Tuberculosis
Conditions
Keywords
Tuberculosis vaccine
Brief summary
This observer blind study will assess the safety and immunogenicity of GSK Biologicals' investigational 692342 vaccine administered at 0, 1 month to healthy adolescents living in a TB-endemic region.
Interventions
BIOLOGICALGSK's investigational vaccine 692342
Intramuscular injection, 2 doses
BIOLOGICALPlacebo
Intramuscular injection, 2 doses
Sponsors
Aeras
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they and their parent(s)/ legal guardian(s) can and will comply with the requirements of the protocol. * A male or female between, and including, 13 and 17 years of age at the time of the first vaccination. * Written informed consent obtained from the subject's parent(s) or legal guardian(s). * Written informed assent obtained from the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Seronegative for HIV-1. * No history of TB disease. * No active pulmonary disease on chest X-ray. * Availability for the duration of the immunisation and follow-up period, with the family not planning to move away from the study area within the next year. * 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 is abstinent, 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 vaccination period and for 2 months after completion of the vaccination series.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) 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. * History of previous administration of investigational Mycobacterium tuberculosis vaccines. * History of previous exposure to components of the investigational vaccine. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Any condition or illness (acute, chronic or history) or medication, which in the opinion of the investigator might interfere with the evaluation of the safety or immunogenicity of the study vaccine. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of vaccine, or planned administration during the study. * Planned participation or participation in another experimental clinical study during the study period. * A family history of congenital or hereditary immunodeficiency. * Any chronic drug therapy to be continued during the study period, with the exception of vitamins and/or dietary supplements, birth control pills, anti-histamines for seasonal allergies and Specific Serotonin Reuptake Inhibitors (SSRIs). * History of allergic reactions (significant IgE-mediated events) or anaphylaxis to any vaccine. * History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine. * Pregnant female, lactating female or female planning to become pregnant or discontinue contraceptive precautions. * Drug and/or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Haematological Levels Below Normal | At Day 0, 7, 30, 37 and 60 | Among haematological parameters assessed were platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological parameters assessed in terms of normal laboratory values were - normal, below and above. |
| Number of Subjects With Normal Haematological Levels | At Day 0, 7, 30, 37 and 60 | Among haematological parameters assessed were platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological parameters assessed in terms of normal laboratory values were - normal, below and above. |
| Number of Subjects With Biochemical and Haematological Above Normal Levels | At Day 0, 7, 30, 37 and 60 | Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], creatinine \[CREA\], haemoglobin \[Hgb\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - normal, below and above. |
| Number of Subjects With Haematological Levels Above Normal | At Day 0, 7, 30, 37 and 60 | Among haematological parameters assessed were platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological parameters assessed in terms of normal laboratory values were - normal, below and above. |
| Number of Subjects With Biochemical and Haematological Below Normal Levels | At Day 0, 7, 30, 37 and 60 | Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], creatinine \[CREA\], haemoglobin \[Hgb\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - normal, below and above. |
| Number of Subjects With 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 activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed. |
| Number of Subjects With 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, temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal symptoms (gastro) \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 30-day (Days 0-29) post-vaccination period | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (from Day 0 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. |
| Number of Subjects With Normal Biochemical and Haematological Levels | At Day 0, 7, 30, 37 and 60 | Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], creatinine \[CREA\], haemoglobin \[Hgb\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - normal, below and above. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | At Day 0, 7, 30, 37, 60 and 210 | Among cytokines expressed were interleukin-2 \[IL-2\], interferon-gamma \[IFN-γ\], tumour necrosis factor-alpha \[TNF-α\] and cluster of differentiation 40-ligand \[CD40-L\], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS). |
| Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | At Day 0, 7, 30, 37, 60 and 210 | Among cytokines expressed were interleukin-2 \[IL-2\], interferon-gamma \[IFN-γ\], tumour necrosis factor-alpha \[TNF-α\] and cluster of differentiation 40-ligand \[CD40-L\], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS). |
| Anti-M72 Specific Antibody Concentrations | At Day 0, 30, 60 and 210 | Antibody concentrations given in Enzyme-Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL) were expressed as Geometric Mean Concentrations (GMCs). |
| Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | At Day 0, 7, 30, 37, 60 and 210 | Among cytokines expressed were interleukin-2 \[IL-2\], interferon-gamma \[IFN-γ\], tumour necrosis factor-alpha \[TNF-α\] and cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS). |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSK692342 Group Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region. | 40 |
| Placebo Group Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region. | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | GSK692342 Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 14.8 Years STANDARD_DEVIATION 1.2 | 14.9 Years STANDARD_DEVIATION 1.12 | 14.83 Years STANDARD_DEVIATION 1.17 |
| Sex: Female, Male Female | 18 Participants | 11 Participants | 29 Participants |
| Sex: Female, Male Male | 22 Participants | 9 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 38 / 40 | 15 / 20 |
| serious Total, serious adverse events | 0 / 40 | 0 / 20 |
Outcome results
Primary
