Safety and Immunogenicity Study of a Candidate Tuberculos... | NCT01262976 | Trialant
NCT01262976
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Sep 17, 2018Actual
Enrollment
240Actual
Phase
Phase 2
Conditions
Tuberculosis
Interventions
GSK's investigational vaccine 692342
Physiological saline
Countries
India
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01262976
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
113935
Secondary IDs
Not provided
Brief Title
Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Human Immunodeficiency Virus (HIV)-Positive Adults
Official Title
Safety and Immunogenicity of GSK Biologicals' Candidate Tuberculosis Vaccine (692342) When Administered to HIV-positive Adults Living in a Tuberculosis Endemic Region
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Nov 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 17, 2011Actual
Primary Completion Date
Jul 17, 2012Actual
Completion Date
Jun 4, 2015Actual
First Submitted Date
Dec 16, 2010
First Submission Date that Met QC Criteria
Dec 16, 2010
First Posted Date
Dec 20, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 12, 2016
Results First Submitted that Met QC Criteria
Dec 5, 2017
Results First Posted Date
Sep 17, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 11, 2013
Certification/Extension First Submitted that Passed QC Review
Apr 11, 2013
Certification/Extension First Posted Date
Apr 18, 2013Estimated
Last Update Submitted Date
Dec 5, 2017
Last Update Posted Date
Sep 17, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The purpose of the study is to assess the safety and immunogenicity of a GlaxoSmithKline (GSK) Biologicals' candidate tuberculosis vaccine (692342) administered to Human Immunodeficiency Virus (HIV)-positive adults aged 18 to 59 years, living in a tuberculosis endemic region.
Subjects will be followed-up for 3 years.
Subjects will be enrolled in 3 cohorts:
HIV-positive adults on highly active antiretroviral therapy
HIV-positive adults not on highly active antiretroviral therapy
HIV-negative adults
Each cohort will have 2 groups.
Detailed Description
This Protocol Posting has been updated following Protocol Amendment 1, February 2011, leading to the update of the outcome measures and the inclusion and exclusion criteria.
Conditions Module
Conditions
Tuberculosis
Keywords
Tuberculosis vaccine
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
240Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
HIV(+)-HA/GSK692342
Experimental
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Biological: GSK's investigational vaccine 692342
HIV(+)-HA/Placebo
Placebo Comparator
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Biological: Physiological saline
HIV(+)-TN/GSK692342
Experimental
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Biological: GSK's investigational vaccine 692342
HIV(+)-TN/Placebo
Placebo Comparator
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Biological: Physiological saline
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK's investigational vaccine 692342
Biological
Intramuscular, 2 doses
HIV(+)-HA/GSK692342
HIV(+)-TN/GSK692342
HIV(-)/GSK692342
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Subjects With Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed were pain and swelling. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site.
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Grade 3 Solicited General Symptoms
Solicited general symptoms assessed 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. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C.
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Grade 3 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. Grade 3 AE = an AE which prevented normal, everyday activities.
During the 30-day (Days 0-29) post-vaccination period
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.
From screening up to one month post Dose 2
Number of Subjects With Grade 3 and Grade 4 Haematological and Biochemical Levels
Secondary Outcomes
Measure
Description
Time Frame
Anti-Mycobacterium Tuberculosis Fusion Protein (M72) Specific Antibody Concentrations
Concentration of M72-specific antibodies, as measured by the enzyme-linked immunosorbent assay (ELISA), were given in ELISA units per milliliter (EU/mL) and expressed as geometric mean concentrations (GMCs).
At Days 0, 30, 60, 210 and at Years 1, 2 and 3
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
A male or female between, and including, 18 and 59 years of age at the time of the first vaccination.
Written informed consent obtained from the subject prior to any study procedure.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
has practiced adequate contraception for 30 days prior to vaccination,
has a negative pregnancy test on the day of vaccination, and
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Clinically acceptable laboratory values at screening as determined by the investigator.
No evidence of tuberculosis disease with no evidence of pulmonary pathology as confirmed by chest X-ray.
