.0
|
65.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 404.0
|
114.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 404.0
|
70.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 420.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L, Week 6
|
86.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 345.5
|
140.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 470.0
|
110.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 400.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 470.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L, Week 30
|
22.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 290.0
|
110.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 398.0
|
—
|
130.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 416.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_IFN- γ, Week 48
|
79.0 P24-specific CD4+ T-cells/million cells
Interval 42.0 to 200.0
|
102.0 P24-specific CD4+ T-cells/million cells
Interval 44.0 to 204.0
|
—
|
99.5 P24-specific CD4+ T-cells/million cells
Interval 49.5 to 200.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
IL-2, Pre-vaccination
|
21.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 59.0
|
3.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 49.0
|
5.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 55.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 33.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
IL-2, Week 6
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 58.5
|
6.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 37.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 44.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 24.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
IL-2, Week 28
|
2.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 32.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 44.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 34.5
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 29.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
TNF-α, Week 6
|
24.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 103.0
|
32.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 126.0
|
32.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 109.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 133.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
TNF-α, Week 28
|
34.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 120.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 32.0
|
4.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 64.0
|
39.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 180.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
TNF-α, Week 30
|
65.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 234.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 148.0
|
—
|
20.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 171.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
IFN- γ, Pre-vaccination
|
124.0 P24-specific CD4+ T-cells/million cells
Interval 53.0 to 249.0
|
112.0 P24-specific CD4+ T-cells/million cells
Interval 46.0 to 275.0
|
124.0 P24-specific CD4+ T-cells/million cells
Interval 46.0 to 275.0
|
164.0 P24-specific CD4+ T-cells/million cells
Interval 105.0 to 561.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
IFN- γ, Week 6
|
139.0 P24-specific CD4+ T-cells/million cells
Interval 50.5 to 242.0
|
125.0 P24-specific CD4+ T-cells/million cells
Interval 62.0 to 320.0
|
128.5 P24-specific CD4+ T-cells/million cells
Interval 59.0 to 267.0
|
233.5 P24-specific CD4+ T-cells/million cells
Interval 123.0 to 653.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
IFN- γ, Week 28
|
99.5 P24-specific CD4+ T-cells/million cells
Interval 53.0 to 199.0
|
118.5 P24-specific CD4+ T-cells/million cells
Interval 45.0 to 326.0
|
105.0 P24-specific CD4+ T-cells/million cells
Interval 51.5 to 282.5
|
271.0 P24-specific CD4+ T-cells/million cells
Interval 75.0 to 494.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
TNF-α_IL-2, Pre-vaccination
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 13.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 13.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
TNF-α_IL-2, Week 6
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 24.0
|
1.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 29.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 29.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
TNF-α_IL-2, Week 28
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 16.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 13.5
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
TNF-α_IL-2, Week 30
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 15.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 14.0
|
—
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
TNF-α_IL-2, Week 48
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 21.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 12.0
|
—
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
IFN- γ_IL-2, Pre-vaccination
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
IFN- γ_IL-2, Week 6
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
IFN- γ_IL-2, Week 28
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
IFN- γ_IL-2, Week 30
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 22.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
IFN- γ_IL-2, Week 48
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
IFN- γ, Week 30
|
157.5 P24-specific CD4+ T-cells/million cells
Interval 60.0 to 290.0
|
167.0 P24-specific CD4+ T-cells/million cells
Interval 61.0 to 375.0
|
—
|
224.5 P24-specific CD4+ T-cells/million cells
Interval 67.5 to 432.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_IL-2, Pre-vaccination
|
43.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 81.0
|
22.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 51.0
|
35.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 67.0
|
22.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 54.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_IL-2, Week 30
|
46.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 74.0
|
51.0 P24-specific CD4+ T-cells/million cells
Interval 12.0 to 83.0
|
—
|
9.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 67.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_IL-2, Week 48
|
30.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 108.0
|
34.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 80.0
|
—
|
2.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 38.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_TNF-α, Week 6
|
55.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 105.5
|
72.0 P24-specific CD4+ T-cells/million cells
Interval 15.0 to 108.0
|
64.5 P24-specific CD4+ T-cells/million cells
Interval 8.0 to 108.0
|
26.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 89.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_TNF-α, Week 28
|
49.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 111.0
|
13.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 61.0
|
29.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 82.5
|
46.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 112.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_TNF-α, Week 30
|
86.5 P24-specific CD4+ T-cells/million cells
Interval 15.0 to 165.0
|
48.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 90.0
|
—
|
61.5 P24-specific CD4+ T-cells/million cells
Interval 2.5 to 124.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_TNF-α, Week 48
|
63.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 130.0
|
6.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 137.0
|
—
|
48.0 P24-specific CD4+ T-cells/million cells
Interval 14.0 to 109.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_IFN- γ, Pre-vaccination
|
127.0 P24-specific CD4+ T-cells/million cells
Interval 60.0 to 200.0
|
96.5 P24-specific CD4+ T-cells/million cells
Interval 43.0 to 199.0
|
119.0 P24-specific CD4+ T-cells/million cells
Interval 45.0 to 200.0
|
120.0 P24-specific CD4+ T-cells/million cells
Interval 48.0 to 319.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
TNF-α_IFN- γ, Week 30
|
26.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 75.0
|
43.0 P24-specific CD4+ T-cells/million cells
Interval 15.0 to 72.0
|
—
|
52.0 P24-specific CD4+ T-cells/million cells
Interval 7.0 to 211.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IL-2, Pre-vaccination
|
19.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 73.0
|
20.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 55.0
|
20.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 65.0
|
36.0 P24-specific CD4+ T-cells/million cells
Interval 2.0 to 65.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IL-2, Week 28
|
41.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 130.0
|
36.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 102.0
|
39.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 105.0
|
25.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 55.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ, Week 30
|
83.5 P24-specific CD4+ T-cells/million cells
Interval 37.0 to 162.0
|
57.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 125.0
|
—
|
83.5 P24-specific CD4+ T-cells/million cells
Interval 26.0 to 165.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ, Week 48
|
64.0 P24-specific CD4+ T-cells/million cells
Interval 30.0 to 157.0
|
61.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 122.0
|
—
|
68. P24-specific CD4+ T-cells/million cells
Interval 28.5 to 133.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
TNF-α_IFN- γ_IL-2, Week 28
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 18.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
TNF-α_IFN- γ_IL-2, Week 48
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 20.0
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 19.0
|
—
|
1.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Pre-vaccination
|
41.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 88.0
|
38.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 67.0
|
40.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 79.0
|
36.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 85.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 28
|
52.0 P24-specific CD4+ T-cells/million cells
Interval 28.0 to 104.0
|
41.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 88.0
|
49.5 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 90.0
|
27.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 118.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 30
|
85.5 P24-specific CD4+ T-cells/million cells
Interval 23.0 to 206.0
|
46.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 118.0
|
—
|
24.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 62.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 48
|
57.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 143.0
|
53.0 P24-specific CD4+ T-cells/million cells
Interval 11.0 to 86.0
|
—
|
24.0 P24-specific CD4+ T-cells/million cells
Interval 1.0 to 84.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_IFN- γ, Week 6
|
122.5 P24-specific CD4+ T-cells/million cells
Interval 50.5 to 201.5
|
81.5 P24-specific CD4+ T-cells/million cells
Interval 41.0 to 240.0
|
98.0 P24-specific CD4+ T-cells/million cells
Interval 43.0 to 218.0
|
129.5 P24-specific CD4+ T-cells/million cells
Interval 68.0 to 312.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_IFN- γ, Week 28
|
87.5 P24-specific CD4+ T-cells/million cells
Interval 46.0 to 203.0
|
94.0 P24-specific CD4+ T-cells/million cells
Interval 44.0 to 168.0
|
89.0 P24-specific CD4+ T-cells/million cells
Interval 45.0 to 186.0
|
106.0 P24-specific CD4+ T-cells/million cells
Interval 61.0 to 210.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
CD40L_IFN- γ, Week 30
|
113.5 P24-specific CD4+ T-cells/million cells
Interval 65.0 to 195.0
|
106.0 P24-specific CD4+ T-cells/million cells
Interval 53.0 to 231.0
|
—
|
137.5 P24-specific CD4+ T-cells/million cells
Interval 61.0 to 202.5
|
SECONDARY outcome
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.
The cytokine co-expression profile was defined by the frequency of reverse transcriptase (RT)-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).