Number of Subjects With Biochemical and Haematological Above Normal Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], creatinine \[CREA\], haemoglobin \[Hgb\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - normal, below and above.
Time frame: At Day 0, 7, 30, 37 and 60
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | AST, Day 60- above | 1 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | ALT, Day 7- above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | ALT, Day 30- above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | ALT, Day 37- above | 2 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | ALT, Day 60- above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | AST, Day 0- above | 1 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | AST, Day 7- above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | AST, Day 30- above | 1 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | AST, Day 37- above | 1 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | CREA, Day 0- above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | CREA, Day 7- above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | CREA, Day 30- above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | CREA, Day 37- above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | CREA, Day 60- above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | Hgb, Day 0- above | 1 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | Hgb, Day 7- above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | Hgb, Day 30- above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | Hgb, Day 37- above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | Hgb, Day 60- above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | ALT, Day 0-above | 3 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | Hgb, Day 37- above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | ALT, Day 0-above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | CREA, Day 7- above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | ALT, Day 7- above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | Hgb, Day 7- above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | ALT, Day 30- above | 1 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | CREA, Day 30- above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | ALT, Day 37- above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | AST, Day 37- above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | ALT, Day 60- above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | CREA, Day 37- above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | AST, Day 0- above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | Hgb, Day 30- above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | AST, Day 7- above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | CREA, Day 60- above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | AST, Day 30- above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | Hgb, Day 60- above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | AST, Day 60- above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | Hgb, Day 0- above | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Above Normal Levels | CREA, Day 0- above | 0 Subjects |
Primary
Number of Subjects With Biochemical and Haematological Below Normal Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], creatinine \[CREA\], haemoglobin \[Hgb\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - normal, below and above.
Time frame: At Day 0, 7, 30, 37 and 60
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | ALT, Day 0-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | ALT, Day 7- below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | ALT, Day 30-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | ALT, Day 37-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | ALT, Day 60-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | AST, Day 0-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | AST, Day 7-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | AST, Day 30-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | AST, Day 37- below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | AST, Day 60- below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | CREA, Day 0- below | 17 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | CREA, Day 7- below | 20 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | CREA, Day 37-below | 23 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | CREA, Day 60-below | 23 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | Hgb, Day 0- below | 8 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | Hgb, Day 7- below | 12 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | Hgb, Day 30- below | 13 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | Hgb, Day 37- below | 18 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | Hgb, Day 60- below | 8 Subjects |
| GSK692342 Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | CREA, Day 30-below | 22 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | Hgb, Day 37- below | 4 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | ALT, Day 0-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | CREA, Day 0- below | 10 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | ALT, Day 7- below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | Hgb, Day 7- below | 4 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | ALT, Day 30-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | CREA, Day 7- below | 15 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | ALT, Day 37-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | CREA, Day 30-below | 13 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | ALT, Day 60-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | CREA, Day 37-below | 11 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | AST, Day 0-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | Hgb, Day 30- below | 4 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | AST, Day 7-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | CREA, Day 60-below | 12 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | AST, Day 30-below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | Hgb, Day 60- below | 4 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | AST, Day 37- below | 0 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | Hgb, Day 0- below | 3 Subjects |
| Placebo Group | Number of Subjects With Biochemical and Haematological Below Normal Levels | AST, Day 60- below | 0 Subjects |
Primary
Number of Subjects With Haematological Levels Above Normal
Among haematological parameters assessed were platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological parameters assessed in terms of normal laboratory values were - normal, below and above.