No history of extra pulmonary tuberculosis.
Based on their medical history, all subjects must have no history of chemotherapy for tuberculosis.
Additional inclusion criteria for subjects to be enrolled in HIV+ on highly active antiretroviral therapy cohort:
Subjects must be HIV-positive and under care of a physician for at least 6 months.
Subjects must have a CD4+T cell count >= 250 cells/mm3 at screening.
Subjects must be stable on highly active antiretroviral therapy for at least 6 months, with an undetectable HIV viral load level at screening.
Additional inclusion criteria for subjects to be enrolled in HIV+ treatment naïve cohort:
Subjects must be HIV-positive and under care of a physician for at least 6 months
Subjects must be highly active antiretroviral therapy-naïve (never received anti-retroviral therapy after HIV diagnosis)
Subjects must have a CD4 + T cell count above 350 cells/mm3 at screening.
Subjects for whom commencement of highly active antiretroviral therapy is not expected based on current assessment within next year.
Subjects must have a viral load between 5000 - 80000 copies/mL at screening.
Additional inclusion criteria for subjects to be enrolled in HIV-negative cohort
• Subjects must be negative for HIV-1.
Exclusion Criteria:
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Administration of a registered live vaccine not foreseen by the study within 30 days preceding the first dose of study vaccine and administration of a registered inactivated vaccine within 14 days preceding the first dose of study vaccine.
History of previous administration of experimental Mtb vaccines.
History of previous exposure to components of the investigational vaccine within 30 days preceding the first dose of study vaccine
Chronic administration of immunosuppressant or other immune-modifying drugs within six months prior to the first vaccine/product dose. For corticosteroids, this will mean prednisone >= 20 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
Any condition or illness or medication, which in the opinion of the Investigator might interfere with the evaluation of the safety or immunogenicity of the vaccine.
Planned participation or participation in another experimental protocol with an experimental product during the study period.
Administration of any immunoglobulin, any immunotherapy and/or any blood products within the three months preceding the first dose of study vaccination, or planned administrations during the study period.
Subjects taking any of the following medication: chronic administration of systemic steroids, interleukins, systemic interferon or systemic chemotherapy.
History of allergic reactions or anaphylaxis to any drug or vaccine.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
History of chronic alcohol consumption and/or drug abuse which in the Investigator's opinion would put the subject at risk.
Pregnant female, lactating female or female planning to become pregnant or stop contraception.
Acute or chronic clinically relevant pulmonary, cardiovascular, hepatic or renal function abnormality as determined by physical examination or laboratory screening tests.
Additional exclusion criteria for subjects to be enrolled in HIV+ on highly active antiretroviral therapy cohort:
Any change in anti-retroviral drug regimen within 12 weeks prior to screening.
Any chronic drug therapy, other than highly active antiretroviral therapy or prophylaxis for opportunistic HIV related infections, birth control pills, anti-histamines for seasonal allergies and SSRIs.
Kumarasamy N, Poongulali S, Beulah FE, Akite EJ, Ayuk LN, Bollaerts A, Demoitie MA, Jongert E, Ofori-Anyinam O, Van Der Meeren O. Long-term safety and immunogenicity of the M72/AS01E candidate tuberculosis vaccine in HIV-positive and -negative Indian adults: Results from a phase II randomized controlled trial. Medicine (Baltimore). 2018 Nov;97(45):e13120. doi: 10.1097/MD.0000000000013120.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
FG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
FG002
HIV(+)-TN/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
FG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
FG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
FG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Periods
Title
Milestones
Reasons Not Completed
Up to Month 2
Type
Comment
Milestone Data
STARTED
FG00040 subjects
FG00140 subjects
FG00240 subjects
FG00340 subjects
FG00440 subjects
FG00540 subjects
COMPLETED
FG00037 subjects
FG00139 subjects
FG00239 subjects
FG00338 subjects
FG004
NOT COMPLETED
FG0003 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Serious Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Up to Month 7
Type
Comment
Milestone Data
STARTED
FG00040 subjects
FG00140 subjects
FG00240 subjects
FG003
Up to Year 1
Type
Comment
Milestone Data
STARTED
FG00040 subjects
FG00140 subjects
FG00240 subjects
FG003
Up to Year 2
Type
Comment
Milestone Data
STARTED
FG00040 subjects
FG00140 subjects
FG00240 subjects
FG003
Up to Year 3
Type
Comment
Milestone Data
STARTED
FG00040 subjects
FG00140 subjects
FG00240 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
BG001
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Subjects With Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed were pain and swelling. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.
