Tuberculosis
Conditions
Keywords
Tuberculosis vaccine, HIV-negative, tuberculosis treatment
Brief summary
This study will assess the safety and immunogenicity of GSK Biologicals' investigational tuberculosis (TB) vaccine (GSK 692342) compared to placebo when administered at 0, 1 months to human immunodeficiency virus (HIV) negative adults who have received treatment for TB disease (denoted TB-treated cohort) or are currently receiving treatment for TB disease (denoted TB-treatment cohort). For comparative purposes, subjects who have never had TB disease (denoted TB-naïve cohort) will also be enrolled.
Detailed description
A Protocol Amendment 1, May 2012, was made following the decision to add a second country in the study (i.e. Estonia).
Interventions
Intramuscular injection, 2 doses
BIOLOGICALPlacebo
Intramuscular injection, 2 doses
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes can and will comply with the requirements of the protocol. * A male or female between, and including, 18 and 59 years of age at the time of the first vaccination. * Written informed consent obtained from the subject. * Female subjects of non-childbearing potential may be enrolled in the study. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. * Seronegative for HIV- 1 and -2 antibodies. * No history of or current extrapulmonary tuberculosis TB. Additionally, based on medical history, * Subjects in the TB-naive cohort must * have no active pulmonary disease as indicated by chest X-ray. * have no signs and symptoms of TB. * have no history of chemoprophylaxis or treatment for TB. * Subjects in the TB-treated cohort must * have a history of successful treatment for pulmonary TB (completed at least 1 year prior to vaccination). * have no active pulmonary disease on chest X-ray. * Subjects in the TB-treatment cohort must - have documented treatment for pulmonary TB (smear- or culture confirmed) ongoing for 2-4 months prior to vaccination.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Administration of a registered live vaccine not foreseen by the study within 30 days preceding the first dose of study vaccine and administration of a registered inactivated vaccine within 14 days preceding the first dose of study vaccine. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Any chronic drug therapy to be continued during the study period, which in the opinion of the investigator could adversely interfere with the vaccine. * History of previous administration of experimental TB vaccines. * History of previous exposure to components of the investigational vaccine within 30 days preceding the first dose of study vaccine. * Administration of any immunoglobulins, any immunotherapy and/or any blood products within the 3 months preceding the first dose of study vaccination, or planned administrations during the study period. * Planned participation or participation in another experimental protocol during the study period. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * History of chronic alcohol and/or drug abuse. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Major congenital defects. * Pregnant female, lactating female or female planning to become pregnant or discontinue contraceptive precautions during the active phase of the study (from study start till 2 months after dose 2). * Additionally, for the TB naïve and TB treated cohorts: \- Acute or chronic clinically relevant pulmonary, cardiovascular, hepatic or renal function abnormality as determined by physical examination or laboratory screening tests * Additionally, for the TB treatment cohort: * Acute or chronic clinically relevant pulmonary, cardiovascular, hepatic or renal function abnormality as determined by physical examination or laboratory screening tests. Individuals with grade 3 levels will be excluded. * Failure to convert while on anti-TB treatment at the end of the second month of anti-TB therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | 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. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | 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. |
| Number of Subjects With Adverse Events (AEs) | During the 30 day (Days 0-29), after vaccination | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | Up to day 210 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) | 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). |
| Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) | 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). |
| Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) | 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). |
| Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) | 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). |
| Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) | 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). |
| Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) | 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). |
| Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) | 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). |
| Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) | 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). |
| Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) | 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). |
| Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Prior to dose 1 (Day 0), post-dose 1 (Day 30), post-dose 2 (Days 60 and 210) | 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. |
| Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) | 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). |
| Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) | 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). |
| Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Immune Markers | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) | 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). |
| Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) | 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). |
| Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) | 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). |
| Frequency of M72-specific CD8+ T-cells Expressing Immune Markers in Any Combination | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) | 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). |
| Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) | 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). |
| Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) | 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). |
| Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) | 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). |
| Concentrations of Anti-M72 Antibodies | Prior to dose 1 (Day 0), post-dose 1 (Day 30), post-dose 2 (Days 60 and 210) | Concentrations are presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EU/mL). |
| Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) | 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). |
| Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) | 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). |
Countries
Estonia, Taiwan
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| 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. | 6 |
| 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. | 24 |
| 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. | 25 |
| 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. | 40 |
| 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. | 40 |
| Total | 142 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | TB Treatment GSK 692342 Group | TB Treatment Saline Group | TB Treated GSK 692342 Group | TB Treated Saline Group | TB Naive GSK 692342 Group | TB Naive Saline Group | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 42.9 Years STANDARD_DEVIATION 11.5 | 44.7 Years STANDARD_DEVIATION 11.8 | 44.5 Years STANDARD_DEVIATION 10.3 | 47 Years STANDARD_DEVIATION 9.8 | 33.8 Years STANDARD_DEVIATION 8.5 | 33.3 Years STANDARD_DEVIATION 9.8 | 38.7 Years STANDARD_DEVIATION 9.98 |
| Race/Ethnicity, Customized Geographic ancestry Asian - East Asian Heritage | 3 Participants | 1 Participants | 11 Participants | 11 Participants | 40 Participants | 40 Participants | 106 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Caucasian/European Heritage | 4 Participants | 5 Participants | 13 Participants | 14 Participants | 0 Participants | 0 Participants | 36 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 13 Participants | 7 Participants | 16 Participants | 21 Participants | 60 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 11 Participants | 18 Participants | 24 Participants | 19 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 6 | 0 / 24 | 0 / 25 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 6 / 7 | 3 / 6 | 24 / 24 | 14 / 25 | 40 / 40 | 26 / 40 |
| serious Total, serious adverse events | 0 / 7 | 0 / 6 | 2 / 24 | 2 / 25 | 1 / 40 | 0 / 40 |
Outcome results
Primary
Number of Subjects With Adverse Events (AEs)
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.
Time frame: During the 30 day (Days 0-29), after vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered and for whom data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TB Treatment GSK 692342 Group | Number of Subjects With Adverse Events (AEs) | 1 Subjects |
| TB Treatment Saline Group | Number of Subjects With Adverse Events (AEs) | 2 Subjects |
| TB Treated GSK 692342 Group | Number of Subjects With Adverse Events (AEs) | 14 Subjects |
| TB Treated Saline Group | Number of Subjects With Adverse Events (AEs) | 7 Subjects |
| TB Naive GSK 692342 Group | Number of Subjects With Adverse Events (AEs) | 19 Subjects |
| TB Naive Saline Group | Number of Subjects With Adverse Events (AEs) | 8 Subjects |
Primary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
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.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 3 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 6 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 6 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 2 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 3 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 2 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 3 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 2 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 2 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 2 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 2 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 5 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 3 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 1 Participants |