Time frame: At Day 0, 7, 30, 37 and 60
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 37- above | 2 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 37- above | 7 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 0-above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 60- above | 7 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 0- above | 9 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 0- above | 2 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 30- above | 1 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 7- above | 2 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 7- above | 3 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 30- above | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 7- above | 2 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 37- above | 1 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 30- above | 7 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 60- above | 5 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 60- above | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 60- above | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 60- above | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 0-above | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 7- above | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 30- above | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | PLA, Day 37- above | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 0- above | 5 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 7- above | 2 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 30- above | 4 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 37- above | 2 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | RBC, Day 60- above | 4 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 0- above | 2 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 7- above | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 30- above | 2 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Above Normal | WBC, Day 37- above | 2 Subjects |
Primary
Number of Subjects With Haematological Levels Below Normal
Among haematological parameters assessed were platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological parameters assessed in terms of normal laboratory values were - normal, below and above.
Time frame: At Day 0, 7, 30, 37 and 60
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 0-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 7-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 30-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 37-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 60-below | 0 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 0-below | 2 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 7-below | 5 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 30-below | 3 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 37-below | 5 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 60-below | 4 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 0-below | 2 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 7-below | 4 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 37-below | 1 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 60-below | 2 Subjects |
| GSK692342 Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 30-below | 3 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 30-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 0-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 7-below | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 7-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 37-below | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 30-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 30-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 37-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 60-below | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | PLA, Day 60-below | 0 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 60-below | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 0-below | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 0-below | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | RBC, Day 7-below | 1 Subjects |
| Placebo Group | Number of Subjects With Haematological Levels Below Normal | WBC, Day 37-below | 1 Subjects |
Primary
Number of Subjects With Normal Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], creatinine \[CREA\], haemoglobin \[Hgb\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - normal, below and above.
Time frame: At Day 0, 7, 30, 37 and 60
Population: The analysis was performedon the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 0-normal | 36 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 7-normal | 40 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 37-normal | 38 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 7-normal | 40 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 30-normal | 38 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 37-normal | 39 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 0-normal | 23 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 7-normal | 20 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 30-normal | 18 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 37-normal | 17 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 60-normal | 17 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | Hgb, Day 0-normal | 31 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | Hgb, Day 7-normal | 28 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | Hgb, Day 30-normal | 27 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | Hgb, Day 37-normal | 22 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | Hgb, Day 60-normal | 32 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 0-normal | 37 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 30-normal | 40 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 60-normal | 40 Subjects |
| GSK692342 Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 60-normal | 38 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 60-normal | 20 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 60-normal | 8 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | Hgb, Day 60-normal | 16 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 37-normal | 20 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 0-normal | 17 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | Hgb, Day 0-normal | 17 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 7-normal | 20 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 30-normal | 19 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 30-normal | 20 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | Hgb, Day 7-normal | 16 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 37-normal | 20 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | AST, Day 60-normal | 20 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 0-normal | 20 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 0-normal | 10 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | Hgb, Day 30-normal | 16 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 7-normal | 5 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | ALT, Day 7-normal | 20 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 30-normal | 7 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | Hgb, Day 37-normal | 16 Subjects |
| Placebo Group | Number of Subjects With Normal Biochemical and Haematological Levels | CREA, Day 37-normal | 9 Subjects |
Primary
Number of Subjects With Normal Haematological Levels
Among haematological parameters assessed were platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological parameters assessed in terms of normal laboratory values were - normal, below and above.