Posted
Count of Participants
Participants
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Adverse Events Module
Frequency Threshold
5
Time Frame
Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myocardial infarction
Cardiac disorders
MedDRA 19.1
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal discomfort
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
GSK Response Center
GlaxoSmithKline
866-435-7343
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D014376
Tuberculosis
Ancestor Terms
ID
Term
D009164
Mycobacterium Infections
D000193
Actinomycetales Infections
D016908
Gram-Positive Bacterial Infections
D001424
Bacterial Infections
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
HIV(-)/GSK692342
Experimental
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Biological: GSK's investigational vaccine 692342
HIV(-)/Placebo
Placebo Comparator
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Biological: Physiological saline
Physiological saline
Biological
Intramuscular, 2 doses
HIV(+)-HA/Placebo
HIV(+)-TN/Placebo
HIV(-)/Placebo
Haematological and biochemical parameters assessed were haemoglobin [Hgb], white blood cells [WBC], platelets [PLA], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CREA]. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
At Day 0
Number of Subjects With Grade 3 and 4 Haematological and Biochemical Levels
Haematological and biochemical parameters assessed were haemoglobin [Hgb], white blood cells [WBC], platelets [PLA], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CREA]. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
At Day 7
Number of Subjects With Grade 3 and Grade 4 Haematological/Biochemical Levels
Haematological and biochemical parameters assessed were haemoglobin [Hgb], white blood cells [WBC], platelets [PLA], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CREA]. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
At Day 30
Number of Subjects With Grade 3-4 Haematological and Biochemical Levels
Haematological and biochemical parameters assessed were haemoglobin [Hgb], white blood cells [WBC], platelets [PLA], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CREA]. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
At Day 37
Number of Subjects With Grade 3-4 Haematological/Biochemical Levels
Haematological and biochemical parameters assessed were haemoglobin [Hgb], white blood cells [WBC], platelets [PLA], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CREA]. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
At Day 60
Number of Seroconverted Subjects for M72-specific Antibodies
A seroconverted subject for M72 antibodies was defined as a seronegative subject at baseline, with the appearance of M72 antibody concentration higher than or equal to (≥) the cut-off value of 2.8 EL.U/mL post vaccination. Antibody concentrations below the cut-off value of the assay were given an arbitrary value of half the cut-off value for the purpose of GMC calculation.
At Days 0, 30, 60, 210 and at Years 1, 2 and 3
Frequency of M72-cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Immune Markers
Among immune markers expressed after background reduction were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). This endpoint presents results for CD4-all doubles.
At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combinations: CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-),CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+),CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-),CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+).
At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combination: CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+),CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-),CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+),CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-)
At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combination: CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-),CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+),CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), CD4.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+).
At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3
Frequency of M72-cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers
Among immune markers expressed after background reduction were interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for CD8-all doubles.
At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L) interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combination: CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+),CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-),CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+),CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-),CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+).
At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L) interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combination: CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-),CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+),CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-),CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+),CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-).
At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L) interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combination: CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-),CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-),CD8.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+).
At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3
Number of Subjects With Any Solicited Local Symptoms
Solicited local symptoms assessed were pain and swelling. Any = occurrence of the symptom regardless of intensity grade.
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any Solicited General Symptoms
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms (Gastro), headache, malaise, myalgia and temperature. Any = occurrence of the symptom regardless of intensity grade.