| TB Treatment Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 1 Participants |
| TB Treatment Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 1 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 21 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 4 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 22 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 19 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 6 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 7 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 2 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 4 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 3 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 5 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 2 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 4 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 8 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 2 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 5 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 1 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 7 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Participants |
| TB Treated Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 2 Participants |
| TB Treated Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 1 Participants |
| TB Treated Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 1 Participants |
| TB Treated Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 3 Participants |
| TB Treated Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 1 Participants |
| TB Treated Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 38 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 4 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 5 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 6 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 2 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 5 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 7 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 1 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 11 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 39 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 36 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 11 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 10 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 2 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Participants |
| TB Naive Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 5 Participants |
| TB Naive Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 8 Participants |
| TB Naive Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 6 Participants |
| TB Naive Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
Primary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
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.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Malaise, Dose 1 | 1 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Malaise, Across doses | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 1 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms,Across doses | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 1 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms,Across doses | 2 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Malaise, Dose 1 | 1 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 2 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Across doses | 4 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 1 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Malaise, Across doses | 3 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Malaise, Dose 1 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 3 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 3 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 3 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 3 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 2 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Malaise, Across doses | 3 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 1 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 2 | 2 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Dose 2 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 3 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 1 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 3 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 1 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Dose 2 | 4 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Dose 2 | 4 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 2 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 1 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 3 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 3 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Dose 1 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 3 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 1 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 3 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 3 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 3 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Dose 1 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Malaise, Dose 2 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Across doses | 4 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Dose 1 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms,Across doses | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Malaise, Dose 2 | 3 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Across doses | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Malaise, Dose 2 | 3 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Malaise, Dose 1 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 1 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 1 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 1 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 2 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 2 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 2 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 1 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 1 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Across doses | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Malaise, Across doses | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Malaise, Across doses | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 1 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Malaise, Across doses | 2 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 2 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 1 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms,Across doses | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms,Across doses | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Malaise, Dose 1 | 1 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Across doses | 1 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms,Across doses | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Malaise, Dose 1 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 1 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 2 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 1 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Dose 2 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Dose 2 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Dose 2 | 1 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Across doses | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Dose 1 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 1 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Dose 1 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Malaise, Dose 2 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Malaise, Dose 2 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Dose 1 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Malaise, Dose 2 | 2 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 8 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 14 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 9 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 2 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 1 | 4 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 1 | 1 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 1 | 2 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 11 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 4 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 1 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Malaise, Dose 1 | 11 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Malaise, Dose 1 | 8 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Malaise, Dose 1 | 1 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 13 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 2 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Dose 1 | 1 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Dose 1 | 0 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Dose 1 | 0 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 13 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 11 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 2 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 2 | 7 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 2 | 5 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 2 | 0 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 12 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 8 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 0 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Malaise, Dose 2 | 11 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Malaise, Dose 2 | 10 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Malaise, Dose 2 | 3 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 14 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 13 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 3 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Dose 2 | 9 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Dose 2 | 8 