Trial Outcomes & Findings for Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Adults With TB Disease (NCT NCT01424501)
NCT ID: NCT01424501
Last Updated: 2018-08-20
Results Overview
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 activities. Grade 3 redness/swelling = redness/swelling spreading beyond (\>) 100 millimeters (mm) of injection site.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
142 participants
Primary outcome timeframe
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Results posted on
2018-08-20
Participant Flow
During the screening the following was performed: informed consent was obtained and signed from parents or guardians of subjects, check for inclusion/exclusion criteria and contraindications/precautions, and medical history of subjects was collected. Prior to vaccination, subjects' pre-vaccination body temperature was evaluated.
Participant milestones
| Measure |
TB Treatment GSK 692342 Group
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
24
|
25
|
40
|
40
|
|
Overall Study
COMPLETED
|
6
|
5
|
22
|
25
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
TB Treatment GSK 692342 Group
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Adults With TB Disease
Baseline characteristics by cohort
| Measure |
TB Treatment GSK 692342 Group
n=7 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=24 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=25 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=40 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=40 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.9 Years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
44.7 Years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
44.5 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
47 Years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
33.8 Years
STANDARD_DEVIATION 8.5 • n=21 Participants
|
33.3 Years
STANDARD_DEVIATION 9.8 • n=8 Participants
|
38.7 Years
STANDARD_DEVIATION 9.98 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
60 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
82 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - East Asian Heritage
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
106 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Caucasian/European Heritage
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administered, for whom data were available and who had their symptom sheets filled in.
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 activities. Grade 3 redness/swelling = redness/swelling spreading beyond (\>) 100 millimeters (mm) of injection site.
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=7 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=24 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=25 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=40 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=40 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1
|
6 Participants
|
1 Participants
|
21 Participants
|
2 Participants
|
38 Participants
|
5 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 1
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1
|
2 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2
|
5 Participants
|
1 Participants
|
19 Participants
|
1 Participants
|
36 Participants
|
6 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 2
|
3 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2
|
3 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
11 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Across doses
|
6 Participants
|
1 Participants
|
22 Participants
|
3 Participants
|
39 Participants
|
8 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Across doses
|
0 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Across doses
|
3 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
10 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Across doses
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Across doses
|
3 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
11 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Across doses
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administered, for whom data were available and who had their symptoms sheets filled in.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, malaise, myalgia and temperature \[body temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of any solicited general symptom regardless of their intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = body temperature above (\>) 39.5°C. Related = event assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=7 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=24 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=25 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=40 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=40 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal symptoms,Across doses
|
2 Participants
|
0 Participants
|
10 Participants
|
4 Participants
|
16 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 1
|
1 Participants
|
2 Participants
|
14 Participants
|
6 Participants
|
19 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 1
|
1 Participants
|
0 Participants
|
9 Participants
|
3 Participants
|
16 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 1
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal symptoms, Dose 1
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal symptoms, Dose 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal symptoms, Dose 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 1
|
1 Participants
|
0 Participants
|
11 Participants
|
4 Participants
|
8 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 1
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
7 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Malaise, Dose 1
|
1 Participants
|
1 Participants
|
11 Participants
|
2 Participants
|
14 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Malaise, Dose 1
|
1 Participants
|
0 Participants
|
8 Participants
|
1 Participants
|
10 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Malaise, Dose 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 1
|
2 Participants
|
0 Participants
|
13 Participants
|
4 Participants
|
24 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 1
|
1 Participants
|
0 Participants
|
8 Participants
|
1 Participants
|
21 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature/(Axillary), Dose 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature/(Axillary), Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature/(Axillary), Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 2
|
3 Participants
|
1 Participants
|
13 Participants
|
5 Participants
|
33 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 2
|
3 Participants
|
0 Participants
|
11 Participants
|
0 Participants
|
30 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 2
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal symptoms, Dose 2
|
2 Participants
|
0 Participants
|
7 Participants
|
3 Participants
|
13 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal symptoms, Dose 2
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
11 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal symptoms, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 2
|
3 Participants
|
1 Participants
|
12 Participants
|
2 Participants
|
22 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 2
|
3 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
20 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Malaise, Dose 2
|
3 Participants
|
2 Participants
|
11 Participants
|
5 Participants
|
32 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Malaise, Dose 2
|
3 Participants
|
0 Participants
|
10 Participants
|
0 Participants
|
29 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Malaise, Dose 2
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 2
|
3 Participants
|
1 Participants
|
14 Participants
|
4 Participants
|
28 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 2
|
3 Participants
|
0 Participants
|
13 Participants
|
1 Participants
|
27 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 2
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature/(Axillary), Dose 2
|
4 Participants
|
1 Participants
|
9 Participants
|
0 Participants
|
16 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature/(Axillary), Dose 2
|
4 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
16 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature/(Axillary), Dose 2
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Across doses
|
3 Participants
|
2 Participants
|
17 Participants
|
8 Participants
|
36 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Across doses
|
3 Participants
|
0 Participants
|
13 Participants
|
3 Participants
|
34 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Across doses
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal symptoms,Across doses
|
0 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
13 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal symptoms,Across doses
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Across doses
|
3 Participants
|
1 Participants
|
18 Participants
|
4 Participants
|
24 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Across doses
|
3 Participants
|
0 Participants
|
9 Participants
|
1 Participants
|
23 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Across doses
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Malaise, Across doses
|
3 Participants
|
2 Participants
|
16 Participants
|
6 Participants
|
35 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Malaise, Across doses
|
3 Participants
|
0 Participants
|
12 Participants
|
1 Participants
|
31 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Malaise, Across doses
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Across doses
|
3 Participants
|
1 Participants
|
18 Participants
|
5 Participants
|
34 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Across doses
|
3 Participants
|
0 Participants
|
15 Participants
|
2 Participants
|
34 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Across doses
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature/(Axillary), Across doses
|
4 Participants
|
1 Participants
|
10 Participants
|
0 Participants
|
17 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature/(Axillary), Across doses
|
4 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
17 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature/(Axillary), Across doses
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 30 day (Days 0-29), after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered and 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 outside the specified period of follow-up for solicited symptoms.
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=7 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=24 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=25 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=40 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=40 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Adverse Events (AEs)
|
1 Subjects
|
2 Subjects
|
14 Subjects
|
7 Subjects
|
19 Subjects
|
8 Subjects
|
PRIMARY outcome
Timeframe: Up to day 210Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered and 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 |
TB Treatment GSK 692342 Group
n=7 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=24 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=25 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=40 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=40 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Day 30), post-dose 2 (Days 60 and 210)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity,which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules,receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Cut-off values assessed were greater than or equal to (≥) 2.8, as measured by Enzyme-Linked Immunosorbent Assay (ELISA) in the sera of subjects seronegative before vaccination.
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=7 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=4 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=21 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=25 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=38 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=39 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies
Anti-M72, Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies
Anti-M72, Day 30
|
5 Participants
|
0 Participants
|
19 Participants
|
0 Participants
|
26 Participants
|
2 Participants
|
|
Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies
Anti-M72, Day 60
|
6 Participants
|
0 Participants
|
18 Participants
|
0 Participants
|
37 Participants
|
3 Participants
|
|
Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies
Anti-M72, Day 210
|
6 Participants
|
0 Participants
|
18 Participants
|
0 Participants
|
38 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Day 30), post-dose 2 (Days 60 and 210)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Concentrations are presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EU/mL).