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any Unsolicited AEs
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
During the 30-day (Days 0-29) post-vaccination period
Number of Subjects With 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.
From one month post Dose 2 up to study end (Year 3)
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Biochemical and haematological parameters included haemoglobin [Hgb], white blood cells [WBC], platelets [PLA], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CREA]. Levels assessed were - normal, grade 1, grade 2 and missing grade. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
At Days 0, 7, 30, 37 and 60
38 subjects
FG00536 subjects
2 subjects
FG0054 subjects
0 subjects
FG0040 subjects
FG0050 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Migrated/moved from study area
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0051 subjects
Other
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0052 subjects
40 subjects
FG00440 subjects
FG00540 subjects
COMPLETED
FG00035 subjects
FG00140 subjects
FG00234 subjects
FG00334 subjects
FG00438 subjects
FG00536 subjects
NOT COMPLETED
FG0005 subjects
FG0010 subjects
FG0026 subjects
FG0036 subjects
FG0042 subjects
FG0054 subjects
Type
Comment
Reasons
Serious Adverse Event
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Migrated/moved from study area
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0033 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0033 subjects
FG004
Other
FG0003 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
40 subjects
FG00440 subjects
FG00540 subjects
COMPLETED
FG00031 subjects
FG00139 subjects
FG00237 subjects
FG00336 subjects
FG00429 subjects
FG00531 subjects
NOT COMPLETED
FG0009 subjects
FG0011 subjects
FG0023 subjects
FG0034 subjects
FG00411 subjects
FG0059 subjects
Type
Comment
Reasons
Serious Adverse Event
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Migrated/moved from study area
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG004
Lost to Follow-up
FG0004 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Other
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Subjects with unknown completion status
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
40 subjects
FG00440 subjects
FG00540 subjects
COMPLETED
FG00035 subjects
FG00139 subjects
FG00235 subjects
FG00336 subjects
FG00436 subjects
FG00535 subjects
NOT COMPLETED
FG0005 subjects
FG0011 subjects
FG0025 subjects
FG0034 subjects
FG0044 subjects
FG0055 subjects
Type
Comment
Reasons
Serious Adverse Event
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Migrated/moved from study area
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG004
Subjects with unknown completion status
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Other
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
40 subjects
FG00440 subjects
FG00540 subjects
COMPLETED
FG00034 subjects
FG00138 subjects
FG00233 subjects
FG00335 subjects
FG00438 subjects
FG00536 subjects
NOT COMPLETED
FG0006 subjects
FG0012 subjects
FG0027 subjects
FG0035 subjects
FG0042 subjects
FG0054 subjects
Type
Comment
Reasons
Serious Adverse Event
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Migrated/moved from study area
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0012 subjects
FG0024 subjects
FG0033 subjects
FG004
Subjects with unknown completion status
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Other
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
HIV(+)HA-/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
BG002
HIV(+)-TN/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
BG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
BG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
BG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
BG006
Total
Total of all reporting groups
40
BG00140
BG00240
BG00340
BG00440
BG00540
BG006240
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00036.0± 6.5
BG00135.5± 6.2
BG00232.6± 6.5
BG00332.2± 5.3
BG00433.9± 7.6
BG00534.6± 6.4
BG00634.1± 6.5
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00027
BG00126
BG00229
BG00328
BG00430
BG00527
BG006167
Male
BG00013
BG00114
BG00211
BG00312
BG004
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Geographic ancestry
Title
Measurements
Asian - Central/South Asian Heritage
BG00040
BG00140
BG00238
BG00336
BG00438
BG00539
BG006231
Asian - East Asian Heritage
BG0000
BG0010
BG0020
BG0031
BG004
Asian - South East Asian Heritage
BG0000
BG0010
BG0022
BG0033
BG004
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/ GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG00340
OG00440
OG00540
Title
Denominators
Categories
Grade 3 Pain, Dose 1
ParticipantsOG00040
ParticipantsOG00140
ParticipantsOG00240
ParticipantsOG00340
ParticipantsOG00440
ParticipantsOG00540
Title
Measurements
OG0001
OG0010
OG0021
OG003
Grade 3 Swelling, Dose 1
ParticipantsOG00040
ParticipantsOG00140
ParticipantsOG00240
ParticipantsOG00340
Grade 3 Pain, Dose 2
ParticipantsOG00039
ParticipantsOG00139
ParticipantsOG00240
ParticipantsOG00340
Grade 3 Swelling, Dose 2
ParticipantsOG00039
ParticipantsOG00139
ParticipantsOG00240
ParticipantsOG00340
Grade 3 Pain, Across doses
ParticipantsOG00040
ParticipantsOG00140
ParticipantsOG00240
ParticipantsOG00340
Grade 3 Swelling, Across doses
ParticipantsOG00040
ParticipantsOG00140
ParticipantsOG00240
ParticipantsOG00340
Primary
Number of Subjects With Grade 3 Solicited General Symptoms
Solicited general symptoms assessed 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. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.
