Safety and Immunogenicity of a Candidate Tuberculosis (TB... | NCT00707967

NCT00707967

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Subjects receiving the candidate vaccine	Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342
Group B	Placebo Comparator	Subjects receiving the adjuvant	Biological: Control vaccine with the adjuvant system.
Group C	Placebo Comparator	Subjects receiving physiological saline	Biological: Control vaccine with physiological saline

Name	Type	Description	Arm Group Labels	Other Names
GSK's candidate Mycobacterium tuberculosis vaccine 692342	Biological	Intramuscular injection, 2 doses at 0, 1 month	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects With Solicited Local Symptoms	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.	During the 7-day period (Days 0-6) post vaccination following each dose
Number of Subjects With Solicited General Symptoms	Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.	During the 7-day period (Days 0-6) post vaccination following each dose
Number of Subjects With Unsolicited Adverse Events (AEs)	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.	During the 30-day period (Days 0-29) post vaccination
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

Secondary Outcomes

Measure	Description	Time Frame
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines	Among cytokines expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).

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 50 years of age at the time of the first vaccination.
Written informed consent obtained from the subject prior to any study procedure.
Subjects must be HIV-positive and must have:
- received Highly Active Antiretroviral therapy for a minimum of 12 consecutive months prior to screening
- documented suppressed HIV-1 RNA levels following HAART-treatment.
- a protocol defined CD4+ T cell count at screening
If the subject is female, she must be of non-childbearing potential, or she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of vaccination.
Clinically acceptable laboratory values prior to randomisation as determined by the Investigator.
No evidence of TB disease with no pulmonary pathology as confirmed by chest X-ray.
No history of extrapulmonary TB.
No history of chemotherapy for TB.

Exclusion Criteria:

Any change in antiretroviral drug regimen within 12 weeks prior to screening.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Administration of a registered live vaccine not foreseen by the study within 30 days preceding the first dose of study vaccine and administration of a registered inactivated vaccine within 14 days preceding the first dose of study vaccine.
History of previous administration of experimental Mycobacterium tuberculosis vaccines.
History of previous exposure to experimental products containing components of the experimental vaccine.
Chronic administration of immunosuppressive or other immune-modifying drugs within six months prior to the first vaccine dose.
Administration of any immunoglobulins, 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.
Any condition or illness (acute, chronic or history) or medication, which in the opinion of the Investigator might interfere with the evaluation of the safety or immunogenicity of the vaccine.
Planned participation or participation in another experimental protocol during the study period.
A family history of congenital or hereditary immunodeficiency. •Any chronic drug therapy, other than HAART or prophylaxis for opportunistic HIV-related infections to be continued during the study period. Vitamins and/or dietary supplements, birth control pills, anti-histamines for seasonal allergies and SSRIs are allowed.
Subjects taking any of the following medication: systemic steroids, interleukins, systemic interferons or systemic chemotherapy.
History of allergic reactions or anaphylaxis to any 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.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Lausanne		1011	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24911353	Derived	Thacher EG, Cavassini M, Audran R, Thierry AC, Bollaerts A, Cohen J, Demoitie MA, Ejigu D, Mettens P, Moris P, Ofori-Anyinam O, Spertini F. Safety and immunogenicity of the M72/AS01 candidate tuberculosis vaccine in HIV-infected adults on combination antiretroviral therapy: a phase I/II, randomized trial. AIDS. 2014 Jul 31;28(12):1769-81. doi: 10.1097/QAD.0000000000000343.
24864125

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	GSK692342 Group	Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
FG001	Control Group

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	GSK692342 Group	Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
BG001	Control Group	Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
BG002	Placebo Group	Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00022 BG0018 BG0027 BG00337

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Any Pain, Dose 1

Title	Measurements
	OG00020 OG0016 OG0021

Grade 3 Pain, Dose 1

Primary

Number of Subjects With Solicited General Symptoms

Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Number

Subjects

During the 7-day period (Days 0-6) post vaccination following each dose

ID	Title	Description
OG000	GSK692342 Group	Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG001	Control Group	Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG002	Placebo Group

Primary

Number of Subjects With Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Number

Subjects

During the 30-day period (Days 0-29) post vaccination

ID	Title	Description
OG000	GSK692342 Group	Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG001	Control Group	Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG002

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.

Posted

Number

Subjects

During the entire study period, from Day 0 up to Day 210

ID	Title	Description
OG000	GSK692342 Group	Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG001	Control Group	Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG002	Placebo Group	Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.

Primary

Number of Subjects With Normal Biochemical and Haematological Levels

Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Number

Subjects

At Day 0, 7, 30, 37 and 60

ID	Title	Description
OG000	GSK692342 Group	Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG001	Control Group	Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG002	Placebo Group	Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.