Time frame: At Day 0, 7, 30, 37 and 60
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | PLA, Day 0-normal | 40 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | PLA, Day 7-normal | 38 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | PLA, Day 37-normal | 38 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | PLA, Day 60-normal | 39 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | RBC, Day 0-normal | 29 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | RBC, Day 7-normal | 32 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | RBC, Day 30-normal | 30 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | RBC, Day 37-normal | 28 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | RBC, Day 60-normal | 29 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | WBC, Day 0-normal | 36 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | WBC, Day 7-normal | 34 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | WBC, Day 30-normal | 37 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | WBC, Day 37-normal | 38 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | WBC, Day 60-normal | 33 Subjects |
| GSK692342 Group | Number of Subjects With Normal Haematological Levels | PLA, Day 30-normal | 39 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | WBC, Day 37-normal | 17 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | PLA, Day 0-normal | 19 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | RBC, Day 60-normal | 15 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | PLA, Day 30-normal | 19 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | PLA, Day 37-normal | 19 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | WBC, Day 0-normal | 17 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | PLA, Day 60-normal | 20 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | WBC, Day 60-normal | 18 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | RBC, Day 0-normal | 14 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | WBC, Day 7-normal | 18 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | RBC, Day 7-normal | 17 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | PLA, Day 7-normal | 19 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | RBC, Day 30-normal | 16 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | WBC, Day 30-normal | 18 Subjects |
| Placebo Group | Number of Subjects With Normal Haematological Levels | RBC, Day 37-normal | 17 Subjects |
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: During the entire study period (from Day 0 up to Day 210)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK692342 Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Subjects |
| Placebo Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Subjects |
Primary
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were fatigue, temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal symptoms (gastro) \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the 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 vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Across [N=40;20] | 3 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 1 [N=40;18] | 11 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 1 [N=40;18] | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 1 [N=40;18] | 9 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 1 [N=40;18] | 9 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 1 [N=40;18] | 1 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 1 [N=40;18] | 16 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 1 [N=40;18] | 15 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 1 [N=40;18] | 3 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 1 [N=40;18] | 6 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 1 [N=40;18] | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 1 [N=40;18] | 4 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 1 [N=40;18] | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 2 [N=40;20] | 5 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 1 [N=40;18] | 12 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 1 [N=40;18] | 11 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 1 [N=40;18] | 1 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 2 [N=40;20] | 20 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 2 [N=40;20] | 20 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 2 [N=40;20] | 13 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 2 [N=40;20] | 13 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 2 [N=40;20] | 27 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 2 [N=40;20] | 27 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 2 [N=40;20] | 6 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 2 [N=40;20] | 13 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 2 [N=40;20] | 13 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 2 [N=40;20] | 3 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 2 [N=40;20] | 2 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 2 [N=40;20] | 24 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 2 [N=40;20] | 3 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Across [N=40;20] | 21 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Across [N=40;20] | 21 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Across [N=40;20] | 3 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Across [N=40;20] | 18 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Across [N=40;20] | 18 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Across [N=40;20] | 1 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Headache, Across [N=40;20] | 28 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Headache, Across [N=40;20] | 28 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Across [N=40;20] | 7 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Across [N=40;20] | 14 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Across [N=40;20] | 14 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Across [N=40;20] | 3 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Across [N=40;20] | 7 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Across [N=40;20] | 7 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Across [N=40;20] | 2 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Across [N=40;20] | 24 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Across [N=40;20] | 24 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 1 [N=40;18] | 4 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 2 [N=40;20] | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 1 [N=40;18] | 6 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 2 [N=40;20] | 3 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 2 [N=40;20] | 5 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 2 [N=40;20] | 24 Subjects |