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=7 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=4 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=21 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=25 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=38 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=39 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Concentrations of Anti-M72 Antibodies
Anti-M72, Day 0
|
1.4 EU/mL
Interval 1.4 to 1.4
|
1.4 EU/mL
Interval 1.4 to 1.4
|
1.4 EU/mL
Interval 1.4 to 1.4
|
1.4 EU/mL
Interval 1.4 to 1.4
|
1.4 EU/mL
Interval 1.4 to 1.5
|
1.5 EU/mL
Interval 1.4 to 1.6
|
|
Concentrations of Anti-M72 Antibodies
Anti-M72, Day 30
|
6.7 EU/mL
Interval 2.1 to 21.0
|
1.4 EU/mL
Interval 1.4 to 1.4
|
11.7 EU/mL
Interval 6.3 to 22.0
|
1.4 EU/mL
Interval 1.4 to 1.4
|
4.5 EU/mL
Interval 3.3 to 6.2
|
1.5 EU/mL
Interval 1.4 to 1.6
|
|
Concentrations of Anti-M72 Antibodies
Anti-M72, Day 60
|
206.6 EU/mL
Interval 46.2 to 923.2
|
1.4 EU/mL
Interval 1.4 to 1.4
|
226.2 EU/mL
Interval 99.0 to 517.2
|
1.4 EU/mL
Interval 1.4 to 1.4
|
248.6 EU/mL
Interval 171.0 to 361.4
|
1.7 EU/mL
Interval 1.3 to 2.3
|
|
Concentrations of Anti-M72 Antibodies
Anti-M72, Day 210
|
38.4 EU/mL
Interval 18.9 to 77.9
|
1.4 EU/mL
Interval 1.4 to 1.4
|
50.9 EU/mL
Interval 27.3 to 94.8
|
1.4 EU/mL
Interval 1.4 to 1.4
|
45.6 EU/mL
Interval 34.2 to 60.8
|
1.4 EU/mL
Interval 1.4 to 1.5
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=3 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=18 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=22 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=37 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=36 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers
CD4-ALL doubles, Day 0
|
247 CD4+ T-cells/million cells
Interval 204.5 to 333.5
|
178 CD4+ T-cells/million cells
Interval 70.0 to 651.0
|
347 CD4+ T-cells/million cells
Interval 196.0 to 523.0
|
549.5 CD4+ T-cells/million cells
Interval 375.0 to 997.0
|
286 CD4+ T-cells/million cells
Interval 173.0 to 471.0
|
352 CD4+ T-cells/million cells
Interval 170.0 to 579.0
|
|
Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers
CD4-ALL doubles, Day 7
|
997.5 CD4+ T-cells/million cells
Interval 714.0 to 1345.0
|
182 CD4+ T-cells/million cells
Interval 82.0 to 431.0
|
1097 CD4+ T-cells/million cells
Interval 985.0 to 1760.0
|
469 CD4+ T-cells/million cells
Interval 328.0 to 1075.0
|
801.5 CD4+ T-cells/million cells
Interval 440.0 to 1492.0
|
265.5 CD4+ T-cells/million cells
Interval 167.5 to 571.5
|
|
Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers
CD4-ALL doubles, Day 30
|
2959 CD4+ T-cells/million cells
Interval 1289.0 to 2989.0
|
730 CD4+ T-cells/million cells
Interval 216.0 to 1244.0
|
2616.5 CD4+ T-cells/million cells
Interval 1417.0 to 5614.0
|
466 CD4+ T-cells/million cells
Interval 261.5 to 1145.5
|
1228.5 CD4+ T-cells/million cells
Interval 941.0 to 2131.0
|
312.5 CD4+ T-cells/million cells
Interval 202.0 to 726.0
|
|
Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers
CD4-ALL doubles, Day 37
|
4433 CD4+ T-cells/million cells
Interval 3024.0 to 10010.0
|
273 CD4+ T-cells/million cells
Interval 221.0 to 445.0
|
5705.5 CD4+ T-cells/million cells
Interval 2219.0 to 11228.0
|
533 CD4+ T-cells/million cells
Interval 227.0 to 1235.0
|
5987.5 CD4+ T-cells/million cells
Interval 3987.0 to 9605.0
|
247 CD4+ T-cells/million cells
Interval 175.0 to 387.0
|
|
Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers
CD4-ALL doubles, Day 60
|
5648 CD4+ T-cells/million cells
Interval 3686.0 to 7957.0
|
241 CD4+ T-cells/million cells
Interval 224.0 to 258.0
|
2072 CD4+ T-cells/million cells
Interval 1083.0 to 4199.0
|
517 CD4+ T-cells/million cells
Interval 352.0 to 1242.0
|
5153 CD4+ T-cells/million cells
Interval 2884.0 to 8978.0
|
240 CD4+ T-cells/million cells
Interval 146.0 to 476.0
|
|
Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers
CD4-ALL doubles, Day 210
|
2922.5 CD4+ T-cells/million cells
Interval 967.0 to 4411.0
|
118 CD4+ T-cells/million cells
Interval 116.0 to 307.0
|
1154 CD4+ T-cells/million cells
Interval 1028.0 to 1808.0
|
445 CD4+ T-cells/million cells
Interval 243.0 to 734.0
|
2155 CD4+ T-cells/million cells
Interval 1389.0 to 4160.0
|
254 CD4+ T-cells/million cells
Interval 166.0 to 383.0
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a), CD40-ligand (CD40-L), Interleukin-17 (IL-17) and/or Interleukin-13 (IL-13).
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=3 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=18 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=22 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=37 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=36 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6
CD4-At least 2, Day 0
|
260 CD4+ T-cells/million cells
Interval 217.5 to 346.5
|
207 CD4+ T-cells/million cells
Interval 96.0 to 687.0
|
364 CD4+ T-cells/million cells
Interval 238.0 to 536.0
|
562.5 CD4+ T-cells/million cells
Interval 402.0 to 1010.0
|
325 CD4+ T-cells/million cells
Interval 240.0 to 512.0
|
365 CD4+ T-cells/million cells
Interval 214.0 to 609.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6
CD4- At least 2, Day 7
|
1010.5 CD4+ T-cells/million cells
Interval 733.5 to 1358.0
|
208 CD4+ T-cells/million cells
Interval 95.0 to 457.0
|
1152 CD4+ T-cells/million cells
Interval 1011.0 to 1895.0
|
482 CD4+ T-cells/million cells
Interval 347.0 to 1088.0
|
856 CD4+ T-cells/million cells
Interval 479.0 to 1505.0
|
278.5 CD4+ T-cells/million cells
Interval 193.5 to 600.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6
CD4- At least 2, Day 30
|
2972 CD4+ T-cells/million cells
Interval 1302.0 to 3002.0
|
765 CD4+ T-cells/million cells
Interval 229.0 to 1301.0
|
2636 CD4+ T-cells/million cells
Interval 1437.0 to 5655.0
|
497 CD4+ T-cells/million cells
Interval 282.0 to 1179.0
|
1248.5 CD4+ T-cells/million cells
Interval 954.0 to 2144.0
|
348.5 CD4+ T-cells/million cells
Interval 238.0 to 754.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6
CD4- At least 2, Day 37
|
4446 CD4+ T-cells/million cells
Interval 3037.0 to 10107.0
|
316 CD4+ T-cells/million cells
Interval 234.0 to 458.0
|
5733.5 CD4+ T-cells/million cells
Interval 2232.0 to 11281.0
|
565 CD4+ T-cells/million cells
Interval 260.0 to 1262.0
|
6051.5 CD4+ T-cells/million cells
Interval 4191.0 to 9679.0
|
277.5 CD4+ T-cells/million cells
Interval 190.0 to 425.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6
CD4- At least 2, Day 60
|
5661 CD4+ T-cells/million cells
Interval 3699.0 to 7976.5
|
254 CD4+ T-cells/million cells
Interval 237.0 to 271.0
|
2101 CD4+ T-cells/million cells
Interval 1115.0 to 4275.0
|
583 CD4+ T-cells/million cells
Interval 378.0 to 1256.0
|
5185 CD4+ T-cells/million cells
Interval 2897.0 to 9031.0
|
258 CD4+ T-cells/million cells
Interval 160.5 to 496.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6
CD4- At least 2, Day 210
|
2948.5 CD4+ T-cells/million cells
Interval 993.0 to 4670.0
|
131 CD4+ T-cells/million cells
Interval 129.0 to 320.0
|
1167 CD4+ T-cells/million cells
Interval 1041.0 to 1821.0
|
480 CD4+ T-cells/million cells
Interval 298.0 to 770.0
|
2269 CD4+ T-cells/million cells
Interval 1419.0 to 4173.0
|
299 CD4+ T-cells/million cells
Interval 201.5 to 449.5
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=3 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=18 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=22 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=37 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=36 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa+/IFNg+, Day 0
|
106.5 CD4+ T-cells/million cells
Interval 68.0 to 134.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 252.0
|
87 CD4+ T-cells/million cells
Interval 34.0 to 140.0
|
124 CD4+ T-cells/million cells
Interval 74.0 to 186.0
|
60 CD4+ T-cells/million cells
Interval 4.0 to 108.0
|
54 CD4+ T-cells/million cells
Interval 17.0 to 142.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa+/IFNg+, Day 7
|
267.5 CD4+ T-cells/million cells
Interval 218.5 to 493.5
|
42 CD4+ T-cells/million cells
Interval 4.0 to 241.0
|
329 CD4+ T-cells/million cells
Interval 140.0 to 454.0
|
84 CD4+ T-cells/million cells
Interval 25.0 to 154.0
|
87 CD4+ T-cells/million cells
Interval 24.0 to 229.0
|
55.5 CD4+ T-cells/million cells
Interval 4.0 to 132.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa+/IFNg+, Day 30
|
1066 CD4+ T-cells/million cells
Interval 261.0 to 1233.0
|
330.5 CD4+ T-cells/million cells
Interval 33.0 to 628.0
|
776 CD4+ T-cells/million cells
Interval 341.0 to 1070.5
|
71 CD4+ T-cells/million cells
Interval 30.5 to 161.5
|
89.5 CD4+ T-cells/million cells
Interval 37.0 to 287.0
|
47 CD4+ T-cells/million cells
Interval 17.0 to 157.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa+/IFNg+, Day 37
|
1186 CD4+ T-cells/million cells
Interval 1084.0 to 1403.0
|
80 CD4+ T-cells/million cells
Interval 44.0 to 158.0
|
897.5 CD4+ T-cells/million cells
Interval 333.0 to 1123.0
|
87 CD4+ T-cells/million cells