Primary

Number of Subjects With Normal Haematological Levels

Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Number

Subjects

At Day 0, 7, 30, 37 and 60

ID	Title	Description
OG000	GSK692342 Group	Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG001	Control Group	Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG002	Placebo Group	Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.

Primary

Number of Subjects With Normal Haematological Levels

Among biochemical and haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Number

Subjects

At Day 0, 7, 30, 37 and 60

ID	Title	Description
OG000	GSK692342 Group	Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG001	Control Group	Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG002	Placebo Group	Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.

Primary

Number of Subjects With Biochemical and Haematological Levels Below Normal

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Number

Subjects

At Day 0, 7, 30, 37 and 60

ID	Title	Description
OG000	GSK692342 Group	Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG001	Control Group	Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG002	Placebo Group	Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.

Primary

Number of Subjects With Haematological Levels Below Normal

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Number

Subjects

At Day 0, 7, 30, 37 and 60

ID	Title	Description
OG000	GSK692342 Group	Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG001	Control Group	Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG002	Placebo Group	Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.

Primary

Number of Subjects With Haematological Levels Below Normal

Among biochemical and haematological parameters assessed were [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Number

Subjects

At Day 0, 7, 30, 37 and 60

ID	Title	Description
OG000	GSK692342 Group	Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG001	Control Group	Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG002	Placebo Group	Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.

Primary

Number of Subjects With Biochemical and Haematological Levels Above Normal

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Number

Subjects

At Day 0, 7, 30, 37 and 60

ID	Title	Description
OG000	GSK692342 Group	Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG001	Control Group	Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG002	Placebo Group	Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.

Primary

Number of Subjects With Haematological Levels Above Normal

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Number

Subjects

At Day 0, 7, 30, 37 and 60

ID	Title	Description
OG000	GSK692342 Group	Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG001	Control Group	Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG002	Placebo Group	Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.

Primary

Number of Subjects With Haematological Levels Above Normal

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Number

Subjects

At Day 0, 7, 30, 37 and 60

ID	Title	Description
OG000	GSK692342 Group	Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG001	Control Group	Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG002	Placebo Group	Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.

Secondary

Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines

Among cytokines expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.

Posted

Median

Inter-Quartile Range

T cells/million cells

At Day 0, 30, 60 and 210

ID	Title	Description
OG000	GSK692342 Group	Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG001	Control Group	Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG002	Placebo Group

Secondary

Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule

Expressed cytokine combinations for CD4+ T cells were CD40-L and interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α]; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.

For CD8+ T cells no vaccine induced responses were observed, thus results are presented only for the frequency of M72-specific CD8+ T cells expressing at least two cytokines.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.

Posted

Median

Inter-Quartile Range

T cells/million cells

At Day 0, 30, 60 and 210

ID	Title	Description
OG000	GSK692342 Group	Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG001	Control Group	Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG002	Placebo Group

Secondary

Cell Count of CD4+ T Cells

CD4+ T cell counts are defined by values greater than (>) 200 cells per cubic millimeters (mm3) at screening for enrolment into the study.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Median

Inter-Quartile Range

T cells/cubic millimeter

At Day 0, 30, 60 and 210

ID	Title	Description
OG000	GSK692342 Group	Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG001	Control Group	Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG002	Placebo Group	Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.

Secondary

Anti-M72 Specific Antibody Concentrations

Concentrations given in Enzyme-Linked Immunosorbent Assay units per milliliter (EL.U/mL) were expressed in 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 variables were available.

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

At Day 0, 30, 60 and 210

ID	Title	Description
OG000	GSK692342 Group	Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG001	Control Group	Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG002	Placebo Group	Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.

Secondary

Number of Subjects With Significant Highly Active Anti-Retroviral Therapy (HAART) Changes

Recorded significant HAART change refers to one subject switching the Combivir drug to Truvada as planned by personal physician, with no relationship to vaccination, prior to study enrolment.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Number

Subjects

From Day 60 to Day 210

ID	Title	Description
OG000	GSK692342 Group	Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG001	Control Group	Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
OG002	Placebo Group	Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	GSK692342 Group	Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	2	22	21	22
EG001	Control Group	Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	0	8	8	8
EG002	Placebo Group	Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	0	7	6	7