| GSK692342 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 1 [N=40;18] | 11 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 2 [N=40;20] | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 1 [N=40;18] | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 2 [N=40;20] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 1 [N=40;18] | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 2 [N=40;20] | 1 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 1 [N=40;18] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Across [N=40;20] | 3 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 1 [N=40;18] | 3 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 2 [N=40;20] | 1 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 1 [N=40;18] | 3 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 2 [N=40;20] | 1 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 1 [N=40;18] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 2 [N=40;20] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 1 [N=40;18] | 3 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Across [N=40;20] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 1 [N=40;18] | 3 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Across [N=40;20] | 5 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 1 [N=40;18] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 1 [N=40;18] | 1 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 1 [N=40;18] | 1 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Across [N=40;20] | 5 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 1 [N=40;18] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Across [N=40;20] | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 1 [N=40;18] | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Across [N=40;20] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Across [N=40;20] | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 1 [N=40;18] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Across [N=40;20] | 5 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 1 [N=40;18] | 1 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 1 [N=40;18] | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 1 [N=40;18] | 1 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Across [N=40;20] | 5 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 1 [N=40;18] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Across [N=40;20] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 2 [N=40;20] | 3 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Across [N=40;20] | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 2 [N=40;20] | 3 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Across [N=40;20] | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 2 [N=40;20] | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Headache, Across [N=40;20] | 5 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 2 [N=40;20] | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Across [N=40;20] | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 2 [N=40;20] | 3 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Headache, Across [N=40;20] | 5 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 2 [N=40;20] | 3 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 2 [N=40;20] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 2 [N=40;20] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Across [N=40;20] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 2 [N=40;20] | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Across [N=40;20] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 2 [N=40;20] | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Across [N=40;20] | 3 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 2 [N=40;20] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 2 [N=40;20] | 1 Subjects |
Primary
Number of Subjects With 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 activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.
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 vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across [N=40;20] | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 [N=40;18] | 3 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1 [N=40;18] | 7 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1 [N=40;18] | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1 [N=40;18] | 14 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1 [N=40;18] | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 [N=40;20] | 35 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 [N=40;20] | 7 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 [N=40;20] | 10 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 [N=40;20] | 1 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 [N=40;20] | 13 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 [N=40;20] | 0 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across [N=40;20] | 38 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across [N=40;20] | 8 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across [N=40;20] | 13 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across [N=40;20] | 1 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across [N=40;20] | 20 Subjects |
| GSK692342 Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 [N=40;18] | 37 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across [N=40;20] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 [N=40;18] | 3 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 [N=40;20] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 [N=40;18] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across [N=40;20] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1 [N=40;18] | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 [N=40;20] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1 [N=40;18] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across [N=40;20] | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1 [N=40;18] | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 [N=40;20] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1 [N=40;18] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across [N=40;20] | 2 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 [N=40;20] | 5 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across [N=40;20] | 7 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 [N=40;20] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across [N=40;20] | 0 Subjects |
| Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 [N=40;20] | 0 Subjects |
Primary
Number of Subjects With Unsolicited 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 out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: During the 30-day (Days 0-29) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK692342 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 9 Subjects |
| Placebo Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 3 Subjects |
Secondary
Anti-M72 Specific Antibody Concentrations
Antibody concentrations given in Enzyme-Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL) were expressed as Geometric Mean Concentrations (GMCs).
Time frame: At Day 0, 30, 60 and 210
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK692342 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D210 | 121.9 EL.U/mL |
| GSK692342 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D30 | 22.2 EL.U/mL |
| GSK692342 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D0 | 1.4 EL.U/mL |
| GSK692342 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D60 | 1077.8 EL.U/mL |
| Placebo Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D0 | 1.4 EL.U/mL |
| Placebo Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D210 | 1.5 EL.U/mL |
| Placebo Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D60 | 1.8 EL.U/mL |
| Placebo Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D30 | 1.6 EL.U/mL |
Secondary
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines
Among cytokines expressed were interleukin-2 \[IL-2\], interferon-gamma \[IFN-γ\], tumour necrosis factor-alpha \[TNF-α\] and cluster of differentiation 40-ligand \[CD40-L\], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).
