Trial Outcomes & Findings for Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subjects (NCT NCT01165203)
NCT ID: NCT01165203
Last Updated: 2018-04-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
123 participants
Primary outcome timeframe
From Month 0 to Month 18
Results posted on
2018-04-30
Participant Flow
Participant milestones
| Measure |
GSK1437173A Group
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|
|
Active Phase
STARTED
|
74
|
49
|
|
Active Phase
COMPLETED
|
69
|
47
|
|
Active Phase
NOT COMPLETED
|
5
|
2
|
|
Extended Safety Follow-up Phase
STARTED
|
74
|
49
|
|
Extended Safety Follow-up Phase
COMPLETED
|
67
|
45
|
|
Extended Safety Follow-up Phase
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
| Measure |
GSK1437173A Group
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|
|
Active Phase
Serious Adverse Event
|
1
|
0
|
|
Active Phase
Withdrawal by Subject
|
2
|
1
|
|
Active Phase
Migrated/moved from study area
|
0
|
1
|
|
Active Phase
Lost to Follow-up
|
2
|
0
|
|
Extended Safety Follow-up Phase
Serious Adverse Event
|
1
|
0
|
|
Extended Safety Follow-up Phase
Withdrawal by Subject
|
2
|
2
|
|
Extended Safety Follow-up Phase
Migrated/moved from study area
|
2
|
1
|
|
Extended Safety Follow-up Phase
Lost to Follow-up
|
2
|
0
|
|
Extended Safety Follow-up Phase
Other-subjects business reasons
|
0
|
1
|
Baseline Characteristics
Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subjects
Baseline characteristics by cohort
| Measure |
GSK1437173A Group
n=74 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=49 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.6 Years
STANDARD_DEVIATION 10.68 • n=5 Participants
|
45.1 Years
STANDARD_DEVIATION 11.36 • n=7 Participants
|
46.0 Years
STANDARD_DEVIATION 10.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African heritage/African American
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-East Asian heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-Japanese heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White-Caucasian/European heritage
|
66 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unspecified
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Month 0 to Month 18Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated 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 |
GSK1437173A Group
n=74 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=49 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
6 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From screening (up to 21 days prior to Month 0) until Month 18Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated 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 |
GSK1437173A Group
n=74 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=49 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From screening (up to 21 days prior to Month 0) until Month 18Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated 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 |
GSK1437173A Group
n=74 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=49 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Fatal SAEs
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Month 0 until Month 18Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
AEs of specific interest include new onset of autoimmune diseases (NOADs) and other immune mediated inflammatory disorders from administration of the first dose of vaccine/placebo.
Outcome measures
| Measure |
GSK1437173A Group
n=74 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=49 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Adverse Events (AEs) of Specific Interest
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within the 7-day (Days 0-6) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated 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 = incidence of a particular symptom regardless of their intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Outcome measures
| Measure |
GSK1437173A Group
n=73 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=48 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any Swelling, Dose 1
|
12 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any Swelling, Dose 2
|
11 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any Redness, Dose 3
|
9 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 Redness, Dose 3
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 Redness, Across doses
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 Swelling, Across doses
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any Pain, Dose 3
|
43 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any Pain, Dose 1
|
69 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any Redness, Dose 1
|
17 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any Pain, Dose 2
|
57 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
8 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any Redness, Dose 2
|
19 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 Pain, Dose 3
|
7 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any Swelling, Dose 3
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 Swelling, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any Pain, Across doses
|
72 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 Pain, Across doses
|
12 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any Redness, Across doses
|
28 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any Swelling, Across doses
|
20 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within the 7-day (Days 0-6) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Assessed solicited general symptoms were fatigue, gastrointestinal (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature \[defined as oral/axillary temperature above (\>) 37.5 degrees Celsius (°C)\]. Any = incidence of a particular symptom regardless of their intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK1437173A Group
n=73 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=48 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 1
|
25 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 1
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 1
|
16 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Across doses
|
47 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Across doses
|
6 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 1
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 1
|
13 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 1
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 1
|
34 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 1
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 1
|
26 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering, Dose 1
|
19 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering, Dose 1
|
11 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 1
|
7 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 1
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 2
|
41 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 2
|
7 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 2
|
25 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 2
|
18 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 2
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 2
|
8 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 2
|
32 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 2
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 2
|
18 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 2
|
33 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 2
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 2
|
24 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering, Dose 2
|
23 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering, Dose 2
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering, Dose 2
|
17 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 2
|
12 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 2
|
10 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 3
|
36 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 3
|
7 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 3
|
24 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 3
|
8 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 3
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 3
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 3
|
33 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 3
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 3
|
21 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 3
|
32 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 3
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 3
|
22 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering, Dose 3
|
14 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 3
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Across doses
|
55 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Across doses
|
12 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Across doses
|
41 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Across doses
|
28 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Across doses
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Across doses
|
16 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Across doses
|
34 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Across doses
|
54 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Across doses
|
10 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Across doses
|
44 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering, Across doses
|
37 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Across doses
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering, Across doses
|
11 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering, Across doses
|
29 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Across doses
|
22 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Across doses
|
17 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 1
|
30 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 1
|
17 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering, Dose 3
|
20 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering, Dose 3
|
7 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 3
|
11 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 30 days (Days 0-29) after each vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated 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 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK1437173A Group
n=74 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=49 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Unsolicited AEs
Any AE(s)
|
41 Participants
|
26 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Unsolicited AEs
Grade 3 AE(s)
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Unsolicited AEs
Related AE(s)
|
11 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Screening Visit (up to 21 days prior to Month 0)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.
Outcome measures
| Measure |
GSK1437173A Group
n=74 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=49 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Below
|
6 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Within
|
74 Participants
|
49 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Within
|
70 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Above
|
4 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Within
|
72 Participants
|
47 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Above
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Within
|
70 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Above
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Within
|
69 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Above
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Within
|
74 Participants
|
49 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Below
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Within
|
69 Participants
|
47 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Above
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated / Direct · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated / Direct · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Within
|
68 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Above
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Below
|
14 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Within
|
59 Participants
|
38 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Above
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Below
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Within
|
69 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Above
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Below
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Within
|
69 Participants
|
47 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Within
|
58 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Above
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Within
|
74 Participants
|
48 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Below
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Within
|
71 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Above
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Below
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Within
|
73 Participants
|
49 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Below
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Within
|
69 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Above
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Within
|
65 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Above
|
9 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated / Direct · Within
|
73 Participants
|
49 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated / Direct · Above
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Below
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Below
|
13 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Below
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Within
|
70 Participants
|
48 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Unknown
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 1Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.