Outcome measures
| Measure |
3D_HIV Group
n=41 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=42 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=79 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=37 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
IL-2, Pre-vaccination
|
21.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 62.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 24.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 62.0
|
9.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 59.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
IL-2, Week 6
|
34.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 121.0
|
12.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 50.0
|
14.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 63.5
|
13.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 35.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
IL-2, Week 28
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 66.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 50.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 62.5
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 3.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
TNF-α, Week 30
|
85.0 RT-specific CD4+ T-cells/million cells
Interval 3.0 to 250.0
|
11.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 133.0
|
—
|
41.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 171.5
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
TNF-α, Week 48
|
59.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 180.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 87.0
|
—
|
30.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 127.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
IFN- γ, Pre-vaccination
|
21.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 75.0
|
25.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 108.0
|
23.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 89.0
|
45.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 70.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_IL-2, Week 28
|
64.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 143.0
|
80.0 RT-specific CD4+ T-cells/million cells
Interval 20.0 to 148.0
|
77.5 RT-specific CD4+ T-cells/million cells
Interval 5.0 to 145.5
|
15.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 36.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
TNF-α_IL-2, Week 6
|
22.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 57.0
|
24.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 55.0
|
22.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 56.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
TNF-α_IL-2, Week 28
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 25.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 21.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 23.5
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 16.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
TNF-α_IL-2, Week 30
|
7.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 64.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 16.0
|
—
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
TNF-α_IL-2, Week 48
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 39.5
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_TNF-α_IL-2, Week 28
|
142.0 RT-specific CD4+ T-cells/million cells
Interval 65.0 to 353.0
|
95.0 RT-specific CD4+ T-cells/million cells
Interval 36.0 to 185.0
|
121.5 RT-specific CD4+ T-cells/million cells
Interval 40.5 to 227.0
|
49.0 RT-specific CD4+ T-cells/million cells
Interval 3.0 to 66.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_TNF-α_IL-2, Week 30
|
491.0 RT-specific CD4+ T-cells/million cells
Interval 226.0 to 878.0
|
91.0 RT-specific CD4+ T-cells/million cells
Interval 34.0 to 245.0
|
—
|
76.0 RT-specific CD4+ T-cells/million cells
Interval 22.0 to 101.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_IFN- γ_IL-2, Pre-vaccination
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 38.0
|
6.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 28.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 32.0
|
9.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 24.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_IFN- γ_IL-2, Week 6
|
141.0 RT-specific CD4+ T-cells/million cells
Interval 22.0 to 284.0
|
96.0 RT-specific CD4+ T-cells/million cells
Interval 46.0 to 239.0
|
123.5 RT-specific CD4+ T-cells/million cells
Interval 26.5 to 261.5
|
14.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 43.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
TNF-α_IFN- γ_IL-2, Week 30
|
7.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 51.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L, Week 48
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 359.0
|
44.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 423.0
|
—
|
30.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 328.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
IL-2, Week 30
|
25.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 101.0
|
5.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 49.0
|
—
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 48.5
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
IL-2, Week 48
|
20.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 55.5
|
8.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 48.0
|
—
|
4.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 30.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
TNF-α, Pre-vaccination
|
61.0 RT-specific CD4+ T-cells/million cells
Interval 17.0 to 106.0
|
18.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 199.0
|
40.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 170.0
|
46.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 233.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
TNF-α, Week 6
|
78.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 285.0
|
69.0 RT-specific CD4+ T-cells/million cells
Interval 13.0 to 126.0
|
73.5 RT-specific CD4+ T-cells/million cells
Interval 1.5 to 172.5
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 116.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
TNF-α, Week 28
|
40.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 136.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 62.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 72.0
|
41.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 112.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
IFN- γ, Week 6
|
85.0 RT-specific CD4+ T-cells/million cells
Interval 32.0 to 159.0
|
27.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 106.0
|
65.0 RT-specific CD4+ T-cells/million cells
Interval 10.5 to 144.0
|
28.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 64.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
IFN- γ, Week 28
|
18.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 96.0
|
27.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 77.0
|
21.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 90.5
|
44.0 RT-specific CD4+ T-cells/million cells
Interval 9.0 to 97.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
IFN- γ, Week 30
|
57.5 RT-specific CD4+ T-cells/million cells
Interval 27.0 to 125.0
|
40.0 RT-specific CD4+ T-cells/million cells
Interval 3.0 to 90.0
|
—
|
47.0 RT-specific CD4+ T-cells/million cells
Interval 6.0 to 88.5
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
IFN- γ, Week 48
|
42.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 84.0
|
46.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 114.0
|
—
|
55.0 RT-specific CD4+ T-cells/million cells
Interval 10.0 to 92.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_IL-2, Pre-vaccination
|
44.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 108.0
|
43.5 RT-specific CD4+ T-cells/million cells
Interval 5.0 to 85.0
|
44.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 95.0
|
11.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 49.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_IL-2, Week 6
|
183.0 RT-specific CD4+ T-cells/million cells
Interval 56.0 to 450.0
|
179.0 RT-specific CD4+ T-cells/million cells
Interval 78.0 to 277.0
|
181.0 RT-specific CD4+ T-cells/million cells
Interval 66.0 to 380.5
|
27.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 90.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_IL-2, Week 30
|
118.5 RT-specific CD4+ T-cells/million cells
Interval 84.0 to 352.0
|
57.0 RT-specific CD4+ T-cells/million cells
Interval 5.0 to 153.0
|
—
|
30.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 66.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_IL-2, Week 48
|
63.0 RT-specific CD4+ T-cells/million cells
Interval 12.5 to 126.5
|
45.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 105.0
|
—
|
3.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 62.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_TNF-α, Pre-vaccination
|
36.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 99.0
|
39.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 68.0
|
37.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 86.0
|
30.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 78.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_TNF-α, Week 6
|
156.0 RT-specific CD4+ T-cells/million cells
Interval 79.0 to 293.0
|
116.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 197.0
|
132.5 RT-specific CD4+ T-cells/million cells
Interval 46.5 to 219.5
|
32.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 64.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_TNF-α, Week 28
|
35.5 RT-specific CD4+ T-cells/million cells
Interval 2.0 to 76.0
|
22.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 95.0
|
30.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 89.5
|
28.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 73.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_TNF-α, Week 30
|
175.0 RT-specific CD4+ T-cells/million cells
Interval 54.0 to 229.0
|
23.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 60.0
|
—
|
36.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 93.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_TNF-α, Week 48
|
39.0 RT-specific CD4+ T-cells/million cells
Interval 1.5 to 99.5
|
31.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 80.0
|
—
|
39.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 163.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_IFN- γ, Pre-vaccination
|
26.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 42.0
|
17.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 64.0
|
22.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 58.0
|
23.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 55.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_IFN- γ, Week 6
|
89.0 RT-specific CD4+ T-cells/million cells
Interval 44.0 to 192.0
|
76.0 RT-specific CD4+ T-cells/million cells
Interval 29.0 to 154.0
|
81.0 RT-specific CD4+ T-cells/million cells
Interval 36.0 to 176.5
|
31.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 67.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_IFN- γ, Week 28
|
15.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 45.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 54.0
|
5.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 50.0
|
23.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 52.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_IFN- γ, Week 30
|
71.0 RT-specific CD4+ T-cells/million cells
Interval 22.0 to 177.0
|
22.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 45.0
|
—
|
28.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 61.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_IFN- γ, Week 48
|
31.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 46.0
|
7.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 36.0
|
—
|
30.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 57.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
TNF-α_IL-2, Pre-vaccination
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 15.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 14.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
IFN- γ_IL-2, Pre-vaccination
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
IFN- γ_IL-2, Week 6
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 16.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 14.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 15.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
IFN- γ_IL-2, Week 28
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
IFN- γ_IL-2, Week 30
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 14.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
IFN- γ_IL-2, Week 48
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
TNF-α_IFN- γ, Pre-vaccination
|
7.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 37.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 29.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 37.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 48.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
TNF-α_IFN- γ, Week 6
|
35.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 66.0
|
17.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 58.0
|
27.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 61.5
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 48.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
TNF-α_IFN- γ, Week 28
|
9.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 31.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 34.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 32.5
|
19.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 40.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
TNF-α_IFN- γ, Week 30
|
22.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 75.0
|
16.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 41.0
|
—
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 35.5
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
TNF-α_IFN- γ, Week 48
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 32.5
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 13.0
|
—
|
13.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 41.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_TNF-α_IL-2, Pre-vaccination
|
23.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 59.0
|
25.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 68.0
|
23.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 68.0
|
23.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 70.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_TNF-α_IL-2, Week 6
|
476.0 RT-specific CD4+ T-cells/million cells
Interval 182.0 to 1046.0
|
315.0 RT-specific CD4+ T-cells/million cells
Interval 129.0 to 623.0
|
346.5 RT-specific CD4+ T-cells/million cells
Interval 168.0 to 734.5
|
43.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 91.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_TNF-α_IL-2, Week 48
|
185.0 RT-specific CD4+ T-cells/million cells
Interval 58.5 to 361.5
|
66.0 RT-specific CD4+ T-cells/million cells
Interval 2.0 to 120.0
|
—
|
20.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 39.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_IFN- γ_IL-2, Week 28
|
26.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 45.0
|
17.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 51.0
|
21.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 51.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 27.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_IFN- γ_IL-2, Week 30
|
131.0 RT-specific CD4+ T-cells/million cells
Interval 42.0 to 289.0
|
20.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 57.0
|
—
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 28.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_IFN- γ_IL-2, Week 48
|
21.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 60.0
|
11.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 51.0
|
—
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 26.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ, Pre-vaccination
|
18.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 35.0
|
1.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 22.0
|
14.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 31.0
|
27.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 50.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ, Week 6
|
141.0 RT-specific CD4+ T-cells/million cells
Interval 59.0 to 227.0
|
64.0 RT-specific CD4+ T-cells/million cells
Interval 24.0 to 113.0
|
90.0 RT-specific CD4+ T-cells/million cells
Interval 30.0 to 175.5
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 54.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ, Week 28
|
14.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 47.0
|
17.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 42.0
|
15.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 44.0
|
19.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 77.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ, Week 30
|
71.5 RT-specific CD4+ T-cells/million cells
Interval 24.0 to 198.0
|
20.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 44.0
|
—
|
22.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 61.5
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ, Week 48
|
25.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 56.5
|
21.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 50.0
|
—
|
21.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 54.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
TNF-α_IFN- γ_IL-2, Pre-vaccination
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
TNF-α_IFN- γ_IL-2, Week 6
|
18.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 45.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 31.0
|
7.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 42.5
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
TNF-α_IFN- γ_IL-2, Week 28
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 18.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 9.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
TNF-α_IFN- γ_IL-2, Week 48
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 18.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Pre-vaccination
|
29.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 59.0
|
14.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 46.0
|
20.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 55.0
|
23.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 70.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 6
|
371.0 RT-specific CD4+ T-cells/million cells
Interval 203.0 to 837.0
|
262.0 RT-specific CD4+ T-cells/million cells
Interval 128.0 to 665.0
|
337.0 RT-specific CD4+ T-cells/million cells
Interval 131.0 to 747.5
|
56.0 RT-specific CD4+ T-cells/million cells
Interval 14.0 to 108.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 28
|
100.5 RT-specific CD4+ T-cells/million cells
Interval 36.0 to 192.0
|
70.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 172.0
|
85.5 RT-specific CD4+ T-cells/million cells
Interval 29.0 to 182.0
|
18.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 55.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 30
|
459.5 RT-specific CD4+ T-cells/million cells
Interval 198.0 to 963.0
|
48.0 RT-specific CD4+ T-cells/million cells
Interval 6.0 to 164.0
|
—
|
34.5 RT-specific CD4+ T-cells/million cells
Interval 2.0 to 86.5
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 48
|
96.0 RT-specific CD4+ T-cells/million cells
Interval 21.0 to 262.5
|
58.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 121.0
|
—
|
33.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 55.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L, Pre-vaccination
|
24.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 701.0
|
78.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 472.0
|
41.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 590.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 380.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L, Week 6
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 460.0
|
40.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 260.0
|
20.5 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 285.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 150.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L, Week 28
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 230.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 200.0
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 206.5
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 207.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
CD40L, Week 30
|
1.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 350.0
|
90.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 441.0
|
—
|
135.0 RT-specific CD4+ T-cells/million cells
Interval 1.0 to 365.0
|
SECONDARY outcome
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.