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Dose 2 | 2 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 17 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 13 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 4 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms,Across doses | 10 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms,Across doses | 6 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms,Across doses | 2 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 18 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 9 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 1 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Malaise, Across doses | 16 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Malaise, Across doses | 12 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Malaise, Across doses | 4 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 18 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 15 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 5 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Across doses | 10 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Across doses | 8 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Across doses | 2 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 2 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 4 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 8 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 6 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 1 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Malaise, Dose 1 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 1 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Malaise, Dose 2 | 5 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 3 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 4 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 4 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Malaise, Dose 2 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Malaise, Dose 1 | 1 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Across doses | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 1 | 2 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 3 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms,Across doses | 1 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Dose 1 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Across doses | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms,Across doses | 4 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 2 | 1 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Malaise, Dose 1 | 2 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms,Across doses | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 1 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 2 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 5 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 2 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 2 | 3 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 5 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Dose 1 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Dose 2 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Malaise, Across doses | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 1 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 1 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Malaise, Across doses | 1 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Dose 2 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Malaise, Dose 2 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 1 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Dose 1 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 4 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Malaise, Across doses | 6 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Dose 2 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Across doses | 0 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Dose 2 | 16 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Dose 1 | 0 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Malaise, Dose 2 | 32 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 34 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Malaise, Dose 2 | 29 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Dose 1 | 2 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Malaise, Dose 2 | 3 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Dose 1 | 2 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 2 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 28 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 27 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 0 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 2 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 21 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 2 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Dose 2 | 16 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 24 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Dose 2 | 0 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Malaise, Dose 1 | 1 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 36 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 16 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 34 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Malaise, Dose 1 | 10 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 5 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Malaise, Dose 1 | 14 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms,Across doses | 16 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Across doses | 17 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms,Across doses | 13 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 0 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms,Across doses | 1 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 7 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 24 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 23 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 8 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Across doses | 0 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 1 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 1 | 0 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Malaise, Across doses | 35 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Across doses | 17 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Malaise, Across doses | 31 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 1 | 3 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Malaise, Across doses | 4 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 1 | 5 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 19 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 2 | 13 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 34 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 2 | 11 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 3 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 2 | 1 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 30 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 22 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 20 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 33 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 1 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 1 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 7 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Dose 2 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Malaise, Dose 2 | 3 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Malaise, Across doses | 9 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Dose 2 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 3 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 1 | 3 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 7 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Dose 1 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Malaise, Across doses | 8 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Dose 1 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Dose 2 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Across doses | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Dose 1 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 3 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Malaise, Across doses | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 1 | 5 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Malaise, Dose 2 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 7 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 6 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 1 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 2 | 3 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 6 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Across doses | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms,Across doses | 4 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Malaise, Dose 2 | 3 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms,Across doses | 6 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Across doses | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Malaise, Dose 1 | 8 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 2 | 3 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms,Across doses | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 5 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 3 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 1 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 9 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 3 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 6 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Malaise, Dose 1 | 7 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 5 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 8 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 10 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 7 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 6 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 7 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Malaise, Dose 1 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 2 | 0 Participants |
| TB Naive Saline Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 0 Participants |
Primary
Number of Subjects With Serious Adverse Events (SAEs)
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.