Interval 52.0 to 135.0
|
436.5 CD4+ T-cells/million cells
Interval 192.0 to 592.0
|
45 CD4+ T-cells/million cells
Interval 11.0 to 106.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa+/IFNg+, Day 60
|
1444 CD4+ T-cells/million cells
Interval 1039.0 to 1615.5
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
417 CD4+ T-cells/million cells
Interval 87.0 to 815.0
|
132 CD4+ T-cells/million cells
Interval 73.0 to 171.0
|
436 CD4+ T-cells/million cells
Interval 219.0 to 826.0
|
31 CD4+ T-cells/million cells
Interval 4.0 to 130.5
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa+/IFNg+, Day 210
|
585.5 CD4+ T-cells/million cells
Interval 288.0 to 997.0
|
18 CD4+ T-cells/million cells
Interval 4.0 to 74.0
|
288 CD4+ T-cells/million cells
Interval 217.0 to 313.0
|
68 CD4+ T-cells/million cells
Interval 38.0 to 157.0
|
201 CD4+ T-cells/million cells
Interval 95.0 to 504.0
|
35.5 CD4+ T-cells/million cells
Interval 18.0 to 89.5
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa+/IFNg-, Day 0
|
12 CD4+ T-cells/million cells
Interval 4.0 to 22.0
|
55 CD4+ T-cells/million cells
Interval 4.0 to 93.0
|
25 CD4+ T-cells/million cells
Interval 4.0 to 48.0
|
20.5 CD4+ T-cells/million cells
Interval 4.0 to 58.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 26.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 33.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa+/IFNg-, Day 7
|
33 CD4+ T-cells/million cells
Interval 17.0 to 44.0
|
17 CD4+ T-cells/million cells
Interval 4.0 to 45.0
|
44 CD4+ T-cells/million cells
Interval 31.0 to 116.0
|
27 CD4+ T-cells/million cells
Interval 4.0 to 34.0
|
19 CD4+ T-cells/million cells
Interval 4.0 to 54.0
|
16.5 CD4+ T-cells/million cells
Interval 4.0 to 34.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa+/IFNg-, Day 30
|
204 CD4+ T-cells/million cells
Interval 162.0 to 213.0
|
48 CD4+ T-cells/million cells
Interval 4.0 to 92.0
|
250 CD4+ T-cells/million cells
Interval 149.5 to 370.5
|
16 CD4+ T-cells/million cells
Interval 4.0 to 43.0
|
279.5 CD4+ T-cells/million cells
Interval 144.0 to 385.0
|
20.5 CD4+ T-cells/million cells
Interval 4.0 to 50.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa+/IFNg-, Day 37
|
436 CD4+ T-cells/million cells
Interval 246.0 to 550.0
|
35 CD4+ T-cells/million cells
Interval 31.0 to 49.0
|
292 CD4+ T-cells/million cells
Interval 154.0 to 525.0
|
9 CD4+ T-cells/million cells
Interval 4.0 to 43.0
|
558.5 CD4+ T-cells/million cells
Interval 250.0 to 884.0
|
4.5 CD4+ T-cells/million cells
Interval 4.0 to 37.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa+/IFNg-, Day 60
|
654 CD4+ T-cells/million cells
Interval 561.5 to 1140.5
|
28 CD4+ T-cells/million cells
Interval 24.0 to 32.0
|
301 CD4+ T-cells/million cells
Interval 183.0 to 458.0
|
19 CD4+ T-cells/million cells
Interval 4.0 to 42.0
|
1117 CD4+ T-cells/million cells
Interval 551.0 to 1690.0
|
20 CD4+ T-cells/million cells
Interval 4.0 to 33.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa+/IFNg-, Day 210
|
448 CD4+ T-cells/million cells
Interval 202.0 to 552.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 5.0
|
148 CD4+ T-cells/million cells
Interval 116.0 to 209.0
|
18 CD4+ T-cells/million cells
Interval 4.0 to 31.0
|
566 CD4+ T-cells/million cells
Interval 245.0 to 997.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 27.5
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=3 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=18 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=22 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=37 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=36 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa-/IFNg+, Day 0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 11.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 26.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 23.0
|
17 CD4+ T-cells/million cells
Interval 4.0 to 31.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 27.0
|
12.5 CD4+ T-cells/million cells
Interval 4.0 to 34.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa-/IFNg+, Day 7
|
33 CD4+ T-cells/million cells
Interval 12.0 to 50.5
|
4 CD4+ T-cells/million cells
Interval 4.0 to 47.0
|
40 CD4+ T-cells/million cells
Interval 31.0 to 103.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 19.0
|
32.5 CD4+ T-cells/million cells
Interval 4.0 to 84.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 27.5
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa-/IFNg+, Day 30
|
48 CD4+ T-cells/million cells
Interval 47.0 to 117.0
|
25.5 CD4+ T-cells/million cells
Interval 4.0 to 47.0
|
82.5 CD4+ T-cells/million cells
Interval 39.0 to 116.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 18.5
|
39.5 CD4+ T-cells/million cells
Interval 25.0 to 76.0
|
17 CD4+ T-cells/million cells
Interval 4.0 to 37.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa-/IFNg+, Day 37
|
118 CD4+ T-cells/million cells
Interval 89.0 to 307.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 19.0
|
133.5 CD4+ T-cells/million cells
Interval 42.0 to 242.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 20.0
|
278 CD4+ T-cells/million cells
Interval 161.0 to 525.0
|
17 CD4+ T-cells/million cells
Interval 4.0 to 47.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa-/IFNg+, Day 60
|
151.5 CD4+ T-cells/million cells
Interval 129.5 to 246.0
|
32 CD4+ T-cells/million cells
Interval 4.0 to 60.0
|
75 CD4+ T-cells/million cells
Interval 44.0 to 236.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 18.0
|
269 CD4+ T-cells/million cells
Interval 128.0 to 500.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 28.5
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa-/IFNg+, Day 210
|
112.5 CD4+ T-cells/million cells
Interval 31.0 to 218.0
|
18 CD4+ T-cells/million cells
Interval 4.0 to 60.0
|
47 CD4+ T-cells/million cells
Interval 24.0 to 95.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 29.0
|
126 CD4+ T-cells/million cells
Interval 61.0 to 296.0
|
10.5 CD4+ T-cells/million cells
Interval 4.0 to 40.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa-/IFNg-, Day 0
|
11.5 CD4+ T-cells/million cells
Interval 4.0 to 41.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 17.0
|
14 CD4+ T-cells/million cells
Interval 4.0 to 22.0
|
17.5 CD4+ T-cells/million cells
Interval 4.0 to 45.0
|
19.5 CD4+ T-cells/million cells
Interval 4.0 to 37.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 24.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa-/IFNg-, Day 7
|
45.5 CD4+ T-cells/million cells
Interval 4.0 to 88.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 17.0
|
43 CD4+ T-cells/million cells
Interval 17.0 to 75.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 46.0
|
44.5 CD4+ T-cells/million cells
Interval 4.0 to 69.0
|
5 CD4+ T-cells/million cells
Interval 4.0 to 49.5
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa-/IFNg-, Day 30
|
102 CD4+ T-cells/million cells
Interval 32.0 to 201.0
|
84.5 CD4+ T-cells/million cells
Interval 33.0 to 136.0
|
150.5 CD4+ T-cells/million cells
Interval 69.0 to 253.5
|
25 CD4+ T-cells/million cells
Interval 4.0 to 53.0
|
300 CD4+ T-cells/million cells
Interval 202.0 to 519.0
|
18 CD4+ T-cells/million cells
Interval 4.0 to 49.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa-/IFNg-, Day 37
|
263 CD4+ T-cells/million cells
Interval 94.0 to 305.0
|
20 CD4+ T-cells/million cells
Interval 4.0 to 65.0
|
182 CD4+ T-cells/million cells
Interval 67.0 to 393.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 29.0
|
732 CD4+ T-cells/million cells
Interval 498.0 to 946.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 16.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa-/IFNg-, Day 60
|
381.5 CD4+ T-cells/million cells
Interval 223.5 to 561.5
|
46.5 CD4+ T-cells/million cells
Interval 32.0 to 61.0
|
171 CD4+ T-cells/million cells
Interval 84.0 to 514.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 38.0
|
939 CD4+ T-cells/million cells
Interval 534.0 to 1537.0
|
17.5 CD4+ T-cells/million cells
Interval 4.0 to 30.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa-/IFNg-, Day 210
|
166.5 CD4+ T-cells/million cells
Interval 66.0 to 380.0
|
18 CD4+ T-cells/million cells
Interval 4.0 to 31.0
|
126 CD4+ T-cells/million cells
Interval 101.0 to 148.0
|
17 CD4+ T-cells/million cells
Interval 4.0 to 32.0
|
453 CD4+ T-cells/million cells
Interval 281.0 to 768.0
|
11 CD4+ T-cells/million cells
Interval 4.0 to 37.0
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=3 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=18 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=22 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=37 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=36 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa+/IFNg+, Day 0
|
67 CD4+ T-cells/million cells
Interval 47.0 to 74.5
|
55 CD4+ T-cells/million cells
Interval 4.0 to 161.0
|
61 CD4+ T-cells/million cells
Interval 19.0 to 218.0
|
188.5 CD4+ T-cells/million cells
Interval 66.0 to 272.0
|
48.5 CD4+ T-cells/million cells
Interval 17.0 to 101.0