The cytokine co-expression profile was defined by the frequency of F4co-Computed CD8+ T-cells \[Frequency of CD8+ T cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD8+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)\] expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.
Outcome measures
| Measure |
3D_HIV Group
n=38 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=40 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=75 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=35 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
IL-2, Week 28
|
192.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 281.0
|
114.5 F4co-Computed CD8+ T-cells/million cells
Interval 41.0 to 247.5
|
124.0 F4co-Computed CD8+ T-cells/million cells
Interval 20.0 to 272.0
|
80.0 F4co-Computed CD8+ T-cells/million cells
Interval 6.0 to 175.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
TNF-α_IFN_IL-2, Week 30
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 27.0
|
22.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 126.0
|
—
|
30.5 F4co-Computed CD8+ T-cells/million cells
Interval 12.0 to 134.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_TNF-α_IFN- γ_IL-2, Week 48
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
—
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
IL-2, Week 30
|
80.5 F4co-Computed CD8+ T-cells/million cells
Interval 11.0 to 162.0
|
152.0 F4co-Computed CD8+ T-cells/million cells
Interval 44.0 to 278.0
|
—
|
74.5 F4co-Computed CD8+ T-cells/million cells
Interval 25.0 to 221.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L, Pre-vaccination
|
79.5 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 264.0
|
204.0 F4co-Computed CD8+ T-cells/million cells
Interval 20.0 to 367.0
|
100.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 281.0
|
223.0 F4co-Computed CD8+ T-cells/million cells
Interval 39.0 to 377.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L, Week 6
|
76.0 F4co-Computed CD8+ T-cells/million cells
Interval 5.0 to 185.0
|
110.5 F4co-Computed CD8+ T-cells/million cells
Interval 18.5 to 376.5
|
96.5 F4co-Computed CD8+ T-cells/million cells
Interval 5.5 to 284.5
|
179.5 F4co-Computed CD8+ T-cells/million cells
Interval 21.0 to 265.5
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L, Week 28
|
167.0 F4co-Computed CD8+ T-cells/million cells
Interval 85.0 to 222.0
|
200.0 F4co-Computed CD8+ T-cells/million cells
Interval 28.5 to 349.0
|
174.0 F4co-Computed CD8+ T-cells/million cells
Interval 55.0 to 275.0
|
108.0 F4co-Computed CD8+ T-cells/million cells
Interval 34.0 to 233.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L, Week 30
|
197.5 F4co-Computed CD8+ T-cells/million cells
Interval 24.0 to 421.0
|
143.0 F4co-Computed CD8+ T-cells/million cells
Interval 24.0 to 363.0
|
—
|
95.0 F4co-Computed CD8+ T-cells/million cells
Interval 18.0 to 282.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L, Week 48
|
83.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 296.0
|
64.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 224.5
|
—
|
66.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 320.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
IL-2, Pre-vaccination
|
71.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 190.0
|
98.0 F4co-Computed CD8+ T-cells/million cells
Interval 18.0 to 269.0
|
83.0 F4co-Computed CD8+ T-cells/million cells
Interval 7.0 to 236.0
|
81.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 159.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
IL-2, Week 6
|
93.5 F4co-Computed CD8+ T-cells/million cells
Interval 25.5 to 266.0
|
149.0 F4co-Computed CD8+ T-cells/million cells
Interval 51.0 to 265.0
|
119.5 F4co-Computed CD8+ T-cells/million cells
Interval 42.0 to 266.0
|
50.5 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 143.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
IL-2, Week 48
|
84.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 278.0
|
83.5 F4co-Computed CD8+ T-cells/million cells
Interval 6.5 to 155.0
|
—
|
179.0 F4co-Computed CD8+ T-cells/million cells
Interval 18.0 to 315.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
TNF-α, Pre-vaccination
|
183.5 F4co-Computed CD8+ T-cells/million cells
Interval 74.0 to 434.0
|
213.0 F4co-Computed CD8+ T-cells/million cells
Interval 119.0 to 431.0
|
192.0 F4co-Computed CD8+ T-cells/million cells
Interval 82.0 to 434.0
|
314.0 F4co-Computed CD8+ T-cells/million cells
Interval 148.0 to 621.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
TNF-α, Week 6
|
227.0 F4co-Computed CD8+ T-cells/million cells
Interval 24.0 to 326.0
|
267.5 F4co-Computed CD8+ T-cells/million cells
Interval 144.5 to 543.5
|
244.0 F4co-Computed CD8+ T-cells/million cells
Interval 76.0 to 422.5
|
242.5 F4co-Computed CD8+ T-cells/million cells
Interval 94.0 to 585.5
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
TNF-α, Week 28
|
195.0 F4co-Computed CD8+ T-cells/million cells
Interval 44.0 to 484.0
|
158.5 F4co-Computed CD8+ T-cells/million cells
Interval 66.0 to 308.5
|
178.0 F4co-Computed CD8+ T-cells/million cells
Interval 66.0 to 454.0
|
227.0 F4co-Computed CD8+ T-cells/million cells
Interval 90.0 to 561.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
TNF-α, Week 30
|
176.0 F4co-Computed CD8+ T-cells/million cells
Interval 19.0 to 346.0
|
179.0 F4co-Computed CD8+ T-cells/million cells
Interval 22.0 to 416.0
|
—
|
240.0 F4co-Computed CD8+ T-cells/million cells
Interval 112.0 to 600.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
TNF-α, Week 48
|
246.0 F4co-Computed CD8+ T-cells/million cells
Interval 82.0 to 463.0
|
200.5 F4co-Computed CD8+ T-cells/million cells
Interval 30.0 to 527.5
|
—
|
273.0 F4co-Computed CD8+ T-cells/million cells
Interval 21.0 to 508.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
IFN- γ, Pre-vaccination
|
13049.5 F4co-Computed CD8+ T-cells/million cells
Interval 8790.0 to 23850.0
|
16362.0 F4co-Computed CD8+ T-cells/million cells
Interval 10584.0 to 34174.0
|
15324.0 F4co-Computed CD8+ T-cells/million cells
Interval 8820.0 to 27122.0
|
21932.0 F4co-Computed CD8+ T-cells/million cells
Interval 11820.0 to 34367.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
IFN- γ, Week 6
|
15467.0 F4co-Computed CD8+ T-cells/million cells
Interval 8103.0 to 20814.0
|
17126.0 F4co-Computed CD8+ T-cells/million cells
Interval 9396.5 to 35148.0
|
16697.0 F4co-Computed CD8+ T-cells/million cells
Interval 8830.5 to 22174.0
|
25219.0 F4co-Computed CD8+ T-cells/million cells
Interval 14676.0 to 39710.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
IFN- γ, Week 28
|
16351.0 F4co-Computed CD8+ T-cells/million cells
Interval 10308.0 to 26108.0
|
14143.0 F4co-Computed CD8+ T-cells/million cells
Interval 8982.0 to 30999.5
|
14770.0 F4co-Computed CD8+ T-cells/million cells
Interval 9056.0 to 27519.0
|
21406.0 F4co-Computed CD8+ T-cells/million cells
Interval 14414.0 to 31530.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
IFN- γ, Week 30
|
13512.0 F4co-Computed CD8+ T-cells/million cells
Interval 8067.0 to 20647.0
|
14730.0 F4co-Computed CD8+ T-cells/million cells
Interval 8580.0 to 31970.0
|
—
|
25319.5 F4co-Computed CD8+ T-cells/million cells
Interval 14013.0 to 32660.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
IFN- γ, Week 48
|
14423.0 F4co-Computed CD8+ T-cells/million cells
Interval 7680.0 to 25368.0
|
18658.0 F4co-Computed CD8+ T-cells/million cells
Interval 9160.5 to 27347.0
|
—
|
20890.0 F4co-Computed CD8+ T-cells/million cells
Interval 12037.0 to 29108.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_IL-2, Pre-vaccination
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_IL-2, Week 6
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_IL-2, Week 28
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_IL-2, Week 30
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
—
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 16.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_IL-2, Week 48
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
—
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_TNF-α, Pre-vaccination
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 14.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 22.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_TNF-α, Week 6
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 17.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 16.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 16.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 14.5
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_TNF-α, Week 28
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 12.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 14.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 12.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_TNF-α, Week 30
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 25.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 15.0
|
—
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 17.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_TNF-α, Week 48
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 22.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 20.0
|
—
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 19.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_IFN- γ, Pre-vaccination
|
19.5 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 42.0
|
21.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 60.0
|
21.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 51.0
|
35.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 73.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_IFN- γ, Week 6
|