Outcome measures
| Measure |
GSK1437173A Group
n=73 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=45 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Above
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Within
|
71 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Above
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Within
|
69 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Above
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Unknown
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Within
|
72 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated/Direct · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated/Direct · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated/Direct · Within
|
73 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated/Direct · Above
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Below
|
4 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Within
|
66 Participants
|
38 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Above
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Below
|
13 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Within
|
57 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Above
|
9 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Unknown
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Unknown
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Within
|
64 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Within
|
70 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Unknown
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Below
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Within
|
67 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Within
|
67 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Within
|
69 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Above
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Within
|
65 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Above
|
8 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Unknown
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Above
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Below
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Within
|
62 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Below
|
7 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Within
|
66 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Unknown
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Below
|
12 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Within
|
57 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Above
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Below
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Within
|
73 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Unknown
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Below
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Within
|
71 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Below
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Within
|
66 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Below
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Within
|
73 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Below
|
8 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Above
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Unknown
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Below
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Above
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 2Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.
Outcome measures
| Measure |
GSK1437173A Group
n=71 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=47 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Above
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Above
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated/Direct · Within
|
69 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated/Direct · Above
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Above
|
10 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Within
|
53 Participants
|
38 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Above
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Within
|
70 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Within
|
68 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Unknown
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Within
|
70 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Within
|
67 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Above
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Within
|
67 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Within
|
68 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Within
|
67 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Above
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Unknown
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Within
|
70 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Within
|
64 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Above
|
7 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated/Direct · Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated/Direct · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Below
|
5 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Within
|
65 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Above
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Unknown
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Below
|
9 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Within
|
61 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Above
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Below
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Within
|
59 Participants
|
38 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Below
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Within
|
69 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Unknown
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Below
|
15 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Above
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Above
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Unknown
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Below
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Above
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Unknown
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Below
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Within
|
66 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Below
|
7 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Within
|
63 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Above
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Unknown
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Below
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Within
|
69 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Unknown
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Below
|
6 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Within
|
64 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Above
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 3Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown.
Outcome measures
| Measure |
GSK1437173A Group
n=72 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=47 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Within
|
61 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Unknown
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Above
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Unknown
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated/Direct · Unknown
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated/Direct · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated/Direct · Above
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Below
|
12 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Above
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Unknown
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Within
|
71 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Within
|
66 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Within
|
66 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Above
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Below
|
5 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Within
|
72 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Unknown
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Within
|
66 Participants
|
36 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Above
|
5 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Unknown
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Within
|
67 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Above
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Unknown
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Within
|
67 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Above
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Unknown
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Within
|
68 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Above
|
10 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated/Direct · Within
|
70 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Unknown
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Below
|
5 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Within
|
66 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Above
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Within
|
59 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Above
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Below
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Within
|
62 Participants
|
38 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Above
|
7 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Unknown
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Below
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Within
|
66 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Below
|
14 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Within
|
57 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Within
|
72 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Below
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Unknown
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Within
|
71 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Below
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Below
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Within
|
69 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Within
|
67 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Above
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.
Outcome measures
| Measure |
GSK1437173A Group
n=71 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=47 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Unknown
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Below
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Within
|
67 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Above
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated/Direct · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Below
|
7 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Within
|
62 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Above
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Unknown
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Below
|
13 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Within
|
55 Participants
|
36 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Above
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Below
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Within
|
62 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Within
|
63 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Below
|
13 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Within
|
55 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Above
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Within
|
70 Participants
|
47 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Unknown
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Below
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Within
|
65 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Above
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Within
|
67 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Within
|
71 Participants
|
47 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Unknown
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Below
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Within
|
64 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Above
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Unknown
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Within
|
67 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Unknown
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Below
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Within
|
62 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Above
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Above
|
8 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Above
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Within
|
68 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Above
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Within
|
67 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Within
|
66 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Above
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Unknown
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Within
|
69 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Within
|
60 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Above
|
11 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated/Direct · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated/Direct · Within
|
68 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated/Direct · Above
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Below
|
7 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Above
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Unknown
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Below
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 7Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown.
Outcome measures
| Measure |
GSK1437173A Group
n=68 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=47 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Below
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Above
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Lymphocytes · Within
|
67 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Unknown
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Within
|
64 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Unknown
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Below
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Within
|
64 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Albumin · Above
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Within
|
63 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Unknown
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Within
|
68 Participants
|
47 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Within
|
57 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Above
|
10 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated/Direct · Unknown
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated/Direct · Within
|
67 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated/Direct · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Below
|
11 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Within
|
56 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Eosinophils · Above
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Within
|
61 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Below
|
19 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Within
|
49 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Below
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Within
|
63 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Monocytes · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Unknown
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Below
|
7 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Above
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Below
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Within
|
66 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Below
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Within
|
62 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Above
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Unknown
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alanine Aminotransferase · Above
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Unknown
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Alkaline Phosphatase · Above
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Within
|
65 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Aspartate Aminotransferase · Above
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Basophils · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Total Bilirubin · Unknown
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bilirubin Conjugated/Direct · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Unknown
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Below
|
7 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Within
|
57 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Creatinine · Above
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Within
|
63 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Glucose · Above
|
4 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Unknown
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Bicarbonate · Below
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Haemoglobin · Above
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Unknown
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Below
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Potassium · Within
|
66 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Sodium · Within
|
67 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Neutrophils · Within
|
61 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Platelets · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
White Blood Cells · Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Month 0 until Month 18Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
In this analysis, results were tabulated for the main study groups. Significant changes to ART appeared due to failure to control HIV viral load and due to failure to maintain high CD4 cells count.
Outcome measures
| Measure |
GSK1437173A Group
n=74 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=49 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects
Failure to control HIV viral load
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects
Failure to maintain high CD4 cells count
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Month 0 until Month 18Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
In this analysis, results were tabulated for the main study groups.
Outcome measures
| Measure |
GSK1437173A Group
n=74 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=49 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any AIDS-defining Condition
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Month 1 to Month 7Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
In this analysis, results were tabulated for the main study groups.
Outcome measures
| Measure |
GSK1437173A Group
n=74 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=49 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count
Change in HIV viral load
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count
Change in CD4 cells count
|
7 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Month 0 to Month 18Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
In this analysis, results were tabulated by HIV status
Outcome measures
| Measure |
GSK1437173A Group
n=56 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=38 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
n=9 Participants
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
n=5 Participants
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
n=9 Participants
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
n=6 Participants
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status
Due to failure to control HIV viral load
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status
Due to failure to maintain high CD4 cells count
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Month 0 to Month 18Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
In this analysis, results were tabulated by HIV status
Outcome measures
| Measure |
GSK1437173A Group
n=56 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=38 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
n=9 Participants
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
n=5 Participants
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
n=9 Participants
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
n=6 Participants
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any AIDS-defining Condition, by HIV Status
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Month 1 to Month 7Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
In this analysis, results were tabulated by HIV status.
Outcome measures
| Measure |
GSK1437173A Group
n=56 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=38 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
n=9 Participants
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
n=5 Participants
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
n=9 Participants
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
n=6 Participants
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status
Change in HIV viral load
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status
Change in CD4 cells count
|
5 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Month 7Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available at Month 7.
The analysis focused on CD4 T-cells expressing at least 2 cytokines (among interferon-gamma (IFN-g) , interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-a) and/or CD40 ligand (CD40L)) as determined by in vitro intracellular cytokine staining (ICS) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrollment.
Outcome measures
| Measure |
GSK1437173A Group
n=30 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=20 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Frequency of gE-specific CD4 T-cells
|
4684.50 CD4 T-cells/million T-cells
Standard Deviation 5376.83
|
158.64 CD4 T-cells/million T-cells
Standard Deviation 151.15
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 7-Anti-gE antibody (Ab) concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrolment. Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).
Outcome measures
| Measure |
GSK1437173A Group
n=54 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=36 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
-Anti-gE Antibody (Ab) Concentrations
|
63812.6 mIU/mL
Interval 51183.6 to 79557.7
|
1028.4 mIU/mL
Interval 658.9 to 1605.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 0, 1, 2, 3, 6, 7 and 18Population: The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).
The analysis focused on CD4 T cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated for the main study groups.
Outcome measures
| Measure |
GSK1437173A Group
n=49 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=35 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells
VZV-specific CD4 [2+] T-cells, Month 3
|
1878.81 CD4 T-cells/million T-cells
Standard Deviation 1615.20
|
987.24 CD4 T-cells/million T-cells
Standard Deviation 1988.86
|
—
|
—
|
—
|
—
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells
VZV-specific CD4 [2+] T-cells, Month 6
|
1646.83 CD4 T-cells/million T-cells
Standard Deviation 1202.32
|
674.20 CD4 T-cells/million T-cells
Standard Deviation 657.00
|
—
|
—
|
—
|
—
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells
VZV-specific CD4 [2+] T-cells, Month 7
|
2626.71 CD4 T-cells/million T-cells
Standard Deviation 2514.40
|
1204.44 CD4 T-cells/million T-cells
Standard Deviation 1911.53
|
—
|
—
|
—
|
—
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells
VZV-specific CD4 [2+] T-cells, Month 18
|
995.35 CD4 T-cells/million T-cells
Standard Deviation 842.96
|
531.24 CD4 T-cells/million T-cells
Standard Deviation 579.63
|
—
|
—
|
—
|
—
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells
gE-specific CD4 [2+] T-cells, Month 2
|
649.68 CD4 T-cells/million T-cells
Standard Deviation 555.51
|
140.95 CD4 T-cells/million T-cells
Standard Deviation 197.99
|
—
|
—
|
—
|
—
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells
gE-specific CD4 [2+] T-cells, Month 3
|
3503.69 CD4 T-cells/million T-cells
Standard Deviation 2971.74
|
160.10 CD4 T-cells/million T-cells
Standard Deviation 220.32
|
—
|
—
|
—
|
—
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells
gE-specific CD4 [2+] T-cells, Month 6
|
2647.71 CD4 T-cells/million T-cells
Standard Deviation 1972.00
|
133.70 CD4 T-cells/million T-cells
Standard Deviation 137.94
|
—
|
—
|
—
|
—
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells
gE-specific CD4 [2+] T-cells, Month 7
|
4684.50 CD4 T-cells/million T-cells
Standard Deviation 5376.83
|
158.64 CD4 T-cells/million T-cells
Standard Deviation 151.15
|
—
|
—
|
—
|
—
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells
gE-specific CD4 [2+] T-cells, Month 18
|
1929.30 CD4 T-cells/million T-cells
Standard Deviation 1603.50
|
139.50 CD4 T-cells/million T-cells
Standard Deviation 219.57
|
—
|
—
|
—
|
—
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells
VZV-specific CD4 [2+] T-cells, pre-vaccination
|
750.20 CD4 T-cells/million T-cells
Standard Deviation 989.36
|
835.80 CD4 T-cells/million T-cells
Standard Deviation 1949.39
|
—
|
—
|
—
|
—
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells
VZV-specific CD4 [2+] T-cells, Month 1
|
768.60 CD4 T-cells/million T-cells
Standard Deviation 739.68
|
913.87 CD4 T-cells/million T-cells
Standard Deviation 2262.66
|
—
|
—
|
—
|
—
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells
VZV-specific CD4 [2+] T-cells, Month 2
|
734.09 CD4 T-cells/million T-cells
Standard Deviation 680.34
|
874.13 CD4 T-cells/million T-cells
Standard Deviation 2027.95
|
—
|
—
|
—
|
—
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells
gE-specific CD4 [2+] T-cells, pre-vaccination
|
218.26 CD4 T-cells/million T-cells
Standard Deviation 254.94
|
123.15 CD4 T-cells/million T-cells
Standard Deviation 170.79
|
—
|
—
|
—
|
—
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells
gE-specific CD4 [2+] T-cells, Month 1
|
704.06 CD4 T-cells/million T-cells
Standard Deviation 614.49
|
132.49 CD4 T-cells/million T-cells
Standard Deviation 213.05
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Months 0, 1, 2, 3, 6, 7 and 18Population: The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).
The analysis focused on CD4 T-cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated by HIV status.
Outcome measures
| Measure |
GSK1437173A Group
n=40 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=28 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
n=5 Participants
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
n=3 Participants
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
n=5 Participants
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
n=4 Participants
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status
VZV-specific CD4 [2+] T-cells, Month 2
|
716.33 CD4 T-cells/million T-cells
Standard Deviation 699.22
|
991.07 CD4 T-cells/million T-cells
Standard Deviation 2190.70
|
814.64 CD4 T-cells/million T-cells
Standard Deviation 920.49
|
329.96 CD4 T-cells/million T-cells
Standard Deviation 53.46
|
769.13 CD4 T-cells/million T-cells
Standard Deviation 469.02
|
131.90 CD4 T-cells/million T-cells
Standard Deviation 185.13
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status
VZV-specific CD4 [2+] T-cells, pre-vaccination
|
789.48 CD4 T-cells/million T-cells
Standard Deviation 1037.59
|
927.27 CD4 T-cells/million T-cells
Standard Deviation 2053.32
|
1.00 CD4 T-cells/million T-cells
Standard Deviation 0.00
|
86.96 CD4 T-cells/million T-cells
Standard Deviation NA
There were not enough subjects for SD analysis to be computed.
|
896.13 CD4 T-cells/million T-cells
Standard Deviation 749.70
|
112.66 CD4 T-cells/million T-cells
Standard Deviation 157.91
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status
VZV-specific CD4 [2+] T-cells, Month 1
|
830.78 CD4 T-cells/million T-cells
Standard Deviation 775.61
|
1049.73 CD4 T-cells/million T-cells
Standard Deviation 2442.95
|
114.79 CD4 T-cells/million T-cells
Standard Deviation 114.03
|
146.91 CD4 T-cells/million T-cells
Standard Deviation 142.99
|
1049.36 CD4 T-cells/million T-cells
Standard Deviation 546.09
|
186.38 CD4 T-cells/million T-cells
Standard Deviation 31.21
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status
VZV-specific CD4 [2+] T-cells, Month 3
|
1973.47 CD4 T-cells/million T-cells
Standard Deviation 1669.57
|
1075.62 CD4 T-cells/million T-cells
Standard Deviation 2186.45
|
1804.94 CD4 T-cells/million T-cells
Standard Deviation 2350.96
|
408.18 CD4 T-cells/million T-cells
Standard Deviation 330.78
|
1298.35 CD4 T-cells/million T-cells
Standard Deviation 725.44
|
918.17 CD4 T-cells/million T-cells
Standard Deviation 1580.86
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status
VZV-specific CD4 [2+] T-cells, Month 6
|
1624.32 CD4 T-cells/million T-cells
Standard Deviation 1161.05
|
786.72 CD4 T-cells/million T-cells
Standard Deviation 657.24
|
1996.37 CD4 T-cells/million T-cells
Standard Deviation 1937.58
|
136.42 CD4 T-cells/million T-cells
Standard Deviation NA
There were not enough subjects for SD analysis to be computed.
|
1160.93 CD4 T-cells/million T-cells
Standard Deviation NA
There were not enough subjects for SD analysis to be computed.
|
42.92 CD4 T-cells/million T-cells
Standard Deviation 37.09
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status
VZV-specific CD4 [2+] T-cells, Month 18
|
1051.12 CD4 T-cells/million T-cells
Standard Deviation 816.86
|
599.00 CD4 T-cells/million T-cells
Standard Deviation 587.08
|
853.05 CD4 T-cells/million T-cells
Standard Deviation 1235.35
|
580.71 CD4 T-cells/million T-cells
Standard Deviation 683.08
|
634.55 CD4 T-cells/million T-cells
Standard Deviation 933.54
|
19.77 CD4 T-cells/million T-cells
Standard Deviation 22.14
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status
gE-specific CD4 [2+] T-cells, pre-vaccination
|
215.99 CD4 T-cells/million T-cells
Standard Deviation 266.22
|
136.29 CD4 T-cells/million T-cells
Standard Deviation 176.85
|
51.15 CD4 T-cells/million T-cells
Standard Deviation 70.92
|
1.00 CD4 T-cells/million T-cells
Standard Deviation NA
There were not enough subjects for SD analysis to be computed.
|
350.86 CD4 T-cells/million T-cells
Standard Deviation 161.96
|
26.57 CD4 T-cells/million T-cells
Standard Deviation 36.17
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status
gE-specific CD4 [2+] T-cells, Month 1
|
682.62 CD4 T-cells/million T-cells
Standard Deviation 595.89
|
134.21 CD4 T-cells/million T-cells
Standard Deviation 224.96
|
584.10 CD4 T-cells/million T-cells
Standard Deviation 652.67
|
161.73 CD4 T-cells/million T-cells
Standard Deviation 227.30
|
952.65 CD4 T-cells/million T-cells
Standard Deviation 763.24
|
84.33 CD4 T-cells/million T-cells
Standard Deviation 117.84
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status
gE-specific CD4 [2+] T-cells, Month 3
|
3722.21 CD4 T-cells/million T-cells
Standard Deviation 2789.70
|
190.58 CD4 T-cells/million T-cells
Standard Deviation 233.81
|
4754.94 CD4 T-cells/million T-cells
Standard Deviation 6004.05
|
1.00 CD4 T-cells/million T-cells
Standard Deviation 0.00
|
1310.76 CD4 T-cells/million T-cells
Standard Deviation 670.56
|
95.71 CD4 T-cells/million T-cells
Standard Deviation 164.04
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status
gE-specific CD4 [2+] T-cells, Month 6
|
2386.40 CD4 T-cells/million T-cells
Standard Deviation 1571.28
|
152.52 CD4 T-cells/million T-cells
Standard Deviation 141.50
|
5403.79 CD4 T-cells/million T-cells
Standard Deviation 3326.03
|
97.99 CD4 T-cells/million T-cells
Standard Deviation NA
There were not enough subjects for SD analysis to be computed.
|
912.30 CD4 T-cells/million T-cells
Standard Deviation NA
There were not enough subjects for SD analysis to be computed.
|
1.00 CD4 T-cells/million T-cells
Standard Deviation 0.00
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status
VZV-specific CD4 [2+] T-cells, Month 7
|
2285.90 CD4 T-cells/million T-cells
Standard Deviation 1998.16
|
1261.84 CD4 T-cells/million T-cells
Standard Deviation 1946.12
|
6235.67 CD4 T-cells/million T-cells
Standard Deviation 4334.14
|
113.88 CD4 T-cells/million T-cells
Standard Deviation NA
There were not enough subjects for SD analysis to be computed.
|
660.88 CD4 T-cells/million T-cells
Standard Deviation NA
There were not enough subjects for SD analysis to be computed.
|
—
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status
gE-specific CD4 [2+] T-cells, Month 2
|
610.30 CD4 T-cells/million T-cells
Standard Deviation 558.27
|
157.92 CD4 T-cells/million T-cells
Standard Deviation 208.48
|
960.39 CD4 T-cells/million T-cells
Standard Deviation 632.86
|
94.19 CD4 T-cells/million T-cells
Standard Deviation 131.79
|
629.54 CD4 T-cells/million T-cells
Standard Deviation 513.99
|
1.00 CD4 T-cells/million T-cells
Standard Deviation 0.00
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status
gE-specific CD4 [2+] T-cells, Month 7
|
3649.92 CD4 T-cells/million T-cells
Standard Deviation 3112.69
|
166.94 CD4 T-cells/million T-cells
Standard Deviation 150.54
|
14925.30 CD4 T-cells/million T-cells
Standard Deviation 10934.07
|
1.00 CD4 T-cells/million T-cells
Standard Deviation NA
There were not enough subjects for SD analysis to be computed.
|
861.21 CD4 T-cells/million T-cells
Standard Deviation NA
There were not enough subjects for SD analysis to be computed.
|
—
|
|
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status
gE-specific CD4 [2+] T-cells, Month 18
|
2071.17 CD4 T-cells/million T-cells
Standard Deviation 1583.58
|
159.05 CD4 T-cells/million T-cells
Standard Deviation 239.50
|
2035.18 CD4 T-cells/million T-cells
Standard Deviation 2100.82
|
109.97 CD4 T-cells/million T-cells
Standard Deviation 93.90
|
709.62 CD4 T-cells/million T-cells
Standard Deviation 1011.03
|
24.81 CD4 T-cells/million T-cells
Standard Deviation 47.63
|
SECONDARY outcome
Timeframe: At Months 0, 1, 2, 3, 6, 7 and 18Population: The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).
Antibody concentrations were as determined by ELISA and tabulated for the main study groups. Anti-VZV and anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.
Outcome measures
| Measure |
GSK1437173A Group
n=54 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=37 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
-Anti-VZV and Anti-gE Antibody Concentrations
Anti-gE, Month 6
|
34159.4 mIU/mL
Interval 27221.0 to 42866.2
|
1013.1 mIU/mL
Interval 660.5 to 1553.7
|
—
|
—
|
—
|
—
|
|
-Anti-VZV and Anti-gE Antibody Concentrations
Anti-gE, Month 7
|
63812.6 mIU/mL
Interval 51183.6 to 79557.7
|
1028.4 mIU/mL
Interval 658.9 to 1605.0
|
—
|
—
|
—
|
—
|
|
-Anti-VZV and Anti-gE Antibody Concentrations
Anti-gE, Month 18
|
25242.2 mIU/mL
Interval 19618.9 to 32477.3
|
918.0 mIU/mL
Interval 588.0 to 1433.1
|
—
|
—
|
—
|
—
|
|
-Anti-VZV and Anti-gE Antibody Concentrations
Anti-VZV, Pre-vaccination
|
1292.7 mIU/mL
Interval 999.8 to 1671.4
|
1074.7 mIU/mL
Interval 672.7 to 1717.0
|
—
|
—
|
—
|
—
|
|
-Anti-VZV and Anti-gE Antibody Concentrations
Anti-VZV, Month 1
|
6953.8 mIU/mL
Interval 5425.1 to 8913.3
|
1173.8 mIU/mL
Interval 762.9 to 1805.8
|
—
|
—
|
—
|
—
|
|
-Anti-VZV and Anti-gE Antibody Concentrations
Anti-VZV, Month 2
|
5170.9 mIU/mL
Interval 4032.7 to 6630.4
|
987.6 mIU/mL
Interval 596.3 to 1635.8
|
—
|
—
|
—
|
—
|
|
-Anti-VZV and Anti-gE Antibody Concentrations
Anti-VZV, Month 3
|
11119.7 mIU/mL
Interval 9190.8 to 13453.3
|
1037.8 mIU/mL
Interval 620.2 to 1736.5
|
—
|
—
|
—
|
—
|
|
-Anti-VZV and Anti-gE Antibody Concentrations
Anti-VZV, Month 6
|
8244.0 mIU/mL
Interval 6678.6 to 10176.3
|
1069.8 mIU/mL
Interval 653.3 to 1751.7
|
—
|
—
|
—
|
—
|
|
-Anti-VZV and Anti-gE Antibody Concentrations
Anti-VZV, Month 7
|
14560.8 mIU/mL
Interval 11849.0 to 17893.1
|
999.3 mIU/mL
Interval 598.3 to 1669.2
|
—
|
—
|
—
|
—
|
|
-Anti-VZV and Anti-gE Antibody Concentrations
Anti-VZV, Month 18
|
7493.3 mIU/mL
Interval 5926.7 to 9473.9
|
922.9 mIU/mL
Interval 521.1 to 1634.6
|
—
|
—
|
—
|
—
|
|
-Anti-VZV and Anti-gE Antibody Concentrations
Anti-gE, Pre-vaccination
|
1218.4 mIU/mL
Interval 895.0 to 1658.7
|
849.5 mIU/mL
Interval 551.1 to 1309.4
|
—
|
—
|
—
|
—
|
|
-Anti-VZV and Anti-gE Antibody Concentrations
Anti-gE, Month 1
|
24113.2 mIU/mL
Interval 18317.4 to 31743.0
|
1059.0 mIU/mL
Interval 749.4 to 1496.5
|
—
|
—
|
—
|
—
|
|
-Anti-VZV and Anti-gE Antibody Concentrations
Anti-gE, Month 2
|
17112.6 mIU/mL
Interval 12929.5 to 22649.1
|
903.3 mIU/mL
Interval 590.9 to 1380.9
|
—
|
—
|
—
|
—
|
|
-Anti-VZV and Anti-gE Antibody Concentrations
Anti-gE, Month 3
|
50443.0 mIU/mL
Interval 40899.6 to 62213.2
|
992.9 mIU/mL
Interval 647.4 to 1522.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Months 0, 1, 2, 3, 6, 7 and 18Population: The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).
Antibody concentrations were as determined by ELISA and tabulated by HIV status. Anti-VZV and anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.
Outcome measures
| Measure |
GSK1437173A Group
n=44 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=30 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
n=5 Participants
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
n=4 Participants
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
n=5 Participants
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
n=4 Participants
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
-Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status
Anti-VZV, Pre-vaccination
|
1161.5 mIU/mL
Interval 900.3 to 1498.6
|
985.1 mIU/mL
Interval 568.7 to 1706.4
|
2272.6 mIU/mL
Interval 559.1 to 9236.6
|
2511.9 mIU/mL
Interval 693.0 to 9104.4
|
1658.0 mIU/mL
Interval 315.9 to 8701.1
|
1068.5 mIU/mL
Interval 117.3 to 9735.4
|
|
-Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status
Anti-VZV, Month 1
|
7017.8 mIU/mL
Interval 5441.2 to 9051.3
|
1059.6 mIU/mL
Interval 641.1 to 1751.2
|
6731.0 mIU/mL
Interval 572.7 to 79107.0
|
2871.0 mIU/mL
Interval 1386.7 to 5944.3
|
6706.0 mIU/mL
Interval 2477.9 to 18148.5
|
1167.3 mIU/mL
Interval 130.1 to 10475.4
|
|
-Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status
Anti-VZV, Month 2
|
5056.5 mIU/mL
Interval 3973.9 to 6434.0
|
886.9 mIU/mL
Interval 498.6 to 1577.4
|
5649.6 mIU/mL
Interval 418.4 to 76276.9
|
2902.1 mIU/mL
Interval 1.9 to 4493973.0
|
6100.0 mIU/mL
Interval 480.4 to 77462.7
|
1191.1 mIU/mL
Interval 119.6 to 11860.7
|
|
-Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status
Anti-VZV, Month 3
|
11631.9 mIU/mL
Interval 9523.8 to 14206.6
|
1002.7 mIU/mL
Interval 565.8 to 1777.1
|
9110.7 mIU/mL
Interval 2224.8 to 37308.9
|
2479.3 mIU/mL
There were not enough subjects for a Lower Limit (LL) and Upper Limit (UL) to be computed.
|
8990.7 mIU/mL
Interval 5233.1 to 15446.6
|
1062.0 mIU/mL
Interval 81.1 to 13906.2
|
|
-Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status
Anti-VZV, Month 6
|
9027.6 mIU/mL
Interval 7225.1 to 11279.6
|
957.0 mIU/mL
Interval 537.2 to 1705.0
|
7634.7 mIU/mL
Interval 2054.6 to 28369.5
|
3164.8 mIU/mL
Interval 510.5 to 19621.7
|
4384.3 mIU/mL
Interval 2322.5 to 8276.5
|
1006.3 mIU/mL
Interval 115.7 to 8754.6
|
|
-Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status
Anti-VZV, Month 7
|
15278.5 mIU/mL
Interval 12420.2 to 18794.5
|
930.5 mIU/mL
Interval 511.6 to 1692.3
|
14763.2 mIU/mL
Interval 2859.6 to 76216.1
|
2177.3 mIU/mL
Interval 8.7 to 544573.1
|
8845.8 mIU/mL
Interval 5463.6 to 14321.5
|
1076.7 mIU/mL
Interval 109.5 to 10591.1
|
|
-Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status
Anti-gE, Pre-vaccination
|
1113.2 mIU/mL
Interval 794.3 to 1560.3
|
791.0 mIU/mL
Interval 490.7 to 1275.1
|
1845.1 mIU/mL
Interval 465.1 to 7319.1
|
2420.7 mIU/mL
Interval 512.0 to 11445.2
|
1748.6 mIU/mL
Interval 308.5 to 9912.2
|
661.2 mIU/mL
Interval 43.8 to 9984.8
|
|
-Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status
Anti-gE, Month 1
|
25530.6 mIU/mL
Interval 19158.6 to 34021.9
|
1029.5 mIU/mL
Interval 719.5 to 1473.1
|
18767.2 mIU/mL
Interval 2219.4 to 158697.1
|
2328.1 mIU/mL
Interval 446.4 to 12141.8
|
18742.3 mIU/mL
Interval 6616.7 to 53089.1
|
720.0 mIU/mL
Interval 50.6 to 10238.5
|
|
-Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status
Anti-gE, Month 2
|
18208.6 mIU/mL
Interval 13537.4 to 24491.6
|
839.8 mIU/mL
Interval 524.6 to 1344.4
|
13106.4 mIU/mL
Interval 1619.0 to 106104.2
|
2465.5 mIU/mL
Interval 561.9 to 10817.4
|
13100.6 mIU/mL
Interval 4828.6 to 35543.7
|
735.0 mIU/mL
Interval 52.7 to 10245.9
|
|
-Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status
Anti-gE, Month 6
|
38068.2 mIU/mL
Interval 29964.3 to 48363.7
|
932.8 mIU/mL
Interval 582.6 to 1493.3
|
24725.0 mIU/mL
Interval 5143.2 to 118862.3
|
2629.2 mIU/mL
Interval 561.7 to 12306.8
|
18189.6 mIU/mL
Interval 11258.0 to 29389.0
|
920.6 mIU/mL
Interval 54.8 to 15461.5
|
|
-Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status
Anti-gE, Month 7
|
71309.6 mIU/mL
Interval 57019.3 to 89181.5
|
928.8 mIU/mL
Interval 566.8 to 1522.1
|
47382.6 mIU/mL
Interval 9151.2 to 245336.2
|
2553.0 mIU/mL
Interval 610.1 to 10683.1
|
32334.6 mIU/mL
Interval 17277.6 to 60513.4
|
1087.6 mIU/mL
Interval 60.2 to 19641.4
|
|
-Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status
Anti-VZV, Month 18
|
8242.2 mIU/mL
Interval 6484.1 to 10476.9
|
838.1 mIU/mL
Interval 435.9 to 1611.5
|
6106.2 mIU/mL
Interval 748.6 to 49809.5
|
1955.3 mIU/mL
Interval 188.8 to 20249.5
|
4361.7 mIU/mL
Interval 1721.5 to 11050.9
|
1209.2 mIU/mL
Interval 13.9 to 105230.8
|
|
-Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status
Anti-gE, Month 3
|
54777.7 mIU/mL
Interval 44077.1 to 68076.1
|
955.6 mIU/mL
Interval 590.6 to 1546.2
|
36592.6 mIU/mL
Interval 7026.0 to 190581.1
|
2166.3 mIU/mL
Interval 618.9 to 7583.1
|
33662.4 mIU/mL
Interval 20665.6 to 54833.0
|
736.6 mIU/mL
Interval 52.1 to 10414.5
|
|
-Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status
Anti-gE, Month 18
|
28854.6 mIU/mL
Interval 22512.5 to 36983.3
|
849.4 mIU/mL
Interval 514.6 to 1401.9
|
18995.8 mIU/mL
Interval 1733.3 to 208181.4
|
1953.7 mIU/mL
Interval 572.7 to 6665.3
|
10869.2 mIU/mL
Interval 4435.4 to 26635.7
|
757.8 mIU/mL
Interval 34.8 to 16519.1
|
SECONDARY outcome
Timeframe: From Month 0 until Month 18Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Outcome measures
| Measure |
GSK1437173A Group
n=74 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=49 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Herpes Zoster (HZ) Cases and Complications
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
CD4 count was tabulated by HIV status.
Outcome measures
| Measure |
GSK1437173A Group
n=56 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=38 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
n=9 Participants
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
n=5 Participants
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
n=9 Participants
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
n=6 Participants
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
CD4 Count
CD4+, pre-vaccination
|
631.46 CD4 T-cells/million T-cells
Standard Deviation 236.36
|
683.39 CD4 T-cells/million T-cells
Standard Deviation 228.29
|
152.11 CD4 T-cells/million T-cells
Standard Deviation 38.39
|
132.20 CD4 T-cells/million T-cells
Standard Deviation 11.19
|
805.33 CD4 T-cells/million T-cells
Standard Deviation 132.38
|
901.67 CD4 T-cells/million T-cells
Standard Deviation 177.61
|
|
CD4 Count
CD4+, Month 1
|
630.55 CD4 T-cells/million T-cells
Standard Deviation 241.78
|
694.69 CD4 T-cells/million T-cells
Standard Deviation 307.98
|
151.11 CD4 T-cells/million T-cells
Standard Deviation 38.72
|
163.00 CD4 T-cells/million T-cells
Standard Deviation 53.66
|
879.67 CD4 T-cells/million T-cells
Standard Deviation 277.37
|
773.40 CD4 T-cells/million T-cells
Standard Deviation 144.85
|
|
CD4 Count
CD4+, Month 2
|
667.69 CD4 T-cells/million T-cells
Standard Deviation 309.22
|
656.14 CD4 T-cells/million T-cells
Standard Deviation 262.43
|
131.13 CD4 T-cells/million T-cells
Standard Deviation 39.57
|
133.75 CD4 T-cells/million T-cells
Standard Deviation 31.86
|
808.75 CD4 T-cells/million T-cells
Standard Deviation 211.32
|
804.00 CD4 T-cells/million T-cells
Standard Deviation 199.09
|
|
CD4 Count
CD4+, Month 3
|
633.60 CD4 T-cells/million T-cells
Standard Deviation 228.75
|
640.14 CD4 T-cells/million T-cells
Standard Deviation 238.05
|
153.11 CD4 T-cells/million T-cells
Standard Deviation 54.27
|
142.60 CD4 T-cells/million T-cells
Standard Deviation 36.49
|
783.63 CD4 T-cells/million T-cells
Standard Deviation 239.92
|
762.60 CD4 T-cells/million T-cells
Standard Deviation 185.66
|
|
CD4 Count
CD4+, Month 6
|
655.02 CD4 T-cells/million T-cells
Standard Deviation 264.67
|
668.28 CD4 T-cells/million T-cells
Standard Deviation 308.64
|
145.33 CD4 T-cells/million T-cells
Standard Deviation 29.74
|
145.20 CD4 T-cells/million T-cells
Standard Deviation 43.18
|
776.43 CD4 T-cells/million T-cells
Standard Deviation 303.30
|
1082.80 CD4 T-cells/million T-cells
Standard Deviation 649.82
|
|
CD4 Count
CD4+, Month 7
|
654.69 CD4 T-cells/million T-cells
Standard Deviation 271.31
|
658.81 CD4 T-cells/million T-cells
Standard Deviation 246.53
|
170.25 CD4 T-cells/million T-cells
Standard Deviation 44.52
|
150.40 CD4 T-cells/million T-cells
Standard Deviation 35.11
|
869.14 CD4 T-cells/million T-cells
Standard Deviation 297.04
|
866.00 CD4 T-cells/million T-cells
Standard Deviation 144.30
|
|
CD4 Count
CD4+, Month 18
|
679.71 CD4 T-cells/million T-cells
Standard Deviation 247.57
|
651.06 CD4 T-cells/million T-cells
Standard Deviation 247.30
|
168.43 CD4 T-cells/million T-cells
Standard Deviation 58.49
|
151.40 CD4 T-cells/million T-cells
Standard Deviation 57.48
|
720.00 CD4 T-cells/million T-cells
Standard Deviation 228.77
|
824.40 CD4 T-cells/million T-cells
Standard Deviation 207.57
|
SECONDARY outcome
Timeframe: At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18Population: The analysis was performed on the Total Vaccinated cohort, which included only vaccinated subjects with at least one vaccine administration documented, who had available results of ≥ 40 copies/mL.
HIV VL was tabulated by HIV status, for subjects with a number of available results greater than or equal to (≥) 40 copies/mL.
Outcome measures
| Measure |
GSK1437173A Group
n=4 Participants
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=4 Participants
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - GSK 1437173A
n=2 Participants
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
ART Low CD4 Cohort - Placebo
n=1 Participants
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - GSK 1437173A
n=9 Participants
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Non-ART High CD4 Cohort - Placebo
n=6 Participants
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
HIV VL
HIV VL, Month 3
|
75.00 HIV-RNA copies/mL
Standard Deviation 37.75
|
—
|
84.00 HIV-RNA copies/mL
Standard Deviation NA
There were not enough subjects for SD analysis to be computed.
|
—
|
19453.50 HIV-RNA copies/mL
Standard Deviation 11878.74
|
16270.00 HIV-RNA copies/mL
Standard Deviation 15785.91
|
|
HIV VL
HIV VL, Month 6
|
19699.25 HIV-RNA copies/mL
Standard Deviation 39272.50
|
112.00 HIV-RNA copies/mL
Standard Deviation NA
There were not enough subjects for SD analysis to be computed.
|
66053.50 HIV-RNA copies/mL
Standard Deviation 93328.90
|
51.00 HIV-RNA copies/mL
Standard Deviation NA
There were not enough subjects for SD analysis to be computed.
|
37091.29 HIV-RNA copies/mL
Standard Deviation 33678.60
|
46429.60 HIV-RNA copies/mL
Standard Deviation 52567.42
|
|
HIV VL
HIV VL, pre-vaccination
|
—
|
—
|
62.00 HIV-RNA copies/mL
Standard Deviation NA
There were not enough subjects for SD analysis to be computed.
|
—
|
23014.11 HIV-RNA copies/mL
Standard Deviation 18435.10
|
16022.17 HIV-RNA copies/mL
Standard Deviation 23652.18
|
|
HIV VL
HIV VL, Month 1
|
42.00 HIV-RNA copies/mL
Standard Deviation NA
There were not enough subjects for SD analysis to be computed.
|
—
|
48.00 HIV-RNA copies/mL
Standard Deviation NA
There were not enough subjects for SD analysis to be computed.
|
—
|
24538.89 HIV-RNA copies/mL
Standard Deviation 19056.10
|
14415.80 HIV-RNA copies/mL
Standard Deviation 9289.92
|
|
HIV VL
HIV VL, Month 2
|
48.67 HIV-RNA copies/mL
Standard Deviation 10.79
|
55.00 HIV-RNA copies/mL
Standard Deviation NA
There were not enough subjects for SD analysis to be computed.
|
48.00 HIV-RNA copies/mL
Standard Deviation 2.83
|
—
|
24134.25 HIV-RNA copies/mL
Standard Deviation 13753.92
|
18188.25 HIV-RNA copies/mL
Standard Deviation 15199.35
|
|
HIV VL
HIV VL, Month 7
|
530.67 HIV-RNA copies/mL
Standard Deviation 785.50
|
55.75 HIV-RNA copies/mL
Standard Deviation 6.29
|
248.00 HIV-RNA copies/mL
Standard Deviation NA
There were not enough subjects for SD analysis to be computed.
|
—
|
35534.00 HIV-RNA copies/mL
Standard Deviation 39549.42
|
25774.60 HIV-RNA copies/mL
Standard Deviation 27360.66
|
|
HIV VL
HIV VL, Month 18
|
70.33 HIV-RNA copies/mL
Standard Deviation 29.54
|
92.67 HIV-RNA copies/mL
Standard Deviation 64.53
|
48.00 HIV-RNA copies/mL
Standard Deviation NA
There were not enough subjects for SD analysis to be computed.
|
—
|
60597.00 HIV-RNA copies/mL
Standard Deviation 48313.15
|
14742.60 HIV-RNA copies/mL
Standard Deviation 18306.17
|
Adverse Events
GSK1437173A Group
Serious events: 6 serious events
Other events: 72 other events
Deaths: 0 deaths
Placebo Group
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK1437173A Group
n=74 participants at risk
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=49 participants at risk
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|
|
Infections and infestations
Anal abscess
|
1.4%
1/74 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
0.00%
0/49 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
|
Cardiac disorders
Coronary artery disease
|
1.4%
1/74 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
0.00%
0/49 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/74 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
2.0%
1/49 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
|
Reproductive system and breast disorders
Epididymitis
|
1.4%
1/74 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
0.00%
0/49 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer recurrent
|
1.4%
1/74 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
0.00%
0/49 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
1.4%
1/74 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
0.00%
0/49 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
|
Nervous system disorders
Partial seizures
|
1.4%
1/74 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
0.00%
0/49 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/74 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
2.0%
1/49 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
|
Hepatobiliary disorders
Portal hypertension
|
1.4%
1/74 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
0.00%
0/49 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
Other adverse events
| Measure |
GSK1437173A Group
n=74 participants at risk
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
Placebo Group
n=49 participants at risk
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
|
|---|---|---|
|
General disorders
Pain
|
98.6%
72/73 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
12.5%
6/48 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
|
General disorders
Redness
|
38.4%
28/73 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
0.00%
0/48 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
|
General disorders
Swelling
|
27.4%
20/73 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
0.00%
0/48 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
|
General disorders
Fatigue
|
75.3%
55/73 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
29.2%
14/48 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
|
General disorders
Gastrointestinal
|
38.4%
28/73 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
22.9%
11/48 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
|
General disorders
Headache
|
64.4%
47/73 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
31.2%
15/48 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
|
General disorders
Myalgia
|
74.0%
54/73 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
18.8%
9/48 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
|
General disorders
Shivering
|
50.7%
37/73 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
10.4%
5/48 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
|
General disorders
Temperature
|
30.1%
22/73 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
6.2%
3/48 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
|
General disorders
Influenza like illness
|
8.1%
6/74 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
2.0%
1/49 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
4/74 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
4.1%
2/49 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.4%
4/74 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
2.0%
1/49 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
|
Infections and infestations
Upper respiratory tract infection
|
6.8%
5/74 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
0.00%
0/49 • Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
|
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