|
44.5 CD4+ T-cells/million cells
Interval 19.0 to 164.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa+/IFNg+, Day 7
|
270.5 CD4+ T-cells/million cells
Interval 224.0 to 408.5
|
4 CD4+ T-cells/million cells
Interval 4.0 to 73.0
|
389 CD4+ T-cells/million cells
Interval 207.0 to 735.0
|
151 CD4+ T-cells/million cells
Interval 79.0 to 278.0
|
232 CD4+ T-cells/million cells
Interval 46.0 to 491.0
|
43 CD4+ T-cells/million cells
Interval 10.5 to 148.5
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa+/IFNg+, Day 30
|
563 CD4+ T-cells/million cells
Interval 541.0 to 1023.0
|
115 CD4+ T-cells/million cells
Interval 4.0 to 226.0
|
902 CD4+ T-cells/million cells
Interval 397.5 to 2177.0
|
132.5 CD4+ T-cells/million cells
Interval 54.5 to 398.0
|
156.5 CD4+ T-cells/million cells
Interval 76.0 to 481.0
|
71.5 CD4+ T-cells/million cells
Interval 18.0 to 221.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa+/IFNg+, Day 37
|
1236 CD4+ T-cells/million cells
Interval 886.0 to 3361.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 111.0
|
1828 CD4+ T-cells/million cells
Interval 462.0 to 3273.0
|
253 CD4+ T-cells/million cells
Interval 45.0 to 463.0
|
738.5 CD4+ T-cells/million cells
Interval 422.0 to 1663.0
|
46.5 CD4+ T-cells/million cells
Interval 17.0 to 114.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa+/IFNg+, Day 60
|
2219.5 CD4+ T-cells/million cells
Interval 1183.0 to 3234.0
|
24.5 CD4+ T-cells/million cells
Interval 4.0 to 45.0
|
608 CD4+ T-cells/million cells
Interval 361.0 to 1433.0
|
149.5 CD4+ T-cells/million cells
Interval 97.0 to 340.0
|
560 CD4+ T-cells/million cells
Interval 192.0 to 1563.0
|
55.5 CD4+ T-cells/million cells
Interval 25.5 to 150.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa+/IFNg+, Day 210
|
869 CD4+ T-cells/million cells
Interval 202.0 to 1422.0
|
32 CD4+ T-cells/million cells
Interval 4.0 to 33.0
|
439 CD4+ T-cells/million cells
Interval 218.0 to 620.0
|
174 CD4+ T-cells/million cells
Interval 46.0 to 248.0
|
301 CD4+ T-cells/million cells
Interval 137.0 to 602.0
|
22 CD4+ T-cells/million cells
Interval 4.0 to 137.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa+/IFNg-, Day 0
|
10 CD4+ T-cells/million cells
Interval 4.0 to 20.5
|
20 CD4+ T-cells/million cells
Interval 4.0 to 73.0
|
8 CD4+ T-cells/million cells
Interval 4.0 to 38.0
|
18 CD4+ T-cells/million cells
Interval 4.0 to 43.0
|
9.5 CD4+ T-cells/million cells
Interval 4.0 to 47.0
|
20 CD4+ T-cells/million cells
Interval 4.0 to 52.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa+/IFNg-, Day 7
|
34 CD4+ T-cells/million cells
Interval 18.0 to 40.5
|
17 CD4+ T-cells/million cells
Interval 4.0 to 47.0
|
58 CD4+ T-cells/million cells
Interval 24.0 to 74.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 31.0
|
40.5 CD4+ T-cells/million cells
Interval 17.0 to 98.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 41.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa+/IFNg-, Day 30
|
132 CD4+ T-cells/million cells
Interval 45.0 to 150.0
|
25.5 CD4+ T-cells/million cells
Interval 4.0 to 47.0
|
152.5 CD4+ T-cells/million cells
Interval 79.0 to 215.0
|
25.5 CD4+ T-cells/million cells
Interval 4.0 to 52.5
|
125.5 CD4+ T-cells/million cells
Interval 71.0 to 216.0
|
17 CD4+ T-cells/million cells
Interval 4.0 to 28.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa+/IFNg-, Day 37
|
276 CD4+ T-cells/million cells
Interval 117.0 to 889.0
|
37 CD4+ T-cells/million cells
Interval 4.0 to 87.0
|
375.5 CD4+ T-cells/million cells
Interval 230.0 to 805.0
|
40 CD4+ T-cells/million cells
Interval 4.0 to 84.0
|
915 CD4+ T-cells/million cells
Interval 471.0 to 1575.0
|
18 CD4+ T-cells/million cells
Interval 4.0 to 38.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa+/IFNg-, Day 60
|
359.5 CD4+ T-cells/million cells
Interval 255.0 to 556.5
|
62.5 CD4+ T-cells/million cells
Interval 4.0 to 121.0
|
176 CD4+ T-cells/million cells
Interval 75.0 to 327.0
|
26 CD4+ T-cells/million cells
Interval 4.0 to 65.0
|
792 CD4+ T-cells/million cells
Interval 421.0 to 1060.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 38.5
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa+/IFNg-, Day 210
|
167 CD4+ T-cells/million cells
Interval 75.0 to 191.0
|
19 CD4+ T-cells/million cells
Interval 4.0 to 35.0
|
77 CD4+ T-cells/million cells
Interval 23.0 to 134.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 40.0
|
272 CD4+ T-cells/million cells
Interval 142.0 to 358.0
|
18 CD4+ T-cells/million cells
Interval 4.0 to 34.5
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=3 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=18 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=22 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=37 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=36 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa-/IFNg+, Day 0
|
10.5 CD4+ T-cells/million cells
Interval 4.0 to 40.0
|
17 CD4+ T-cells/million cells
Interval 4.0 to 20.0
|
25 CD4+ T-cells/million cells
Interval 6.0 to 61.0
|
43 CD4+ T-cells/million cells
Interval 4.0 to 80.0
|
27.5 CD4+ T-cells/million cells
Interval 4.0 to 54.0
|
12 CD4+ T-cells/million cells
Interval 4.0 to 60.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa-/IFNg+, Day 7
|
113.5 CD4+ T-cells/million cells
Interval 62.5 to 155.5
|
4 CD4+ T-cells/million cells
Interval 4.0 to 31.0
|
227 CD4+ T-cells/million cells
Interval 65.0 to 469.0
|
22 CD4+ T-cells/million cells
Interval 4.0 to 71.0
|
163 CD4+ T-cells/million cells
Interval 100.0 to 239.0
|
29.5 CD4+ T-cells/million cells
Interval 4.0 to 54.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa-/IFNg+, Day 30
|
71 CD4+ T-cells/million cells
Interval 60.0 to 75.0
|
41 CD4+ T-cells/million cells
Interval 32.0 to 50.0
|
124.5 CD4+ T-cells/million cells
Interval 64.5 to 284.0
|
13.5 CD4+ T-cells/million cells
Interval 4.0 to 65.0
|
86.5 CD4+ T-cells/million cells
Interval 27.0 to 154.0
|
30 CD4+ T-cells/million cells
Interval 4.0 to 59.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa-/IFNg+, Day 37
|
406 CD4+ T-cells/million cells
Interval 406.0 to 1923.0
|
5 CD4+ T-cells/million cells
Interval 4.0 to 31.0
|
649 CD4+ T-cells/million cells
Interval 245.0 to 1982.0
|
17 CD4+ T-cells/million cells
Interval 4.0 to 72.0
|
1355.5 CD4+ T-cells/million cells
Interval 917.0 to 2882.0
|
19 CD4+ T-cells/million cells
Interval 4.0 to 58.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa-/IFNg+, Day 60
|
213 CD4+ T-cells/million cells
Interval 75.0 to 378.5
|
17.5 CD4+ T-cells/million cells
Interval 4.0 to 31.0
|
147 CD4+ T-cells/million cells
Interval 58.0 to 339.0
|
20.5 CD4+ T-cells/million cells
Interval 4.0 to 46.0
|
399 CD4+ T-cells/million cells
Interval 135.0 to 664.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 35.5
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa-/IFNg+, Day 210
|
129 CD4+ T-cells/million cells
Interval 18.0 to 304.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 73.0
|
57 CD4+ T-cells/million cells
Interval 37.0 to 115.0
|
32 CD4+ T-cells/million cells
Interval 4.0 to 62.0
|
107 CD4+ T-cells/million cells
Interval 65.0 to 180.0
|
30.5 CD4+ T-cells/million cells
Interval 5.0 to 48.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa-/IFNg-, Day 0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 98.5
|
103 CD4+ T-cells/million cells
Interval 4.0 to 244.0
|
19 CD4+ T-cells/million cells
Interval 4.0 to 41.0
|
10.5 CD4+ T-cells/million cells
Interval 4.0 to 73.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 29.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 32.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa-/IFNg-, Day 7
|
4 CD4+ T-cells/million cells
Interval 4.0 to 10.5
|
4 CD4+ T-cells/million cells
Interval 4.0 to 506.0
|
14 CD4+ T-cells/million cells
Interval 4.0 to 83.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 23.0
|
19 CD4+ T-cells/million cells
Interval 4.0 to 171.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 41.5
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa-/IFNg-, Day 30
|
4 CD4+ T-cells/million cells
Interval 4.0 to 18.0
|
1375.5 CD4+ T-cells/million cells
Interval 4.0 to 2747.0
|
208 CD4+ T-cells/million cells
Interval 11.0 to 689.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 37.0
|
342 CD4+ T-cells/million cells
Interval 133.0 to 769.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 136.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa-/IFNg-, Day 37
|
937 CD4+ T-cells/million cells
Interval 17.0 to 1644.0
|
213 CD4+ T-cells/million cells
Interval 20.0 to 373.0
|
1544 CD4+ T-cells/million cells
Interval 787.0 to 2630.0
|
18 CD4+ T-cells/million cells
Interval 4.0 to 200.0
|
3575.5 CD4+ T-cells/million cells
Interval 2450.0 to 6212.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 32.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa-/IFNg-, Day 60
|
4 CD4+ T-cells/million cells
Interval 4.0 to 373.5
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
168 CD4+ T-cells/million cells
Interval 4.0 to 727.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 104.0
|
