Efficacy and Safety of GSK Biologicals HIV Vaccine in Ant... | NCT01218113

Label	Type	Description	Intervention Names
3D_HIV Group	Experimental	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	Biological: GSK Biologicals HIV Vaccine 732462
2D_HIV Group	Experimental	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	Biological: GSK Biologicals HIV Vaccine 732462 Drug: Placebo
Control Group	Placebo Comparator	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
GSK Biologicals HIV Vaccine 732462	Biological	2 or 3 doses according to protocol schedule	2D_HIV Group 3D_HIV Group

Measure	Description	Time Frame
Geometric Mean Change in Human Immunodeficiency Virus Type 1 (HIV-1) Viral Load (VL) From Baseline	Changes from baseline in HIV-1 viral load (ratio of each value over baseline value) were obtained using crude values and expressed in RNA copies/milliliter [copies/mL]. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic.	At Week 48, post-Dose 3
Geometric Mean Change in HIV-1 VL From Baseline	Changes from baseline in HIV-1 viral load (difference of each value minus baseline value) were obtained using log10-transformed values and expressed in log10-RNA copies/mL. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic.	At Week 48, post-Dose 3
Number of Subjects With Solicited Local Symptoms	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.	During the 7-day (Days 0-6) period following Dose 1
Number of Subjects With Solicited Local Symptoms	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.

Measure	Description	Time Frame
Geometric Mean Change in HIV-1 Viral Load (LV) From Baseline	Changes from baseline in HIV-1 viral load (ratio of each value over baseline value) were obtained using crude values and expressed in RNA copies/mL. Baseline of HIV-1 viral load was defined as the geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic. Changes from baseline were measured at Week 1 to 28 for the HIV Group, Weeks 30 and 38 for the 3D_HIV Group and 2D_HIV Group and from Week 1 to Week 38 for the Control Group.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Bakersfield	California	93301	United States
GSK Investigational Site

ID	Title	Description
FG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
FG001	2D_HIV Group

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

Geometric Mean Change in Human Immunodeficiency Virus Type 1 (HIV-1) Viral Load (VL) From Baseline

Changes from baseline in HIV-1 viral load (ratio of each value over baseline value) were obtained using crude values and expressed in RNA copies/milliliter [copies/mL]. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic.

The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.

Posted

Geometric Mean

Standard Deviation

RNA copies/mL

At Week 48, post-Dose 3

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG002	Control Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.

Units	Counts
Participants	OG00046 OG00155 OG00250

Title

Denominators

Categories

Title	Measurements
	OG0001.0± 0.35 OG0011.5± 0.38 OG0021.3± 0.34

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	To show the difference in change from baseline of HIV-1 VL at week 48 between persons who received 3 doses of the HIV vaccine 732462 and persons who received placebo alone.	Repeated-measures mixed model				Geometric Mean Ratio	0.801			2-Sided	97.5	0.553	1.162					Non-Inferiority	Crierion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (3D_HIV Group - Control Group) is below 0.

Primary

Geometric Mean Change in HIV-1 VL From Baseline

The analysis was performed on the Modified Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.

Posted

Geometric Mean

Standard Deviation

log10(RNA copies/mL)

At Week 48, post-Dose 3

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Primary

Number of Subjects With Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 vaccination was identical for both groups.

Posted

Count of Participants

Participants

During the 7-day (Days 0-6) period following Dose 1

ID	Title	Description
OG000	HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	Control Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.

Primary

Number of Subjects With Solicited Local Symptoms

Posted

Count of Participants

Participants

During the 7-day (Days 0-6) period following Dose 2

ID	Title	Description
OG000	HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	Control Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.

Primary

Number of Subjects With Solicited Local Symptoms

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in.

Posted

Count of Participants

Participants

During the 7-day (Days 0-6) period following Dose 3

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Primary

Number of Subjects With Solicited Local Symptoms

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in.

Posted

Count of Participants

Participants

During the 7-day (Days 0-6) post-vaccination period, across doses

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Primary

Number of Subjects With Solicited General Symptoms

Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination

Posted

Count of Participants

Participants

During the 7-day (Days 0-6) period following Dose 1

ID	Title	Description
OG000	HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.

Primary

Number of Subjects With Solicited General Symptoms

Posted

Count of Participants

Participants

During the 7-day (Days 0-6) period following Dose 2

ID	Title	Description
OG000	HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.

Primary

Number of Subjects With Solicited General Symptoms

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in.

Posted

Count of Participants

Participants

During the 7-day (Days 0-6) period following Dose 3

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.

Primary

Number of Subjects With Solicited General Symptoms

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in.

Posted

Count of Participants

Participants

During the 7-day (Days 0-6) post-vaccination period, across doses

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.

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 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. Grade 3 (G3) AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were tabulated following Dose 1 and Dose 2 vaccinations.

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 and 2 vaccinations were identical for both groups.

Posted

Count of Participants

Participants

During the 28-Day (Days 0-27) period following Dose 1 and Dose 2

ID	Title	Description
OG000	HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	Control Group

Primary

Number of Subjects With Unsolicited AEs

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

During the 28-Day (Days 0-27) post-vaccination period

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

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 subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

During the entire study period (up to Week 48)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG002	Control Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.

Primary

Number of Subjects With Potentially Immune-Mediated Diseases (pIMDs)

Potentially Immune-Mediated Diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

During the entire study period (up to Week 48)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG002	Control Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.

Primary

Number of Subjects With Abnormal Haematological and Biochemical Values

Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since the screening timepoint was identical for both groups.