Time frame: At Day 0, 7, 30, 37, 60 and 210
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D30[N=39;20] | 43.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D7[N=36;15] | 59.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D30[N=39;20] | 101.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D37[N=39;20] | 248.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D60[N=38;20] | 174.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D7[N=36;15] | 309.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D30[N=39;20] | 66.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D37[N=39;20] | 470.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D60[N=38;20] | 109.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D210[N=37;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D7[N=36;15] | 232.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D0[N=38;19] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D37[N=39;20] | 314.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D60[N=38;20] | 98.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D210[N=37;20] | 29.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D0[N=38;19] | 21.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D7[N=36;15] | 64.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D30[N=39;20] | 131.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D37[N=39;20] | 342.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D60[N=38;20] | 270.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D30[N=39;20] | 62.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D37[N=39;20] | 461.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D60[N=38;20] | 118.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D210[N=37;20] | 197.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D7[N=36;15] | 64.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D30[N=39;20] | 22.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D37[N=39;20] | 112.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D60[N=38;20] | 59.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D210[N=37;20] | 45.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D0[N=38;19] | 21.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D7[N=36;15] | 448.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D30[N=39;20] | 97.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D37[N=39;20] | 606.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D60[N=38;20] | 314.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D210[N=37;20] | 15.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D0[N=38;19] | 11.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D7[N=36;15] | 443.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D30[N=39;20] | 121.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D37[N=39;20] | 505.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D60[N=38;20] | 346.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D210[N=37;20] | 560.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D210[N=37;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D0[N=38;19] | 24.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D210[N=37;20] | 347.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D7[N=36;15] | 206.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D37[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D37[N=39;20] | 22.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D60[N=38;20] | 21.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D60[N=38;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D37[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D210[N=37;20] | 15.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D0[N=38;19] | 25.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D60[N=38;20] | 22.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D7[N=36;15] | 29.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D30[N=39;20] | 25.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D60[N=38;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D37[N=39;20] | 23.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D60[N=38;20] | 20.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D60[N=38;20] | 23.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D37[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D37[N=39;20] | 11.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D60[N=38;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D60[N=38;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D0[N=38;19] | 24.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D7[N=36;15] | 21.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D30[N=39;20] | 22.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D210[N=37;20] | 49.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D37[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D210[N=37;20] | 21.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D37[N=39;20] | 43.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D30[N=39;20] | 22.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D30[N=39;20] | 1.0 T cells/million cells |
Secondary
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines
Among cytokines expressed were interleukin-2 \[IL-2\], interferon-gamma \[IFN-γ\], tumour necrosis factor-alpha \[TNF-α\] and cluster of differentiation 40-ligand \[CD40-L\], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).