Time frame: Up to day 210
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered and for whom data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TB Treatment GSK 692342 Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Subjects |
| TB Treatment Saline Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Subjects |
| TB Treated GSK 692342 Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Subjects |
| TB Treated Saline Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Subjects |
| TB Naive GSK 692342 Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Subjects |
| TB Naive Saline Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Subjects |
Secondary
Concentrations of Anti-M72 Antibodies
Concentrations are presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EU/mL).
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 0 | 1.4 EU/mL |
| TB Treatment GSK 692342 Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 30 | 6.7 EU/mL |
| TB Treatment GSK 692342 Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 60 | 206.6 EU/mL |
| TB Treatment GSK 692342 Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 210 | 38.4 EU/mL |
| TB Treatment Saline Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 60 | 1.4 EU/mL |
| TB Treatment Saline Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 30 | 1.4 EU/mL |
| TB Treatment Saline Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 0 | 1.4 EU/mL |
| TB Treatment Saline Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 210 | 1.4 EU/mL |
| TB Treated GSK 692342 Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 210 | 50.9 EU/mL |
| TB Treated GSK 692342 Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 60 | 226.2 EU/mL |
| TB Treated GSK 692342 Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 30 | 11.7 EU/mL |
| TB Treated GSK 692342 Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 0 | 1.4 EU/mL |
| TB Treated Saline Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 0 | 1.4 EU/mL |
| TB Treated Saline Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 210 | 1.4 EU/mL |
| TB Treated Saline Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 30 | 1.4 EU/mL |
| TB Treated Saline Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 60 | 1.4 EU/mL |
| TB Naive GSK 692342 Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 60 | 248.6 EU/mL |
| TB Naive GSK 692342 Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 210 | 45.6 EU/mL |
| TB Naive GSK 692342 Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 30 | 4.5 EU/mL |
| TB Naive GSK 692342 Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 0 | 1.4 EU/mL |
| TB Naive Saline Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 30 | 1.5 EU/mL |
| TB Naive Saline Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 60 | 1.7 EU/mL |
| TB Naive Saline Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 210 | 1.4 EU/mL |
| TB Naive Saline Group | Concentrations of Anti-M72 Antibodies | Anti-M72, Day 0 | 1.5 EU/mL |
Secondary
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 30 | 132 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 0 | 67 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 7 | 34 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 210 | 167 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 30 | 563 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 37 | 1236 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 37 | 276 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 210 | 869 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 0 | 10 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 210 | 32 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 0 | 20 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 30 | 25.5 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 7 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 60 | 24.5 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 37 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 0 | 55 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 7 | 17 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 60 | 62.5 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 30 | 115 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 210 | 19 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 37 | 37 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 60 | 176 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 30 | 902 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 30 | 152.5 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 37 | 1828 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 210 | 77 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 37 | 375.5 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 0 | 8 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 7 | 58 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 60 | 608 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 7 | 389 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 0 | 61 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 210 | 439 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 7 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 0 | 188.5 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 7 | 151 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 30 | 132.5 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 37 | 253 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 60 | 149.5 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 210 | 174 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 0 | 18 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 30 | 25.5 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 37 | 40 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 60 | 26 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 210 | 4 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 60 | 560 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 30 | 156.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 0 | 48.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 210 | 272 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 60 | 792 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 37 | 738.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 7 | 232 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 30 | 125.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 37 | 915 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 0 | 9.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 7 | 40.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 210 | 301 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 7 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 60 | 55.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 30 | 17 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 37 | 46.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 210 | 18 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 37 | 18 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 30 | 71.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 7 | 43 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 60 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 0 | 44.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg-, Day 0 | 20 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa+/IFNg+, Day 210 | 22 CD4+ T-cells/million cells |
Secondary
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 210 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg-, Day 0 | 103 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg-, Day 30 | 1375.5 CD4+ T-cells/million cells |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 60 | 17.5 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 37 | 5 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 0 | 17 CD4+ T-cells/million cells |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 30 | 41 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg-, Day 210 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg-, Day 37 | 213 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg-, Day 60 | 168 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 30 | 124.5 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg-, Day 30 | 208 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 37 | 649 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg-, Day 210 | 296 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg-, Day 37 | 1544 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg-, Day 0 | 19 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg-, Day 7 | 14 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 60 | 147 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 7 | 227 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 0 | 25 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 210 | 57 CD4+ T-cells/million cells |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 0 | 43 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 7 | 22 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 30 | 13.5 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 37 | 17 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 60 | 20.5 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 210 | 32 CD4+ T-cells/million cells |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg-, Day 37 | 18 CD4+ T-cells/million cells |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg-, Day 210 | 45 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 60 | 399 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 30 | 86.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 0 | 27.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg-, Day 210 | 497 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg-, Day 60 | 1426 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 37 | 1355.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 7 | 163 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg-, Day 30 | 342 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg-, Day 37 | 3575.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg-, Day 7 | 19 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 210 | 107 CD4+ T-cells/million cells |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 37 | 19 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg-, Day 210 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg-, Day 37 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 30 | 30 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 7 | 29.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 0 | 12 CD4+ T-cells/million cells |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa-/IFNg+, Day 210 | 30.5 CD4+ T-cells/million cells |