1426 CD4+ T-cells/million cells
Interval 653.0 to 2820.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 89.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa-/IFNg-, Day 210
|
10.5 CD4+ T-cells/million cells
Interval 4.0 to 712.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
296 CD4+ T-cells/million cells
Interval 13.0 to 743.0
|
45 CD4+ T-cells/million cells
Interval 4.0 to 233.0
|
497 CD4+ T-cells/million cells
Interval 34.0 to 900.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 89.5
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=3 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=18 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=22 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=37 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=36 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg+, Day 0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 26.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg+, Day 7
|
4 CD4+ T-cells/million cells
Interval 4.0 to 68.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 17.0
|
19 CD4+ T-cells/million cells
Interval 4.0 to 74.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 18.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 26.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg+, Day 30
|
4 CD4+ T-cells/million cells
Interval 4.0 to 41.0
|
26 CD4+ T-cells/million cells
Interval 4.0 to 48.0
|
35 CD4+ T-cells/million cells
Interval 4.0 to 85.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 10.5
|
4 CD4+ T-cells/million cells
Interval 4.0 to 25.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 19.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg+, Day 37
|
89 CD4+ T-cells/million cells
Interval 46.0 to 93.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
64.5 CD4+ T-cells/million cells
Interval 17.0 to 148.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
32.5 CD4+ T-cells/million cells
Interval 4.0 to 66.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg+, Day 60
|
39.5 CD4+ T-cells/million cells
Interval 17.5 to 62.5
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 60.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
19 CD4+ T-cells/million cells
Interval 4.0 to 33.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg+, Day 210
|
19 CD4+ T-cells/million cells
Interval 4.0 to 32.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 19.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 31.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg-, Day 0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 11.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 20.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg-, Day 7
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg-, Day 30
|
17 CD4+ T-cells/million cells
Interval 4.0 to 17.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
19.5 CD4+ T-cells/million cells
Interval 4.0 to 54.5
|
4 CD4+ T-cells/million cells
Interval 4.0 to 17.5
|
17.5 CD4+ T-cells/million cells
Interval 4.0 to 33.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg-, Day 37
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 24.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
34 CD4+ T-cells/million cells
Interval 8.0 to 67.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg-, Day 60
|
21 CD4+ T-cells/million cells
Interval 10.5 to 55.5
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 19.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
45 CD4+ T-cells/million cells
Interval 16.0 to 79.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg-, Day 210
|
4 CD4+ T-cells/million cells
Interval 4.0 to 21.0
|
17 CD4+ T-cells/million cells
Interval 4.0 to 18.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 34.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 10.5
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=3 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=18 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=22 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=37 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=36 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg+, Day 0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg+, Day 7
|
4 CD4+ T-cells/million cells
Interval 4.0 to 16.5
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
17 CD4+ T-cells/million cells
Interval 4.0 to 18.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 19.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg+, Day 30
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
11 CD4+ T-cells/million cells
Interval 4.0 to 23.5
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg+, Day 37
|
17 CD4+ T-cells/million cells
Interval 17.0 to 32.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
17 CD4+ T-cells/million cells
Interval 4.0 to 24.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
19.5 CD4+ T-cells/million cells
Interval 4.0 to 61.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg+, Day 60
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 20.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 22.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg+, Day 210
|
4 CD4+ T-cells/million cells
Interval 4.0 to 24.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg-, Day 0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 10.5
|
4 CD4+ T-cells/million cells
Interval 4.0 to 20.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 23.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 18.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 21.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg-, Day 7
|
4 CD4+ T-cells/million cells
Interval 4.0 to 18.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 17.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 17.0
|
17 CD4+ T-cells/million cells
Interval 4.0 to 30.0
|
18.5 CD4+ T-cells/million cells
Interval 4.0 to 26.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 12.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg-, Day 30
|
30 CD4+ T-cells/million cells
Interval 19.0 to 32.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
21 CD4+ T-cells/million cells
Interval 6.5 to 44.5
|
4 CD4+ T-cells/million cells
Interval 4.0 to 19.0
|
18 CD4+ T-cells/million cells
Interval 4.0 to 32.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 20.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg-, Day 37
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
27.5 CD4+ T-cells/million cells
Interval 17.0 to 45.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 5.0
|
40.5 CD4+ T-cells/million cells
Interval 19.0 to 82.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 20.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg-, Day 60
|
11 CD4+ T-cells/million cells
Interval 4.5 to 28.5
|
17.5 CD4+ T-cells/million cells
Interval 4.0 to 31.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 20.0
|
11 CD4+ T-cells/million cells
Interval 4.0 to 23.0
|
49 CD4+ T-cells/million cells
Interval 20.0 to 70.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 18.0
|
|
Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg-, Day 210
|
17.5 CD4+ T-cells/million cells
Interval 4.0 to 59.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 32.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 17.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 26.0
|
25 CD4+ T-cells/million cells
Interval 8.0 to 44.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 19.5
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=3 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=18 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=22 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=37 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=36 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg+, Day 0
|
10.5 CD4+ T-cells/million cells
Interval 4.0 to 25.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
24 CD4+ T-cells/million cells
Interval 4.0 to 59.0
|
13.5 CD4+ T-cells/million cells
Interval 4.0 to 136.0
|
17.5 CD4+ T-cells/million cells
Interval 4.0 to 32.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 57.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg+, Day 7
|
53.5 CD4+ T-cells/million cells
Interval 34.5 to 87.5
|
4 CD4+ T-cells/million cells
Interval 4.0 to 17.0
|
102 CD4+ T-cells/million cells
Interval 40.0 to 230.0
|
18 CD4+ T-cells/million cells
Interval 4.0 to 234.0
|
53 CD4+ T-cells/million cells
Interval 17.0 to 246.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 53.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg+, Day 30
|
76 CD4+ T-cells/million cells
Interval 4.0 to 117.0
|
26 CD4+ T-cells/million cells
Interval 4.0 to 48.0
|
112 CD4+ T-cells/million cells
Interval 21.5 to 212.0
|
44 CD4+ T-cells/million cells
Interval 10.5 to 334.5
|
42 CD4+ T-cells/million cells
Interval 4.0 to 89.0
|
20 CD4+ T-cells/million cells
Interval 4.0 to 46.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg+, Day 37
|
246 CD4+ T-cells/million cells
Interval 116.0 to 288.0
|
34 CD4+ T-cells/million cells