Posted
Count of Participants
Participants
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/ GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG003
Title
Denominators
Categories
Grade 3 Fatigue, Dose 1
ParticipantsOG00040
ParticipantsOG00140
ParticipantsOG00240
ParticipantsOG003
Primary
Number of Subjects With Grade 3 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. Grade 3 AE = an AE which prevented normal, everyday activities.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Posted
Count of Participants
Participants
During the 30-day (Days 0-29) post-vaccination period
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/ GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG003
Title
Denominators
Categories
Title
Measurements
OG00026
OG00127
OG00235
OG003
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.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Posted
Count of Participants
Participants
From screening up to one month post Dose 2
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/ GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0022
OG003
Primary
Number of Subjects With Grade 3 and Grade 4 Haematological and Biochemical Levels
Haematological and biochemical parameters assessed were haemoglobin [Hgb], white blood cells [WBC], platelets [PLA], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CREA]. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Posted
Count of Participants
Participants
At Day 0
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG003
Title
Denominators
Categories
Grade 3 - Hgb (Change from baseline)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Subjects With Grade 3 and 4 Haematological and Biochemical Levels
Haematological and biochemical parameters assessed were haemoglobin [Hgb], white blood cells [WBC], platelets [PLA], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CREA]. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Posted
Count of Participants
Participants
At Day 7
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG003
Title
Denominators
Categories
Grade 3 - Hgb (Change from baseline)
ParticipantsOG00040
ParticipantsOG00140
ParticipantsOG00240
ParticipantsOG003
Primary
Number of Subjects With Grade 3 and Grade 4 Haematological/Biochemical Levels
Haematological and biochemical parameters assessed were haemoglobin [Hgb], white blood cells [WBC], platelets [PLA], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CREA]. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Posted
Count of Participants
Participants
At Day 30
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/ GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG003
Title
Denominators
Categories
Grade 3 - Hgb (Change from baseline)
ParticipantsOG00039
ParticipantsOG00140
ParticipantsOG00240
ParticipantsOG003
Primary
Number of Subjects With Grade 3-4 Haematological and Biochemical Levels
Haematological and biochemical parameters assessed were haemoglobin [Hgb], white blood cells [WBC], platelets [PLA], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CREA]. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Posted
Count of Participants
Participants
At Day 37
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/ GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG003
Title
Denominators
Categories
Grade 3 - Hgb (Change from baseline)
ParticipantsOG00038
ParticipantsOG00139
ParticipantsOG00239
ParticipantsOG003
Primary
Number of Subjects With Grade 3-4 Haematological/Biochemical Levels
Haematological and biochemical parameters assessed were haemoglobin [Hgb], white blood cells [WBC], platelets [PLA], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CREA]. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Posted
Count of Participants
Participants
At Day 60
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/ GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG003
Title
Denominators
Categories
Grade 3 - Hgb (Change from baseline)
ParticipantsOG00037
ParticipantsOG00139
ParticipantsOG00239
ParticipantsOG003
Secondary
Anti-Mycobacterium Tuberculosis Fusion Protein (M72) Specific Antibody Concentrations
Concentration of M72-specific antibodies, as measured by the enzyme-linked immunosorbent assay (ELISA), were given in ELISA units per milliliter (EU/mL) and expressed as geometric mean concentrations (GMCs).