27.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 63.5
|
24.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 52.0
|
25.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 57.5
|
25.5 F4co-Computed CD8+ T-cells/million cells
Interval 10.0 to 57.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_IFN- γ, Week 28
|
23.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 53.0
|
19.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 38.0
|
21.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 44.0
|
22.0 F4co-Computed CD8+ T-cells/million cells
Interval 13.0 to 46.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_IFN- γ, Week 30
|
17.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 37.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 32.0
|
—
|
45.5 F4co-Computed CD8+ T-cells/million cells
Interval 19.0 to 82.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_IFN- γ, Week 48
|
31.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 46.0
|
21.5 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 45.0
|
—
|
28.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 53.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
TNF-α_IL-2, Pre-vaccination
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
TNF-α_IL-2, Week 6
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 9.5
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 20.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
TNF-α_IL-2, Week 28
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 15.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
TNF-α_IL-2, Week 30
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 25.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
—
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 15.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
TNF-α_IL-2, Week 48
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 16.5
|
—
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 15.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
IFN- γ_IL-2, Pre-vaccination
|
72.0 F4co-Computed CD8+ T-cells/million cells
Interval 21.0 to 191.0
|
102.0 F4co-Computed CD8+ T-cells/million cells
Interval 34.0 to 202.0
|
84.0 F4co-Computed CD8+ T-cells/million cells
Interval 28.0 to 202.0
|
117.0 F4co-Computed CD8+ T-cells/million cells
Interval 61.0 to 380.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
IFN- γ_IL-2, Week 6
|
70.0 F4co-Computed CD8+ T-cells/million cells
Interval 19.5 to 139.5
|
111.0 F4co-Computed CD8+ T-cells/million cells
Interval 33.0 to 204.0
|
84.5 F4co-Computed CD8+ T-cells/million cells
Interval 25.5 to 152.5
|
119.0 F4co-Computed CD8+ T-cells/million cells
Interval 39.5 to 507.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
IFN- γ_IL-2, Week 28
|
76.0 F4co-Computed CD8+ T-cells/million cells
Interval 21.0 to 149.0
|
66.5 F4co-Computed CD8+ T-cells/million cells
Interval 32.0 to 245.5
|
71.0 F4co-Computed CD8+ T-cells/million cells
Interval 23.0 to 229.0
|
100.0 F4co-Computed CD8+ T-cells/million cells
Interval 35.0 to 208.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
IFN- γ_IL-2, Week 30
|
51.0 F4co-Computed CD8+ T-cells/million cells
Interval 19.0 to 137.0
|
103.0 F4co-Computed CD8+ T-cells/million cells
Interval 25.0 to 213.0
|
—
|
74.5 F4co-Computed CD8+ T-cells/million cells
Interval 38.0 to 298.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
IFN- γ_IL-2, Week 48
|
68.0 F4co-Computed CD8+ T-cells/million cells
Interval 20.0 to 168.0
|
80.0 F4co-Computed CD8+ T-cells/million cells
Interval 29.0 to 192.5
|
—
|
81.0 F4co-Computed CD8+ T-cells/million cells
Interval 19.0 to 257.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
TNF-α_IFN- γ, Pre-vaccination
|
1049.5 F4co-Computed CD8+ T-cells/million cells
Interval 539.0 to 2678.0
|
1820.0 F4co-Computed CD8+ T-cells/million cells
Interval 841.0 to 2671.0
|
1469.0 F4co-Computed CD8+ T-cells/million cells
Interval 572.0 to 2678.0
|
2095.0 F4co-Computed CD8+ T-cells/million cells
Interval 1062.0 to 4440.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
TNF-α_IFN- γ, Week 6
|
957.5 F4co-Computed CD8+ T-cells/million cells
Interval 476.0 to 2395.0
|
1864.5 F4co-Computed CD8+ T-cells/million cells
Interval 1197.5 to 2480.5
|
1610.5 F4co-Computed CD8+ T-cells/million cells
Interval 777.5 to 2458.5
|
2199.0 F4co-Computed CD8+ T-cells/million cells
Interval 1184.0 to 5725.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
TNF-α_IFN- γ, Week 28
|
1563.0 F4co-Computed CD8+ T-cells/million cells
Interval 590.0 to 2732.0
|
1782.5 F4co-Computed CD8+ T-cells/million cells
Interval 629.5 to 3126.5
|
1563.0 F4co-Computed CD8+ T-cells/million cells
Interval 622.0 to 2941.0
|
2012.0 F4co-Computed CD8+ T-cells/million cells
Interval 921.0 to 4006.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
TNF-α_IFN- γ, Week 30
|
985.0 F4co-Computed CD8+ T-cells/million cells
Interval 560.0 to 1981.0
|
1904.0 F4co-Computed CD8+ T-cells/million cells
Interval 706.0 to 3290.0
|
—
|
2260.0 F4co-Computed CD8+ T-cells/million cells
Interval 826.0 to 5091.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
TNF-α_IFN- γ, Week 48
|
993.0 F4co-Computed CD8+ T-cells/million cells
Interval 460.0 to 2222.0
|
1900.0 F4co-Computed CD8+ T-cells/million cells
Interval 764.5 to 3052.5
|
—
|
1787.0 F4co-Computed CD8+ T-cells/million cells
Interval 843.0 to 5013.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_TNF-α_IL-2, Pre-vaccination
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_TNF-α_IL-2, Week 6
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_TNF-α_IL-2, Week 28
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_TNF-α_IL-2, Week 30
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
—
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_TNF-α_IL-2, Week 48
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
—
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_IFN- γ_IL-2, Pre-vaccination
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_IFN- γ_IL-2, Week 6
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_IFN- γ_IL-2, Week 28
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_IFN- γ_IL-2, Week 30
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
—
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_IFN- γ_IL-2, Week 48
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
—
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_TNF-α_IFN- γ, Pre-vaccination
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 20.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 10.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 16.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 36.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_TNF-α_IFN- γ, Week 6
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 11.5
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 9.5
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 10.5
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 27.5
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_TNF-α_IFN- γ, Week 28
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 7.5
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 15.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_TNF-α_IFN- γ, Week 30
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 15.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 17.0
|
—
|
4.5 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 23.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_TNF-α_IFN- γ, Week 48
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 19.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 9.0
|
—
|
17.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 37.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
TNF-α_IFN_IL-2, Pre-vaccination
|
17.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 50.0
|
36.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 97.0
|
30.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 72.0
|
40.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 125.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
TNF-α_IFN_IL-2, Week 6
|
9.5 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 41.0
|
18.5 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 65.0
|
16.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 58.0
|
58.0 F4co-Computed CD8+ T-cells/million cells
Interval 11.5 to 176.5
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
TNF-α_IFN_IL-2, Week 28
|
15.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 52.0
|
19.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 68.0
|
17.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 56.0
|
21.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 117.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
TNF-α_IFN_IL-2, Week 48
|
33.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 54.0
|
19.5 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 46.0
|
—
|
26.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 62.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_TNF-α_IFN- γ_IL-2, Pre-vaccination
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_TNF-α_IFN- γ_IL-2, Week 6
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_TNF-α_IFN- γ_IL-2, Week 28
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Cytokine Expression Profile of F4co-Computed CD8+ T Cells
CD40L_TNF-α_IFN- γ_IL-2, Week 30
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 25.0
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
—
|
4.0 F4co-Computed CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.
The cytokine co-expression profile was defined by the frequency of Nef-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.