Secondary
Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 30 | 21 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 210 | 4 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 30 | 76 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 60 | 67 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 37 | 246 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 37 | 46 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 210 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 0 | 18 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 30 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 7 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 60 | 14 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 37 | 34 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 0 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 7 | 17 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 60 | 50 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 30 | 26 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 210 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 37 | 66 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 60 | 23 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 30 | 112 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 30 | 51.5 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 37 | 212.5 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 210 | 5 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 37 | 87 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 0 | 20 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 7 | 19 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 60 | 34 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 7 | 102 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 0 | 24 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 210 | 30 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 7 | 17 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 0 | 13.5 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 7 | 18 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 30 | 44 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 37 | 50 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 60 | 46 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 210 | 29 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 0 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 30 | 32.5 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 37 | 11 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 60 | 36 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 210 | 23 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 60 | 69 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 30 | 42 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 0 | 17.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 210 | 24 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 60 | 88 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 37 | 185.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 7 | 53 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 30 | 8 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 37 | 309 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 0 | 8 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 7 | 26 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 210 | 46 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 7 | 28.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 60 | 18.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 30 | 12.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 37 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 210 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 37 | 7.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 30 | 20 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 7 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 60 | 22 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 0 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 0 | 22.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 210 | 11.5 CD4+ T-cells/million cells |
Secondary
Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 7 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 37 | 34 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 210 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 0 | 20 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 30 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 60 | 4 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 210 | 30 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 60 | 32 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 37 | 273 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 30 | 52 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 0 | 47 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 7 | 59 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 37 | 27 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 7 | 46 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 30 | 33.5 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 210 | 34 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 60 | 51.5 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 0 | 51 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 0 | 70 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 60 | 129 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 7 | 78 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 30 | 47 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 37 | 495.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 210 | 31 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 37 | 19 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 30 | 26.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 60 | 19.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 210 | 55 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 7 | 25.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 0 | 14.5 CD4+ T-cells/million cells |
Secondary
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 30 | 73 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 210 | 53 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 60 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 0 | 143 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 30 | 161 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 60 | 16.5 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 7 | 110 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 60 | 44.5 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 30 | 41.5 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 210 | 122 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 60 | 101 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 210 | 333 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 0 | 29 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 60 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 60 | 14.5 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 37 | 43 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 60 | 85 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 210 | 121 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 60 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 210 | 22 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 60 | 61 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 37 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 7 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 30 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 37 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 0 | 7.5 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 7 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 7 | 26 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 60 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 30 | 99.5 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 37 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 210 | 33.5 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 37 | 13.5 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 7 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 60 | 36.5 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg-, Day 0 | 25 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines | CD40L+/IL2-/TNFa-/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
Secondary
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Immune Markers
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa+/IFNg-, Day 60 | 24.5 CD8+ T-cells/million cells |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Immune Markers | CD40L+/IL2-/TNFa+/IFNg+, Day 30 | 36.5 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
Secondary
Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 7 | 17 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 7 | 50 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 0 | 21 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 60 | 16 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 37 | 41 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 37 | 40 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 60 | 19 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 210 | 51 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 60 | 35 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 60 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 30 | 80 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 7 | 32 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 37 | 28.5 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 60 | 29 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 37 | 36.5 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 60 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 0 | 30 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 30 | 47.5 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 60 | 18.5 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 0 | 7.5 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 37 | 28 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 60 | 58 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 30 | 91.5 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 60 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 7 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 37 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 60 | 20 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 7 | 20.5 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 30 | 20.5 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 37 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 0 | 25.5 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 37 | 5 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 60 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 7 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 37 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 30 | 24.5 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 0 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 60 | 4.5 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 7 | 9 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination | CD40L-/IL2-/TNFa+/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