Interval 4.0 to 65.0
|
212.5 CD4+ T-cells/million cells
Interval 94.0 to 698.0
|
50 CD4+ T-cells/million cells
Interval 5.0 to 361.0
|
185.5 CD4+ T-cells/million cells
Interval 61.0 to 463.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 33.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg+, Day 60
|
162.5 CD4+ T-cells/million cells
Interval 76.0 to 214.0
|
14 CD4+ T-cells/million cells
Interval 4.0 to 24.0
|
34 CD4+ T-cells/million cells
Interval 19.0 to 338.0
|
46 CD4+ T-cells/million cells
Interval 4.0 to 534.0
|
69 CD4+ T-cells/million cells
Interval 32.0 to 277.0
|
18.5 CD4+ T-cells/million cells
Interval 4.0 to 45.5
|
|
Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg+, Day 210
|
19.5 CD4+ T-cells/million cells
Interval 4.0 to 156.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 18.0
|
30 CD4+ T-cells/million cells
Interval 18.0 to 112.0
|
29 CD4+ T-cells/million cells
Interval 4.0 to 169.0
|
46 CD4+ T-cells/million cells
Interval 4.0 to 77.0
|
11.5 CD4+ T-cells/million cells
Interval 4.0 to 38.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg-, Day 0
|
11.5 CD4+ T-cells/million cells
Interval 5.0 to 31.0
|
18 CD4+ T-cells/million cells
Interval 18.0 to 29.0
|
20 CD4+ T-cells/million cells
Interval 4.0 to 55.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 41.0
|
8 CD4+ T-cells/million cells
Interval 4.0 to 38.0
|
22.5 CD4+ T-cells/million cells
Interval 4.0 to 68.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg-, Day 7
|
25.5 CD4+ T-cells/million cells
Interval 11.0 to 38.0
|
17 CD4+ T-cells/million cells
Interval 4.0 to 45.0
|
19 CD4+ T-cells/million cells
Interval 4.0 to 75.0
|
17 CD4+ T-cells/million cells
Interval 4.0 to 32.0
|
26 CD4+ T-cells/million cells
Interval 4.0 to 57.0
|
28.5 CD4+ T-cells/million cells
Interval 4.0 to 81.5
|
|
Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg-, Day 30
|
21 CD4+ T-cells/million cells
Interval 6.0 to 26.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
51.5 CD4+ T-cells/million cells
Interval 15.0 to 101.0
|
32.5 CD4+ T-cells/million cells
Interval 4.5 to 67.0
|
8 CD4+ T-cells/million cells
Interval 4.0 to 61.0
|
12.5 CD4+ T-cells/million cells
Interval 4.0 to 31.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg-, Day 37
|
46 CD4+ T-cells/million cells
Interval 31.0 to 153.0
|
66 CD4+ T-cells/million cells
Interval 31.0 to 117.0
|
87 CD4+ T-cells/million cells
Interval 31.0 to 256.0
|
11 CD4+ T-cells/million cells
Interval 4.0 to 119.0
|
309 CD4+ T-cells/million cells
Interval 137.0 to 532.0
|
7.5 CD4+ T-cells/million cells
Interval 4.0 to 26.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg-, Day 60
|
67 CD4+ T-cells/million cells
Interval 57.5 to 108.0
|
50 CD4+ T-cells/million cells
Interval 40.0 to 60.0
|
23 CD4+ T-cells/million cells
Interval 4.0 to 104.0
|
36 CD4+ T-cells/million cells
Interval 4.0 to 59.0
|
88 CD4+ T-cells/million cells
Interval 35.0 to 225.0
|
22 CD4+ T-cells/million cells
Interval 4.0 to 44.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg-, Day 210
|
4 CD4+ T-cells/million cells
Interval 4.0 to 60.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
5 CD4+ T-cells/million cells
Interval 4.0 to 57.0
|
23 CD4+ T-cells/million cells
Interval 4.0 to 54.0
|
24 CD4+ T-cells/million cells
Interval 4.0 to 76.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 34.5
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=3 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=18 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=22 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=37 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=36 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination
CD40L-/IL2-/TNFa-/IFNg+, Day 0
|
17.5 CD4+ T-cells/million cells
Interval 4.0 to 52.5
|
20 CD4+ T-cells/million cells
Interval 4.0 to 61.0
|
47 CD4+ T-cells/million cells
Interval 4.0 to 64.0
|
51 CD4+ T-cells/million cells
Interval 4.0 to 99.0
|
70 CD4+ T-cells/million cells
Interval 38.0 to 157.0
|
14.5 CD4+ T-cells/million cells
Interval 4.0 to 85.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination
CD40L-/IL2-/TNFa-/IFNg+, Day 7
|
69.5 CD4+ T-cells/million cells
Interval 17.5 to 114.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 83.0
|
59 CD4+ T-cells/million cells
Interval 12.0 to 363.0
|
46 CD4+ T-cells/million cells
Interval 6.0 to 482.0
|
78 CD4+ T-cells/million cells
Interval 32.0 to 248.0
|
25.5 CD4+ T-cells/million cells
Interval 4.0 to 76.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination
CD40L-/IL2-/TNFa-/IFNg+, Day 30
|
45 CD4+ T-cells/million cells
Interval 45.0 to 61.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
52 CD4+ T-cells/million cells
Interval 4.0 to 201.5
|
33.5 CD4+ T-cells/million cells
Interval 4.0 to 270.0
|
47 CD4+ T-cells/million cells
Interval 4.0 to 138.0
|
26.5 CD4+ T-cells/million cells
Interval 4.0 to 132.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination
CD40L-/IL2-/TNFa-/IFNg+, Day 37
|
191 CD4+ T-cells/million cells
Interval 89.0 to 408.0
|
34 CD4+ T-cells/million cells
Interval 31.0 to 97.0
|
273 CD4+ T-cells/million cells
Interval 131.0 to 720.0
|
27 CD4+ T-cells/million cells
Interval 4.0 to 261.0
|
495.5 CD4+ T-cells/million cells
Interval 267.0 to 1466.0
|
19 CD4+ T-cells/million cells
Interval 4.0 to 86.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination
CD40L-/IL2-/TNFa-/IFNg+, Day 60
|
14.5 CD4+ T-cells/million cells
Interval 4.0 to 48.5
|
4 CD4+ T-cells/million cells
Interval 4.0 to 4.0
|
32 CD4+ T-cells/million cells
Interval 4.0 to 267.0
|
51.5 CD4+ T-cells/million cells
Interval 17.0 to 144.0
|
129 CD4+ T-cells/million cells
Interval 40.0 to 276.0
|
19.5 CD4+ T-cells/million cells
Interval 4.0 to 84.0
|
|
Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination
CD40L-/IL2-/TNFa-/IFNg+, Day 210
|
53.5 CD4+ T-cells/million cells
Interval 31.0 to 117.0
|
4 CD4+ T-cells/million cells
Interval 4.0 to 60.0
|
30 CD4+ T-cells/million cells
Interval 4.0 to 85.0
|
34 CD4+ T-cells/million cells
Interval 4.0 to 92.0
|
31 CD4+ T-cells/million cells
Interval 4.0 to 126.0
|
55 CD4+ T-cells/million cells
Interval 32.5 to 115.0
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=3 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=18 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=22 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=37 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=36 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers
CD8-All Doubles, Day 0
|
93 CD8+ T-cells/million cells
Interval 63.5 to 269.0
|
44 CD8+ T-cells/million cells
Interval 44.0 to 135.0
|
99 CD8+ T-cells/million cells
Interval 75.0 to 159.0
|
110.5 CD8+ T-cells/million cells
Interval 59.0 to 326.0
|
73 CD8+ T-cells/million cells
Interval 44.0 to 144.0
|
69.5 CD8+ T-cells/million cells
Interval 44.0 to 132.0
|
|
Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers
CD8-All Doubles, Day 7
|
94.5 CD8+ T-cells/million cells
Interval 80.5 to 141.0
|
72 CD8+ T-cells/million cells
Interval 45.0 to 77.0
|
222 CD8+ T-cells/million cells
Interval 146.0 to 329.0
|
62 CD8+ T-cells/million cells
Interval 44.0 to 324.0
|
74.5 CD8+ T-cells/million cells
Interval 44.0 to 144.0
|
92.5 CD8+ T-cells/million cells
Interval 53.0 to 191.0
|
|
Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers
CD8-All Doubles, Day 30
|
44 CD8+ T-cells/million cells
Interval 44.0 to 64.0
|
81.5 CD8+ T-cells/million cells
Interval 44.0 to 119.0
|
243 CD8+ T-cells/million cells
Interval 101.0 to 385.0
|
153.5 CD8+ T-cells/million cells
Interval 75.5 to 1064.0
|
80 CD8+ T-cells/million cells
Interval 44.0 to 150.0
|
77.5 CD8+ T-cells/million cells
Interval 59.0 to 172.0
|
|
Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers
CD8-All Doubles, Day 37
|
126 CD8+ T-cells/million cells
Interval 118.0 to 134.0
|
76 CD8+ T-cells/million cells
Interval 44.0 to 93.0
|
347 CD8+ T-cells/million cells
Interval 97.0 to 604.0
|
108 CD8+ T-cells/million cells
Interval 59.0 to 295.0
|
72.5 CD8+ T-cells/million cells
Interval 57.0 to 149.0
|
75.5 CD8+ T-cells/million cells
Interval 44.0 to 140.0
|
|
Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers
CD8-All Doubles, Day 60
|
85.5 CD8+ T-cells/million cells
Interval 55.5 to 233.0
|
118 CD8+ T-cells/million cells
Interval 69.0 to 167.0
|
189 CD8+ T-cells/million cells
Interval 60.0 to 367.0
|
161 CD8+ T-cells/million cells
Interval 84.0 to 491.0
|
96 CD8+ T-cells/million cells
Interval 44.0 to 245.0
|
71 CD8+ T-cells/million cells
Interval 44.0 to 157.5
|
|
Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers
CD8-All Doubles, Day 210
|
347.5 CD8+ T-cells/million cells
Interval 170.0 to 572.0
|
78 CD8+ T-cells/million cells
Interval 44.0 to 91.0
|
259 CD8+ T-cells/million cells
Interval 61.0 to 312.0
|
119 CD8+ T-cells/million cells
Interval 44.0 to 390.0
|
110 CD8+ T-cells/million cells
Interval 69.0 to 248.0
|
71.5 CD8+ T-cells/million cells
Interval 49.5 to 233.0
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a), CD40-ligand (CD40-L), Interleukin-17 (IL-17) and/or Interleukin-13 (IL-13).