Outcome measures
| Measure |
3D_HIV Group
n=38 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=40 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=75 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=35 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L, Pre-vaccination
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 20.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 65.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 51.0
|
51.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 143.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
IL-2, Week 28
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 31.0
|
14.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 69.5
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 61.0
|
19.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 100.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
IL-2, Week 30
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 44.0
|
35.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 89.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 79.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_TNF-α_IL-2, Pre-vaccination
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_TNF-α_IL-2, Week 28
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ, Week 28
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ, Week 30
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
TNF-α_IFN- γ_IL-2, Pre-vaccination
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 12.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 17.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 13.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 21.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
TNF-α_IFN- γ_IL-2, Week 30
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 18.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 13.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 26.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
TNF-α_IFN- γ_IL-2, Week 48
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 12.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 48
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L, Week 6
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 78.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 90.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 84.5
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 99.5
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L, Week 28
|
16.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 94.0
|
12.5 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 91.5
|
16.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 94.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 35.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L, Week 30
|
5.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 111.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 80.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 40.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L, Week 48
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 39.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 48.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 65.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
IL-2, Pre-vaccination
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 32.0
|
4.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 55.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 53.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 37.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
IL-2, Week 6
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 73.0
|
6.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 83.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 75.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 23.5
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
IL-2, Week 48
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 42.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 31.0
|
—
|
4.5 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 66.5
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
TNF-α, Pre-vaccination
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 67.0
|
21.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 81.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 75.0
|
39.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 187.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
TNF-α, Week 6
|
32.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 78.5
|
31.5 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 119.5
|
32.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 94.0
|
42.5 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 119.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
TNF-α, Week 28
|
12.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 84.0
|
9.5 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 64.0
|
12.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 72.0
|
29.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 119.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
TNF-α, Week 30
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 83.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 63.0
|
—
|
50.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 143.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
TNF-α, Week 48
|
18.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 77.5
|
11.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 153.0
|
—
|
26.5 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 142.5
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
IFN- γ, Pre-vaccination
|
2947.0 Nef-specific CD8+ T-cells/million cells
Interval 1230.0 to 5976.0
|
2150.0 Nef-specific CD8+ T-cells/million cells
Interval 1020.0 to 7966.0
|
2646.0 Nef-specific CD8+ T-cells/million cells
Interval 1049.0 to 6678.0
|
3224.0 Nef-specific CD8+ T-cells/million cells
Interval 1607.0 to 8951.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
IFN- γ, Week 6
|
2942.0 Nef-specific CD8+ T-cells/million cells
Interval 853.0 to 5634.0
|
2951.0 Nef-specific CD8+ T-cells/million cells
Interval 1199.5 to 8049.0
|
2942.0 Nef-specific CD8+ T-cells/million cells
Interval 906.0 to 6203.0
|
4330.0 Nef-specific CD8+ T-cells/million cells
Interval 2055.0 to 9013.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
IFN- γ, Week 28
|
2396.0 Nef-specific CD8+ T-cells/million cells
Interval 907.0 to 5646.0
|
2850.0 Nef-specific CD8+ T-cells/million cells
Interval 996.0 to 7154.0
|
2748.0 Nef-specific CD8+ T-cells/million cells
Interval 959.0 to 6291.0
|
3449.0 Nef-specific CD8+ T-cells/million cells
Interval 1880.0 to 7427.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
IFN- γ, Week 30
|
2586.0 Nef-specific CD8+ T-cells/million cells
Interval 969.0 to 4509.0
|
2778.0 Nef-specific CD8+ T-cells/million cells
Interval 1213.0 to 7998.0
|
—
|
3469.0 Nef-specific CD8+ T-cells/million cells
Interval 2069.0 to 8384.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
IFN- γ, Week 48
|
2236.5 Nef-specific CD8+ T-cells/million cells
Interval 862.0 to 4932.5
|
2228.0 Nef-specific CD8+ T-cells/million cells
Interval 961.0 to 6537.0
|
—
|
3584.0 Nef-specific CD8+ T-cells/million cells
Interval 2034.5 to 6793.5
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_IL-2, Pre-vaccination
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_IL-2, Week 6
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_IL-2, Week 28
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_IL-2, Week 30
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_IL-2, Week 48
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_TNF-α, Pre-vaccination
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_TNF-α, Week 6
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_TNF-α, Week 28
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_TNF-α, Week 30
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_TNF-α, Week 48
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_IFN- γ, Pre-vaccination
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 10.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 13.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_IFN- γ, Week 6
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 13.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 7.5
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 12.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 17.5
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_IFN- γ, Week 28
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 17.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 13.5
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 15.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 14.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_IFN- γ, Week 30
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 16.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_IFN- γ, Week 48
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 6.5
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 14.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 7.5
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
TNF-α_IL-2, Pre-vaccination
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
TNF-α_IL-2, Week 6
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
TNF-α_IL-2, Week 28
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
TNF-α_IL-2, Week 30
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
TNF-α_IL-2, Week 48
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
IFN- γ_IL-2, Pre-vaccination
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 39.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 82.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 59.0
|
16.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 55.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
IFN- γ_IL-2, Week 6
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 27.5
|
11.5 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 41.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 34.0
|
22.5 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 46.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
IFN- γ_IL-2, Week 28
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 39.0
|
19.5 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 71.0
|
17.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 55.0
|
13.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 48.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
IFN- γ_IL-2, Week 30
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 37.0
|
18.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 65.0
|
—
|
12.5 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 58.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
IFN- γ_IL-2, Week 48
|
8.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 38.5
|
19.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 62.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 34.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
TNF-α_IFN- γ, Pre-vaccination
|
157.5 Nef-specific CD8+ T-cells/million cells
Interval 56.0 to 378.0
|
174.0 Nef-specific CD8+ T-cells/million cells
Interval 90.0 to 547.0
|
160.0 Nef-specific CD8+ T-cells/million cells
Interval 75.0 to 383.0
|
259.0 Nef-specific CD8+ T-cells/million cells
Interval 124.0 to 1318.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
TNF-α_IFN- γ, Week 6
|
152.5 Nef-specific CD8+ T-cells/million cells
Interval 43.0 to 321.5
|
216.5 Nef-specific CD8+ T-cells/million cells
Interval 64.5 to 487.0
|
156.5 Nef-specific CD8+ T-cells/million cells
Interval 46.5 to 407.5
|
345.5 Nef-specific CD8+ T-cells/million cells
Interval 210.5 to 1302.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
TNF-α_IFN- γ, Week 28
|
161.0 Nef-specific CD8+ T-cells/million cells
Interval 39.0 to 369.0
|
191.5 Nef-specific CD8+ T-cells/million cells
Interval 65.5 to 517.5
|
175.0 Nef-specific CD8+ T-cells/million cells
Interval 61.0 to 515.0
|
333.0 Nef-specific CD8+ T-cells/million cells
Interval 145.0 to 1010.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
TNF-α_IFN- γ, Week 30
|
138.0 Nef-specific CD8+ T-cells/million cells
Interval 34.0 to 333.0
|
256.0 Nef-specific CD8+ T-cells/million cells
Interval 79.0 to 510.0
|
—
|
292.5 Nef-specific CD8+ T-cells/million cells
Interval 120.0 to 1380.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
TNF-α_IFN- γ, Week 48
|
110.0 Nef-specific CD8+ T-cells/million cells
Interval 33.0 to 324.5
|
156.0 Nef-specific CD8+ T-cells/million cells
Interval 48.0 to 553.0
|
—
|
293.5 Nef-specific CD8+ T-cells/million cells
Interval 62.0 to 962.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_TNF-α_IL-2, Week 6
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_TNF-α_IL-2, Week 30
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_TNF-α_IL-2, Week 48
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_IFN- γ_IL-2, Pre-vaccination
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_IFN- γ_IL-2, Week 6
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_IFN- γ_IL-2, Week 28
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_IFN- γ_IL-2, Week 30
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_IFN- γ_IL-2, Week 48
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ, Pre-vaccination
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ, Week 6
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ, Week 48
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
TNF-α_IFN- γ_IL-2, Week 6
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
7.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 22.5
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
TNF-α_IFN- γ_IL-2, Week 28
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 9.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 21.5
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 17.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 19.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Pre-vaccination
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 6
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 28
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 30
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 Nef-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.
The cytokine co-expression profile was defined by the frequency of P17-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.
Outcome measures
| Measure |
3D_HIV Group
n=38 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=40 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=75 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=35 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
IL-2, Pre-vaccination
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 63.0
|
29.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 79.0
|
7.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 74.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 57.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
IL-2, Week 6
|
17.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 80.0
|
16.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 41.5
|
17.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 51.0
|
4.5 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 34.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L, Pre-vaccination
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 66.0
|
9.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 76.0
|
7.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 74.0
|
20.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 111.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_TNF-α, Pre-vaccination
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_IFN- γ_IL-2, Pre-vaccination
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_IFN- γ_IL-2, Week 6
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_IFN- γ_IL-2, Week 28
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L, Week 6
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 24.0
|
23.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 113.5
|
2.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 66.0
|
17.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 103.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L, Week 28
|
15.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 112.0
|
42.5 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 95.0
|
40.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 99.0
|
4.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 66.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L, Week 30
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 95.0
|
3.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 100.5
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 38.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L, Week 48
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 32.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 59.0
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 85.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
IL-2, Week 28
|
19.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 83.0
|
37.5 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 80.0
|
37.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 83.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 81.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
IL-2, Week 30
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 18.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 65.5
|
—
|
22.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 57.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
IL-2, Week 48
|
2.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 73.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 35.0
|
—
|
21.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 87.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
TNF-α, Pre-vaccination
|
11.5 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 64.0
|
27.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 69.0
|
13.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 69.0
|
29.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 133.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
TNF-α, Week 6
|
25.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 76.0
|
39.5 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 79.0
|
29.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 76.0
|
19.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 134.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
TNF-α, Week 28
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 61.0
|
6.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 52.5
|
5.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 60.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 77.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
TNF-α, Week 30
|
2.5 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 59.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 39.5
|
—
|
11.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 116.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
TNF-α, Week 48
|
11.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 71.0
|
17.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 86.0
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 52.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
IFN- γ, Pre-vaccination
|
497.0 P17-specific CD8+ T-cells/million cells
Interval 21.0 to 1794.0
|
901.0 P17-specific CD8+ T-cells/million cells
Interval 115.0 to 2700.0
|
811.0 P17-specific CD8+ T-cells/million cells
Interval 83.0 to 2603.0
|
1617.0 P17-specific CD8+ T-cells/million cells
Interval 524.0 to 6545.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
IFN- γ, Week 6
|
642.0 P17-specific CD8+ T-cells/million cells
Interval 69.0 to 2471.0
|
1144.0 P17-specific CD8+ T-cells/million cells
Interval 207.0 to 3376.0
|
733.0 P17-specific CD8+ T-cells/million cells
Interval 112.0 to 3154.0
|
1450.5 P17-specific CD8+ T-cells/million cells
Interval 550.0 to 5866.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
IFN- γ, Week 28
|
694.0 P17-specific CD8+ T-cells/million cells
Interval 35.0 to 2002.0
|
1070.0 P17-specific CD8+ T-cells/million cells
Interval 169.5 to 2712.0
|
880.0 P17-specific CD8+ T-cells/million cells
Interval 58.0 to 2404.0
|
994.0 P17-specific CD8+ T-cells/million cells
Interval 378.0 to 3542.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
IFN- γ, Week 30
|
276.0 P17-specific CD8+ T-cells/million cells
Interval 61.0 to 2387.0
|
1199.5 P17-specific CD8+ T-cells/million cells
Interval 230.5 to 2718.0
|
—
|
1279.0 P17-specific CD8+ T-cells/million cells
Interval 279.0 to 4396.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
IFN- γ, Week 48
|
406.0 P17-specific CD8+ T-cells/million cells
Interval 58.0 to 1670.0
|
1049.0 P17-specific CD8+ T-cells/million cells
Interval 100.0 to 2990.0
|
—
|
1059.0 P17-specific CD8+ T-cells/million cells
Interval 190.5 to 4540.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_IL-2, Pre-vaccination
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_IL-2, Week 6
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_IL-2, Week 28
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_IL-2, Week 30
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_IL-2, Week 48
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_TNF-α, Week 6
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_TNF-α, Week 28
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_TNF-α, Week 30
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_TNF-α, Week 48
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_IFN- γ, Pre-vaccination
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 19.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_IFN- γ, Week 6
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 12.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 5.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_IFN- γ, Week 28
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 12.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_IFN- γ, Week 30
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 16.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_IFN- γ, Week 48
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 15.0
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
TNF-α_IL-2, Pre-vaccination
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
TNF-α_IL-2, Week 6
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
TNF-α_IL-2, Week 28
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
TNF-α_IL-2, Week 30
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
TNF-α_IL-2, Week 48
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
IFN- γ_IL-2, Pre-vaccination
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 15.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 16.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 16.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 42.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
IFN- γ_IL-2, Week 6
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 3.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 7.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 3.0
|
7.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 32.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
IFN- γ_IL-2, Week 28
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 19.5
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 15.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 30.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
IFN- γ_IL-2, Week 30
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 16.5
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 22.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
IFN- γ_IL-2, Week 48
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 25.0
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 15.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
TNF-α_IFN- γ, Pre-vaccination
|
47.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 158.0
|
60.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 179.0
|
49.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 173.0
|
164.0 P17-specific CD8+ T-cells/million cells
Interval 32.0 to 682.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
TNF-α_IFN- γ, Week 6
|
52.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 173.0
|
107.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 346.0
|
66.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 268.0
|
130.0 P17-specific CD8+ T-cells/million cells
Interval 17.5 to 707.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
TNF-α_IFN- γ, Week 28
|
69.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 146.0
|
61.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 238.0
|
63.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 228.0
|
110.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 468.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
TNF-α_IFN- γ, Week 30
|
67.5 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 140.0
|
76.5 P17-specific CD8+ T-cells/million cells
Interval 16.5 to 299.5
|
—
|
128.0 P17-specific CD8+ T-cells/million cells
Interval 4.0 to 410.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
TNF-α_IFN- γ, Week 48
|
66.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 148.0
|
111.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 217.0
|
—
|
130.0 P17-specific CD8+ T-cells/million cells
Interval 19.5 to 541.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IL-2, Pre-vaccination
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IL-2, Week 6
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IL-2, Week 28
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IL-2, Week 30
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IL-2, Week 48
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_IFN- γ_IL-2, Week 30
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_IFN- γ_IL-2, Week 48
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ, Pre-vaccination
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ, Week 6
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ, Week 28
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ, Week 30
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ, Week 48
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
TNF-α_IFN- γ_IL-2, Pre-vaccination
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 13.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
TNF-α_IFN- γ_IL-2, Week 6
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 13.5
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
TNF-α_IFN- γ_IL-2, Week 28
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 11.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
TNF-α_IFN- γ_IL-2, Week 30
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 14.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
TNF-α_IFN- γ_IL-2, Week 48
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 14.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Pre-vaccination
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 6
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 28
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 30
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 48
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P17-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.