Secondary
Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 60 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 37 | 33 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 0 | 6 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 7 | 9 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 30 | 118 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 210 | 51 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 60 | 70 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 37 | 100.5 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 0 | 70 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 30 | 127.5 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 7 | 152 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 30 | 386.5 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 0 | 216.5 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 7 | 205 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 37 | 229 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 60 | 172 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 210 | 85 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 37 | 46.5 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 7 | 69.5 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 210 | 69 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 30 | 64.5 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 60 | 13 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 7 | 90.5 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 37 | 83.5 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 60 | 59 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 0 | 78.5 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 30 | 151.5 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination | CD40L-/IL2-/TNFa-/IFNg+, Day 210 | 60 CD8+ T-cells/million cells |
Secondary
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 30 | 204 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 7 | 33 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 210 | 448 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 30 | 1066 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 60 | 654 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 37 | 1186 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 60 | 1444 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 37 | 436 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 0 | 12 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 210 | 18 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 0 | 55 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 30 | 48 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 7 | 42 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 60 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 37 | 80 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 0 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 7 | 17 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 60 | 28 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 30 | 330.5 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 210 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 37 | 35 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 60 | 301 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 30 | 776 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 30 | 250 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 37 | 897.5 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 210 | 148 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 37 | 292 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 0 | 25 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 7 | 44 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 60 | 417 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 7 | 329 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 0 | 87 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 210 | 288 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 7 | 27 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 0 | 124 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 7 | 84 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 30 | 71 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 37 | 87 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 60 | 132 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 210 | 68 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 0 | 20.5 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 30 | 16 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 37 | 9 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 60 | 19 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 210 | 18 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 60 | 436 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 30 | 89.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 0 | 60 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 210 | 566 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 60 | 1117 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 37 | 436.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 7 | 87 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 30 | 279.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 37 | 558.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 0 | 4 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 7 | 19 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 210 | 201 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 7 | 16.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 60 | 31 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 30 | 20.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 37 | 45 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 210 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 37 | 4.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 30 | 47 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 7 | 55.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 60 | 20 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 0 | 54 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg-, Day 0 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa+/IFNg+, Day 210 | 35.5 CD4+ T-cells/million cells |
Secondary
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 210 | 18 CD4+ T-cells/million cells |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 30 | 84.5 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 7 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 60 | 32 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 37 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 7 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 60 | 46.5 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 30 | 25.5 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 210 | 18 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 37 | 20 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 60 | 171 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 30 | 82.5 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 30 | 150.5 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 37 | 133.5 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 210 | 126 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 37 | 182 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 0 | 14 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 7 | 43 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 60 | 75 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 7 | 40 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 210 | 47 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 7 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 0 | 17 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 7 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 30 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 37 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 60 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 210 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 0 | 17.5 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 30 | 25 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 37 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 60 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 210 | 17 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 60 | 269 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 30 | 39.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 210 | 453 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 60 | 939 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 37 | 278 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 7 | 32.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 30 | 300 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 37 | 732 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 0 | 19.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 7 | 44.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 210 | 126 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 7 | 5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 60 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 30 | 18 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 37 | 17 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 210 | 11 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 37 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 30 | 17 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 7 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg-, Day 60 | 17.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 0 | 12.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa-/IFNg+, Day 210 | 10.5 CD4+ T-cells/million cells |