Time frame: At Day 0, 7, 30, 37, 60 and 210
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D60[N=38;20] | 296.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D7[N=36;15] | 36.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D30[N=39;20] | 172.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D37[N=39;20] | 593.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D60[N=38;20] | 344.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D210[N=37;20] | 263.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D0[N=38;19] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D7[N=36;15] | 74.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D30[N=39;20] | 163.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D37[N=39;20] | 506.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D0[N=38;19] | 42.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D210[N=37;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D0[N=38;19] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D7[N=36;15] | 84.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D30[N=39;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D37[N=39;20] | 357.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D60[N=38;20] | 90.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D210[N=37;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D7[N=36;15] | 579.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D30[N=39;20] | 103.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D37[N=39;20] | 871.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D60[N=38;20] | 183.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D210[N=37;20] | 36.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D0[N=38;19] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D30[N=39;20] | 190.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D37[N=39;20] | 588.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D60[N=38;20] | 375.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D210[N=37;20] | 402.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D0[N=38;19] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D7[N=36;15] | 47.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D30[N=39;20] | 23.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D37[N=39;20] | 107.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D60[N=38;20] | 65.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D210[N=37;20] | 44.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D7[N=36;15] | 120.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D30[N=39;20] | 23.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D37[N=39;20] | 169.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D210[N=37;20] | 70.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D0[N=38;19] | 68.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40(+)+IL-2(+)+TNFα(-)+IFNγ(-)D7[N=36;15] | 95.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D60[N=38;20] | 66.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D60[N=38;20] | 50.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D0[N=38;19] | 92.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D60[N=38;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D37[N=39;20] | 13.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40(+)+IL-2(+)+TNFα(-)+IFNγ(-)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D60[N=38;20] | 10.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D210[N=37;20] | 46.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D7[N=36;15] | 28.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D37[N=39;20] | 11.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D37[N=39;20] | 17.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D60[N=38;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D60[N=38;20] | 40.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D7[N=36;15] | 20.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D30[N=39;20] | 9.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D37[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D37[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D60[N=38;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D7[N=36;15] | 47.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D0[N=38;19] | 18.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D30[N=39;20] | 32.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D37[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D37[N=39;20] | 43.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines | CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D60[N=38;20] | 1.0 T cells/million cells |
Secondary
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines
Among cytokines expressed were interleukin-2 \[IL-2\], interferon-gamma \[IFN-γ\], tumour necrosis factor-alpha \[TNF-α\] and cluster of differentiation 40-ligand \[CD40-L\], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).
Time frame: At Day 0, 7, 30, 37, 60 and 210
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D7[N=36;15] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D7[N=36;15] | 98.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D30[N=39;20] | 2.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D37[N=39;20] | 39.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D60[N=38;20] | 5.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D210[N=37;20] | 28.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D0[N=38;19] | 3.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D30[N=39;20] | 26.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D37[N=39;20] | 13.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D0[N=38;19] | 16.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D7[N=36;15] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D30[N=39;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D37[N=39;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D210[N=37;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D0[N=38;19] | 66.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D7[N=36;15] | 303.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D30[N=39;20] | 93.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D37[N=39;20] | 190.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D210[N=37;20] | 61.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D7[N=36;15] | 7.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D60[N=38;20] | 40.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D210[N=37;20] | 4.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D60[N=38;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D60[N=38;20] | 70.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D7[N=36;15] | 94.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D0[N=38;19] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D7[N=36;15] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D30[N=39;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D37[N=39;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D60[N=38;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D210[N=37;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D0[N=38;19] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D0[N=38;19] | 20.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D30[N=39;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D37[N=39;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D60[N=38;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D210[N=37;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D30[N=39;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D37[N=39;20] | 33.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D60[N=38;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D210[N=37;20] | 24.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D0[N=38;19] | 19.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D60[N=38;20] | 109.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D37[N=39;20] | 42.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D60[N=38;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D60[N=38;20] | 104.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D210[N=37;20] | 7.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D30[N=39;20] | 5.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D210[N=37;20] | 18.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D37[N=39;20] | 35.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D210[N=37;20] | 34.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D37[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D7[N=36;15] | 8.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D37[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D60[N=38;20] | 8.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D60[N=38;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D37[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D0[N=38;19] | 87.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D60[N=38;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D7[N=36;15] | 109.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D60[N=38;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D30[N=39;20] | 76.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D37[N=39;20] | 95.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D210[N=37;20] | 37.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D37[N=39;20] | 1.0 T cells/million cells |
Secondary
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines
Among cytokines expressed were interleukin-2 \[IL-2\], interferon-gamma \[IFN-γ\], tumour necrosis factor-alpha \[TNF-α\] and cluster of differentiation 40-ligand \[CD40-L\], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).