The cytokine co-expression profile was defined by the frequency of P24-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.
Outcome measures
| Measure |
3D_HIV Group
n=38 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=40 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=75 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=35 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
IFN- γ, Week 48
|
5122.0 P24-specific CD8+ T-cells/million cells
Interval 1729.0 to 8072.0
|
4974.0 P24-specific CD8+ T-cells/million cells
Interval 1572.0 to 9962.0
|
—
|
6070.0 P24-specific CD8+ T-cells/million cells
Interval 1588.5 to 17183.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L, Pre-vaccination
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 64.0
|
26.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 110.0
|
3.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 88.0
|
54.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 86.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L, Week 6
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 9.0
|
10.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 110.5
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 74.0
|
26.5 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 74.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L, Week 28
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 42.0
|
25.5 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 129.0
|
7.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 89.0
|
28.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 76.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L, Week 30
|
38.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 147.0
|
18.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 80.0
|
—
|
1.5 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 105.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L, Week 48
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 85.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 78.0
|
—
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 77.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
IL-2, Pre-vaccination
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 31.0
|
2.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 38.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 37.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 20.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
IL-2, Week 6
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 69.0
|
5.5 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 69.0
|
2.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 69.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 19.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
IL-2, Week 28
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 64.0
|
21.5 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 51.5
|
12.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 55.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 41.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
IL-2, Week 30
|
8.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 54.0
|
35.5 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 75.0
|
—
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 29.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
IL-2, Week 48
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 64.0
|
4.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 47.0
|
—
|
11.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 62.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
TNF-α, Pre-vaccination
|
54.5 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 109.0
|
50.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 139.0
|
51.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 131.0
|
89.0 P24-specific CD8+ T-cells/million cells
Interval 12.0 to 178.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
TNF-α, Week 6
|
37.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 111.0
|
82.5 P24-specific CD8+ T-cells/million cells
Interval 4.5 to 175.0
|
71.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 154.0
|
40.0 P24-specific CD8+ T-cells/million cells
Interval 4.0 to 128.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
TNF-α, Week 28
|
69.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 129.0
|
40.5 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 70.0
|
47.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 97.0
|
48.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 111.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
TNF-α, Week 30
|
29.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 165.0
|
19.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 103.0
|
—
|
74.5 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 154.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
TNF-α, Week 48
|
53.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 140.0
|
37.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 135.0
|
—
|
17.5 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 182.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
IFN- γ, Pre-vaccination
|
4897.0 P24-specific CD8+ T-cells/million cells
Interval 2034.0 to 7095.0
|
6910.0 P24-specific CD8+ T-cells/million cells
Interval 1140.0 to 11555.0
|
5933.0 P24-specific CD8+ T-cells/million cells
Interval 1361.0 to 10100.0
|
6749.0 P24-specific CD8+ T-cells/million cells
Interval 2530.0 to 17157.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
IFN- γ, Week 6
|
4570.0 P24-specific CD8+ T-cells/million cells
Interval 1899.0 to 7039.0
|
5096.0 P24-specific CD8+ T-cells/million cells
Interval 1217.5 to 13414.5
|
4657.0 P24-specific CD8+ T-cells/million cells
Interval 1458.0 to 9252.0
|
9141.5 P24-specific CD8+ T-cells/million cells
Interval 2594.0 to 19732.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
IFN- γ, Week 28
|
5862.0 P24-specific CD8+ T-cells/million cells
Interval 1562.0 to 7767.0
|
4345.0 P24-specific CD8+ T-cells/million cells
Interval 1216.5 to 10098.0
|
5268.0 P24-specific CD8+ T-cells/million cells
Interval 1444.0 to 9807.0
|
6198.0 P24-specific CD8+ T-cells/million cells
Interval 2202.0 to 17804.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
IFN- γ, Week 30
|
5056.0 P24-specific CD8+ T-cells/million cells
Interval 1670.0 to 8265.0
|
4358.0 P24-specific CD8+ T-cells/million cells
Interval 960.0 to 11810.5
|
—
|
7770.0 P24-specific CD8+ T-cells/million cells
Interval 3089.0 to 18585.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_IL-2, Pre-vaccination
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_IL-2, Week 6
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_IL-2, Week 28
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_IL-2, Week 30
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_IL-2, Week 48
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_TNF-α, Pre-vaccination
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_TNF-α, Week 6
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_TNF-α, Week 28
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_TNF-α, Week 30
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_TNF-α, Week 48
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_IFN- γ, Pre-vaccination
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 20.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 17.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 20.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 28.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_IFN- γ, Week 6
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 22.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 17.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 19.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 30.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_IFN- γ, Week 28
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 16.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 7.5
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 14.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 22.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_IFN- γ, Week 30
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 14.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 8.5
|
—
|
11.5 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 42.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_IFN- γ, Week 48
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 17.0
|
—
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 14.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
TNF-α_IL-2, Pre-vaccination
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
TNF-α_IL-2, Week 6
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
TNF-α_IL-2, Week 28
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
TNF-α_IL-2, Week 30
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
TNF-α_IL-2, Week 48
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
IFN- γ_IL-2, Pre-vaccination
|
7.5 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 47.0
|
26.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 61.0
|
19.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 60.0
|
28.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 159.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
IFN- γ_IL-2, Week 6
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 29.0
|
19.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 71.5
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 54.0
|
22.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 215.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
IFN- γ_IL-2, Week 28
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 36.0
|
20.5 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 41.5
|
18.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 38.0
|
22.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 92.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
IFN- γ_IL-2, Week 30
|
11.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 39.0
|
18.5 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 61.5
|
—
|
25.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 132.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
IFN- γ_IL-2, Week 48
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 36.0
|
2.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 56.0
|
—
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 92.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
TNF-α_IFN- γ, Pre-vaccination
|
291.5 P24-specific CD8+ T-cells/million cells
Interval 182.0 to 693.0
|
586.0 P24-specific CD8+ T-cells/million cells
Interval 139.0 to 1045.0
|
319.0 P24-specific CD8+ T-cells/million cells
Interval 160.0 to 919.0
|
705.0 P24-specific CD8+ T-cells/million cells
Interval 137.0 to 1290.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
TNF-α_IFN- γ, Week 6
|
236.0 P24-specific CD8+ T-cells/million cells
Interval 134.0 to 674.0
|
390.5 P24-specific CD8+ T-cells/million cells
Interval 167.0 to 1087.5
|
283.0 P24-specific CD8+ T-cells/million cells
Interval 139.0 to 884.0
|
751.5 P24-specific CD8+ T-cells/million cells
Interval 143.5 to 2159.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
TNF-α_IFN- γ, Week 28
|
471.0 P24-specific CD8+ T-cells/million cells
Interval 195.0 to 1020.0
|
492.0 P24-specific CD8+ T-cells/million cells
Interval 103.5 to 1038.0
|
471.0 P24-specific CD8+ T-cells/million cells
Interval 118.0 to 1022.0
|
484.0 P24-specific CD8+ T-cells/million cells
Interval 118.0 to 1604.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
TNF-α_IFN- γ, Week 30
|
246.0 P24-specific CD8+ T-cells/million cells
Interval 111.0 to 542.0
|
313.5 P24-specific CD8+ T-cells/million cells
Interval 93.5 to 1256.0
|
—
|
761.0 P24-specific CD8+ T-cells/million cells
Interval 177.0 to 1630.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
TNF-α_IFN- γ, Week 48
|
299.0 P24-specific CD8+ T-cells/million cells
Interval 119.0 to 865.0
|
423.0 P24-specific CD8+ T-cells/million cells
Interval 128.0 to 1030.0
|
—
|
497.0 P24-specific CD8+ T-cells/million cells
Interval 193.5 to 1362.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IL-2, Pre-vaccination
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IL-2, Week 6
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IL-2, Week 28
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IL-2, Week 30
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IL-2, Week 48
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_IFN- γ_IL-2, Pre-vaccination
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_IFN- γ_IL-2, Week 6
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_IFN- γ_IL-2, Week 28
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_IFN- γ_IL-2, Week 30
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_IFN- γ_IL-2, Week 48
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ, Pre-vaccination
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 17.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ, Week 6
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 20.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ, Week 28
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ, Week 30
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ, Week 48
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 11.0
|
—
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 14.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
TNF-α_IFN- γ_IL-2, Pre-vaccination
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 27.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 26.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 37.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
TNF-α_IFN- γ_IL-2, Week 6
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 21.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 21.5
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 21.0
|
8.5 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 70.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
TNF-α_IFN- γ_IL-2, Week 28
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 12.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 7.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 12.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 32.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
TNF-α_IFN- γ_IL-2, Week 30
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 19.5
|
—
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 27.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
TNF-α_IFN- γ_IL-2, Week 48
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 14.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 9.0
|
—
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 20.5
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Pre-vaccination
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 6
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 28
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 30
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 48
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 P24-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.