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=3 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=18 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=22 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=37 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=36 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6
CD8-At least 2, Day 0
|
106 CD8+ T-cells/million cells
Interval 76.5 to 282.0
|
57 CD8+ T-cells/million cells
Interval 57.0 to 148.0
|
143 CD8+ T-cells/million cells
Interval 88.0 to 172.0
|
151.5 CD8+ T-cells/million cells
Interval 81.0 to 339.0
|
96 CD8+ T-cells/million cells
Interval 57.0 to 157.0
|
85.5 CD8+ T-cells/million cells
Interval 57.0 to 169.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6
CD8- At least 2, Day 7
|
107.5 CD8+ T-cells/million cells
Interval 93.5 to 154.0
|
85 CD8+ T-cells/million cells
Interval 58.0 to 90.0
|
245 CD8+ T-cells/million cells
Interval 159.0 to 369.0
|
75 CD8+ T-cells/million cells
Interval 57.0 to 337.0
|
116 CD8+ T-cells/million cells
Interval 71.0 to 158.0
|
124 CD8+ T-cells/million cells
Interval 88.0 to 232.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6
CD8- At least 2, Day 30
|
57 CD8+ T-cells/million cells
Interval 57.0 to 77.0
|
109 CD8+ T-cells/million cells
Interval 86.0 to 132.0
|
256 CD8+ T-cells/million cells
Interval 114.0 to 410.5
|
166.5 CD8+ T-cells/million cells
Interval 88.5 to 1077.0
|
96 CD8+ T-cells/million cells
Interval 73.0 to 163.0
|
106.5 CD8+ T-cells/million cells
Interval 77.0 to 198.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6
CD8- At least 2, Day 37
|
139 CD8+ T-cells/million cells
Interval 131.0 to 147.0
|
89 CD8+ T-cells/million cells
Interval 57.0 to 106.0
|
362 CD8+ T-cells/million cells
Interval 110.0 to 617.0
|
121 CD8+ T-cells/million cells
Interval 72.0 to 308.0
|
85.5 CD8+ T-cells/million cells
Interval 70.0 to 162.0
|
103.5 CD8+ T-cells/million cells
Interval 58.0 to 161.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6
CD8- At least 2, Day 60
|
98.5 CD8+ T-cells/million cells
Interval 68.5 to 246.0
|
131 CD8+ T-cells/million cells
Interval 82.0 to 180.0
|
202 CD8+ T-cells/million cells
Interval 89.0 to 380.0
|
174 CD8+ T-cells/million cells
Interval 97.0 to 504.0
|
111 CD8+ T-cells/million cells
Interval 76.0 to 270.0
|
106.5 CD8+ T-cells/million cells
Interval 57.0 to 191.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6
CD8- At least 2, Day 210
|
403.5 CD8+ T-cells/million cells
Interval 183.0 to 585.0
|
91 CD8+ T-cells/million cells
Interval 57.0 to 151.0
|
272 CD8+ T-cells/million cells
Interval 74.0 to 379.0
|
133 CD8+ T-cells/million cells
Interval 76.0 to 403.0
|
137 CD8+ T-cells/million cells
Interval 83.0 to 291.0
|
124.5 CD8+ T-cells/million cells
Interval 81.5 to 292.0
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=3 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=18 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=22 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=37 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=36 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa+/IFNg-, Day 210
|
35 CD8+ T-cells/million cells
Interval 4.0 to 46.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 25.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa+/IFNg+, Day 0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa+/IFNg+, Day 7
|
4 CD8+ T-cells/million cells
Interval 4.0 to 14.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 62.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa+/IFNg+, Day 30
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 25.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa+/IFNg+, Day 37
|
4 CD8+ T-cells/million cells
Interval 4.0 to 41.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 48.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa+/IFNg+, Day 60
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa+/IFNg+, Day 210
|
58 CD8+ T-cells/million cells
Interval 4.0 to 99.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 38.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 33.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa+/IFNg-, Day 0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa+/IFNg-, Day 7
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa+/IFNg-, Day 30
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa+/IFNg-, Day 37
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers
CD40L+/IL2+/TNFa+/IFNg-, Day 60
|
4 CD8+ T-cells/million cells
Interval 4.0 to 19.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=3 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=18 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=22 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=37 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=36 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa-/IFNg-, Day 7
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 32.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa-/IFNg+, Day 0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa-/IFNg+, Day 7
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa-/IFNg+, Day 30
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa-/IFNg+, Day 37
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa-/IFNg+, Day 60
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa-/IFNg+, Day 210
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa-/IFNg-, Day 0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa-/IFNg-, Day 30
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa-/IFNg-, Day 37
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa-/IFNg-, Day 60
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
14 CD8+ T-cells/million cells
Interval 4.0 to 24.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines
CD40L+/IL2+/TNFa-/IFNg-, Day 210
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=3 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=18 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=22 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=37 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=36 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa+/IFNg-, Day 0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa+/IFNg-, Day 60
|
4 CD8+ T-cells/million cells
Interval 4.0 to 21.0
|
24.5 CD8+ T-cells/million cells
Interval 4.0 to 45.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 20.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa+/IFNg+, Day 0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 33.5
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 23.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa+/IFNg+, Day 7
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 55.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa+/IFNg+, Day 30
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
36.5 CD8+ T-cells/million cells
Interval 4.0 to 84.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa+/IFNg+, Day 37
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 168.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 21.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa+/IFNg+, Day 60
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 42.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 24.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa+/IFNg+, Day 210
|
4 CD8+ T-cells/million cells
Interval 4.0 to 13.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 51.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 56.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 21.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa+/IFNg-, Day 7
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 37.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa+/IFNg-, Day 30
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 17.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa+/IFNg-, Day 37
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Immune Markers
CD40L+/IL2-/TNFa+/IFNg-, Day 210
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 21.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 19.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 9.0
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=3 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=18 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=22 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=37 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=36 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa-/IFNg-, Day 37
|
4 CD8+ T-cells/million cells
Interval 4.0 to 203.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 216.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 293.0
|
43 CD8+ T-cells/million cells
Interval 4.0 to 125.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 127.0
|
13.5 CD8+ T-cells/million cells
Interval 4.0 to 213.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa-/IFNg-, Day 60
|
18.5 CD8+ T-cells/million cells
Interval 4.0 to 163.5
|
44.5 CD8+ T-cells/million cells
Interval 4.0 to 85.0
|
101 CD8+ T-cells/million cells
Interval 4.0 to 345.0
|
85 CD8+ T-cells/million cells
Interval 4.0 to 270.0
|
61 CD8+ T-cells/million cells
Interval 4.0 to 153.0
|
36.5 CD8+ T-cells/million cells
Interval 4.0 to 214.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa-/IFNg+, Day 30
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
41.5 CD8+ T-cells/million cells
Interval 4.0 to 79.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 28.5
|
4 CD8+ T-cells/million cells
Interval 4.0 to 25.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 31.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa-/IFNg+, Day 210
|
19.5 CD8+ T-cells/million cells
Interval 4.0 to 88.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 35.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 29.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 34.5
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa-/IFNg-, Day 7
|
33.5 CD8+ T-cells/million cells
Interval 4.0 to 68.0
|
110 CD8+ T-cells/million cells
Interval 93.0 to 390.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 413.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 183.0
|
26 CD8+ T-cells/million cells
Interval 4.0 to 164.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa-/IFNg+, Day 0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 23.5
|
4 CD8+ T-cells/million cells
Interval 4.0 to 26.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 5.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 26.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 18.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa-/IFNg+, Day 7
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 54.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 22.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 24.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.5
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa-/IFNg+, Day 37
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 36.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 21.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 23.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa-/IFNg+, Day 60
|
4 CD8+ T-cells/million cells
Interval 4.0 to 21.0
|
16.5 CD8+ T-cells/million cells
Interval 4.0 to 29.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
14.5 CD8+ T-cells/million cells
Interval 4.0 to 46.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 76.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 14.5
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa-/IFNg-, Day 0
|
97.5 CD8+ T-cells/million cells
Interval 4.0 to 412.0
|
143 CD8+ T-cells/million cells
Interval 4.0 to 178.0
|
29 CD8+ T-cells/million cells
Interval 4.0 to 203.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 139.0
|
7.5 CD8+ T-cells/million cells
Interval 4.0 to 130.0
|
25 CD8+ T-cells/million cells
Interval 4.0 to 222.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa-/IFNg-, Day 30
|
73 CD8+ T-cells/million cells
Interval 4.0 to 113.0
|
161 CD8+ T-cells/million cells
Interval 83.0 to 239.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 23.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 78.5
|
4 CD8+ T-cells/million cells
Interval 4.0 to 71.0
|
99.5 CD8+ T-cells/million cells
Interval 4.0 to 288.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines
CD40L+/IL2-/TNFa-/IFNg-, Day 210
|
53 CD8+ T-cells/million cells
Interval 15.0 to 92.0
|
122 CD8+ T-cells/million cells
Interval 4.0 to 202.0
|
333 CD8+ T-cells/million cells
Interval 4.0 to 583.0
|
121 CD8+ T-cells/million cells
Interval 4.0 to 249.0
|
22 CD8+ T-cells/million cells
Interval 4.0 to 311.0
|
33.5 CD8+ T-cells/million cells
Interval 4.0 to 302.5
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=3 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=18 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=22 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=37 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=36 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg-, Day 60
|
4 CD8+ T-cells/million cells
Interval 4.0 to 15.5
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg+, Day 0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg+, Day 7
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg+, Day 30
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg+, Day 37
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg+, Day 60
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg+, Day 210
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg-, Day 0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg-, Day 7
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg-, Day 30
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg-, Day 37
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination
CD40L-/IL2+/TNFa+/IFNg-, Day 210
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=3 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=18 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=22 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=37 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=36 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Frequency of M72-specific CD8+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg+, Day 0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg+, Day 7
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg+, Day 30
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg+, Day 37
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg+, Day 60
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg+, Day 210
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg-, Day 0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 41.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 5.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg-, Day 7
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 37.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 20.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 23.5
|
|
Frequency of M72-specific CD8+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg-, Day 30
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 32.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 19.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg-, Day 37
|
28 CD8+ T-cells/million cells
Interval 4.0 to 49.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 6.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 18.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 28.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg-, Day 60
|
4 CD8+ T-cells/million cells
Interval 4.0 to 15.5
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 20.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 19.0
|
|
Frequency of M72-specific CD8+ T-cells Expressing Immune Markers in Any Combination
CD40L-/IL2+/TNFa-/IFNg-, Day 210
|
4 CD8+ T-cells/million cells
Interval 4.0 to 13.0
|
38 CD8+ T-cells/million cells
Interval 4.0 to 98.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 19.0
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=3 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=18 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=22 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=37 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=36 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg+, Day 0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 199.5
|
4 CD8+ T-cells/million cells
Interval 4.0 to 73.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 47.0
|
30 CD8+ T-cells/million cells
Interval 4.0 to 286.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 37.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 45.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg+, Day 7
|
50 CD8+ T-cells/million cells
Interval 30.5 to 101.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 5.0