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
At Days 0, 30, 60, 210 and at Years 1, 2 and 3
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/ GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00039
OG00139
OG00239
OG003
Title
Denominators
Categories
Anti-M72, Day 0
ParticipantsOG00039
ParticipantsOG00139
ParticipantsOG00239
ParticipantsOG003
Secondary
Number of Seroconverted Subjects for M72-specific Antibodies
A seroconverted subject for M72 antibodies was defined as a seronegative subject at baseline, with the appearance of M72 antibody concentration higher than or equal to (≥) the cut-off value of 2.8 EL.U/mL post vaccination. Antibody concentrations below the cut-off value of the assay were given an arbitrary value of half the cut-off value for the purpose of GMC calculation.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Posted
Count of Participants
Participants
At Days 0, 30, 60, 210 and at Years 1, 2 and 3
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/ GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00039
OG00139
OG00239
OG003
Title
Denominators
Categories
Anti-M72, Day 0
ParticipantsOG00039
ParticipantsOG00139
ParticipantsOG00239
ParticipantsOG003
Secondary
Frequency of M72-cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Immune Markers
Among immune markers expressed after background reduction were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). This endpoint presents results for CD4-all doubles.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Posted
Median
Inter-Quartile Range
T-cells/million cells
At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/ GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00034
OG00137
OG00234
OG003
Title
Denominators
Categories
CD4-all doubles, Day 0
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00232
ParticipantsOG003
Secondary
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combinations: CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-),CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+),CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-),CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+).
The analysis was performed on the ATP cohort for immunogenicity,which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Posted
Median
Inter-Quartile Range
T-cells/million cells
At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/ GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00034
OG00137
OG00234
OG003
Title
Denominators
Categories
CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), Day 0
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00232
ParticipantsOG003
Secondary
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combination: CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+),CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-),CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+),CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-)
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Posted
Median
Inter-Quartile Range
T-cells/million cells
At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/ GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00034
OG00137
OG00234
OG003
Title
Denominators
Categories
CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), Day 0
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00232
ParticipantsOG003
Secondary
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combination: CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-),CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+),CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), CD4.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+).
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Posted
Median
Inter-Quartile Range
T-cells/million cells
At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/ GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00034
OG00137
OG00234
OG003
Title
Denominators
Categories
CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), Day 0
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00232
ParticipantsOG003
Secondary
Frequency of M72-cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers
Among immune markers expressed after background reduction were interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for CD8-all doubles.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Posted
Median
Inter-Quartile Range
T-cells/million cells
At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/ GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00034
OG00137
OG00234
OG003
Title
Denominators
Categories
CD8-all doubles, Day 0
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00232
ParticipantsOG003
Secondary
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L) interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combination: CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+),CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-),CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+),CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-),CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+).
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Posted
Median
Inter-Quartile Range
T-cells/million cells
At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/ GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00034
OG00137
OG00234
OG003
Title
Denominators
Categories
CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), Day 0
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00232
ParticipantsOG003
Secondary
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L) interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combination: CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-),CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+),CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-),CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+),CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-).
The analysis was performed on the ATP cohort for immunogenicity,which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Posted
Median
Inter-Quartile Range
T-cells/million cells
At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/ GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00034
OG00137
OG00234
OG003
Title
Denominators
Categories
CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), Day 0
ParticipantsOG00034
ParticipantsOG00137
ParticipantsOG00232
ParticipantsOG003
Secondary
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L) interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combination: CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-),CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-),CD8.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+).