The cytokine co-expression profile was defined by the frequency of reverse transcriptase (RT)-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.
Outcome measures
| Measure |
3D_HIV Group
n=38 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=40 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=75 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=35 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
TNF-α, Week 6
|
61.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 125.5
|
70.0 RT-specific CD8+ T-cells/million cells
Interval 8.0 to 133.5
|
63.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 127.0
|
82.0 RT-specific CD8+ T-cells/million cells
Interval 16.0 to 157.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ, Week 48
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
TNF-α_IFN- γ_IL-2, Week 48
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 10.5
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 18.0
|
—
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 17.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_IL-2, Week 48
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
TNF-α_IL-2, Pre-vaccination
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
TNF-α_IL-2, Week 6
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L, Pre-vaccination
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 67.0
|
60.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 137.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 90.0
|
12.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 142.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L, Week 6
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 12.5
|
15.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 97.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 84.0
|
35.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 62.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L, Week 28
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 50.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 127.5
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 76.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 66.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L, Week 30
|
19.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 71.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 88.0
|
—
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 62.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L, Week 48
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 54.5
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 94.0
|
—
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 58.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
IL-2, Pre-vaccination
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 22.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 48.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 48.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 66.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
IL-2, Week 6
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 59.5
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 77.5
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 70.5
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 35.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
IL-2, Week 28
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 60.0
|
15.5 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 72.0
|
13.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 70.0
|
2.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 44.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
IL-2, Week 30
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 44.0
|
21.5 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 83.0
|
—
|
12.5 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 55.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
IL-2, Week 48
|
2.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 61.5
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 51.0
|
—
|
40.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 109.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
TNF-α, Pre-vaccination
|
71.5 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 150.0
|
67.0 RT-specific CD8+ T-cells/million cells
Interval 12.0 to 143.0
|
68.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 150.0
|
84.0 RT-specific CD8+ T-cells/million cells
Interval 35.0 to 196.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
TNF-α, Week 28
|
42.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 119.0
|
50.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 162.5
|
48.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 131.0
|
80.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 187.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
TNF-α, Week 30
|
33.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 102.0
|
76.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 164.5
|
—
|
97.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 187.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
TNF-α, Week 48
|
63.5 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 158.0
|
63.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 125.0
|
—
|
109.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 193.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
IFN- γ, Pre-vaccination
|
3370.0 RT-specific CD8+ T-cells/million cells
Interval 1592.0 to 6581.0
|
2161.0 RT-specific CD8+ T-cells/million cells
Interval 1464.0 to 6962.0
|
3138.0 RT-specific CD8+ T-cells/million cells
Interval 1464.0 to 6784.0
|
3950.0 RT-specific CD8+ T-cells/million cells
Interval 1335.0 to 6877.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
IFN- γ, Week 6
|
3474.0 RT-specific CD8+ T-cells/million cells
Interval 1187.5 to 6812.0
|
2885.0 RT-specific CD8+ T-cells/million cells
Interval 1774.0 to 6141.0
|
3050.5 RT-specific CD8+ T-cells/million cells
Interval 1453.0 to 6341.0
|
4012.0 RT-specific CD8+ T-cells/million cells
Interval 2452.0 to 8455.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
IFN- γ, Week 28
|
5410.0 RT-specific CD8+ T-cells/million cells
Interval 1201.0 to 7637.0
|
2355.5 RT-specific CD8+ T-cells/million cells
Interval 1355.0 to 5886.0
|
3079.0 RT-specific CD8+ T-cells/million cells
Interval 1342.0 to 7349.0
|
3595.0 RT-specific CD8+ T-cells/million cells
Interval 1370.0 to 6370.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
IFN- γ, Week 30
|
2959.0 RT-specific CD8+ T-cells/million cells
Interval 1287.0 to 7160.0
|
2824.5 RT-specific CD8+ T-cells/million cells
Interval 1767.0 to 5807.5
|
—
|
4000.0 RT-specific CD8+ T-cells/million cells
Interval 1730.0 to 7055.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
IFN- γ, Week 48
|
3081.0 RT-specific CD8+ T-cells/million cells
Interval 1341.5 to 6169.0
|
3187.0 RT-specific CD8+ T-cells/million cells
Interval 1690.0 to 6150.0
|
—
|
4294.0 RT-specific CD8+ T-cells/million cells
Interval 1579.0 to 6806.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_IL-2, Pre-vaccination
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_IL-2, Week 6
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_IL-2, Week 28
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_IL-2, Week 30
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_TNF-α, Pre-vaccination
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_TNF-α, Week 6
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_TNF-α, Week 28
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_TNF-α, Week 30
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_TNF-α, Week 48
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_IFN- γ, Pre-vaccination
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 10.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 18.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 16.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_IFN- γ, Week 6
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 15.5
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_IFN- γ, Week 28
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 15.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_IFN- γ, Week 30
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_IFN- γ, Week 48
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 18.5
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 11.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
TNF-α_IL-2, Week 28
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
TNF-α_IL-2, Week 30
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
TNF-α_IL-2, Week 48
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
IFN- γ_IL-2, Pre-vaccination
|
14.5 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 60.0
|
17.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 54.0
|
17.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 60.0
|
18.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 64.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
IFN- γ_IL-2, Week 6
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 36.0
|
28.0 RT-specific CD8+ T-cells/million cells
Interval 6.0 to 48.5
|
23.5 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 42.5
|
16.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 47.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
IFN- γ_IL-2, Week 28
|
16.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 62.0
|
7.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 55.0
|
13.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 57.0
|
16.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 50.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
IFN- γ_IL-2, Week 30
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 52.0
|
11.5 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 54.5
|
—
|
19.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 45.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
IFN- γ_IL-2, Week 48
|
17.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 36.5
|
8.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 52.0
|
—
|
18.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 47.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
TNF-α_IFN- γ, Pre-vaccination
|
271.0 RT-specific CD8+ T-cells/million cells
Interval 92.0 to 616.0
|
314.0 RT-specific CD8+ T-cells/million cells
Interval 119.0 to 814.0
|
300.0 RT-specific CD8+ T-cells/million cells
Interval 101.0 to 779.0
|
410.0 RT-specific CD8+ T-cells/million cells
Interval 89.0 to 782.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
TNF-α_IFN- γ, Week 6
|
301.0 RT-specific CD8+ T-cells/million cells
Interval 78.5 to 1025.5
|
360.0 RT-specific CD8+ T-cells/million cells
Interval 178.5 to 831.0
|
339.0 RT-specific CD8+ T-cells/million cells
Interval 150.0 to 925.0
|
471.0 RT-specific CD8+ T-cells/million cells
Interval 149.0 to 925.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
TNF-α_IFN- γ, Week 28
|
372.0 RT-specific CD8+ T-cells/million cells
Interval 129.0 to 1249.0
|
455.0 RT-specific CD8+ T-cells/million cells
Interval 118.0 to 843.0
|
454.0 RT-specific CD8+ T-cells/million cells
Interval 119.0 to 1080.0
|
366.0 RT-specific CD8+ T-cells/million cells
Interval 205.0 to 812.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
TNF-α_IFN- γ, Week 30
|
232.0 RT-specific CD8+ T-cells/million cells
Interval 97.0 to 745.0
|
542.5 RT-specific CD8+ T-cells/million cells
Interval 183.0 to 1006.5
|
—
|
490.0 RT-specific CD8+ T-cells/million cells
Interval 207.0 to 1040.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
TNF-α_IFN- γ, Week 48
|
250.5 RT-specific CD8+ T-cells/million cells
Interval 109.0 to 725.0
|
483.5 RT-specific CD8+ T-cells/million cells
Interval 166.0 to 1020.0
|
—
|
404.0 RT-specific CD8+ T-cells/million cells
Interval 174.0 to 725.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_TNF-α_IL-2, Pre-vaccination
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_TNF-α_IL-2, Week 6
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_TNF-α_IL-2, Week 28
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_TNF-α_IL-2, Week 30
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_TNF-α_IL-2, Week 48
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_IFN- γ_IL-2, Pre-vaccination
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_IFN- γ_IL-2, Week 6
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_IFN- γ_IL-2, Week 28
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_IFN- γ_IL-2, Week 30
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_IFN- γ_IL-2, Week 48
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ, Pre-vaccination
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ, Week 6
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ, Week 28
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ, Week 30
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
TNF-α_IFN- γ_IL-2, Pre-vaccination
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 14.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 30.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 21.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 25.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
TNF-α_IFN- γ_IL-2, Week 6
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 16.5
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 23.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 21.0
|
10.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 27.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
TNF-α_IFN- γ_IL-2, Week 28
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 19.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 16.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 16.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
TNF-α_IFN- γ_IL-2, Week 30
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
5.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 26.5
|
—
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 30.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Pre-vaccination
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 6
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 28
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 30
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
|
Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
CD40L_TNF-α_IFN- γ_IL-2, Week 48
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
—
|
1.0 RT-specific CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.
Seropositivity rates for antibodies against P17 antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 187 milli-ELISA units per milliliter (mEL.U/mL).