|
32 CD8+ T-cells/million cells
Interval 4.0 to 109.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 284.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 104.0
|
9 CD8+ T-cells/million cells
Interval 4.0 to 102.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg+, Day 30
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 107.0
|
91.5 CD8+ T-cells/million cells
Interval 4.0 to 1024.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 39.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 73.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg+, Day 37
|
41 CD8+ T-cells/million cells
Interval 4.0 to 66.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 53.0
|
28.5 CD8+ T-cells/million cells
Interval 4.0 to 285.0
|
28 CD8+ T-cells/million cells
Interval 4.0 to 228.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 30.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 85.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg+, Day 60
|
19 CD8+ T-cells/million cells
Interval 4.0 to 144.0
|
35 CD8+ T-cells/million cells
Interval 4.0 to 66.0
|
29 CD8+ T-cells/million cells
Interval 4.0 to 149.0
|
58 CD8+ T-cells/million cells
Interval 4.0 to 432.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 39.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 45.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg+, Day 210
|
51 CD8+ T-cells/million cells
Interval 4.0 to 264.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 184.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 101.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 27.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 30.5
|
|
Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg-, Day 0
|
21 CD8+ T-cells/million cells
Interval 4.0 to 80.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 61.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 36.0
|
7.5 CD8+ T-cells/million cells
Interval 4.0 to 37.0
|
25.5 CD8+ T-cells/million cells
Interval 4.0 to 57.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 18.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg-, Day 7
|
17 CD8+ T-cells/million cells
Interval 4.0 to 61.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 5.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 59.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 82.0
|
20.5 CD8+ T-cells/million cells
Interval 4.0 to 39.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 27.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg-, Day 30
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
80 CD8+ T-cells/million cells
Interval 4.0 to 156.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 67.5
|
47.5 CD8+ T-cells/million cells
Interval 6.0 to 123.0
|
20.5 CD8+ T-cells/million cells
Interval 4.0 to 67.0
|
24.5 CD8+ T-cells/million cells
Interval 4.0 to 71.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg-, Day 37
|
40 CD8+ T-cells/million cells
Interval 4.0 to 128.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 69.0
|
36.5 CD8+ T-cells/million cells
Interval 4.0 to 112.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 43.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 27.0
|
5 CD8+ T-cells/million cells
Interval 4.0 to 64.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg-, Day 60
|
16 CD8+ T-cells/million cells
Interval 4.0 to 54.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 89.0
|
18.5 CD8+ T-cells/million cells
Interval 4.0 to 90.0
|
20 CD8+ T-cells/million cells
Interval 4.0 to 56.0
|
4.5 CD8+ T-cells/million cells
Interval 4.0 to 30.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination
CD40L-/IL2-/TNFa+/IFNg-, Day 210
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 8.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 42.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 60.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 29.0
|
SECONDARY outcome
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Outcome measures
| Measure |
TB Treatment GSK 692342 Group
n=6 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=3 Participants
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=18 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=22 Participants
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=37 Participants
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=36 Participants
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination
CD40L-/IL2-/TNFa-/IFNg+, Day 0
|
54.5 CD8+ T-cells/million cells
Interval 25.5 to 821.0
|
6 CD8+ T-cells/million cells
Interval 4.0 to 95.0
|
70 CD8+ T-cells/million cells
Interval 12.0 to 541.0
|
216.5 CD8+ T-cells/million cells
Interval 57.0 to 1831.0
|
54.5 CD8+ T-cells/million cells
Interval 4.0 to 159.0
|
78.5 CD8+ T-cells/million cells
Interval 25.0 to 349.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination
CD40L-/IL2-/TNFa-/IFNg+, Day 7
|
89 CD8+ T-cells/million cells
Interval 36.5 to 893.5
|
9 CD8+ T-cells/million cells
Interval 4.0 to 31.0
|
152 CD8+ T-cells/million cells
Interval 4.0 to 575.0
|
205 CD8+ T-cells/million cells
Interval 90.0 to 1660.0
|
69.5 CD8+ T-cells/million cells
Interval 43.0 to 830.0
|
90.5 CD8+ T-cells/million cells
Interval 4.5 to 484.5
|
|
Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination
CD40L-/IL2-/TNFa-/IFNg+, Day 30
|
96 CD8+ T-cells/million cells
Interval 26.0 to 163.0
|
118 CD8+ T-cells/million cells
Interval 4.0 to 232.0
|
127.5 CD8+ T-cells/million cells
Interval 13.0 to 327.5
|
386.5 CD8+ T-cells/million cells
Interval 27.0 to 1969.5
|
64.5 CD8+ T-cells/million cells
Interval 4.0 to 438.0
|
151.5 CD8+ T-cells/million cells
Interval 28.0 to 467.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination
CD40L-/IL2-/TNFa-/IFNg+, Day 37
|
48 CD8+ T-cells/million cells
Interval 4.0 to 78.0
|
33 CD8+ T-cells/million cells
Interval 4.0 to 81.0
|
100.5 CD8+ T-cells/million cells
Interval 48.0 to 326.0
|
229 CD8+ T-cells/million cells
Interval 4.0 to 1022.0
|
46.5 CD8+ T-cells/million cells
Interval 4.0 to 179.0
|
83.5 CD8+ T-cells/million cells
Interval 4.0 to 335.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination
CD40L-/IL2-/TNFa-/IFNg+, Day 60
|
147.5 CD8+ T-cells/million cells
Interval 55.0 to 824.5
|
4 CD8+ T-cells/million cells
Interval 4.0 to 4.0
|
70 CD8+ T-cells/million cells
Interval 4.0 to 1116.0
|
172 CD8+ T-cells/million cells
Interval 18.0 to 1492.0
|
13 CD8+ T-cells/million cells
Interval 4.0 to 65.0
|
59 CD8+ T-cells/million cells
Interval 4.0 to 310.0
|
|
Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination
CD40L-/IL2-/TNFa-/IFNg+, Day 210
|
286.5 CD8+ T-cells/million cells
Interval 48.0 to 469.0
|
4 CD8+ T-cells/million cells
Interval 4.0 to 59.0
|
51 CD8+ T-cells/million cells
Interval 4.0 to 245.0
|
85 CD8+ T-cells/million cells
Interval 4.0 to 628.0
|
69 CD8+ T-cells/million cells
Interval 4.0 to 233.0
|
60 CD8+ T-cells/million cells
Interval 22.0 to 232.5
|
Adverse Events
TB Treatment GSK 692342 Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
TB Treatment Saline Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
TB Treated GSK 692342 Group
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
TB Treated Saline Group
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
TB Naive GSK 692342 Group
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
TB Naive Saline Group
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TB Treatment GSK 692342 Group
n=7 participants at risk
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=6 participants at risk
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=24 participants at risk
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=25 participants at risk
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=40 participants at risk
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=40 participants at risk
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/7 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/6 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/24 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/25 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
2.5%
1/40 • Number of events 1 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/7 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/6 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/24 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/7 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/6 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/25 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/7 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/6 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/24 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/25 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
2.5%
1/40 • Number of events 1 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/7 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/6 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/24 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/7 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/6 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/25 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/6 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/24 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
Other adverse events
| Measure |
TB Treatment GSK 692342 Group
n=7 participants at risk
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treatment Saline Group
n=6 participants at risk
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Treated GSK 692342 Group
n=24 participants at risk
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Treated Saline Group
n=25 participants at risk
Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
TB Naive GSK 692342 Group
n=40 participants at risk
Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
|
TB Naive Saline Group
n=40 participants at risk
Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
|
|---|---|---|---|---|---|---|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/7 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
16.7%
1/6 • Number of events 1 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/25 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
Nervous system disorders
Headache
|
42.9%
3/7 • Number of events 4 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
16.7%
1/6 • Number of events 1 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
75.0%
18/24 • Number of events 24 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
16.0%
4/25 • Number of events 6 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
62.5%
25/40 • Number of events 32 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
15.0%
6/40 • Number of events 8 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
General disorders
Pain
|
85.7%
6/7 • Number of events 11 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
16.7%
1/6 • Number of events 2 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
91.7%
22/24 • Number of events 41 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
12.0%
3/25 • Number of events 3 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
97.5%
39/40 • Number of events 74 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
20.0%
8/40 • Number of events 11 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
General disorders
Swelling
|
71.4%
5/7 • Number of events 8 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/6 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
50.0%
12/24 • Number of events 19 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
12.0%
3/25 • Number of events 3 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
55.0%
22/40 • Number of events 29 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
5.0%
2/40 • Number of events 2 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
General disorders
Fatigue
|
42.9%
3/7 • Number of events 4 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
33.3%
2/6 • Number of events 3 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
70.8%
17/24 • Number of events 27 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
32.0%
8/25 • Number of events 11 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
90.0%
36/40 • Number of events 52 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
25.0%
10/40 • Number of events 15 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
28.6%
2/7 • Number of events 2 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/6 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
41.7%
10/24 • Number of events 11 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
16.0%
4/25 • Number of events 5 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
40.0%
16/40 • Number of events 18 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
15.0%
6/40 • Number of events 8 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
General disorders
Malaise
|
42.9%
3/7 • Number of events 4 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
33.3%
2/6 • Number of events 3 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
66.7%
16/24 • Number of events 22 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
24.0%
6/25 • Number of events 7 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
87.5%
35/40 • Number of events 46 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
22.5%
9/40 • Number of events 11 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
42.9%
3/7 • Number of events 5 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
16.7%
1/6 • Number of events 1 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
75.0%
18/24 • Number of events 27 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
20.0%
5/25 • Number of events 8 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
85.0%
34/40 • Number of events 52 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
17.5%
7/40 • Number of events 10 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/6 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
12.5%
3/24 • Number of events 3 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/25 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
1/7 • Number of events 1 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/6 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
12.5%
3/24 • Number of events 4 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
10.0%
4/40 • Number of events 4 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
7.5%
3/40 • Number of events 3 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/7 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/6 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/24 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/25 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
5.0%
2/40 • Number of events 2 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
2.5%
1/40 • Number of events 1 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/6 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/25 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
2.5%
1/40 • Number of events 1 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/6 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/25 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/7 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
16.7%
1/6 • Number of events 1 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/24 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
14.3%
1/7 • Number of events 1 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/6 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/24 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/25 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
71.4%
5/7 • Number of events 9 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
33.3%
2/6 • Number of events 2 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
66.7%
16/24 • Number of events 22 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
24.0%
6/25 • Number of events 6 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
62.5%
25/40 • Number of events 36 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
30.0%
12/40 • Number of events 18 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
|
General disorders
Pyrexia
|
57.1%
4/7 • Number of events 4 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
16.7%
1/6 • Number of events 1 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
45.8%
11/24 • Number of events 11 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/25 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
42.5%
17/40 • Number of events 18 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
0.00%
0/40 • Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
|
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