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Posted
Median
Inter-Quartile Range
T-cells/million cells
At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00034
OG00137
OG00234
OG003
Title
Denominators
Categories
CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), Day 0
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00232
ParticipantsOG003
Secondary
Number of Subjects With Any Solicited Local Symptoms
Solicited local symptoms assessed were pain and swelling. Any = occurrence of the symptom regardless of intensity grade.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in their symptom sheets.
Posted
Count of Participants
Participants
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG003
Title
Denominators
Categories
Any Pain, Dose 1
ParticipantsOG00040
ParticipantsOG00140
ParticipantsOG00240
ParticipantsOG003
Secondary
Number of Subjects With Any Solicited General Symptoms
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms (Gastro), headache, malaise, myalgia and temperature. Any = occurrence of the symptom regardless of intensity grade.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in their symptom sheets.
Posted
Count of Participants
Participants
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG003
Title
Denominators
Categories
Any Fatigue, Dose 1
ParticipantsOG00040
ParticipantsOG00140
ParticipantsOG00240
ParticipantsOG003
Secondary
Number of Subjects With Any Unsolicited AEs
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Posted
Count of Participants
Participants
During the 30-day (Days 0-29) post-vaccination period
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG003
Title
Denominators
Categories
Title
Measurements
OG00026
OG00127
OG00235
OG003
Secondary
Number of Subjects With 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.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Posted
Count of Participants
Participants
From one month post Dose 2 up to study end (Year 3)
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/ GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG003
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
OG0022
OG003
Secondary
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Biochemical and haematological parameters included haemoglobin [Hgb], white blood cells [WBC], platelets [PLA], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CREA]. Levels assessed were - normal, grade 1, grade 2 and missing grade. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Posted
Count of Participants
Participants
At Days 0, 7, 30, 37 and 60
ID
Title
Description
OG000
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG002
HIV(+)-TN/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
OG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG003
Title
Denominators
Categories
Normal - Hgb (Change from baseline), Day 0
ParticipantsOG00040
ParticipantsOG00140
ParticipantsOG00240
ParticipantsOG003
0
40
2
40
29
40
EG001
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
0
40
0
40
29
40
EG002
HIV(+)-TN/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
2
40
3
40
33
40
EG003
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
0
40
0
40
33
40
EG004
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
0
440
0
40
19
40
EG005
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
0
40
0
40
13
40
EG0000 events0 affected40 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected40 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected40 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
Cavernous sinus thrombosis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected40 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
Gastroenteritis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected40 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
Viral infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected40 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
Partial seizures
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0003 events1 affected40 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected40 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
Stevens-johnson syndrome
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected40 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
EG0000 events0 affected40 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected40 at risk
EG0033 events3 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0003 events3 affected40 at risk
EG0011 events1 affected40 at risk
EG0024 events4 affected40 at risk
EG0031 events1 affected40 at risk
EG0041 events1 affected40 at risk
EG0051 events1 affected40 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected40 at risk
EG0022 events2 affected40 at risk
EG0031 events1 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0014 events3 affected40 at risk
EG0023 events3 affected40 at risk
EG0034 events4 affected40 at risk
EG0042 events2 affected40 at risk
EG0051 events1 affected40 at risk
Asthenia
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected40 at risk
EG0024 events4 affected40 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected40 at risk
EG0027 events6 affected40 at risk
EG0035 events4 affected40 at risk
EG0041 events1 affected40 at risk
EG0053 events2 affected40 at risk
Chest pain
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected40 at risk
EG0032 events2 affected40 at risk
EG0040 events0 affected40 at risk
EG0052 events2 affected40 at risk
Constipation