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Appendicitis	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0001 affected22 at risk EG0010 affected8 at risk EG0020 affected7 at risk
Cellulitis	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0001 affected22 at risk EG0010 affected8 at risk EG0020 affected7 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0004 affected22 at risk EG0012 affected8 at risk EG0022 affected7 at risk
Headache	Nervous system disorders	MedDRA 12.1	Systematic Assessment		EG0005 affected22 at risk EG0012 affected8 at risk EG0020 affected7 at risk
Cd4 lymphocytes decreased	Investigations	MedDRA 12.1	Systematic Assessment		EG0005 affected22 at risk EG0010 affected8 at risk EG0021 affected7 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment		EG0004 affected22 at risk EG0010 affected8 at risk EG0020 affected7 at risk
Migraine	Nervous system disorders	MedDRA 12.1	Systematic Assessment		EG0003 affected22 at risk EG0010 affected8 at risk EG0020 affected7 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment		EG0002 affected22 at risk EG0011 affected8 at risk EG0020 affected7 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment		EG0001 affected22 at risk EG0010 affected8 at risk EG0022 affected7 at risk
Fatigue	General disorders	MedDRA 12.1	Systematic Assessment		EG0002 affected22 at risk EG0010 affected8 at risk EG0020 affected7 at risk
Feeling hot	General disorders	MedDRA 12.1	Systematic Assessment		EG0002 affected22 at risk EG0010 affected8 at risk EG0020 affected7 at risk
Injection site pruritus	General disorders	MedDRA 12.1	Systematic Assessment		EG0002 affected22 at risk EG0010 affected8 at risk EG0020 affected7 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment		EG0002 affected22 at risk EG0010 affected8 at risk EG0020 affected7 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment		EG0002 affected22 at risk EG0010 affected8 at risk EG0021 affected7 at risk
Pyrexia	General disorders	MedDRA 12.1	Systematic Assessment		EG0002 affected22 at risk EG0010 affected8 at risk EG0020 affected7 at risk
Pterygium	Eye disorders	MedDRA 12.1	Systematic Assessment		EG0000 affected22 at risk EG0010 affected8 at risk EG0021 affected7 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0001 affected22 at risk EG0010 affected8 at risk EG0021 affected7 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0001 affected22 at risk EG0011 affected8 at risk EG0020 affected7 at risk
Flatulence	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 affected22 at risk EG0011 affected8 at risk EG0020 affected7 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0001 affected22 at risk EG0011 affected8 at risk EG0020 affected7 at risk
Genital herpes	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 affected22 at risk EG0011 affected8 at risk EG0020 affected7 at risk
Oral herpes	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0001 affected22 at risk EG0010 affected8 at risk EG0021 affected7 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 affected22 at risk EG0010 affected8 at risk EG0021 affected7 at risk
Insomnia	Psychiatric disorders	MedDRA 12.1	Systematic Assessment		EG0001 affected22 at risk EG0010 affected8 at risk EG0021 affected7 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment		EG0001 affected22 at risk EG0011 affected8 at risk EG0020 affected7 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 affected22 at risk EG0011 affected8 at risk EG0020 affected7 at risk
Pain	General disorders	MedDRA 12.1	Systematic Assessment		EG00021 affected22 at risk EG0018 affected8 at risk EG0023 affected7 at risk
Redness	General disorders	MedDRA 12.1	Systematic Assessment		EG00013 affected22 at risk EG0012 affected8 at risk EG0020 affected7 at risk
Swelling	General disorders	MedDRA 12.1	Systematic Assessment		EG00010 affected22 at risk EG0012 affected8 at risk EG0020 affected7 at risk
Fatigue	General disorders	MedDRA 12.1	Systematic Assessment	Solicited general symptom	EG00018 affected22 at risk EG0016 affected8 at risk EG0023 affected7 at risk
Gastrointestinal	General disorders	MedDRA 12.1	Systematic Assessment		EG0007 affected22 at risk EG0013 affected8 at risk EG0021 affected7 at risk
Headache	General disorders	MedDRA 12.1	Systematic Assessment	Solicited general symptom	EG00013 affected22 at risk EG0014 affected8 at risk EG0023 affected7 at risk
Malaise	General disorders	MedDRA 12.1	Systematic Assessment		EG0006 affected22 at risk EG0011 affected8 at risk EG0021 affected7 at risk
Myalgia	General disorders	MedDRA 12.1	Systematic Assessment		EG0007 affected22 at risk EG0012 affected8 at risk EG0021 affected7 at risk
Temperature (Axillary)	General disorders	MedDRA 12.1	Systematic Assessment		EG0005 affected22 at risk EG0012 affected8 at risk EG0021 affected7 at risk

ID	Term
D014376	Tuberculosis

Ancestor Terms

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Title	Measurements
	OG0001 OG0010 OG0020

Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.

Units	Counts
Participants	OG00022 OG0018 OG0027

Units	Counts
Participants	OG00022 OG0018 OG0027

Units	Counts
Participants	OG00022 OG0018 OG0027

Units	Counts
Participants	OG00022 OG0018 OG0027

Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.

Units	Counts
Participants	OG00022 OG0018 OG0027

Units	Counts
Participants	OG00022 OG0018 OG0027