Secondary
Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 7 | 208 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 37 | 316 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 210 | 131 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4-At least 2, Day 0 | 207 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 30 | 765 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 60 | 254 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 210 | 1167 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 60 | 2101 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 37 | 5733.5 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 30 | 2636 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4-At least 2, Day 0 | 364 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 7 | 1152 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 37 | 565 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 7 | 482 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 30 | 497 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 210 | 480 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 60 | 583 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4-At least 2, Day 0 | 562.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4-At least 2, Day 0 | 325 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 60 | 5185 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 7 | 856 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 30 | 1248.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 37 | 6051.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 210 | 2269 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 37 | 277.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 30 | 348.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 60 | 258 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 210 | 299 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4- At least 2, Day 7 | 278.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD4-At least 2, Day 0 | 365 CD4+ T-cells/million cells |
Secondary
Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 30 | 17 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 0 | 4 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 7 | 4 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 210 | 4 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 30 | 4 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 60 | 21 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 37 | 89 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 37 | 4 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 210 | 19 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 7 | 4 CD4+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 0 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 210 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 0 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 30 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 7 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 60 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 37 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 0 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 7 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 60 | 4 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 30 | 26 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 210 | 17 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 37 | 4 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 60 | 4 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 30 | 35 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 30 | 19.5 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 37 | 64.5 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 210 | 4 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 37 | 4 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 0 | 4 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 7 | 4 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 60 | 4 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 7 | 19 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 0 | 4 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 210 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 7 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 0 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 7 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 30 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 37 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 60 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 210 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 0 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 30 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 37 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 60 | 4 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 210 | 4 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 60 | 19 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 30 | 4 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 0 | 4 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 210 | 4 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 60 | 45 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 37 | 32.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 7 | 4 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 30 | 17.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 37 | 34 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 0 | 4 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 7 | 4 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 210 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 7 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 60 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 30 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 37 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 210 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 37 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 30 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 7 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 60 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 0 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 0 | 4 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 210 | 4 CD4+ T-cells/million cells |
Secondary
Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination | CD40L-/IL2+/TNFa-/IFNg-, Day 60 | 17.5 CD4+ T-cells/million cells |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination | CD40L-/IL2+/TNFa-/IFNg+, Day 30 | 11 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination | CD40L-/IL2+/TNFa-/IFNg-, Day 30 | 21 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination | CD40L-/IL2+/TNFa-/IFNg-, Day 37 | 27.5 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination | CD40L-/IL2+/TNFa-/IFNg+, Day 7 | 17 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated Saline Group | Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination | CD40L-/IL2+/TNFa-/IFNg-, Day 7 | 17 CD4+ T-cells/million cells |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination | CD40L-/IL2+/TNFa-/IFNg-, Day 210 | 25 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination | CD40L-/IL2+/TNFa-/IFNg-, Day 60 | 49 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination | CD40L-/IL2+/TNFa-/IFNg+, Day 37 | 19.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination | CD40L-/IL2+/TNFa-/IFNg-, Day 30 | 18 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination | CD40L-/IL2+/TNFa-/IFNg-, Day 37 | 40.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination | CD40L-/IL2+/TNFa-/IFNg-, Day 7 | 18.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
Secondary
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 60 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 60 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 60 | 14 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 60 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 60 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 60 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 60 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 60 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 0 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 30 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 37 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 60 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 60 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 0 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 7 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 7 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 37 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 60 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 60 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 0 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 37 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 7 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 37 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg+, Day 7 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines | CD40L+/IL2+/TNFa-/IFNg-, Day 30 | 4 CD8+ T-cells/million cells |
Secondary
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa+/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa+/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa+/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa+/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa+/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa+/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa+/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa+/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa+/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers | CD40L+/IL2+/TNFa+/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
Secondary
Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 7 | 85 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 37 | 89 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 210 | 91 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8-At least 2, Day 0 | 57 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 30 | 109 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 60 | 131 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 210 | 272 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 60 | 202 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 37 | 362 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 30 | 256 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8-At least 2, Day 0 | 143 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 7 | 245 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 37 | 121 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 7 | 75 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 30 | 166.5 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 210 | 133 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 60 | 174 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8-At least 2, Day 0 | 151.5 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8-At least 2, Day 0 | 96 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 60 | 111 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 7 | 116 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 30 | 96 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 37 | 85.5 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 210 | 137 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 37 | 103.5 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 30 | 106.5 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 60 | 106.5 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 210 | 124.5 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8- At least 2, Day 7 | 124 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6 | CD8-At least 2, Day 0 | 85.5 CD8+ T-cells/million cells |
Secondary
Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 60 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 60 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treatment GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 60 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 60 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 60 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 60 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 37 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 60 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 60 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 30 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 0 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 7 | 4 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 7 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 37 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 60 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 0 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 7 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 30 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 37 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 60 | 4 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 37 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 30 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 7 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 0 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 7 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 210 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 0 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 210 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 60 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 37 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg+, Day 30 | 4 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination | CD40L-/IL2+/TNFa+/IFNg-, Day 60 | 4 CD8+ T-cells/million cells |
Secondary
Frequency of M72-specific CD8+ T-cells Expressing Immune Markers in Any Combination
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | 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 |
| TB Treatment Saline Group | Frequency of M72-specific CD8+ T-cells Expressing Immune Markers in Any Combination | CD40L-/IL2+/TNFa-/IFNg-, Day 210 | 38 CD8+ T-cells/million cells |
| TB Treatment Saline Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated GSK 692342 Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Treated Saline Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive GSK 692342 Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
| TB Naive Saline Group | 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 |
Secondary
Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment Saline Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 7 | 182 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 37 | 273 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 210 | 118 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 0 | 178 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 30 | 730 CD4+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 60 | 241 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 210 | 1154 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 60 | 2072 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 37 | 5705.5 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 30 | 2616.5 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 0 | 347 CD4+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 7 | 1097 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 37 | 533 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 7 | 469 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 30 | 466 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 210 | 445 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 60 | 517 CD4+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 0 | 549.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 0 | 286 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 60 | 5153 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 7 | 801.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 30 | 1228.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 37 | 5987.5 CD4+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 210 | 2155 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 37 | 247 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 30 | 312.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 60 | 240 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 210 | 254 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 7 | 265.5 CD4+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers | CD4-ALL doubles, Day 0 | 352 CD4+ T-cells/million cells |
Secondary
Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment GSK 692342 Group | 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 |
| TB Treatment Saline Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 7 | 72 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 37 | 76 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 210 | 78 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 0 | 44 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 30 | 81.5 CD8+ T-cells/million cells |
| TB Treatment Saline Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 60 | 118 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 210 | 259 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 60 | 189 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 37 | 347 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 30 | 243 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 0 | 99 CD8+ T-cells/million cells |
| TB Treated GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 7 | 222 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 37 | 108 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 7 | 62 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 30 | 153.5 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 210 | 119 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 60 | 161 CD8+ T-cells/million cells |
| TB Treated Saline Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 0 | 110.5 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 0 | 73 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 60 | 96 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 7 | 74.5 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 30 | 80 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 37 | 72.5 CD8+ T-cells/million cells |
| TB Naive GSK 692342 Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 210 | 110 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 37 | 75.5 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 30 | 77.5 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 60 | 71 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 210 | 71.5 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 7 | 92.5 CD8+ T-cells/million cells |
| TB Naive Saline Group | Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers | CD8-All Doubles, Day 0 | 69.5 CD8+ T-cells/million cells |
Secondary
Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TB Treatment GSK 692342 Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 0 | 0 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 30 | 5 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 60 | 6 Participants |
| TB Treatment GSK 692342 Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 210 | 6 Participants |
| TB Treatment Saline Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 60 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 30 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 0 | 0 Participants |
| TB Treatment Saline Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 210 | 0 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 210 | 18 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 60 | 18 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 30 | 19 Participants |
| TB Treated GSK 692342 Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 0 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 0 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 210 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 30 | 0 Participants |
| TB Treated Saline Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 60 | 0 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 60 | 37 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 210 | 38 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 30 | 26 Participants |
| TB Naive GSK 692342 Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 0 | 1 Participants |
| TB Naive Saline Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 30 | 2 Participants |
| TB Naive Saline Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 60 | 3 Participants |
| TB Naive Saline Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 210 | 1 Participants |
| TB Naive Saline Group | Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies | Anti-M72, Day 0 | 2 Participants |