Outcome measures
| Measure |
3D_HIV Group
n=44 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=45 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=89 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=40 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Seropositive Subjects for Anti-P17 Antibodies
Anti-P17, Week 6
|
39 Participants
|
37 Participants
|
76 Participants
|
33 Participants
|
|
Number of Seropositive Subjects for Anti-P17 Antibodies
Anti-P17, Pre-vaccination
|
35 Participants
|
38 Participants
|
73 Participants
|
34 Participants
|
|
Number of Seropositive Subjects for Anti-P17 Antibodies
Anti-P17, Week 28
|
37 Participants
|
38 Participants
|
75 Participants
|
32 Participants
|
|
Number of Seropositive Subjects for Anti-P17 Antibodies
Anti-P17, Week 30
|
41 Participants
|
35 Participants
|
—
|
31 Participants
|
|
Number of Seropositive Subjects for Anti-P17 Antibodies
Anti-P17, Week 48
|
31 Participants
|
33 Participants
|
—
|
31 Participants
|
SECONDARY outcome
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.
Seropositivity rates for antibodies against P24 antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 119 milli-ELISA units per milliliter (mEL.U/mL).
Outcome measures
| Measure |
3D_HIV Group
n=44 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=45 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=89 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=40 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Seropositive Subjects for Anti-P24 Antibodies
Anti-P24, Week 28
|
43 Participants
|
44 Participants
|
87 Participants
|
37 Participants
|
|
Number of Seropositive Subjects for Anti-P24 Antibodies
Anti-P24, Pre-vaccination
|
42 Participants
|
45 Participants
|
87 Participants
|
38 Participants
|
|
Number of Seropositive Subjects for Anti-P24 Antibodies
Anti-P24, Week 6
|
43 Participants
|
43 Participants
|
86 Participants
|
38 Participants
|
|
Number of Seropositive Subjects for Anti-P24 Antibodies
Anti-P24, Week 30
|
43 Participants
|
41 Participants
|
—
|
36 Participants
|
|
Number of Seropositive Subjects for Anti-P24 Antibodies
Anti-P24, Week 48
|
39 Participants
|
42 Participants
|
—
|
35 Participants
|
SECONDARY outcome
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.
Seropositivity rates for antibodies against Nef antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 494 milli-ELISA units per milliliter (mEL.U/mL).
Outcome measures
| Measure |
3D_HIV Group
n=44 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=45 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=89 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=40 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Seropositive Subjects for Anti-Nef Antibodies
Anti-Nef, Pre-vaccination
|
22 Participants
|
28 Participants
|
50 Participants
|
21 Participants
|
|
Number of Seropositive Subjects for Anti-Nef Antibodies
Anti-Nef, Week 6
|
38 Participants
|
35 Participants
|
73 Participants
|
17 Participants
|
|
Number of Seropositive Subjects for Anti-Nef Antibodies
Anti-Nef, Week 28
|
24 Participants
|
31 Participants
|
55 Participants
|
20 Participants
|
|
Number of Seropositive Subjects for Anti-Nef Antibodies
Anti-Nef, Week 30
|
42 Participants
|
28 Participants
|
—
|
20 Participants
|
|
Number of Seropositive Subjects for Anti-Nef Antibodies
Anti-Nef, Week 48
|
33 Participants
|
27 Participants
|
—
|
18 Participants
|
SECONDARY outcome
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.
Seropositivity rates for antibodies against RT antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 125 milli-ELISA units per milliliter (mEL.U/mL).
Outcome measures
| Measure |
3D_HIV Group
n=44 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=45 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=89 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=40 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Seropositive Subjects for Anti-RT Antibodies
Anti-RT, Pre-vaccination
|
40 Participants
|
42 Participants
|
82 Participants
|
39 Participants
|
|
Number of Seropositive Subjects for Anti-RT Antibodies
Anti-RT, Week 6
|
43 Participants
|
42 Participants
|
85 Participants
|
40 Participants
|
|
Number of Seropositive Subjects for Anti-RT Antibodies
Anti-RT, Week 28
|
44 Participants
|
45 Participants
|
89 Participants
|
38 Participants
|
|
Number of Seropositive Subjects for Anti-RT Antibodies
Anti-RT, Week 30
|
42 Participants
|
41 Participants
|
—
|
38 Participants
|
|
Number of Seropositive Subjects for Anti-RT Antibodies
Anti-RT, Week 48
|
38 Participants
|
41 Participants
|
—
|
37 Participants
|
SECONDARY outcome
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.
Seropositivity rates for antibodies against F4co antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 42 milli-ELISA units per milliliter (mEL.U/mL).
Outcome measures
| Measure |
3D_HIV Group
n=44 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=45 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=89 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=40 Participants
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Seropositive Subjects for Anti-F4co Antibodies
Anti-F4co, Pre-vaccination
|
44 Participants
|
45 Participants
|
89 Participants
|
40 Participants
|
|
Number of Seropositive Subjects for Anti-F4co Antibodies
Anti-F4co, Week 6
|
44 Participants
|
43 Participants
|
87 Participants
|
40 Participants
|
|
Number of Seropositive Subjects for Anti-F4co Antibodies
Anti-F4co, Week 28
|
44 Participants
|
45 Participants
|
89 Participants
|
39 Participants
|
|
Number of Seropositive Subjects for Anti-F4co Antibodies
Anti-F4co, Week 30
|
43 Participants
|
42 Participants
|
—
|
38 Participants
|
|
Number of Seropositive Subjects for Anti-F4co Antibodies
Anti-F4co, Week 48
|
39 Participants
|
43 Participants
|
—
|
37 Participants
|
Adverse Events
3D_HIV Group
Serious events: 1 serious events
Other events: 60 other events
Deaths: 0 deaths
2D_HIV Group
Serious events: 3 serious events
Other events: 60 other events
Deaths: 0 deaths
Control Group
Serious events: 2 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3D_HIV Group
n=62 participants at risk
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=64 participants at risk
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=64 participants at risk
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/62 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
0.00%
0/64 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
1.6%
1/64 • Number of events 1 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
Infections and infestations
Appendicitis
|
1.6%
1/62 • Number of events 1 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
0.00%
0/64 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
0.00%
0/64 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
Infections and infestations
Gastroenteritis shigella
|
1.6%
1/62 • Number of events 1 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
0.00%
0/64 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
0.00%
0/64 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
Infections and infestations
Hepatitis c
|
0.00%
0/62 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
1.6%
1/64 • Number of events 1 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
0.00%
0/64 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
Infections and infestations
Lymph node tuberculosis
|
0.00%
0/62 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
1.6%
1/64 • Number of events 1 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
0.00%
0/64 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/62 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
0.00%
0/64 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
1.6%
1/64 • Number of events 1 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/62 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
0.00%
0/64 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
1.6%
1/64 • Number of events 1 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/62 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
0.00%
0/64 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
1.6%
1/64 • Number of events 1 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/62 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
0.00%
0/64 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
1.6%
1/64 • Number of events 1 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/62 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
1.6%
1/64 • Number of events 1 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
0.00%
0/64 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/62 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
0.00%
0/64 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
1.6%
1/64 • Number of events 1 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/62 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
1.6%
1/64 • Number of events 1 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
0.00%
0/64 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
Other adverse events
| Measure |
3D_HIV Group
n=62 participants at risk
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
2D_HIV Group
n=64 participants at risk
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
Control Group
n=64 participants at risk
HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
21.0%
13/62 • Number of events 18 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
15.6%
10/64 • Number of events 13 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
6.2%
4/64 • Number of events 6 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.7%
11/62 • Number of events 13 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
15.6%
10/64 • Number of events 11 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
10.9%
7/64 • Number of events 7 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
Gastrointestinal disorders
Diarrhoea
|
29.0%
18/62 • Number of events 23 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
31.2%
20/64 • Number of events 29 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
23.4%
15/64 • Number of events 19 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
29.0%
18/62 • Number of events 23 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
21.9%
14/64 • Number of events 19 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
0.00%
0/64 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
General disorders
Fatigue
|
69.4%
43/62 • Number of events 83 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
60.9%
39/64 • Number of events 66 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
31.2%
20/64 • Number of events 34 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
Nervous system disorders
Headache
|
51.6%
32/62 • Number of events 57 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
51.6%
33/64 • Number of events 57 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
34.4%
22/64 • Number of events 32 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
17.7%
11/62 • Number of events 21 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
31.2%
20/64 • Number of events 27 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
15.6%
10/64 • Number of events 11 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
53.2%
33/62 • Number of events 61 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
51.6%
33/64 • Number of events 55 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
20.3%
13/64 • Number of events 21 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
4/62 • Number of events 4 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
6.2%
4/64 • Number of events 4 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
6.2%
4/64 • Number of events 4 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
Gastrointestinal disorders
Nausea
|
27.4%
17/62 • Number of events 24 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
23.4%
15/64 • Number of events 18 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
12.5%
8/64 • Number of events 8 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
General disorders
Pain
|
93.5%
58/62 • Number of events 146 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
89.1%
57/64 • Number of events 115 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
21.9%
14/64 • Number of events 20 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
General disorders
Pyrexia
|
22.6%
14/62 • Number of events 18 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
14.1%
9/64 • Number of events 11 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
10.9%
7/64 • Number of events 8 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
|
General disorders
Swelling
|
6.5%
4/62 • Number of events 6 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
12.5%
8/64 • Number of events 10 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
0.00%
0/64 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER