Trial Outcomes & Findings for Evaluation of the Immune Response of a HIV Candidate Vaccine After Administration of One Chloroquine Dose (NCT NCT00972725)
NCT ID: NCT00972725
Last Updated: 2018-08-17
Results Overview
Among expressed cytokines were interleukin-2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (INF-γ), as determined by intracellular cytokine staining (ICS).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
At Day 14
Results posted on
2018-08-17
Participant Flow
Out of all the subjects planned for enrollment, only 28 were included in the analyses and hence started the study.
Participant milestones
| Measure |
GSK732461+Nivaquine Group
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
15
|
|
Overall Study
COMPLETED
|
13
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Immune Response of a HIV Candidate Vaccine After Administration of One Chloroquine Dose
Baseline characteristics by cohort
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=15 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.1 Years
STANDARD_DEVIATION 5.33 • n=5 Participants
|
24.3 Years
STANDARD_DEVIATION 3.73 • n=7 Participants
|
24.67 Years
STANDARD_DEVIATION 4.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 14Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Among expressed cytokines were interleukin-2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (INF-γ), as determined by intracellular cytokine staining (ICS).
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=13 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens
At least 3 antigens, Day 14
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens
At least 1 antigen, Day 14
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens
At least 2 antigens, Day 14
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens
At least 4 antigens, Day 14
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 7 Day (Days 0-6) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=15 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Solicited Local Symptoms
Any Pain
|
13 Participants
|
14 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Pain
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Redness
|
3 Participants
|
6 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Redness
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Swelling
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: During the 7 Day (Days 0-6) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Assessed solicited general symptoms were fatigue, temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal symptoms \[nausea, vomiting, diarrhoea and/or abdominal pain\] and headache. Any = occurrence of the symptom regardless of intensity grade. 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 |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=15 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Solicited General Symptoms
Any Headache
|
9 Participants
|
13 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Headache
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Headache
|
8 Participants
|
10 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Temperature
|
8 Participants
|
10 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Temperature
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Temperature
|
7 Participants
|
9 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Fatigue
|
9 Participants
|
14 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Fatigue
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Fatigue
|
9 Participants
|
11 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Gastrointestinal
|
6 Participants
|
5 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Gastrointestinal
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Gastrointestinal
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: During the 32 Day (Days 2-29) post-chloroquine administration and during the 30 Day (Days 0-29) post-vaccine administration periodPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
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 out-side 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 |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=15 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Any AEs
|
8 Participants
|
13 Participants
|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Grade 3 AEs
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Related AEs
|
5 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: During the entire study period (from Day 0 up to Day 360)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
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 |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=15 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the entire study period (from Day 0 up to Day 360)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Adverse events of specific interest include auto-immune diseases (AID) and immune mediated disorders such as neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=15 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With AEs of Specific Interest and Immune-Mediated Disorders (IMDs)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Among haematological and biochemical parameters determined were alanine aminotransferase \[ALT\], aspartate aminotransferase \[ASA\], basophils \[BASO\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[HAEM\], haemoglobin \[HAEMO\], lymphocytes \[LYMPH\], monocytes \[MONO\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\], urea \[UR\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=15 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Levels of Haematological and Biochemical Parameters
MONO, Above
|
0 Participants
|
1 Participants
|
|
Levels of Haematological and Biochemical Parameters
WBC, Within
|
13 Participants
|
13 Participants
|
|
Levels of Haematological and Biochemical Parameters
WBC, Above
|
0 Participants
|
2 Participants
|
|
Levels of Haematological and Biochemical Parameters
ALT, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
ALT, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
ALT, Within
|
13 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
ALT, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
ASA, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
ASA, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
ASA, Within
|
13 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
ASA, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
BASO, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
BASO, Below
|
3 Participants
|
4 Participants
|
|
Levels of Haematological and Biochemical Parameters
BASO, Within
|
10 Participants
|
11 Participants
|
|
Levels of Haematological and Biochemical Parameters
BASO, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
CREA, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
CREA, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
CREA, Within
|
12 Participants
|
14 Participants
|
|
Levels of Haematological and Biochemical Parameters
CREA, Above
|
1 Participants
|
1 Participants
|
|
Levels of Haematological and Biochemical Parameters
EOS, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
EOS, Below
|
1 Participants
|
1 Participants
|
|
Levels of Haematological and Biochemical Parameters
EOS, Within
|
12 Participants
|
14 Participants
|
|
Levels of Haematological and Biochemical Parameters
EOS, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEM, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEM, Below
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEM, Within
|
12 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEM, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEMO, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEMO, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEMO, Within
|
12 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEMO, Above
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
LYMPH, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
LYMPH, Below
|
1 Participants
|
3 Participants
|
|
Levels of Haematological and Biochemical Parameters
LYMPH, Within
|
12 Participants
|
12 Participants
|
|
Levels of Haematological and Biochemical Parameters
LYMPH, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
MONO, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
MONO, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
MONO, Within
|
13 Participants
|
14 Participants
|
|
Levels of Haematological and Biochemical Parameters
NEU, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
NEU, Below
|
2 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
NEU, Within
|
11 Participants
|
13 Participants
|
|
Levels of Haematological and Biochemical Parameters
NEU, Above
|
0 Participants
|
2 Participants
|
|
Levels of Haematological and Biochemical Parameters
PLA, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
PLA, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
PLA, Within
|
13 Participants
|
14 Participants
|
|
Levels of Haematological and Biochemical Parameters
PLA, Above
|
0 Participants
|
1 Participants
|
|
Levels of Haematological and Biochemical Parameters
RBC, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
RBC, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
RBC, Within
|
13 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
RBC, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
UR, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
UR, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
UR, Within
|
13 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
UR, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
WBC, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
WBC, Below
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 7Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Among haematological and biochemical parameters determined were alanine aminotransferase \[ALT\], aspartate aminotransferase \[ASA\], basophils \[BASO\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[HAEM\], haemoglobin \[HAEMO\], lymphocytes \[LYMPH\], monocytes \[MONO\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\], urea \[UR\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=15 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Levels of Haematological and Biochemical Parameters
ALT, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
ALT, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
ALT, Within
|
13 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
ALT, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
LYMPH, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
PLA, Within
|
13 Participants
|
14 Participants
|
|
Levels of Haematological and Biochemical Parameters
PLA, Above
|
0 Participants
|
1 Participants
|
|
Levels of Haematological and Biochemical Parameters
RBC, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
ASA, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
ASA, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
ASA, Within
|
13 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
ASA, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
BASO, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
BASO, Below
|
3 Participants
|
1 Participants
|
|
Levels of Haematological and Biochemical Parameters
BASO, Within
|
10 Participants
|
14 Participants
|
|
Levels of Haematological and Biochemical Parameters
BASO, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
CREA, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
CREA, Below
|
1 Participants
|
1 Participants
|
|
Levels of Haematological and Biochemical Parameters
CREA, Within
|
11 Participants
|
12 Participants
|
|
Levels of Haematological and Biochemical Parameters
CREA, Above
|
1 Participants
|
2 Participants
|
|
Levels of Haematological and Biochemical Parameters
EOS, Unknown
|
1 Participants
|
1 Participants
|
|
Levels of Haematological and Biochemical Parameters
EOS, Below
|
1 Participants
|
1 Participants
|
|
Levels of Haematological and Biochemical Parameters
EOS, Within
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
EOS, Above
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEM, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEM, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEM, Within
|
13 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEM, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEMO, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEMO, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEMO, Within
|
13 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEMO, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
LYMPH, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
LYMPH, Within
|
13 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
LYMPH, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
MONO, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
MONO, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
MONO, Within
|
11 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
MONO, Above
|
2 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
NEU, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
NEU, Below
|
2 Participants
|
1 Participants
|
|
Levels of Haematological and Biochemical Parameters
NEU, Within
|
10 Participants
|
14 Participants
|
|
Levels of Haematological and Biochemical Parameters
NEU, Above
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
PLA, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
PLA, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
RBC, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
RBC, Within
|
13 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
RBC, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
UR, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
UR, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
UR, Within
|
12 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
UR, Above
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
WBC, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
WBC, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
WBC, Within
|
12 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
WBC, Above
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 30Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Among haematological and biochemical parameters determined were alanine aminotransferase \[ALT\], aspartate aminotransferase \[ASA\], basophils \[BASO\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[HAEM\], haemoglobin \[HAEMO\], lymphocytes \[LYMPH\], monocytes \[MONO\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\], urea \[UR\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=15 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Levels of Haematological and Biochemical Parameters
HAEMO, Unknown
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
LYMPH, Below
|
1 Participants
|
1 Participants
|
|
Levels of Haematological and Biochemical Parameters
LYMPH, Within
|
11 Participants
|
14 Participants
|
|
Levels of Haematological and Biochemical Parameters
MONO, Unknown
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
MONO, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
NEU, Below
|
3 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
NEU, Within
|
9 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
PLA, Unknown
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
PLA, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
PLA, Within
|
12 Participants
|
14 Participants
|
|
Levels of Haematological and Biochemical Parameters
RBC, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
UR, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
UR, Within
|
12 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
UR, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
WBC, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
ALT, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
ALT, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
ALT, Within
|
13 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
ALT, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
ASA, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
ASA, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
ASA, Within
|
12 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
ASA, Above
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
BASO, Unknown
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
BASO, Below
|
2 Participants
|
2 Participants
|
|
Levels of Haematological and Biochemical Parameters
BASO, Within
|
9 Participants
|
12 Participants
|
|
Levels of Haematological and Biochemical Parameters
BASO, Above
|
1 Participants
|
1 Participants
|
|
Levels of Haematological and Biochemical Parameters
CREA, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
CREA, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
CREA, Within
|
13 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
CREA, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
EOS, Unknown
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
EOS, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
EOS, Within
|
11 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
EOS, Above
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEM, Unknown
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEM, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEM, Within
|
12 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEM, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEMO, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEMO, Within
|
12 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEMO, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
LYMPH, Unknown
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
LYMPH, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
MONO, Within
|
12 Participants
|
14 Participants
|
|
Levels of Haematological and Biochemical Parameters
MONO, Above
|
0 Participants
|
1 Participants
|
|
Levels of Haematological and Biochemical Parameters
NEU, Unknown
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
NEU, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
PLA, Above
|
0 Participants
|
1 Participants
|
|
Levels of Haematological and Biochemical Parameters
RBC, Unknown
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
RBC, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
RBC, Within
|
12 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
UR, Below
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
WBC, Unknown
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
WBC, Below
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
WBC, Within
|
11 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: At Day 180Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Among haematological and biochemical parameters determined were alanine aminotransferase \[ALT\], aspartate aminotransferase \[ASA\], basophils \[BASO\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[HAEM\], haemoglobin \[HAEMO\], lymphocytes \[LYMPH\], monocytes \[MONO\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\], urea \[UR\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=15 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Levels of Haematological and Biochemical Parameters
ALT, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
BASO, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
CREA, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
CREA, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
EOS, Below
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEM, Within
|
13 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEMO, Within
|
13 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
RBC, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
UR, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
UR, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
ALT, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
ALT, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
ALT, Within
|
13 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
ASA, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
ASA, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
ASA, Within
|
13 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
ASA, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
BASO, Below
|
1 Participants
|
2 Participants
|
|
Levels of Haematological and Biochemical Parameters
BASO, Within
|
12 Participants
|
13 Participants
|
|
Levels of Haematological and Biochemical Parameters
BASO, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
CREA, Within
|
13 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
CREA, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
EOS, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
EOS, Within
|
11 Participants
|
14 Participants
|
|
Levels of Haematological and Biochemical Parameters
EOS, Above
|
1 Participants
|
1 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEM, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEM, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEM, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEMO, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEMO, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
HAEMO, Above
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
LYMPH, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
LYMPH, Below
|
1 Participants
|
3 Participants
|
|
Levels of Haematological and Biochemical Parameters
LYMPH, Within
|
11 Participants
|
12 Participants
|
|
Levels of Haematological and Biochemical Parameters
LYMPH, Above
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
MONO, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
MONO, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
MONO, Within
|
13 Participants
|
14 Participants
|
|
Levels of Haematological and Biochemical Parameters
MONO, Above
|
0 Participants
|
1 Participants
|
|
Levels of Haematological and Biochemical Parameters
NEU, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
NEU, Below
|
2 Participants
|
1 Participants
|
|
Levels of Haematological and Biochemical Parameters
NEU, Within
|
10 Participants
|
14 Participants
|
|
Levels of Haematological and Biochemical Parameters
NEU, Above
|
1 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
PLA, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
PLA, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
PLA, Within
|
13 Participants
|
14 Participants
|
|
Levels of Haematological and Biochemical Parameters
PLA, Above
|
0 Participants
|
1 Participants
|
|
Levels of Haematological and Biochemical Parameters
RBC, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
RBC, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
RBC, Within
|
13 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
UR, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
UR, Within
|
13 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
WBC, Unknown
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
WBC, Below
|
0 Participants
|
0 Participants
|
|
Levels of Haematological and Biochemical Parameters
WBC, Within
|
12 Participants
|
15 Participants
|
|
Levels of Haematological and Biochemical Parameters
WBC, Above
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Magnitude was defined as the frequency of CD8+ T cells group-specific antigen (Gag) proteins 17, 24; negative regulatory factor (Nef); reverse transcriptase (RT) and fusion protein of all 4 antigens (F4co). Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co\_est). Among the cytokines expressed were IL-2, TNF-α and INF-γ.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
P24, D7
|
93.50 T cells/million cells
Interval 21.5 to 159.5
|
54.00 T cells/million cells
Interval 40.0 to 94.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
RT, D0
|
79.00 T cells/million cells
Interval 54.0 to 140.0
|
89.00 T cells/million cells
Interval 40.0 to 225.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
RT, D7
|
127.50 T cells/million cells
Interval 49.0 to 227.0
|
137.00 T cells/million cells
Interval 70.0 to 168.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
RT, D14
|
94.00 T cells/million cells
Interval 53.0 to 214.0
|
102.00 T cells/million cells
Interval 40.0 to 187.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
RT, D30
|
57.00 T cells/million cells
Interval 48.0 to 117.0
|
85.00 T cells/million cells
Interval 14.0 to 113.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
RT, D180
|
14.00 T cells/million cells
Interval 14.0 to 44.0
|
48.50 T cells/million cells
Interval 33.0 to 71.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
Nef, D0
|
75.00 T cells/million cells
Interval 46.0 to 121.0
|
71.00 T cells/million cells
Interval 36.0 to 152.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
Nef, D7
|
63.50 T cells/million cells
Interval 30.0 to 146.0
|
84.00 T cells/million cells
Interval 44.0 to 130.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
Nef, D14
|
123.00 T cells/million cells
Interval 93.0 to 184.0
|
99.00 T cells/million cells
Interval 65.0 to 117.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
Nef, D30
|
61.00 T cells/million cells
Interval 38.0 to 116.0
|
116.00 T cells/million cells
Interval 74.0 to 146.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
Nef, D180
|
39.00 T cells/million cells
Interval 14.0 to 74.0
|
66.00 T cells/million cells
Interval 49.0 to 166.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
P17, D0
|
104.00 T cells/million cells
Interval 41.0 to 127.0
|
76.00 T cells/million cells
Interval 33.0 to 165.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
P17, D7
|
109.50 T cells/million cells
Interval 52.5 to 136.5
|
88.00 T cells/million cells
Interval 42.0 to 113.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
P17, D14
|
124.00 T cells/million cells
Interval 38.0 to 178.0
|
84.00 T cells/million cells
Interval 52.0 to 169.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
P17, D30
|
18.00 T cells/million cells
Interval 14.0 to 72.0
|
98.00 T cells/million cells
Interval 49.0 to 120.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
P17, D180
|
55.00 T cells/million cells
Interval 18.0 to 91.0
|
80.00 T cells/million cells
Interval 68.0 to 142.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
P24, D0
|
68.00 T cells/million cells
Interval 44.0 to 96.0
|
77.50 T cells/million cells
Interval 14.0 to 126.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
P24, D14
|
83.00 T cells/million cells
Interval 68.0 to 105.0
|
91.00 T cells/million cells
Interval 49.0 to 106.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
P24, D30
|
120.00 T cells/million cells
Interval 73.0 to 134.0
|
81.00 T cells/million cells
Interval 44.0 to 119.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
P24, D180
|
62.00 T cells/million cells
Interval 14.0 to 102.0
|
45.00 T cells/million cells
Interval 14.0 to 79.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
Pool_F4co, D0
|
76.00 T cells/million cells
Interval 36.0 to 120.0
|
148.00 T cells/million cells
Interval 73.0 to 201.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
Pool_F4co, D7
|
218.50 T cells/million cells
Interval 81.5 to 242.5
|
129.00 T cells/million cells
Interval 58.0 to 158.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
Pool_F4co, D14
|
92.00 T cells/million cells
Interval 55.0 to 129.0
|
118.00 T cells/million cells
Interval 76.0 to 168.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
Pool_F4co, D30
|
68.00 T cells/million cells
Interval 16.0 to 132.0
|
122.00 T cells/million cells
Interval 81.0 to 144.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
Pool_F4co, D180
|
65.00 T cells/million cells
Interval 14.0 to 156.0
|
74.00 T cells/million cells
Interval 50.0 to 98.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
F4co_est, D0
|
373.00 T cells/million cells
Interval 271.0 to 453.0
|
398.00 T cells/million cells
Interval 224.0 to 552.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
F4co_est, D7
|
448.50 T cells/million cells
Interval 240.0 to 619.0
|
451.00 T cells/million cells
Interval 329.0 to 534.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
F4co_est, D14
|
478.00 T cells/million cells
Interval 313.0 to 554.0
|
450.00 T cells/million cells
Interval 338.0 to 539.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
F4co_est, D30
|
290.00 T cells/million cells
Interval 246.0 to 429.0
|
380.00 T cells/million cells
Interval 241.0 to 555.0
|
|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
F4co_est, D180
|
226.00 T cells/million cells
Interval 108.0 to 299.0
|
287.50 T cells/million cells
Interval 230.0 to 374.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or cluster of differentiation 40-ligand (CD40-L) cytokines as determined by ICS.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+, D0
|
146.00 T cells/million cells
Interval 42.0 to 228.0
|
123.00 T cells/million cells
Interval 1.0 to 179.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+, D7
|
121.50 T cells/million cells
Interval 1.0 to 272.0
|
168.00 T cells/million cells
Interval 89.0 to 389.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+, D14
|
91.00 T cells/million cells
Interval 11.0 to 177.0
|
1.00 T cells/million cells
Interval 1.0 to 83.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+, D30
|
113.00 T cells/million cells
Interval 1.0 to 238.0
|
27.00 T cells/million cells
Interval 1.0 to 190.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+, D180
|
1.00 T cells/million cells
Interval 1.0 to 100.0
|
52.50 T cells/million cells
Interval 1.0 to 178.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IL2+, D0
|
31.00 T cells/million cells
Interval 1.0 to 42.0
|
1.00 T cells/million cells
Interval 1.0 to 79.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IL2+, D7
|
32.50 T cells/million cells
Interval 1.0 to 55.0
|
1.00 T cells/million cells
Interval 1.0 to 71.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IL2+, D14
|
64.00 T cells/million cells
Interval 1.0 to 87.0
|
32.00 T cells/million cells
Interval 1.0 to 60.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IL2+, D30
|
3.00 T cells/million cells
Interval 1.0 to 54.0
|
1.00 T cells/million cells
Interval 1.0 to 36.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IL2+, D180
|
1.00 T cells/million cells
Interval 1.0 to 27.0
|
1.00 T cells/million cells
Interval 1.0 to 31.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 28.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, TNF+, D7
|
1.00 T cells/million cells
Interval 1.0 to 19.5
|
34.00 T cells/million cells
Interval 1.0 to 82.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, TNF+, D14
|
1.00 T cells/million cells
Interval 1.0 to 21.0
|
1.00 T cells/million cells
Interval 1.0 to 30.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 30.0
|
1.00 T cells/million cells
Interval 1.0 to 7.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, TNF+, D180,
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 43.0
|
1.00 T cells/million cells
Interval 1.0 to 40.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 31.0
|
1.00 T cells/million cells
Interval 1.0 to 34.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IFN+, D14
|
14.00 T cells/million cells
Interval 1.0 to 30.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IFN+, D30
|
4.00 T cells/million cells
Interval 1.0 to 30.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 20.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IL2+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IL2+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IL2+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IL2+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IL2+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+TNF+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+TNF+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IL2+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IL2+TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IL2+TNF+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IL2+TNF+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 20.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IL2+TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IL2+TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IL2+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IL2+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IL2+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IL2+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IL2+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 31.5
|
1.00 T cells/million cells
Interval 1.0 to 20.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 37.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IL2+TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IL2+TNF+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IL2+TNF+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IL2+TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IL2+TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IL2+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IL2+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IL2+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IL2+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IL2+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40+TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IL2+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IL2+TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IL2+TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IL2+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, IL2+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IL2+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IL2+TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 6.5
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IL2+TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
RT, CD40L+IL2+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or cluster of differentiation 40-ligand (CD40-L) cytokines as determined by ICS.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+, D0
|
155.00 T cells/million cells
Interval 45.0 to 226.0
|
72.50 T cells/million cells
Interval 1.0 to 166.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+, D7
|
90.50 T cells/million cells
Interval 33.5 to 157.0
|
173.00 T cells/million cells
Interval 30.0 to 280.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+, D14
|
122.00 T cells/million cells
Interval 82.0 to 231.0
|
10.00 T cells/million cells
Interval 1.0 to 81.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+, D30
|
191.00 T cells/million cells
Interval 1.0 to 373.0
|
30.00 T cells/million cells
Interval 1.0 to 107.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+, D180
|
134.00 T cells/million cells
Interval 45.0 to 174.0
|
43.50 T cells/million cells
Interval 1.0 to 169.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IL2+, D0
|
1.00 T cells/million cells
Interval 1.0 to 55.0
|
9.50 T cells/million cells
Interval 1.0 to 70.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IL2+, D7
|
22.00 T cells/million cells
Interval 1.0 to 43.5
|
1.00 T cells/million cells
Interval 1.0 to 30.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IL2+, D14
|
40.00 T cells/million cells
Interval 1.0 to 78.0
|
59.00 T cells/million cells
Interval 1.0 to 74.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IL2+, D30
|
1.00 T cells/million cells
Interval 1.0 to 21.0
|
1.00 T cells/million cells
Interval 1.0 to 74.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IL2+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
26.50 T cells/million cells
Interval 1.0 to 100.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 6.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, TNF+, D7
|
1.00 T cells/million cells
Interval 1.0 to 29.5
|
4.00 T cells/million cells
Interval 1.0 to 60.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, TNF+, D14
|
1.00 T cells/million cells
Interval 1.0 to 35.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 39.0
|
1.00 T cells/million cells
Interval 1.0 to 51.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 20.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 34.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 26.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IFN+, D30
|
2.00 T cells/million cells
Interval 1.0 to 31.0
|
1.00 T cells/million cells
Interval 1.0 to 18.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 36.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IL2+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IL2+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IL2+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IL2+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IL2+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+TNF+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+TNF+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 15.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IL2+TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 35.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IL2+TNF+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IL2+TNF+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IL2+TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 21.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IL2+TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IL2+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IL2+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IL2+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IL2+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IL2+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IL2+TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IL2+IL2+TNF+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IL2+TNF+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IL2+TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IL2+TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IL2+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IL2+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IL2+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IL2+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IL2+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40+TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IL2+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IL2+TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IL2+TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IL2+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, IL2+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IL2+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IL2+TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IL2+TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IL2+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Nef, CD40L+IL2+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+, D0
|
65.00 T cells/million cells
Interval 1.0 to 191.0
|
1.00 T cells/million cells
Interval 1.0 to 158.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+, D7
|
40.50 T cells/million cells
Interval 1.0 to 142.0
|
34.00 T cells/million cells
Interval 1.0 to 128.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+, D14
|
1.00 T cells/million cells
Interval 1.0 to 169.0
|
1.00 T cells/million cells
Interval 1.0 to 33.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+, D30
|
7.00 T cells/million cells
Interval 1.0 to 126.0
|
13.00 T cells/million cells
Interval 1.0 to 165.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+, D180
|
44.00 T cells/million cells
Interval 1.0 to 73.0
|
4.50 T cells/million cells
Interval 1.0 to 50.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IL2+, D0
|
1.00 T cells/million cells
Interval 1.0 to 28.0
|
1.00 T cells/million cells
Interval 1.0 to 26.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IL2+, D7
|
7.50 T cells/million cells
Interval 1.0 to 34.0
|
21.00 T cells/million cells
Interval 1.0 to 34.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IL2+, D14
|
25.00 T cells/million cells
Interval 1.0 to 92.0
|
33.00 T cells/million cells
Interval 1.0 to 60.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IL2+, D30
|
1.00 T cells/million cells
Interval 1.0 to 5.0
|
1.00 T cells/million cells
Interval 1.0 to 35.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IL2+, D180
|
10.00 T cells/million cells
Interval 1.0 to 61.0
|
39.00 T cells/million cells
Interval 1.0 to 67.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 65.0
|
1.00 T cells/million cells
Interval 1.0 to 7.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, TNF+, D7
|
1.00 T cells/million cells
Interval 1.0 to 45.5
|
21.00 T cells/million cells
Interval 1.0 to 68.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, TNF+, D14
|
1.00 T cells/million cells
Interval 1.0 to 36.0
|
1.00 T cells/million cells
Interval 1.0 to 2.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 50.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 31.0
|
1.00 T cells/million cells
Interval 1.0 to 20.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 28.5
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 20.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 22.0
|
1.00 T cells/million cells
Interval 1.0 to 34.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IFN+, D180
|
3.00 T cells/million cells
Interval 1.0 to 26.0
|
1.00 T cells/million cells
Interval 1.0 to 23.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IL2+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IL2+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IL2+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IL2+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IL2+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+TNF+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+TNF+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IL2+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IL2+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40+TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IL2+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IL2+TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IL2+TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IL2+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IL2+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
p17, CD40L+IL2+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IL2+TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IL2+TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IL2+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IL2+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IL2+TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IL2+TNF+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IL2+TNF+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IL2+TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 16.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IL2+TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IL2+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IL2+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IL2+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IL2+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, IL2+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 7.5
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IL2+TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IL2+TNF+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IL2+TNF+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IL2+TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IL2+TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IL2+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IL2+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P17, CD40L+IL2+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+, D0
|
178.00 T cells/million cells
Interval 1.0 to 219.0
|
103.50 T cells/million cells
Interval 1.0 to 163.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+, D7
|
61.50 T cells/million cells
Interval 2.5 to 138.0
|
37.00 T cells/million cells
Interval 1.0 to 219.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+, D14
|
100.00 T cells/million cells
Interval 17.0 to 171.0
|
30.00 T cells/million cells
Interval 1.0 to 130.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+, D30
|
1.00 T cells/million cells
Interval 1.0 to 179.0
|
59.00 T cells/million cells
Interval 1.0 to 133.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+, D180
|
16.00 T cells/million cells
Interval 1.0 to 210.0
|
1.00 T cells/million cells
Interval 1.0 to 37.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IL2+, D0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 37.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IL2+, D7
|
7.50 T cells/million cells
Interval 1.0 to 43.0
|
1.00 T cells/million cells
Interval 1.0 to 26.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IL2+, D14
|
1.00 T cells/million cells
Interval 1.0 to 54.0
|
1.00 T cells/million cells
Interval 1.0 to 38.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IL2+, D30
|
1.00 T cells/million cells
Interval 1.0 to 54.0
|
32.00 T cells/million cells
Interval 1.0 to 73.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IL2+, D180
|
1.00 T cells/million cells
Interval 1.0 to 53.0
|
1.00 T cells/million cells
Interval 1.0 to 34.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 55.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, TNF+, D7
|
1.00 T cells/million cells
Interval 1.0 to 32.0
|
27.00 T cells/million cells
Interval 1.0 to 55.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, TNF+, D14
|
1.00 T cells/million cells
Interval 1.0 to 41.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 60.0
|
1.00 T cells/million cells
Interval 1.0 to 23.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 21.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IFN+, D0
|
5.00 T cells/million cells
Interval 1.0 to 55.0
|
1.00 T cells/million cells
Interval 1.0 to 56.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 35.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 36.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IFN+, D30
|
25.00 T cells/million cells
Interval 1.0 to 44.0
|
1.00 T cells/million cells
Interval 1.0 to 42.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 25.0
|
1.00 T cells/million cells
Interval 1.0 to 19.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IL2+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IL2+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IL2+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IL2+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IL2+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+TNF+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+TNF+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IL2+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40+TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IL2+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IL2+TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IL2+TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IL2+TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IL2+TNF+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IL2+TNF+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IL2+TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IL2+TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IL2+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IL2+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IL2+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IL2+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IL2+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 34.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IL2+TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IL2+TNF+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IL2+TNF+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IL2+TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IL2+TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IL2+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IL2+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IL2+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IL2+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IL2+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, IL2+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IL2+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IL2+TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IL2+TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IL2+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
P24, CD40L+IL2+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co\_est).
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, TNF+, D7
|
1.00 T cells/million cells
Interval 1.0 to 28.5
|
5.00 T cells/million cells
Interval 1.0 to 33.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+, D0
|
114.00 T cells/million cells
Interval 1.0 to 264.0
|
105.00 T cells/million cells
Interval 1.0 to 256.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+, D7
|
141.50 T cells/million cells
Interval 37.5 to 235.0
|
185.00 T cells/million cells
Interval 109.0 to 223.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+, D14
|
113.00 T cells/million cells
Interval 78.0 to 181.0
|
1.00 T cells/million cells
Interval 1.0 to 69.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+, D30
|
84.00 T cells/million cells
Interval 7.0 to 251.0
|
69.00 T cells/million cells
Interval 1.0 to 192.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+, D180
|
61.00 T cells/million cells
Interval 42.0 to 107.0
|
48.00 T cells/million cells
Interval 1.0 to 173.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IL2+, D0
|
1.00 T cells/million cells
Interval 1.0 to 28.0
|
22.00 T cells/million cells
Interval 1.0 to 54.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IL2+, D7
|
26.00 T cells/million cells
Interval 1.0 to 132.0
|
3.00 T cells/million cells
Interval 1.0 to 85.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IL2+, D14
|
31.00 T cells/million cells
Interval 1.0 to 54.0
|
32.00 T cells/million cells
Interval 15.0 to 84.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IL2+, D30
|
1.00 T cells/million cells
Interval 1.0 to 88.0
|
20.00 T cells/million cells
Interval 1.0 to 68.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IL2+, D180
|
27.00 T cells/million cells
Interval 1.0 to 89.0
|
1.00 T cells/million cells
Interval 1.0 to 57.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, TNF+, D0 ]
|
1.00 T cells/million cells
Interval 1.0 to 32.0
|
1.00 T cells/million cells
Interval 1.0 to 23.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, TNF+, D14
|
2.00 T cells/million cells
Interval 1.0 to 32.0
|
1.00 T cells/million cells
Interval 1.0 to 72.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 35.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 17.0
|
28.00 T cells/million cells
Interval 1.0 to 78.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 15.0
|
14.00 T cells/million cells
Interval 1.0 to 33.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IFN+, D14
|
5.00 T cells/million cells
Interval 1.0 to 33.0
|
1.00 T cells/million cells
Interval 1.0 to 27.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
17.00 T cells/million cells
Interval 1.0 to 38.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 41.0
|
1.00 T cells/million cells
Interval 1.0 to 33.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IL2+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IL2+, D7
|
1.00 T cells/million cells
Interval 1.0 to 31.5
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IL2+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IL2+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IL2+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+TNF+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+TNF+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 27.5
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co\_est).
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IL2+TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IL2+TNF+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IL2+TNF+, D14
|
1.00 T cells/million cells
Interval 1.0 to 28.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IL2+TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IL2+TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IL2+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IL2+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IL2+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IL2+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IL2+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 5.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 13.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 23.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IL2+TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IL2+TNF+, D7
|
1.00 T cells/million cells
Interval 1.0 to 7.5
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IL2+TNF+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IL2+TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IL2+TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IL2+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IL2+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IL2+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IL2+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IL2+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40+TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IL2+TNF+IFN+, D180 [
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IL2+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IL2+TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IL2+TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, IL2+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IL2+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IL2+TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IL2+TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IL2+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Pool_F4co, CD40L+IL2+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co\_est).
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+, D0
|
608.00 T cells/million cells
Interval 206.0 to 746.0
|
301.00 T cells/million cells
Interval 139.0 to 603.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IL2+, D0
|
77.00 T cells/million cells
Interval 45.0 to 131.0
|
64.00 T cells/million cells
Interval 26.0 to 143.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+, D7
|
359.50 T cells/million cells
Interval 238.0 to 603.5
|
532.00 T cells/million cells
Interval 191.0 to 834.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+, D14
|
375.00 T cells/million cells
Interval 237.0 to 717.0
|
201.00 T cells/million cells
Interval 94.0 to 305.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+, D30
|
347.00 T cells/million cells
Interval 21.0 to 783.0
|
242.00 T cells/million cells
Interval 71.0 to 693.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+, D180
|
278.00 T cells/million cells
Interval 100.0 to 534.0
|
150.00 T cells/million cells
Interval 67.0 to 346.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IL2+, D7
|
129.00 T cells/million cells
Interval 41.0 to 164.0
|
84.00 T cells/million cells
Interval 35.0 to 188.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IL2+, D14
|
122.00 T cells/million cells
Interval 68.0 to 305.0
|
141.00 T cells/million cells
Interval 71.0 to 253.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IL2+, D30
|
22.00 T cells/million cells
Interval 4.0 to 151.0
|
73.00 T cells/million cells
Interval 38.0 to 168.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IL2+, D180
|
85.00 T cells/million cells
Interval 6.0 to 128.0
|
127.50 T cells/million cells
Interval 46.0 to 169.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, TNF+, D0
|
112.00 T cells/million cells
Interval 4.0 to 163.0
|
9.50 T cells/million cells
Interval 4.0 to 30.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, TNF+, D7
|
57.50 T cells/million cells
Interval 17.0 to 140.0
|
176.00 T cells/million cells
Interval 24.0 to 248.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, TNF+, D14
|
55.00 T cells/million cells
Interval 4.0 to 147.0
|
4.00 T cells/million cells
Interval 4.0 to 86.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, TNF+, D30
|
4.00 T cells/million cells
Interval 4.0 to 160.0
|
67.00 T cells/million cells
Interval 4.0 to 140.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, TNF+, D180
|
4.00 T cells/million cells
Interval 4.0 to 28.0
|
14.50 T cells/million cells
Interval 4.0 to 68.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IFN+, D0
|
60.00 T cells/million cells
Interval 8.0 to 105.0
|
58.50 T cells/million cells
Interval 17.0 to 133.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IFN+, D7
|
36.00 T cells/million cells
Interval 4.0 to 133.5
|
29.00 T cells/million cells
Interval 4.0 to 70.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IFN+, D14
|
56.00 T cells/million cells
Interval 39.0 to 86.0
|
21.00 T cells/million cells
Interval 4.0 to 84.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IFN+, D30
|
52.00 T cells/million cells
Interval 8.0 to 130.0
|
22.00 T cells/million cells
Interval 4.0 to 109.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IFN+, D180
|
30.00 T cells/million cells
Interval 6.0 to 66.0
|
23.50 T cells/million cells
Interval 4.0 to 86.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IL2+, D0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IL2+, D7
|
4.00 T cells/million cells
Interval 4.0 to 9.5
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IL2+, D14
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IL2+, D30
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IL2+, D180
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+TNF+, D0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+TNF+, D7
|
4.00 T cells/million cells
Interval 4.0 to 36.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+TNF+, D14
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+TNF+, D30
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+TNF+, D180
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IFN+, D0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IFN+, D7
|
4.00 T cells/million cells
Interval 4.0 to 23.5
|
5.00 T cells/million cells
Interval 4.0 to 24.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IFN+, D14
|
4.00 T cells/million cells
Interval 4.0 to 17.0
|
4.00 T cells/million cells
Interval 4.0 to 30.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IFN+, D30
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IFN+, D180
|
4.00 T cells/million cells
Interval 4.0 to 28.0
|
4.00 T cells/million cells
Interval 4.0 to 22.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co\_est).
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IL2+TNF+, D0
|
4.00 T cells/million cells
Interval 4.0 to 64.0
|
28.00 T cells/million cells
Interval 4.0 to 43.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IL2+TNF+, D7
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 23.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IL2+TNF+, D14
|
4.00 T cells/million cells
Interval 4.0 to 32.0
|
4.00 T cells/million cells
Interval 4.0 to 23.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IL2+TNF+, D30
|
4.00 T cells/million cells
Interval 4.0 to 44.0
|
4.00 T cells/million cells
Interval 4.0 to 27.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IL2+TNF+, D180
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IL2+IFN+, D0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IL2+IFN+, D7
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IL2+IFN+, D14
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IL2+IFN+, D30
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IL2+IFN+, D180
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, TNF+IFN+, D0
|
4.00 T cells/million cells
Interval 4.0 to 5.0
|
4.00 T cells/million cells
Interval 4.0 to 43.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, TNF+IFN+, D7
|
15.50 T cells/million cells
Interval 4.0 to 50.0
|
23.00 T cells/million cells
Interval 4.0 to 40.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, TNF+IFN+, D14
|
4.00 T cells/million cells
Interval 4.0 to 29.0
|
4.00 T cells/million cells
Interval 4.0 to 29.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, TNF+IFN+, D30
|
4.00 T cells/million cells
Interval 4.0 to 27.0
|
27.00 T cells/million cells
Interval 4.0 to 78.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, TNF+IFN+, D180
|
4.00 T cells/million cells
Interval 4.0 to 5.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IL2+TNF+, D0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IL2+TNF+, D7
|
4.00 T cells/million cells
Interval 4.0 to 25.5
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IL2+TNF+, D14
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IL2+TNF+, D30
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IL2+TNF+, D180
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IL2+IFN+, D0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IL2+IFN+, D7
|
4.00 T cells/million cells
Interval 4.0 to 30.5
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IL2+IFN+, D14
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IL2+IFN+, D30
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IL2+IFN+, D180
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+TNF+IFN+, D0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+TNF+IFN+, D7
|
4.00 T cells/million cells
Interval 4.0 to 9.5
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40+TNF+IFN+, D14
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+TNF+IFN+, D30
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+TNF+IFN+, D180
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IL2+TNF+IFN+, D0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IL2+TNF+IFN+, D7
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IL2+TNF+IFN+, D14
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IL2+TNF+IFN+, D30
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, IL2+TNF+IFN+, D180
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IL2+TNF+IFN+, D0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IL2+TNF+IFN+, D7
|
4.00 T cells/million cells
Interval 4.0 to 9.5
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IL2+TNF+IFN+, D14
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IL2+TNF+IFN+, D30
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
F4co_est, CD40L+IL2+TNF+IFN+, D180
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Among expressed cytokines were interleukin-2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (INF-γ), as determined by ICS.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
1 antigen, Day 0
|
12 Participants
|
11 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
1 antigen, Day 7
|
12 Participants
|
12 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
1 antigen, Day 14
|
12 Participants
|
12 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
1 antigen, Day 30
|
8 Participants
|
13 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
1 antigen, Day 180
|
13 Participants
|
14 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
2 antigens, Day 0
|
10 Participants
|
11 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
2 antigens, Day 7
|
11 Participants
|
11 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
2 antigens, Day 14
|
12 Participants
|
11 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
2 antigens, Day 30
|
7 Participants
|
13 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
2 antigens, Day 180
|
11 Participants
|
13 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
3 antigens, Day 0
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
3 antigens, Day 7
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
3 antigens, Day 14
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
3 antigens, Day 30
|
7 Participants
|
10 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
3 antigens, Day 180
|
10 Participants
|
9 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
4 antigens, Day 0
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
4 antigens, Day 7
|
6 Participants
|
8 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
4 antigens, Day 14
|
6 Participants
|
8 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
4 antigens, Day 30
|
7 Participants
|
6 Participants
|
|
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
4 antigens, Day 180
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Magnitude was defined as the frequency of CD4+ T cells group-specific antigen (Gag) proteins 17, 24, negative regulatory factor (Nef), reverse transcriptase (RT) and fusion protein of all 4 antigens (F4co). Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co\_est). Among the cytokines expressed were IL-2, TNF-α and INF-γ.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
P17, Day 30
|
397.00 T cells/million cells
Interval 44.0 to 1207.0
|
346.00 T cells/million cells
Interval 232.0 to 981.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
Pool_F4co, Day 0
|
1421.00 T cells/million cells
Interval 965.0 to 2045.0
|
2006.50 T cells/million cells
Interval 1135.0 to 4228.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
RT, Day 0
|
846.00 T cells/million cells
Interval 616.0 to 1252.0
|
1125.50 T cells/million cells
Interval 373.0 to 2290.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
RT, Day 7
|
2407.00 T cells/million cells
Interval 1477.5 to 4566.0
|
3286.00 T cells/million cells
Interval 1788.0 to 5334.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
RT, Day 14
|
3162.00 T cells/million cells
Interval 1393.0 to 4433.0
|
3461.00 T cells/million cells
Interval 2931.0 to 3868.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
RT, Day 30
|
2088.00 T cells/million cells
Interval 54.0 to 4545.0
|
2459.00 T cells/million cells
Interval 1897.0 to 3334.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
RT, Day 180
|
1205.00 T cells/million cells
Interval 1037.0 to 2518.0
|
1684.00 T cells/million cells
Interval 919.0 to 2566.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
Nef, Day 0
|
259.00 T cells/million cells
Interval 206.0 to 310.0
|
161.00 T cells/million cells
Interval 98.0 to 589.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
Nef, Day 7
|
586.50 T cells/million cells
Interval 345.5 to 961.5
|
739.00 T cells/million cells
Interval 324.0 to 1292.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
Nef, Day 14
|
890.00 T cells/million cells
Interval 271.0 to 1362.0
|
560.00 T cells/million cells
Interval 227.0 to 1223.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
Nef, Day 30
|
627.00 T cells/million cells
Interval 84.0 to 1731.0
|
386.00 T cells/million cells
Interval 199.0 to 945.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
Nef, Day 180
|
305.00 T cells/million cells
Interval 245.0 to 518.0
|
306.50 T cells/million cells
Interval 162.0 to 785.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
P17, Day 0
|
154.00 T cells/million cells
Interval 121.0 to 264.0
|
176.00 T cells/million cells
Interval 135.0 to 417.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
P17, Day 7
|
464.00 T cells/million cells
Interval 119.0 to 835.5
|
500.00 T cells/million cells
Interval 127.0 to 1678.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
P17, Day 14
|
453.00 T cells/million cells
Interval 160.0 to 593.0
|
503.00 T cells/million cells
Interval 200.0 to 1224.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
P17, Day 180
|
278.00 T cells/million cells
Interval 123.0 to 423.0
|
523.00 T cells/million cells
Interval 172.0 to 837.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
P24, Day 0
|
477.00 T cells/million cells
Interval 322.0 to 642.0
|
434.00 T cells/million cells
Interval 57.0 to 934.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
P24, Day 7
|
872.50 T cells/million cells
Interval 435.0 to 1700.0
|
911.00 T cells/million cells
Interval 549.0 to 1507.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
P24, Day 14
|
1198.00 T cells/million cells
Interval 582.0 to 1653.0
|
827.00 T cells/million cells
Interval 492.0 to 1569.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
P24, Day 30
|
641.00 T cells/million cells
Interval 152.0 to 1136.0
|
793.00 T cells/million cells
Interval 492.0 to 1285.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
P24, Day 180
|
530.00 T cells/million cells
Interval 396.0 to 714.0
|
536.50 T cells/million cells
Interval 302.0 to 826.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
Pool_F4co, Day 7
|
3881.00 T cells/million cells
Interval 2480.0 to 6982.0
|
5515.00 T cells/million cells
Interval 4179.0 to 7947.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
Pool_F4co, Day 14
|
4898.00 T cells/million cells
Interval 2446.0 to 7829.0
|
5651.00 T cells/million cells
Interval 4961.0 to 6599.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
Pool_F4co, Day 30
|
3791.00 T cells/million cells
Interval 322.0 to 6073.0
|
4138.00 T cells/million cells
Interval 3485.0 to 5158.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
Pool_F4co, Day 180
|
2238.00 T cells/million cells
Interval 1983.0 to 3956.0
|
2856.50 T cells/million cells
Interval 2233.0 to 4441.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
F4co_est, Day 0
|
2000.00 T cells/million cells
Interval 1492.0 to 2313.0
|
1974.50 T cells/million cells
Interval 1195.0 to 4657.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
F4co_est, Day 7
|
4390.00 T cells/million cells
Interval 2708.0 to 7841.0
|
6613.00 T cells/million cells
Interval 4980.0 to 8883.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
F4co_est, Day 14
|
5272.00 T cells/million cells
Interval 2772.0 to 8751.0
|
6035.00 T cells/million cells
Interval 5437.0 to 7244.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
F4co_est, Day 30
|
4407.00 T cells/million cells
Interval 354.0 to 7708.0
|
4589.00 T cells/million cells
Interval 3458.0 to 5266.0
|
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
F4co_est, Day 180
|
2530.00 T cells/million cells
Interval 2151.0 to 4596.0
|
3079.00 T cells/million cells
Interval 2448.0 to 5123.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+, D0
|
163.00 T cells/million cells
Interval 52.0 to 240.0
|
184.00 T cells/million cells
Interval 13.0 to 299.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+, D7
|
1080.50 T cells/million cells
Interval 603.0 to 2695.5
|
1209.00 T cells/million cells
Interval 469.0 to 1534.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+, D14
|
522.00 T cells/million cells
Interval 106.0 to 1170.0
|
748.00 T cells/million cells
Interval 168.0 to 994.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+, D30
|
262.00 T cells/million cells
Interval 1.0 to 869.0
|
309.00 T cells/million cells
Interval 233.0 to 543.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+, D180
|
229.00 T cells/million cells
Interval 159.0 to 346.0
|
249.00 T cells/million cells
Interval 135.0 to 420.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IL2+, D0
|
1.00 T cells/million cells
Interval 1.0 to 27.0
|
15.00 T cells/million cells
Interval 12.0 to 82.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IL2+, D7
|
85.50 T cells/million cells
Interval 58.0 to 130.5
|
42.00 T cells/million cells
Interval 14.0 to 76.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IL2+, D14
|
97.00 T cells/million cells
Interval 34.0 to 121.0
|
35.00 T cells/million cells
Interval 15.0 to 80.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IL2+, D30
|
24.00 T cells/million cells
Interval 1.0 to 69.0
|
36.00 T cells/million cells
Interval 28.0 to 68.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IL2+, D180
|
41.00 T cells/million cells
Interval 1.0 to 79.0
|
74.00 T cells/million cells
Interval 41.0 to 104.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, TNF+, D0
|
18.00 T cells/million cells
Interval 1.0 to 143.0
|
61.50 T cells/million cells
Interval 1.0 to 286.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, TNF+, D7
|
421.00 T cells/million cells
Interval 130.5 to 504.5
|
312.00 T cells/million cells
Interval 141.0 to 481.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, TNF+, D14
|
228.00 T cells/million cells
Interval 149.0 to 264.0
|
318.00 T cells/million cells
Interval 84.0 to 479.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, TNF+, D30
|
124.00 T cells/million cells
Interval 2.0 to 191.0
|
231.00 T cells/million cells
Interval 42.0 to 287.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, TNF+, D180
|
74.00 T cells/million cells
Interval 16.0 to 81.0
|
7.00 T cells/million cells
Interval 1.0 to 54.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IFN+, D0
|
7.00 T cells/million cells
Interval 1.0 to 24.0
|
13.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IFN+, D7
|
91.50 T cells/million cells
Interval 18.0 to 143.0
|
56.00 T cells/million cells
Interval 13.0 to 81.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IFN+, D14
|
9.00 T cells/million cells
Interval 1.0 to 16.0
|
16.00 T cells/million cells
Interval 1.0 to 56.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 27.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IFN+, D180
|
13.00 T cells/million cells
Interval 1.0 to 53.0
|
12.50 T cells/million cells
Interval 1.0 to 41.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IL2+, D0
|
377.00 T cells/million cells
Interval 149.0 to 579.0
|
315.00 T cells/million cells
Interval 121.0 to 544.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IL2+, D7
|
924.00 T cells/million cells
Interval 544.0 to 1793.5
|
1424.00 T cells/million cells
Interval 549.0 to 2016.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IL2+, D14
|
922.00 T cells/million cells
Interval 413.0 to 1702.0
|
990.00 T cells/million cells
Interval 556.0 to 1286.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IL2+, D30
|
615.00 T cells/million cells
Interval 1.0 to 1053.0
|
828.00 T cells/million cells
Interval 516.0 to 1127.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IL2+, D180
|
558.00 T cells/million cells
Interval 447.0 to 866.0
|
797.50 T cells/million cells
Interval 364.0 to 1013.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+TNF+, D0
|
41.00 T cells/million cells
Interval 6.0 to 53.0
|
36.50 T cells/million cells
Interval 14.0 to 110.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+TNF+, D7
|
237.00 T cells/million cells
Interval 103.0 to 469.0
|
315.00 T cells/million cells
Interval 95.0 to 373.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+TNF+, D14
|
300.00 T cells/million cells
Interval 107.0 to 410.0
|
291.00 T cells/million cells
Interval 199.0 to 432.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+TNF+, D30
|
204.00 T cells/million cells
Interval 36.0 to 314.0
|
137.00 T cells/million cells
Interval 131.0 to 156.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+TNF+, D180
|
54.00 T cells/million cells
Interval 21.0 to 68.0
|
40.50 T cells/million cells
Interval 27.0 to 66.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 7.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IFN+, D7
|
69.00 T cells/million cells
Interval 18.5 to 160.0
|
84.00 T cells/million cells
Interval 14.0 to 126.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IFN+, D14
|
27.00 T cells/million cells
Interval 14.0 to 83.0
|
28.00 T cells/million cells
Interval 14.0 to 69.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IFN+, D30
|
14.00 T cells/million cells
Interval 1.0 to 32.0
|
15.00 T cells/million cells
Interval 14.0 to 30.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
14.00 T cells/million cells
Interval 1.0 to 24.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IL2+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 27.0
|
13.50 T cells/million cells
Interval 1.0 to 27.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IL2+TNF+, D0
|
14.00 T cells/million cells
Interval 2.0 to 42.0
|
6.50 T cells/million cells
Interval 1.0 to 43.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IL2+TNF+, D7
|
83.50 T cells/million cells
Interval 45.0 to 159.0
|
37.00 T cells/million cells
Interval 14.0 to 56.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IL2+TNF+, D14
|
53.00 T cells/million cells
Interval 15.0 to 183.0
|
22.00 T cells/million cells
Interval 1.0 to 103.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IL2+TNF+, D30
|
27.00 T cells/million cells
Interval 1.0 to 48.0
|
55.00 T cells/million cells
Interval 27.0 to 129.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IL2+TNF+, D180
|
26.00 T cells/million cells
Interval 14.0 to 64.0
|
67.50 T cells/million cells
Interval 41.0 to 94.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IL2+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IL2+IFN+, D7
|
10.50 T cells/million cells
Interval 1.0 to 14.5
|
1.00 T cells/million cells
Interval 1.0 to 9.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IL2+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 15.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IL2+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IL2+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, TNF+IFN+, D7
|
18.00 T cells/million cells
Interval 8.0 to 48.0
|
28.00 T cells/million cells
Interval 1.0 to 37.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, TNF+IFN+, D14
|
23.00 T cells/million cells
Interval 1.0 to 41.0
|
14.00 T cells/million cells
Interval 1.0 to 54.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, TNF+IFN+, D30
|
14.00 T cells/million cells
Interval 1.0 to 27.0
|
19.00 T cells/million cells
Interval 9.0 to 29.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
15.00 T cells/million cells
Interval 1.0 to 41.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IL2+TNF+, D0
|
475.00 T cells/million cells
Interval 218.0 to 664.0
|
474.50 T cells/million cells
Interval 227.0 to 1308.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IL2+TNF+, D7
|
842.00 T cells/million cells
Interval 588.5 to 1928.0
|
1575.00 T cells/million cells
Interval 1013.0 to 2699.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IL2+TNF+, D14
|
1606.00 T cells/million cells
Interval 707.0 to 2546.0
|
1901.00 T cells/million cells
Interval 1551.0 to 2221.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IL2+TNF+, D30
|
1209.00 T cells/million cells
Interval 19.0 to 2489.0
|
1297.00 T cells/million cells
Interval 999.0 to 1791.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IL2+TNF+, D180
|
471.00 T cells/million cells
Interval 350.0 to 851.0
|
709.50 T cells/million cells
Interval 485.0 to 1196.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IL2+IFN+, D0
|
15.00 T cells/million cells
Interval 1.0 to 55.0
|
12.50 T cells/million cells
Interval 1.0 to 29.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IL2+IFN+, D7
|
89.50 T cells/million cells
Interval 18.5 to 316.5
|
151.00 T cells/million cells
Interval 56.0 to 169.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IL2+IFN+, D14
|
54.00 T cells/million cells
Interval 25.0 to 113.0
|
84.00 T cells/million cells
Interval 42.0 to 128.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IL2+IFN+, D30
|
30.00 T cells/million cells
Interval 1.0 to 141.0
|
56.00 T cells/million cells
Interval 15.0 to 102.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IL2+IFN+, D180
|
68.00 T cells/million cells
Interval 14.0 to 104.0
|
40.50 T cells/million cells
Interval 26.0 to 78.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 9.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+TNF+IFN+, D7
|
43.00 T cells/million cells
Interval 27.5 to 86.0
|
56.00 T cells/million cells
Interval 24.0 to 74.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40+TNF+IFN+, D14
|
50.00 T cells/million cells
Interval 30.0 to 81.0
|
28.00 T cells/million cells
Interval 1.0 to 56.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+TNF+IFN+, D30
|
27.00 T cells/million cells
Interval 9.0 to 65.0
|
15.00 T cells/million cells
Interval 14.0 to 42.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 27.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IL2+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 7.0
|
1.00 T cells/million cells
Interval 1.0 to 12.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IL2+TNF+IFN+, D7
|
13.50 T cells/million cells
Interval 1.0 to 25.0
|
14.00 T cells/million cells
Interval 8.0 to 27.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IL2+TNF+IFN+, D14
|
8.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, IL2+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 11.0
|
13.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IL2+TNF+IFN+, D0
|
57.00 T cells/million cells
Interval 14.0 to 92.0
|
48.00 T cells/million cells
Interval 1.0 to 151.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IL2+TNF+IFN+, D7
|
206.50 T cells/million cells
Interval 72.5 to 600.5
|
213.00 T cells/million cells
Interval 82.0 to 573.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IL2+TNF+IFN+, D14
|
254.00 T cells/million cells
Interval 68.0 to 354.0
|
285.00 T cells/million cells
Interval 152.0 to 393.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IL2+TNF+IFN+, D30
|
136.00 T cells/million cells
Interval 1.0 to 499.0
|
237.00 T cells/million cells
Interval 97.0 to 379.0
|
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
RT, CD40L+IL2+TNF+IFN+, D180
|
64.00 T cells/million cells
Interval 52.0 to 236.0
|
87.50 T cells/million cells
Interval 45.0 to 225.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+TNF+, D180
|
13.00 T cells/million cells
Interval 1.0 to 27.0
|
1.00 T cells/million cells
Interval 1.0 to 27.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IFN+, D7
|
14.00 T cells/million cells
Interval 5.0 to 22.5
|
15.00 T cells/million cells
Interval 6.0 to 30.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IFN+, D14
|
14.00 T cells/million cells
Interval 1.0 to 19.0
|
1.00 T cells/million cells
Interval 1.0 to 21.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+, D0
|
113.00 T cells/million cells
Interval 1.0 to 311.0
|
1.00 T cells/million cells
Interval 1.0 to 49.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+, D7
|
339.00 T cells/million cells
Interval 232.5 to 572.0
|
294.00 T cells/million cells
Interval 94.0 to 402.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+, D14
|
224.00 T cells/million cells
Interval 109.0 to 557.0
|
219.00 T cells/million cells
Interval 84.0 to 299.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+, D30
|
193.00 T cells/million cells
Interval 1.0 to 314.0
|
153.00 T cells/million cells
Interval 14.0 to 245.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+, D180
|
107.00 T cells/million cells
Interval 52.0 to 173.0
|
54.00 T cells/million cells
Interval 1.0 to 145.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IL2+, D0
|
1.00 T cells/million cells
Interval 1.0 to 27.0
|
4.00 T cells/million cells
Interval 1.0 to 67.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IL2+, D7
|
29.50 T cells/million cells
Interval 14.5 to 54.5
|
14.00 T cells/million cells
Interval 1.0 to 81.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IL2+, D14
|
25.00 T cells/million cells
Interval 14.0 to 56.0
|
14.00 T cells/million cells
Interval 1.0 to 69.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IL2+, D30
|
1.00 T cells/million cells
Interval 1.0 to 76.0
|
14.00 T cells/million cells
Interval 1.0 to 23.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IL2+, D180
|
21.00 T cells/million cells
Interval 1.0 to 67.0
|
14.00 T cells/million cells
Interval 1.0 to 40.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 66.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, TNF+, D7
|
115.00 T cells/million cells
Interval 16.0 to 155.0
|
97.00 T cells/million cells
Interval 1.0 to 306.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, TNF+, D14
|
28.00 T cells/million cells
Interval 1.0 to 135.0
|
95.00 T cells/million cells
Interval 1.0 to 195.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 22.0
|
10.00 T cells/million cells
Interval 1.0 to 121.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 20.0
|
1.00 T cells/million cells
Interval 1.0 to 15.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 23.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IFN+, D7
|
14.00 T cells/million cells
Interval 1.0 to 25.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IFN+, D14
|
20.00 T cells/million cells
Interval 1.0 to 27.0
|
1.00 T cells/million cells
Interval 1.0 to 23.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 27.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IFN+, D180
|
14.00 T cells/million cells
Interval 9.0 to 41.0
|
14.00 T cells/million cells
Interval 1.0 to 38.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IL2+, D0
|
84.00 T cells/million cells
Interval 1.0 to 137.0
|
57.00 T cells/million cells
Interval 28.0 to 165.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IL2+, D7
|
199.00 T cells/million cells
Interval 120.5 to 348.5
|
263.00 T cells/million cells
Interval 112.0 to 425.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IL2+, D14
|
258.00 T cells/million cells
Interval 57.0 to 424.0
|
191.00 T cells/million cells
Interval 83.0 to 250.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IL2+, D30
|
97.00 T cells/million cells
Interval 1.0 to 518.0
|
139.00 T cells/million cells
Interval 82.0 to 230.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IL2+, D180
|
148.00 T cells/million cells
Interval 94.0 to 243.0
|
129.50 T cells/million cells
Interval 58.0 to 257.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+TNF+, D0
|
3.00 T cells/million cells
Interval 1.0 to 28.0
|
6.50 T cells/million cells
Interval 1.0 to 27.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+TNF+, D7
|
102.50 T cells/million cells
Interval 35.0 to 123.0
|
55.00 T cells/million cells
Interval 42.0 to 137.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+TNF+, D14
|
95.00 T cells/million cells
Interval 11.0 to 162.0
|
56.00 T cells/million cells
Interval 28.0 to 100.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+TNF+, D30
|
56.00 T cells/million cells
Interval 1.0 to 82.0
|
27.00 T cells/million cells
Interval 1.0 to 55.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
13.00 T cells/million cells
Interval 1.0 to 25.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IL2+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 10.0
|
6.00 T cells/million cells
Interval 1.0 to 27.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IL2+IFN+, D180
|
14.00 T cells/million cells
Interval 1.0 to 40.0
|
10.50 T cells/million cells
Interval 1.0 to 27.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+TNF+IFN+, D7
|
12.50 T cells/million cells
Interval 4.0 to 29.5
|
14.00 T cells/million cells
Interval 8.0 to 29.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40+TNF+IFN+, D14
|
14.00 T cells/million cells
Interval 1.0 to 26.0
|
10.00 T cells/million cells
Interval 1.0 to 41.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IL2+TNF+, D0
|
9.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 21.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IL2+TNF+, D7
|
14.00 T cells/million cells
Interval 5.5 to 32.5
|
6.00 T cells/million cells
Interval 1.0 to 42.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IL2+TNF+, D14
|
28.00 T cells/million cells
Interval 1.0 to 56.0
|
14.00 T cells/million cells
Interval 1.0 to 27.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IL2+TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 41.0
|
1.00 T cells/million cells
Interval 1.0 to 41.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IL2+TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IL2+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IL2+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IL2+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IL2+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 11.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, TNF+IFN+, D7
|
5.00 T cells/million cells
Interval 1.0 to 14.5
|
6.00 T cells/million cells
Interval 1.0 to 20.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, TNF+IFN+, D14
|
4.00 T cells/million cells
Interval 1.0 to 29.0
|
1.00 T cells/million cells
Interval 1.0 to 22.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
7.50 T cells/million cells
Interval 1.0 to 41.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IL2+TNF+, D0
|
97.00 T cells/million cells
Interval 81.0 to 167.0
|
93.50 T cells/million cells
Interval 35.0 to 307.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IL2+TNF+, D7
|
268.50 T cells/million cells
Interval 113.5 to 501.0
|
333.00 T cells/million cells
Interval 83.0 to 420.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IL2+TNF+, D14
|
480.00 T cells/million cells
Interval 122.0 to 684.0
|
292.00 T cells/million cells
Interval 139.0 to 555.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IL2+TNF+, D30
|
401.00 T cells/million cells
Interval 72.0 to 627.0
|
191.00 T cells/million cells
Interval 89.0 to 356.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IL2+TNF+, D180
|
118.00 T cells/million cells
Interval 103.0 to 175.0
|
107.00 T cells/million cells
Interval 78.0 to 324.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IL2+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 15.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IL2+IFN+, D7
|
33.00 T cells/million cells
Interval 7.5 to 50.5
|
15.00 T cells/million cells
Interval 8.0 to 49.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IL2+IFN+, D14
|
8.00 T cells/million cells
Interval 1.0 to 56.0
|
10.00 T cells/million cells
Interval 1.0 to 28.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IL2+IFN+, D30
|
14.00 T cells/million cells
Interval 1.0 to 41.0
|
25.00 T cells/million cells
Interval 14.0 to 41.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IL2+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IL2+TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 4.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IL2+TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IL2+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, IL2+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IL2+TNF+IFN+, D0
|
14.00 T cells/million cells
Interval 1.0 to 31.0
|
12.50 T cells/million cells
Interval 1.0 to 41.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IL2+TNF+IFN+, D7
|
67.50 T cells/million cells
Interval 28.0 to 109.0
|
80.00 T cells/million cells
Interval 24.0 to 149.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IL2+TNF+IFN+, D14
|
29.00 T cells/million cells
Interval 14.0 to 80.0
|
28.00 T cells/million cells
Interval 1.0 to 128.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IL2+TNF+IFN+, D30
|
41.00 T cells/million cells
Interval 1.0 to 95.0
|
38.00 T cells/million cells
Interval 28.0 to 96.0
|
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Nef, CD40L+IL2+TNF+IFN+, D180
|
26.00 T cells/million cells
Interval 14.0 to 41.0
|
24.00 T cells/million cells
Interval 1.0 to 75.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IL2+, D180
|
1.00 T cells/million cells
Interval 1.0 to 4.0
|
1.00 T cells/million cells
Interval 1.0 to 24.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IL2+, D30
|
122.00 T cells/million cells
Interval 2.0 to 199.0
|
110.00 T cells/million cells
Interval 58.0 to 248.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+TNF+, D14
|
28.00 T cells/million cells
Interval 1.0 to 74.0
|
41.00 T cells/million cells
Interval 14.0 to 106.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+TNF+, D30
|
41.00 T cells/million cells
Interval 16.0 to 83.0
|
14.00 T cells/million cells
Interval 1.0 to 55.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IFN+, D7
|
7.50 T cells/million cells
Interval 1.0 to 30.5
|
14.00 T cells/million cells
Interval 1.0 to 37.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IFN+, D14
|
8.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+, D0
|
1.00 T cells/million cells
Interval 1.0 to 137.0
|
23.50 T cells/million cells
Interval 1.0 to 103.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+, D7
|
237.50 T cells/million cells
Interval 1.0 to 405.0
|
217.00 T cells/million cells
Interval 54.0 to 421.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+, D14
|
112.00 T cells/million cells
Interval 3.0 to 304.0
|
132.00 T cells/million cells
Interval 14.0 to 250.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+, D30
|
150.00 T cells/million cells
Interval 1.0 to 274.0
|
82.00 T cells/million cells
Interval 1.0 to 236.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+, D180
|
28.00 T cells/million cells
Interval 5.0 to 114.0
|
78.50 T cells/million cells
Interval 60.0 to 108.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IL2+, D0
|
1.00 T cells/million cells
Interval 1.0 to 28.0
|
1.00 T cells/million cells
Interval 1.0 to 55.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IL2+, D7
|
28.00 T cells/million cells
Interval 1.0 to 39.0
|
5.00 T cells/million cells
Interval 1.0 to 47.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IL2+, D14
|
8.00 T cells/million cells
Interval 1.0 to 28.0
|
1.00 T cells/million cells
Interval 1.0 to 8.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IL2+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
14.00 T cells/million cells
Interval 1.0 to 41.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 89.0
|
1.00 T cells/million cells
Interval 1.0 to 42.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, TNF+, D7
|
40.00 T cells/million cells
Interval 11.5 to 195.5
|
68.00 T cells/million cells
Interval 1.0 to 173.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, TNF+, D14
|
67.00 T cells/million cells
Interval 7.0 to 96.0
|
140.00 T cells/million cells
Interval 14.0 to 184.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, TNF+, D30
|
14.00 T cells/million cells
Interval 1.0 to 41.0
|
82.00 T cells/million cells
Interval 1.0 to 270.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 30.0
|
20.00 T cells/million cells
Interval 1.0 to 41.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 7.0
|
1.00 T cells/million cells
Interval 1.0 to 27.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 17.0
|
14.00 T cells/million cells
Interval 1.0 to 18.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 8.0
|
9.00 T cells/million cells
Interval 1.0 to 27.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 7.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IFN+, D180
|
14.00 T cells/million cells
Interval 1.0 to 19.0
|
1.00 T cells/million cells
Interval 1.0 to 16.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IL2+, D0
|
27.00 T cells/million cells
Interval 1.0 to 55.0
|
69.00 T cells/million cells
Interval 1.0 to 124.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IL2+, D7
|
196.00 T cells/million cells
Interval 7.0 to 328.5
|
165.00 T cells/million cells
Interval 56.0 to 380.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IL2+, D14
|
112.00 T cells/million cells
Interval 22.0 to 300.0
|
139.00 T cells/million cells
Interval 109.0 to 340.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IL2+, D180
|
138.00 T cells/million cells
Interval 34.0 to 177.0
|
193.00 T cells/million cells
Interval 72.0 to 307.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+TNF+, D0
|
24.00 T cells/million cells
Interval 1.0 to 43.0
|
1.00 T cells/million cells
Interval 1.0 to 28.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+TNF+, D7
|
41.00 T cells/million cells
Interval 13.0 to 126.5
|
61.00 T cells/million cells
Interval 27.0 to 99.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+TNF+, D180
|
14.00 T cells/million cells
Interval 1.0 to 15.0
|
1.00 T cells/million cells
Interval 1.0 to 19.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IFN+, D30
|
10.00 T cells/million cells
Interval 1.0 to 27.0
|
1.00 T cells/million cells
Interval 1.0 to 27.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IL2+TNF+, D7
|
1.00 T cells/million cells
Interval 1.0 to 40.0
|
1.00 T cells/million cells
Interval 1.0 to 18.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IL2+TNF+, D14
|
10.00 T cells/million cells
Interval 1.0 to 25.0
|
1.00 T cells/million cells
Interval 1.0 to 44.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IL2+TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 22.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IL2+TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 19.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IL2+TNF+, D180
|
4.00 T cells/million cells
Interval 1.0 to 27.0
|
1.00 T cells/million cells
Interval 1.0 to 17.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IL2+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IL2+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IL2+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IL2+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IL2+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, TNF+IFN+, D7
|
7.00 T cells/million cells
Interval 1.0 to 14.5
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 8.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 6.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IL2+TNF+, D0
|
84.00 T cells/million cells
Interval 26.0 to 97.0
|
115.00 T cells/million cells
Interval 58.0 to 269.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IL2+TNF+, D7
|
194.00 T cells/million cells
Interval 13.0 to 322.0
|
302.00 T cells/million cells
Interval 27.0 to 824.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IL2+TNF+, D14
|
192.00 T cells/million cells
Interval 99.0 to 320.0
|
314.00 T cells/million cells
Interval 70.0 to 608.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IL2+TNF+, D30
|
204.00 T cells/million cells
Interval 37.0 to 947.0
|
203.00 T cells/million cells
Interval 136.0 to 442.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IL2+TNF+, D180
|
94.00 T cells/million cells
Interval 14.0 to 115.0
|
239.50 T cells/million cells
Interval 68.0 to 408.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IL2+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 15.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IL2+IFN+, D7
|
27.50 T cells/million cells
Interval 4.0 to 42.0
|
14.00 T cells/million cells
Interval 1.0 to 49.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IL2+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 8.0
|
1.00 T cells/million cells
Interval 1.0 to 33.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IL2+IFN+, D30
|
10.00 T cells/million cells
Interval 1.0 to 14.0
|
14.00 T cells/million cells
Interval 1.0 to 25.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IL2+IFN+, D180
|
13.00 T cells/million cells
Interval 1.0 to 25.0
|
13.00 T cells/million cells
Interval 1.0 to 38.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 10.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+TNF+IFN+, D7
|
5.00 T cells/million cells
Interval 1.0 to 21.0
|
14.00 T cells/million cells
Interval 14.0 to 27.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40+TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
11.00 T cells/million cells
Interval 1.0 to 22.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IL2+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IL2+TNF+IFN+, D7
|
4.00 T cells/million cells
Interval 1.0 to 11.5
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IL2+TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IL2+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, IL2+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IL2+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 32.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IL2+TNF+IFN+, D7
|
34.50 T cells/million cells
Interval 5.5 to 129.5
|
31.00 T cells/million cells
Interval 14.0 to 248.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IL2+TNF+IFN+, D14
|
23.00 T cells/million cells
Interval 1.0 to 92.0
|
42.00 T cells/million cells
Interval 1.0 to 155.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IL2+TNF+IFN+, D30
|
40.00 T cells/million cells
Interval 1.0 to 69.0
|
55.00 T cells/million cells
Interval 1.0 to 150.0
|
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P17, CD40L+IL2+TNF+IFN+, D180
|
14.00 T cells/million cells
Interval 1.0 to 25.0
|
17.50 T cells/million cells
Interval 1.0 to 108.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, TNF+, D180
|
35.00 T cells/million cells
Interval 1.0 to 64.0
|
1.00 T cells/million cells
Interval 1.0 to 13.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+, D0
|
79.00 T cells/million cells
Interval 1.0 to 211.0
|
70.00 T cells/million cells
Interval 1.0 to 265.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+, D7
|
452.00 T cells/million cells
Interval 174.0 to 535.5
|
395.00 T cells/million cells
Interval 80.0 to 477.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+, D14
|
217.00 T cells/million cells
Interval 76.0 to 359.0
|
154.00 T cells/million cells
Interval 44.0 to 362.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+, D30
|
86.00 T cells/million cells
Interval 1.0 to 375.0
|
181.00 T cells/million cells
Interval 1.0 to 247.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+, D180
|
118.00 T cells/million cells
Interval 85.0 to 190.0
|
165.00 T cells/million cells
Interval 1.0 to 236.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IL2+, D0
|
1.00 T cells/million cells
Interval 1.0 to 30.0
|
13.00 T cells/million cells
Interval 1.0 to 72.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IL2+, D7
|
40.50 T cells/million cells
Interval 9.0 to 108.0
|
24.00 T cells/million cells
Interval 1.0 to 42.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IL2+, D14
|
14.00 T cells/million cells
Interval 7.0 to 29.0
|
5.00 T cells/million cells
Interval 1.0 to 28.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IL2+, D30
|
14.00 T cells/million cells
Interval 1.0 to 36.0
|
41.00 T cells/million cells
Interval 14.0 to 73.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IL2+, D180
|
35.00 T cells/million cells
Interval 14.0 to 68.0
|
2.50 T cells/million cells
Interval 1.0 to 54.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 62.0
|
6.00 T cells/million cells
Interval 1.0 to 54.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, TNF+, D7
|
69.00 T cells/million cells
Interval 13.0 to 189.0
|
73.00 T cells/million cells
Interval 1.0 to 245.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, TNF+, D14
|
36.00 T cells/million cells
Interval 1.0 to 138.0
|
53.00 T cells/million cells
Interval 8.0 to 208.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 92.0
|
8.00 T cells/million cells
Interval 1.0 to 136.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 29.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IFN+, D7
|
4.00 T cells/million cells
Interval 1.0 to 21.0
|
14.00 T cells/million cells
Interval 10.0 to 41.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 12.0
|
14.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 21.0
|
1.00 T cells/million cells
Interval 1.0 to 11.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IFN+, D180
|
14.00 T cells/million cells
Interval 1.0 to 65.0
|
1.00 T cells/million cells
Interval 1.0 to 10.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IL2+, D0
|
176.00 T cells/million cells
Interval 74.0 to 218.0
|
137.00 T cells/million cells
Interval 1.0 to 323.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IL2+, D7
|
275.00 T cells/million cells
Interval 216.5 to 510.5
|
230.00 T cells/million cells
Interval 140.0 to 658.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IL2+, D14
|
244.00 T cells/million cells
Interval 133.0 to 480.0
|
284.00 T cells/million cells
Interval 57.0 to 430.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IL2+, D30
|
83.00 T cells/million cells
Interval 21.0 to 139.0
|
189.00 T cells/million cells
Interval 149.0 to 329.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IL2+, D180
|
234.00 T cells/million cells
Interval 126.0 to 334.0
|
196.00 T cells/million cells
Interval 108.0 to 446.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+TNF+, D0
|
14.00 T cells/million cells
Interval 1.0 to 26.0
|
21.00 T cells/million cells
Interval 1.0 to 56.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+TNF+, D7
|
104.00 T cells/million cells
Interval 38.5 to 165.5
|
99.00 T cells/million cells
Interval 41.0 to 160.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+TNF+, D14
|
86.00 T cells/million cells
Interval 38.0 to 211.0
|
125.00 T cells/million cells
Interval 57.0 to 179.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+TNF+, D30
|
54.00 T cells/million cells
Interval 17.0 to 113.0
|
42.00 T cells/million cells
Interval 11.0 to 94.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+TNF+, D180
|
1.00 T cells/million cells
Interval 1.0 to 40.0
|
14.50 T cells/million cells
Interval 1.0 to 27.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 9.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IFN+, D7
|
12.50 T cells/million cells
Interval 1.0 to 41.5
|
1.00 T cells/million cells
Interval 1.0 to 8.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IFN+, D14
|
11.00 T cells/million cells
Interval 1.0 to 28.0
|
9.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 11.0
|
1.00 T cells/million cells
Interval 1.0 to 15.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IL2+TNF+IFN+, D7
|
140.50 T cells/million cells
Interval 14.0 to 225.0
|
70.00 T cells/million cells
Interval 27.0 to 111.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IL2+TNF+, D0
|
1.00 T cells/million cells
Interval 1.0 to 9.0
|
1.00 T cells/million cells
Interval 1.0 to 41.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IL2+TNF+, D7
|
16.50 T cells/million cells
Interval 7.0 to 53.5
|
9.00 T cells/million cells
Interval 1.0 to 42.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IL2+TNF+, D14
|
27.00 T cells/million cells
Interval 10.0 to 33.0
|
22.00 T cells/million cells
Interval 9.0 to 42.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IL2+TNF+, D30
|
1.00 T cells/million cells
Interval 1.0 to 60.0
|
14.00 T cells/million cells
Interval 1.0 to 28.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IL2+TNF+, D180
|
14.00 T cells/million cells
Interval 1.0 to 24.0
|
27.00 T cells/million cells
Interval 1.0 to 50.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IL2+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IL2+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IL2+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IL2+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IL2+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, TNF+IFN+, D7
|
7.50 T cells/million cells
Interval 1.0 to 24.5
|
12.00 T cells/million cells
Interval 1.0 to 38.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 21.0
|
14.00 T cells/million cells
Interval 1.0 to 27.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 17.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IL2+TNF+, D0
|
267.00 T cells/million cells
Interval 145.0 to 314.0
|
135.50 T cells/million cells
Interval 35.0 to 456.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IL2+TNF+, D7
|
389.50 T cells/million cells
Interval 191.0 to 750.0
|
410.00 T cells/million cells
Interval 277.0 to 678.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IL2+TNF+, D14
|
569.00 T cells/million cells
Interval 396.0 to 990.0
|
456.00 T cells/million cells
Interval 262.0 to 923.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IL2+TNF+, D30
|
516.00 T cells/million cells
Interval 49.0 to 692.0
|
379.00 T cells/million cells
Interval 287.0 to 554.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IL2+TNF+, D180
|
233.00 T cells/million cells
Interval 109.0 to 351.0
|
229.50 T cells/million cells
Interval 103.0 to 388.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IL2+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 15.0
|
9.50 T cells/million cells
Interval 1.0 to 27.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IL2+IFN+, D7
|
20.50 T cells/million cells
Interval 10.5 to 30.5
|
14.00 T cells/million cells
Interval 1.0 to 41.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IL2+IFN+, D14
|
11.00 T cells/million cells
Interval 1.0 to 47.0
|
23.00 T cells/million cells
Interval 9.0 to 28.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IL2+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
15.00 T cells/million cells
Interval 9.0 to 41.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IL2+IFN+, D180
|
18.00 T cells/million cells
Interval 1.0 to 42.0
|
14.00 T cells/million cells
Interval 1.0 to 27.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+TNF+IFN+, D7
|
12.50 T cells/million cells
Interval 1.0 to 32.0
|
14.00 T cells/million cells
Interval 1.0 to 19.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40+TNF+IFN+, D14
|
14.00 T cells/million cells
Interval 1.0 to 23.0
|
14.00 T cells/million cells
Interval 9.0 to 17.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 13.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IL2+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IL2+TNF+IFN+, D7
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 6.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IL2+TNF+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IL2+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, IL2+TNF+IFN+, D180
|
1.00 T cells/million cells
Interval 1.0 to 22.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IL2+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 44.0
|
14.50 T cells/million cells
Interval 1.0 to 69.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IL2+TNF+IFN+, D14
|
66.00 T cells/million cells
Interval 7.0 to 113.0
|
81.00 T cells/million cells
Interval 32.0 to 114.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IL2+TNF+IFN+, D30
|
40.00 T cells/million cells
Interval 13.0 to 83.0
|
57.00 T cells/million cells
Interval 1.0 to 111.0
|
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
P24, CD40L+IL2+TNF+IFN+, D180
|
43.00 T cells/million cells
Interval 26.0 to 52.0
|
22.50 T cells/million cells
Interval 1.0 to 67.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co\_est).
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, CD40L+TNF+, D0
|
102.00 T cells/million cells
Interval 50.0 to 141.0
|
69.50 T cells/million cells
Interval 40.0 to 245.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, CD40L+TNF+, D7
|
514.50 T cells/million cells
Interval 263.5 to 739.5
|
575.00 T cells/million cells
Interval 434.0 to 785.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, CD40L+TNF+, D14
|
706.00 T cells/million cells
Interval 216.0 to 908.0
|
498.00 T cells/million cells
Interval 375.0 to 785.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, CD40L+TNF+, D30
|
399.00 T cells/million cells
Interval 35.0 to 589.0
|
291.00 T cells/million cells
Interval 251.0 to 420.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, CD40L+TNF+, D180
|
81.00 T cells/million cells
Interval 54.0 to 135.0
|
74.00 T cells/million cells
Interval 27.0 to 201.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, CD40L+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 7.0
|
1.00 T cells/million cells
Interval 1.0 to 10.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, CD40L+IFN+, D7
|
82.50 T cells/million cells
Interval 25.0 to 275.5
|
112.00 T cells/million cells
Interval 39.0 to 152.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, CD40L+IFN+, D14
|
59.00 T cells/million cells
Interval 27.0 to 85.0
|
56.00 T cells/million cells
Interval 28.0 to 128.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, CD40L+IFN+, D30
|
21.00 T cells/million cells
Interval 1.0 to 55.0
|
41.00 T cells/million cells
Interval 28.0 to 64.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, CD40L+IFN+, D180
|
14.00 T cells/million cells
Interval 1.0 to 32.0
|
27.00 T cells/million cells
Interval 1.0 to 41.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, CD40L+, D0
|
177.00 T cells/million cells
Interval 1.0 to 280.0
|
264.50 T cells/million cells
Interval 84.0 to 372.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, CD40L+, D7
|
1809.50 T cells/million cells
Interval 756.0 to 4021.0
|
2215.00 T cells/million cells
Interval 991.0 to 2576.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, CD40L+, D14
|
1015.00 T cells/million cells
Interval 714.0 to 2566.0
|
1175.00 T cells/million cells
Interval 502.0 to 1520.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, CD40L+, D30
|
653.00 T cells/million cells
Interval 1.0 to 1250.0
|
650.00 T cells/million cells
Interval 420.0 to 907.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, CD40L+, D180
|
497.00 T cells/million cells
Interval 324.0 to 778.0
|
429.00 T cells/million cells
Interval 284.0 to 686.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, IL2+, D0
|
41.00 T cells/million cells
Interval 5.0 to 66.0
|
57.00 T cells/million cells
Interval 14.0 to 101.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, IL2+, D7
|
141.50 T cells/million cells
Interval 48.5 to 245.5
|
81.00 T cells/million cells
Interval 41.0 to 170.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, IL2+, D14
|
100.00 T cells/million cells
Interval 14.0 to 190.0
|
92.00 T cells/million cells
Interval 42.0 to 150.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, IL2+, D30
|
55.00 T cells/million cells
Interval 20.0 to 105.0
|
97.00 T cells/million cells
Interval 48.0 to 108.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, IL2+, D180
|
32.00 T cells/million cells
Interval 14.0 to 135.0
|
58.50 T cells/million cells
Interval 35.0 to 108.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, TNF+, D0
|
20.00 T cells/million cells
Interval 1.0 to 258.0
|
242.50 T cells/million cells
Interval 126.0 to 329.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, TNF+, D7
|
547.50 T cells/million cells
Interval 310.5 to 687.0
|
625.00 T cells/million cells
Interval 394.0 to 896.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, TNF+, D14
|
612.00 T cells/million cells
Interval 313.0 to 780.0
|
610.00 T cells/million cells
Interval 386.0 to 977.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, TNF+, D30
|
225.00 T cells/million cells
Interval 52.0 to 439.0
|
445.00 T cells/million cells
Interval 338.0 to 669.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, TNF+, D180
|
126.00 T cells/million cells
Interval 76.0 to 148.0
|
56.50 T cells/million cells
Interval 26.0 to 121.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, IFN+, D0
|
7.00 T cells/million cells
Interval 1.0 to 41.0
|
1.00 T cells/million cells
Interval 1.0 to 20.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, IFN+, D7
|
110.00 T cells/million cells
Interval 68.5 to 181.5
|
98.00 T cells/million cells
Interval 27.0 to 135.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, IFN+, D14
|
32.00 T cells/million cells
Interval 1.0 to 99.0
|
47.00 T cells/million cells
Interval 18.0 to 129.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, IFN+, D30
|
14.00 T cells/million cells
Interval 1.0 to 28.0
|
38.00 T cells/million cells
Interval 8.0 to 56.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, IFN+, D180
|
35.00 T cells/million cells
Interval 1.0 to 54.0
|
38.50 T cells/million cells
Interval 1.0 to 68.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, CD40L+IL2+, D0
|
469.00 T cells/million cells
Interval 293.0 to 797.0
|
568.50 T cells/million cells
Interval 240.0 to 1084.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, CD40L+IL2+, D7
|
1542.50 T cells/million cells
Interval 899.5 to 2626.0
|
2199.00 T cells/million cells
Interval 1656.0 to 3507.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, CD40L+IL2+, D14
|
1423.00 T cells/million cells
Interval 734.0 to 2876.0
|
2037.00 T cells/million cells
Interval 1276.0 to 2231.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, CD40L+IL2+, D30
|
964.00 T cells/million cells
Interval 62.0 to 1456.0
|
1277.00 T cells/million cells
Interval 1019.0 to 1597.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Pool_F4co, CD40L+IL2+, D180
|
961.00 T cells/million cells
Interval 834.0 to 1369.0
|
1351.50 T cells/million cells
Interval 976.0 to 1743.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co\_est).
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, IL2+TNF+, D0
|
55.00 T cells/million cells
Interval 14.0 to 82.0
|
56.00 T cells/million cells
Interval 12.0 to 141.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, IL2+TNF+, D7
|
160.00 T cells/million cells
Interval 54.0 to 298.5
|
93.00 T cells/million cells
Interval 42.0 to 149.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, IL2+TNF+, D14
|
122.00 T cells/million cells
Interval 59.0 to 172.0
|
83.00 T cells/million cells
Interval 57.0 to 224.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, IL2+TNF+, D30
|
25.00 T cells/million cells
Interval 13.0 to 96.0
|
109.00 T cells/million cells
Interval 82.0 to 127.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, IL2+TNF+, D180
|
26.00 T cells/million cells
Interval 14.0 to 108.0
|
59.50 T cells/million cells
Interval 44.0 to 105.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, IL2+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, IL2+IFN+, D7
|
6.00 T cells/million cells
Interval 1.0 to 32.0
|
1.00 T cells/million cells
Interval 1.0 to 25.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, IL2+IFN+, D14
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
1.00 T cells/million cells
Interval 1.0 to 20.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, IL2+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 11.0
|
11.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, IL2+IFN+, D180
|
14.00 T cells/million cells
Interval 1.0 to 16.0
|
14.00 T cells/million cells
Interval 1.0 to 27.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 27.0
|
1.00 T cells/million cells
Interval 1.0 to 29.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, TNF+IFN+, D7
|
38.00 T cells/million cells
Interval 18.0 to 106.5
|
56.00 T cells/million cells
Interval 41.0 to 117.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, TNF+IFN+, D14
|
51.00 T cells/million cells
Interval 8.0 to 61.0
|
83.00 T cells/million cells
Interval 42.0 to 97.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, TNF+IFN+, D30
|
27.00 T cells/million cells
Interval 1.0 to 69.0
|
75.00 T cells/million cells
Interval 42.0 to 96.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, TNF+IFN+, D180
|
19.00 T cells/million cells
Interval 1.0 to 41.0
|
28.00 T cells/million cells
Interval 1.0 to 54.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, CD40L+IL2+TNF+, D0
|
792.00 T cells/million cells
Interval 544.0 to 995.0
|
836.00 T cells/million cells
Interval 680.0 to 2333.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, CD40L+IL2+TNF+, D7
|
1430.00 T cells/million cells
Interval 961.0 to 3040.0
|
2764.00 T cells/million cells
Interval 1649.0 to 3631.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, CD40L+IL2+TNF+, D14
|
2032.00 T cells/million cells
Interval 1164.0 to 3906.0
|
2804.00 T cells/million cells
Interval 2313.0 to 3500.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, CD40L+IL2+TNF+, D30
|
2243.00 T cells/million cells
Interval 215.0 to 3151.0
|
2137.00 T cells/million cells
Interval 1764.0 to 2653.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, CD40L+IL2+TNF+, D180
|
1146.00 T cells/million cells
Interval 682.0 to 1481.0
|
1246.00 T cells/million cells
Interval 945.0 to 2046.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, CD40L+IL2+IFN+, D0
|
28.00 T cells/million cells
Interval 14.0 to 44.0
|
30.50 T cells/million cells
Interval 1.0 to 96.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, CD40L+IL2+IFN+, D7
|
140.00 T cells/million cells
Interval 83.0 to 426.0
|
204.00 T cells/million cells
Interval 84.0 to 294.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, CD40L+IL2+IFN+, D14
|
96.00 T cells/million cells
Interval 55.0 to 221.0
|
151.00 T cells/million cells
Interval 119.0 to 245.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, CD40L+IL2+IFN+, D30
|
24.00 T cells/million cells
Interval 1.0 to 179.0
|
109.00 T cells/million cells
Interval 58.0 to 154.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, CD40L+IL2+IFN+, D180
|
116.00 T cells/million cells
Interval 27.0 to 188.0
|
60.50 T cells/million cells
Interval 29.0 to 176.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, CD40L+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 1.0
|
1.00 T cells/million cells
Interval 1.0 to 12.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, CD40L+TNF+IFN+, D7
|
70.00 T cells/million cells
Interval 27.5 to 155.0
|
97.00 T cells/million cells
Interval 15.0 to 168.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, CD40+TNF+IFN+, D14
|
74.00 T cells/million cells
Interval 27.0 to 141.0
|
85.00 T cells/million cells
Interval 42.0 to 163.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, CD40L+TNF+IFN+, D30
|
55.00 T cells/million cells
Interval 1.0 to 122.0
|
82.00 T cells/million cells
Interval 31.0 to 127.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, CD40L+TNF+IFN+, D180
|
27.00 T cells/million cells
Interval 13.0 to 41.0
|
27.00 T cells/million cells
Interval 14.0 to 43.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, IL2+TNF+IFN+, D0
|
1.00 T cells/million cells
Interval 1.0 to 14.0
|
11.00 T cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, IL2+TNF+IFN+, D7
|
18.50 T cells/million cells
Interval 4.5 to 68.0
|
14.00 T cells/million cells
Interval 1.0 to 41.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, IL2+TNF+IFN+, D14
|
8.00 T cells/million cells
Interval 1.0 to 17.0
|
14.00 T cells/million cells
Interval 1.0 to 28.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, IL2+TNF+IFN+, D30
|
1.00 T cells/million cells
Interval 1.0 to 22.0
|
17.00 T cells/million cells
Interval 13.0 to 27.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, IL2+TNF+IFN+, D180
|
13.00 T cells/million cells
Interval 1.0 to 14.0
|
17.50 T cells/million cells
Interval 1.0 to 40.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, CD40L+IL2+TNF+IFN+, D0
|
95.00 T cells/million cells
Interval 44.0 to 206.0
|
147.00 T cells/million cells
Interval 1.0 to 304.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, CD40L+IL2+TNF+IFN+, D7
|
285.50 T cells/million cells
Interval 152.0 to 798.5
|
484.00 T cells/million cells
Interval 226.0 to 926.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, CD40L+IL2+TNF+IFN+, D14
|
337.00 T cells/million cells
Interval 176.0 to 802.0
|
639.00 T cells/million cells
Interval 304.0 to 922.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, CD40L+IL2+TNF+IFN+, D30
|
244.00 T cells/million cells
Interval 1.0 to 537.0
|
413.00 T cells/million cells
Interval 183.0 to 757.0
|
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Pool_F4co, CD40L+IL2+TNF+IFN+, D180
|
163.00 T cells/million cells
Interval 80.0 to 438.0
|
216.00 T cells/million cells
Interval 121.0 to 407.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co\_est).
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IFN+, D7
|
123.50 T cells/million cells
Interval 38.0 to 254.5
|
127.00 T cells/million cells
Interval 32.0 to 197.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IFN+, D14
|
68.00 T cells/million cells
Interval 33.0 to 122.0
|
60.00 T cells/million cells
Interval 43.0 to 87.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IFN+, D30
|
24.00 T cells/million cells
Interval 4.0 to 75.0
|
61.00 T cells/million cells
Interval 30.0 to 84.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+TNF+, D7
|
491.50 T cells/million cells
Interval 233.0 to 907.0
|
591.00 T cells/million cells
Interval 326.0 to 721.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+TNF+, D14
|
554.00 T cells/million cells
Interval 246.0 to 747.0
|
596.00 T cells/million cells
Interval 306.0 to 864.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+TNF+, D30
|
382.00 T cells/million cells
Interval 87.0 to 593.0
|
234.00 T cells/million cells
Interval 210.0 to 288.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+TNF+, D180
|
109.00 T cells/million cells
Interval 59.0 to 128.0
|
63.50 T cells/million cells
Interval 49.0 to 146.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+, D0
|
562.00 T cells/million cells
Interval 166.0 to 932.0
|
270.50 T cells/million cells
Interval 101.0 to 828.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+, D7
|
2050.50 T cells/million cells
Interval 1173.5 to 5806.0
|
2296.00 T cells/million cells
Interval 1038.0 to 2839.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+, D14
|
1106.00 T cells/million cells
Interval 411.0 to 2472.0
|
1108.00 T cells/million cells
Interval 404.0 to 1713.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+, D30
|
584.00 T cells/million cells
Interval 4.0 to 1965.0
|
697.00 T cells/million cells
Interval 517.0 to 959.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+, D180
|
543.00 T cells/million cells
Interval 442.0 to 730.0
|
507.00 T cells/million cells
Interval 349.0 to 895.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IL2+, D0
|
54.00 T cells/million cells
Interval 29.0 to 105.0
|
138.00 T cells/million cells
Interval 30.0 to 235.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IL2+, D7
|
201.50 T cells/million cells
Interval 108.5 to 386.0
|
165.00 T cells/million cells
Interval 58.0 to 175.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IL2+, D14
|
130.00 T cells/million cells
Interval 96.0 to 263.0
|
92.00 T cells/million cells
Interval 30.0 to 152.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IL2+, D30
|
75.00 T cells/million cells
Interval 4.0 to 206.0
|
134.00 T cells/million cells
Interval 70.0 to 180.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IL2+, D180
|
82.00 T cells/million cells
Interval 44.0 to 294.0
|
93.00 T cells/million cells
Interval 63.0 to 191.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, TNF+, D0
|
192.00 T cells/million cells
Interval 69.0 to 235.0
|
129.50 T cells/million cells
Interval 67.0 to 488.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, TNF+, D7
|
844.00 T cells/million cells
Interval 272.5 to 1066.5
|
635.00 T cells/million cells
Interval 297.0 to 1151.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, TNF+, D14
|
388.00 T cells/million cells
Interval 267.0 to 605.0
|
477.00 T cells/million cells
Interval 314.0 to 1023.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, TNF+, D30
|
194.00 T cells/million cells
Interval 66.0 to 300.0
|
608.00 T cells/million cells
Interval 194.0 to 654.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, TNF+, D180
|
191.00 T cells/million cells
Interval 19.0 to 243.0
|
40.50 T cells/million cells
Interval 4.0 to 123.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IFN+, D0
|
43.00 T cells/million cells
Interval 11.0 to 71.0
|
42.00 T cells/million cells
Interval 14.0 to 58.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IFN+, D7
|
141.50 T cells/million cells
Interval 44.5 to 189.5
|
93.00 T cells/million cells
Interval 32.0 to 150.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IFN+, D14
|
30.00 T cells/million cells
Interval 17.0 to 102.0
|
71.00 T cells/million cells
Interval 17.0 to 112.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IFN+, D30
|
24.00 T cells/million cells
Interval 4.0 to 57.0
|
30.00 T cells/million cells
Interval 4.0 to 71.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IFN+, D180
|
120.00 T cells/million cells
Interval 45.0 to 139.0
|
36.50 T cells/million cells
Interval 4.0 to 87.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IL2+, D0
|
659.00 T cells/million cells
Interval 467.0 to 722.0
|
761.50 T cells/million cells
Interval 231.0 to 1073.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IL2+, D7
|
2048.00 T cells/million cells
Interval 1017.5 to 2779.5
|
2496.00 T cells/million cells
Interval 1282.0 to 3250.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IL2+, D14
|
1724.00 T cells/million cells
Interval 802.0 to 3005.0
|
1860.00 T cells/million cells
Interval 1493.0 to 2091.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IL2+, D30
|
1042.00 T cells/million cells
Interval 98.0 to 1472.0
|
1217.00 T cells/million cells
Interval 1129.0 to 1643.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IL2+, D180
|
1184.00 T cells/million cells
Interval 883.0 to 1732.0
|
1309.50 T cells/million cells
Interval 876.0 to 1721.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+TNF+, D0
|
74.00 T cells/million cells
Interval 56.0 to 177.0
|
95.00 T cells/million cells
Interval 46.0 to 174.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IFN+, D0
|
4.00 T cells/million cells
Interval 4.0 to 15.0
|
9.00 T cells/million cells
Interval 4.0 to 17.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IFN+, D180
|
17.00 T cells/million cells
Interval 4.0 to 35.0
|
30.00 T cells/million cells
Interval 17.0 to 45.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co\_est).
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IL2+TNF+, D7
|
165.00 T cells/million cells
Interval 69.5 to 267.0
|
86.00 T cells/million cells
Interval 66.0 to 110.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IL2+TNF+, D0
|
37.00 T cells/million cells
Interval 24.0 to 117.0
|
34.50 T cells/million cells
Interval 4.0 to 178.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IL2+IFN+, D0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IL2+IFN+, D7
|
17.00 T cells/million cells
Interval 4.0 to 43.5
|
12.00 T cells/million cells
Interval 4.0 to 18.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IL2+IFN+, D14
|
10.00 T cells/million cells
Interval 4.0 to 31.0
|
4.00 T cells/million cells
Interval 4.0 to 17.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IL2+IFN+, D14
|
107.00 T cells/million cells
Interval 57.0 to 226.0
|
157.00 T cells/million cells
Interval 99.0 to 212.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IL2+IFN+, D30
|
46.00 T cells/million cells
Interval 4.0 to 153.0
|
139.00 T cells/million cells
Interval 97.0 to 182.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+TNF+IFN+, D7
|
86.50 T cells/million cells
Interval 64.0 to 144.0
|
111.00 T cells/million cells
Interval 48.0 to 168.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40+TNF+IFN+, D14
|
82.00 T cells/million cells
Interval 43.0 to 142.0
|
85.00 T cells/million cells
Interval 31.0 to 154.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+TNF+IFN+, D30
|
43.00 T cells/million cells
Interval 12.0 to 99.0
|
44.00 T cells/million cells
Interval 32.0 to 74.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+TNF+IFN+, D180
|
16.00 T cells/million cells
Interval 4.0 to 19.0
|
22.50 T cells/million cells
Interval 4.0 to 43.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IL2+TNF+IFN+, D0
|
4.00 T cells/million cells
Interval 4.0 to 15.0
|
4.00 T cells/million cells
Interval 4.0 to 17.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IL2+TNF+IFN+, D30
|
4.00 T cells/million cells
Interval 4.0 to 14.0
|
27.00 T cells/million cells
Interval 17.0 to 43.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IL2+TNF+IFN+, D180
|
134.00 T cells/million cells
Interval 97.0 to 367.0
|
244.00 T cells/million cells
Interval 82.0 to 419.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IL2+TNF+, D14
|
103.00 T cells/million cells
Interval 56.0 to 284.0
|
49.00 T cells/million cells
Interval 43.0 to 210.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IL2+TNF+, D30
|
30.00 T cells/million cells
Interval 21.0 to 192.0
|
82.00 T cells/million cells
Interval 31.0 to 175.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IL2+TNF+, D180
|
43.00 T cells/million cells
Interval 28.0 to 123.0
|
87.50 T cells/million cells
Interval 70.0 to 187.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IL2+IFN+, D30
|
4.00 T cells/million cells
Interval 4.0 to 4.0
|
4.00 T cells/million cells
Interval 4.0 to 18.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IL2+IFN+, D180
|
4.00 T cells/million cells
Interval 4.0 to 30.0
|
17.00 T cells/million cells
Interval 4.0 to 30.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, TNF+IFN+, D0
|
17.00 T cells/million cells
Interval 4.0 to 32.0
|
14.00 T cells/million cells
Interval 4.0 to 18.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, TNF+IFN+, D7
|
45.00 T cells/million cells
Interval 29.0 to 116.5
|
72.00 T cells/million cells
Interval 30.0 to 88.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, TNF+IFN+, D14
|
56.00 T cells/million cells
Interval 4.0 to 83.0
|
64.00 T cells/million cells
Interval 18.0 to 71.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, TNF+IFN+, D30
|
35.00 T cells/million cells
Interval 21.0 to 57.0
|
86.00 T cells/million cells
Interval 36.0 to 100.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, TNF+IFN+, D180
|
17.00 T cells/million cells
Interval 4.0 to 31.0
|
59.50 T cells/million cells
Interval 17.0 to 96.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IL2+TNF+, D0
|
1050.00 T cells/million cells
Interval 566.0 to 1215.0
|
972.50 T cells/million cells
Interval 398.0 to 2654.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IL2+TNF+, D7
|
1587.00 T cells/million cells
Interval 1067.5 to 3516.5
|
3392.00 T cells/million cells
Interval 1962.0 to 4350.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IL2+TNF+, D14
|
2652.00 T cells/million cells
Interval 1588.0 to 4691.0
|
3279.00 T cells/million cells
Interval 2871.0 to 4311.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IL2+TNF+, D30
|
2635.00 T cells/million cells
Interval 202.0 to 3943.0
|
2593.00 T cells/million cells
Interval 1885.0 to 2825.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IL2+TNF+, D180
|
1088.00 T cells/million cells
Interval 584.0 to 1552.0
|
1288.50 T cells/million cells
Interval 984.0 to 2408.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IL2+IFN+, D0
|
51.00 T cells/million cells
Interval 26.0 to 96.0
|
45.00 T cells/million cells
Interval 29.0 to 82.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IL2+IFN+, D7
|
158.50 T cells/million cells
Interval 77.5 to 429.0
|
254.00 T cells/million cells
Interval 118.0 to 327.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IL2+IFN+, D180
|
123.00 T cells/million cells
Interval 70.0 to 176.0
|
104.00 T cells/million cells
Interval 30.0 to 190.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+TNF+IFN+, D0
|
4.00 T cells/million cells
Interval 4.0 to 17.0
|
8.50 T cells/million cells
Interval 4.0 to 26.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IL2+TNF+IFN+, D7
|
21.00 T cells/million cells
Interval 16.0 to 35.0
|
30.00 T cells/million cells
Interval 11.0 to 58.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IL2+TNF+IFN+, D14
|
17.00 T cells/million cells
Interval 4.0 to 30.0
|
17.00 T cells/million cells
Interval 4.0 to 57.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, IL2+TNF+IFN+, D180
|
25.00 T cells/million cells
Interval 17.0 to 69.0
|
30.00 T cells/million cells
Interval 4.0 to 34.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IL2+TNF+IFN+, D0
|
107.00 T cells/million cells
Interval 71.0 to 142.0
|
138.00 T cells/million cells
Interval 44.0 to 207.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IL2+TNF+IFN+, D7
|
348.00 T cells/million cells
Interval 246.5 to 1074.5
|
512.00 T cells/million cells
Interval 235.0 to 1098.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IL2+TNF+IFN+, D14
|
457.00 T cells/million cells
Interval 97.0 to 608.0
|
601.00 T cells/million cells
Interval 250.0 to 938.0
|
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
F4co_est, CD40L+IL2+TNF+IFN+, D30
|
284.00 T cells/million cells
Interval 21.0 to 747.0
|
384.00 T cells/million cells
Interval 206.0 to 854.0
|
SECONDARY outcome
Timeframe: At Day 0, 7, 14, 30 and 180Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Antibody concentrations were expressed as geometric mean concentrations (GMCs), given in milli-enzyme-linked immunosorbent assay (ELISA) units per millilitre (mEL.U/mL).
Outcome measures
| Measure |
GSK732461+Nivaquine Group
n=13 Participants
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=14 Participants
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-p24, Day 30
|
61372.0 mEL.U/mL
Interval 41678.5 to 90370.9
|
49619.3 mEL.U/mL
Interval 31879.0 to 77231.9
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-RT, Day 0
|
154.0 mEL.U/mL
Interval 95.8 to 247.5
|
198.4 mEL.U/mL
Interval 99.0 to 397.7
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-RT, Day 7
|
31465.3 mEL.U/mL
Interval 13461.3 to 73549.0
|
39928.9 mEL.U/mL
Interval 21751.5 to 73297.1
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-RT, Day 14
|
79774.0 mEL.U/mL
Interval 50733.0 to 125439.0
|
59932.0 mEL.U/mL
Interval 37464.8 to 95872.6
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-RT, Day 30
|
71028.8 mEL.U/mL
Interval 48687.2 to 103622.7
|
57653.6 mEL.U/mL
Interval 35758.1 to 92956.1
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-RT, Day 180
|
27286.9 mEL.U/mL
Interval 18489.9 to 40269.3
|
26520.6 mEL.U/mL
Interval 14387.7 to 48885.0
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-Nef, Day 0
|
394.6 mEL.U/mL
Interval 243.4 to 639.5
|
536.3 mEL.U/mL
Interval 251.9 to 1141.7
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-Nef, Day 7
|
38430.3 mEL.U/mL
Interval 15157.6 to 97435.4
|
38621.8 mEL.U/mL
Interval 19829.5 to 75223.5
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-Nef, Day 14
|
113387.2 mEL.U/mL
Interval 62469.0 to 205808.7
|
63283.3 mEL.U/mL
Interval 36141.0 to 110809.8
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-Nef, Day 30
|
77192.3 mEL.U/mL
Interval 39847.3 to 149537.1
|
42709.2 mEL.U/mL
Interval 21389.9 to 85277.2
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-Nef, Day 180
|
25141.1 mEL.U/mL
Interval 14744.0 to 42870.2
|
21371.8 mEL.U/mL
Interval 10260.3 to 44517.0
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-p17, Day 0
|
93.5 mEL.U/mL
Interval 93.5 to 93.5
|
98.9 mEL.U/mL
Interval 87.6 to 111.6
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-p17, Day 7
|
1599.4 mEL.U/mL
Interval 704.7 to 3629.7
|
1121.5 mEL.U/mL
Interval 390.5 to 3220.5
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-p17, Day 14
|
5069.8 mEL.U/mL
Interval 2356.8 to 10906.1
|
1763.3 mEL.U/mL
Interval 545.6 to 5699.3
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-p17, Day 30
|
5148.5 mEL.U/mL
Interval 2493.1 to 10632.1
|
1610.1 mEL.U/mL
Interval 436.1 to 5944.5
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-p17, Day 180
|
1115.5 mEL.U/mL
Interval 498.9 to 2493.9
|
639.0 mEL.U/mL
Interval 215.1 to 1899.0
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-p24, Day 0
|
377.4 mEL.U/mL
Interval 271.1 to 525.3
|
483.3 mEL.U/mL
Interval 222.0 to 1051.9
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-p24, Day 7
|
31533.9 mEL.U/mL
Interval 14691.0 to 67686.9
|
36200.9 mEL.U/mL
Interval 22284.8 to 58807.3
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-p24, Day 14
|
78313.7 mEL.U/mL
Interval 51412.0 to 119292.0
|
59655.5 mEL.U/mL
Interval 40848.9 to 87120.6
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-p24, Day 180
|
27590.9 mEL.U/mL
Interval 18812.2 to 40466.2
|
27545.3 mEL.U/mL
Interval 16128.6 to 47043.3
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-F4co, Day 0
|
217.8 mEL.U/mL
Interval 147.1 to 322.3
|
330.2 mEL.U/mL
Interval 194.0 to 562.0
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-F4co, Day 7
|
37905.7 mEL.U/mL
Interval 16622.6 to 86438.8
|
39948.9 mEL.U/mL
Interval 24778.8 to 64406.3
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-F4co, Day 14
|
83863.4 mEL.U/mL
Interval 56912.6 to 123576.8
|
63951.9 mEL.U/mL
Interval 45830.2 to 89239.0
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-F4co, Day 30
|
74791.3 mEL.U/mL
Interval 50872.9 to 109955.1
|
65633.5 mEL.U/mL
Interval 42838.2 to 100558.8
|
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Anti-F4co, Day 180
|
42847.4 mEL.U/mL
Interval 28001.7 to 65563.8
|
40715.4 mEL.U/mL
Interval 24865.2 to 66669.5
|
Adverse Events
GSK732461+Nivaquine Group
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
GSK732461 Group
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GSK732461+Nivaquine Group
n=13 participants at risk
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
GSK732461 Group
n=15 participants at risk
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
General disorders
Chills
|
7.7%
1/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
40.0%
6/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
General disorders
Hangover
|
0.00%
0/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
6.7%
1/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
General disorders
Influenza like illness
|
15.4%
2/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
13.3%
2/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
6.7%
1/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
General disorders
Injection site reaction
|
0.00%
0/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
6.7%
1/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
General disorders
Malaise
|
0.00%
0/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
6.7%
1/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
Infections and infestations
Gastroenteritis
|
7.7%
1/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
6.7%
1/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
Infections and infestations
Rhinitis
|
7.7%
1/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
6.7%
1/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
0.00%
0/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
6.7%
1/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
6.7%
1/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.1%
3/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
13.3%
2/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
6.7%
1/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
20.0%
3/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
6.7%
1/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
6.7%
1/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
6.7%
1/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
General disorders
Fatigue
|
69.2%
9/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
93.3%
14/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
General disorders
Gastro-intestinal symptoms
|
46.2%
6/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
33.3%
5/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
General disorders
Headache
|
69.2%
9/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
86.7%
13/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
General disorders
Temperature (Orally)
|
61.5%
8/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
66.7%
10/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
General disorders
Pain
|
100.0%
13/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
93.3%
14/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
General disorders
Redness
|
23.1%
3/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
40.0%
6/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
|
General disorders
Swelling
|
23.1%
3/13 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
33.3%
5/15 • Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).
|
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