Time frame: At Day 0, 7, 30, 37, 60 and 210
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D30[N=39;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D37[N=39;20] | 36.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D30[N=39;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D60[N=38;20] | 21.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D37[N=39;20] | 37.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D0[N=38;19] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D0[N=38;19] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D30[N=39;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D7[N=36;15] | 78.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D37[N=39;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D60[N=38;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D7[N=36;15] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D210[N=37;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D30[N=39;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D37[N=39;20] | 22.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D7[N=36;15] | 41.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D60[N=38;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D37[N=39;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D210[N=37;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D7[N=36;15] | 105.5 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D210[N=37;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D37[N=39;20] | 22.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D60[N=38;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D60[N=38;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D30[N=39;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D210[N=37;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D210[N=37;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D37[N=39;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D7[N=36;15] | 51.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D30[N=39;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D7[N=36;15] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D37[N=39;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D7[N=36;15] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D210[N=37;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D60[N=38;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D7[N=36;15] | 184.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D30[N=39;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D210[N=37;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D60[N=38;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D30[N=39;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D210[N=37;20] | 1.0 T cells/million cells |
| GSK692342 Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D60[N=38;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D37[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D37[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D60[N=38;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D37[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D60[N=38;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D37[N=39;20] | 10.5 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D60[N=38;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D60[N=38;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D37[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D60[N=38;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D37[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D60[N=38;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D7[N=36;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D37[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D60[N=38;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D210[N=37;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D0[N=38;19] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D30[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D37[N=39;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D60[N=38;20] | 1.0 T cells/million cells |
| Placebo Group | Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines | CD8.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D7[N=36;15] | 1.0 T cells/million cells |
Secondary
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines
Among cytokines expressed were interleukin-2 \[IL-2\], interferon-gamma \[IFN-γ\], tumour necrosis factor-alpha \[TNF-α\] and cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).
Time frame: At Day 0, 7, 30, 37, 60 and 210
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK692342 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 0 [N=36;17] | 200.5 T cells/million cells |
| GSK692342 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 7 [N=32;15] | 4618.0 T cells/million cells |
| GSK692342 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 30 [N=38;18] | 2102.0 T cells/million cells |
| GSK692342 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 37 [N=37;19] | 8169.0 T cells/million cells |
| GSK692342 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 60 [N=38;20] | 5621.0 T cells/million cells |
| GSK692342 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 210 [N=36;20] | 2866.0 T cells/million cells |
| GSK692342 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 7 [N=32;15] | 1515.0 T cells/million cells |
| GSK692342 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 30 [N=38;18] | 93.5 T cells/million cells |
| GSK692342 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 60 [N=38;20] | 113.5 T cells/million cells |
| GSK692342 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 210 [N=36;20] | 33.5 T cells/million cells |
| GSK692342 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 0 [N=36;17] | 75.5 T cells/million cells |
| GSK692342 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 37 [N=37;19] | 648.0 T cells/million cells |
| Placebo Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 37 [N=37;19] | 37.0 T cells/million cells |
| Placebo Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 0 [N=36;17] | 57.0 T cells/million cells |
| Placebo Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 7 [N=32;15] | 1.0 T cells/million cells |
| Placebo Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 7 [N=32;15] | 146.0 T cells/million cells |
| Placebo Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 210 [N=36;20] | 31.5 T cells/million cells |
| Placebo Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 30 [N=38;18] | 122.0 T cells/million cells |
| Placebo Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 30 [N=38;18] | 15.5 T cells/million cells |
| Placebo Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 37 [N=37;19] | 159.0 T cells/million cells |
| Placebo Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 210 [N=36;20] | 113.5 T cells/million cells |
| Placebo Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, Day 60 [N=38;20] | 127.0 T cells/million cells |
| Placebo Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 60 [N=38;20] | 76.5 T cells/million cells |
| Placebo Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, Day 0 [N=36;17] | 44.0 T cells/million cells |