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0003 events3 affected40 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected40 at risk
EG0032 events2 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0003 events3 affected40 at risk
EG0012 events1 affected40 at risk
EG0027 events7 affected40 at risk
EG0035 events5 affected40 at risk
EG0040 events0 affected40 at risk
EG0053 events3 affected40 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0014 events4 affected40 at risk
EG0027 events5 affected40 at risk
EG0033 events3 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected40 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected40 at risk
EG0022 events2 affected40 at risk
EG0036 events5 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected40 at risk
EG0022 events2 affected40 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
Fatigue
General disorders
MedDRA 19.1
Systematic Assessment
EG0005 events3 affected40 at risk
EG0013 events2 affected40 at risk
EG0028 events5 affected40 at risk
EG0031 events1 affected40 at risk
EG0043 events2 affected40 at risk
EG0050 events0 affected40 at risk
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected40 at risk
EG0022 events1 affected40 at risk
EG0030 events0 affected40 at risk
EG0042 events2 affected40 at risk
EG0051 events1 affected40 at risk
Headache
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG00012 events9 affected40 at risk
EG0015 events3 affected40 at risk
EG0026 events5 affected40 at risk
EG0037 events7 affected40 at risk
EG00413 events9 affected40 at risk
EG0055 events4 affected40 at risk
Hypoaesthesia
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0013 events3 affected40 at risk
EG0021 events1 affected40 at risk
EG0032 events2 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
Lipoatrophy
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0013 events3 affected40 at risk
EG0020 events0 affected40 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
Malaise
General disorders
MedDRA 19.1
Systematic Assessment
EG0004 events2 affected40 at risk
EG0012 events2 affected40 at risk
EG0022 events1 affected40 at risk
EG0030 events0 affected40 at risk
EG0043 events2 affected40 at risk
EG0050 events0 affected40 at risk
Mouth ulceration
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected40 at risk
EG0022 events2 affected40 at risk
EG0032 events2 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0003 events2 affected40 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected40 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0008 events5 affected40 at risk
EG0010 events0 affected40 at risk
EG0023 events3 affected40 at risk
EG0031 events1 affected40 at risk
EG0046 events3 affected40 at risk
EG0051 events1 affected40 at risk
Nasopharyngitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0007 events5 affected40 at risk
EG0014 events4 affected40 at risk
EG0027 events6 affected40 at risk
EG0034 events4 affected40 at risk
EG0041 events1 affected40 at risk
EG0051 events1 affected40 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0003 events3 affected40 at risk
EG0010 events0 affected40 at risk
EG0022 events2 affected40 at risk
EG0032 events2 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected40 at risk
Oral candidiasis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected40 at risk
EG0022 events2 affected40 at risk
EG0032 events2 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected40 at risk
EG0023 events2 affected40 at risk
EG0031 events1 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
Pain
General disorders
MedDRA 19.1
Systematic Assessment
EG00024 events16 affected40 at risk
EG00115 events10 affected40 at risk
EG00214 events10 affected40 at risk
EG00311 events8 affected40 at risk
EG00416 events10 affected40 at risk
EG0054 events4 affected40 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0016 events5 affected40 at risk
EG0024 events4 affected40 at risk
EG0037 events6 affected40 at risk
EG0041 events1 affected40 at risk
EG0051 events1 affected40 at risk
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0014 events4 affected40 at risk
EG0022 events2 affected40 at risk
EG0034 events4 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected40 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected40 at risk
EG0028 events8 affected40 at risk
EG0039 events7 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
Pyrexia
General disorders
MedDRA 19.1
Systematic Assessment
EG0006 events6 affected40 at risk
EG0012 events2 affected40 at risk
EG00210 events7 affected40 at risk
EG0036 events6 affected40 at risk
EG00412 events9 affected40 at risk
EG0051 events1 affected40 at risk
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected40 at risk
EG0024 events3 affected40 at risk
EG0031 events1 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0013 events3 affected40 at risk
EG0022 events2 affected40 at risk
EG0034 events4 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected40 at risk
Swelling
General disorders
MedDRA 19.1
Systematic Assessment
EG0007 events5 affected40 at risk
EG0011 events1 affected40 at risk
EG0024 events4 affected40 at risk
EG0030 events0 affected40 at risk
EG0046 events4 affected40 at risk
EG0050 events0 affected40 at risk
Vaginal discharge
Reproductive system and breast disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected40 at risk
EG0032 events2 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.