Posted

Count of Participants

Participants

At Screening

ID	Title	Description
OG000	HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
OG001

Primary

Number of Subjects With Abnormal Haematological and Biochemical Values

Posted

Count of Participants

Participants

Pre-vaccination, at Week 0

ID	Title	Description
OG000	HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.

Primary

Number of Subjects With Abnormal Haematological and Biochemical Values

Posted

Count of Participants

Participants

At Week 4

ID	Title	Description
OG000	HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
OG001

Primary

Number of Subjects With Abnormal Haematological and Biochemical Values

Posted

Count of Participants

Participants

At Week 6

ID	Title	Description
OG000	HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
OG001

Primary

Number of Subjects With Abnormal Haematological and Biochemical Values

Posted

Count of Participants

Participants

At Week 16

ID	Title	Description
OG000	HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
OG001

Primary

Number of Subjects With Abnormal Haematological and Biochemical Values

Posted

Count of Participants

Participants

At Week 28

ID	Title	Description
OG000	HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
OG001

Primary

Number of Subjects With Abnormal Haematological and Biochemical Values

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

At Week 30

ID	Title	Description
OG000	Control Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	3D_HIV Group

Primary

Number of Subjects With Abnormal Haematological and Biochemical Values

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

At Week 38

ID	Title	Description
OG000	Control Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	3D_HIV Group

Primary

Number of Subjects With Abnormal Haematological and Biochemical Values

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

At Week 48

ID	Title	Description
OG000	Control Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	3D_HIV Group

Secondary

Geometric Mean Change in HIV-1 Viral Load (LV) From Baseline

Changes from baseline in HIV-1 viral load (ratio of each value over baseline value) were obtained using crude values and expressed in RNA copies/mL. Baseline of HIV-1 viral load was defined as the geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic. Changes from baseline were measured at Week 1 to 28 for the HIV Group, Weeks 30 and 38 for the 3D_HIV Group and 2D_HIV Group and from Week 1 to Week 38 for the Control Group.

Posted

Geometric Mean

Standard Deviation

RNA copies/mL

At Weeks 1, 4, 6, 16, 28, 30 and 38

ID	Title	Description
OG000	HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.

Secondary

Geometric Mean Change in HIV-1 VL From Baseline

Changes from baseline in HIV-1 viral load (difference of each value minus baseline value) were obtained using log10-transformed values and expressed in log10-RNA copies/mL. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic. Changes from baseline were measured at Week 1 to 29 for the HIV Group, Weeks 30 and 38 for the 3D_HIV Group and 2D_HIV Group and from Week 1 to Week 38 for the Control Group.

Posted

Geometric Mean

Standard Deviation

log10(RNA copies/mL)

At Weeks 1, 4, 6, 16, 28, 30 and 38

ID	Title	Description
OG000	HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.

Secondary

Levels of HIV-1 Viral Load (VL)

HIV-1 VL, using crude values, was expressed in RNA copies/mL and measured from Screening to Week 28 for the HIV Group, Weeks 30, 38 and 48 for the 3D_HIV Group and 2D_HIV Group and from Screening to Week 48 for the Control Group.

Posted

Median

Inter-Quartile Range

RNA Copies/mL

At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48

ID	Title	Description
OG000	HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG002	2D_HIV Group

Secondary

Levels of HIV-1 VL

HIV-1 VL, using log10 transformed values, was expressed in log10-RNA copies/mL and measured from Screening to Week 28 for the HIV Group, Weeks 30, 38 and 48 for the 3D_HIV Group and 2D_HIV Group and from Screening to Week 48 for the Control Group.

Posted

Median

Inter-Quartile Range

log10 (RNA Copies/mL)

At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48

ID	Title	Description
OG000	HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG002	2D_HIV Group

Secondary

Percentage of Subjects With Plasmatic HIV-1 Viral Load Decrease Higher Than (>) 1

The proportion of subjects with >1 decrease of HIV-1 VL, was determined using log10-transformed values.

Posted

Number

Percentage of participants

At Week 48

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG002	Control Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.

Secondary

Cluster of Differentiation 4 (CD4) Absolute Cell Count

Result determination, using crude values, was done from Screening to Week 28 for the HIV Group, Weeks 30, 38 and 48 for the 3D_HIV Group and 2D_HIV Group and from Screening (SCR) to Week (W) 48 for the Control Group.

Posted

Mean

Standard Deviation

CD4 cells/cubic millimeter

At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48

ID	Title	Description
OG000	HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG002	2D_HIV Group

Secondary

Mean Change in CD4 Cell Count From Baseline

Baseline for CD4 cell count analysis was defined as the mean of values measured in blood taken at Screening and at pre vaccination (PRE). Result determination, using crude values, was done from week 1 to 28 for the HIV Group, weeks 30, 38 and 48 for the 3D_HIV Group and 2D_HIV Group and from week 1 to week 48 for the Control Group.

Posted

Mean

Standard Deviation

CD4 cells/cubic millimeter

At Weeks 1, 4, 6, 16, 28, 30, 38 and 48

ID	Title	Description
OG000	HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG002

Secondary

Percentage of Subjects With ART (Anti-Retroviral Therapy) Initiation and HIV-related Clinical Events

Only actual ART initiations were reported under the category "ART initiation". HIV-related clinical events were defined as: clinical disease progression, or confirmed VL > 100.000 copies/mL, or confirmed CD4 cell count < 350 cells/ cubic millimeter (mm3).

Posted

Number

Percentage of participants

During the entire study period (up to Week 48)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG002

Secondary

Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)

Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD40L+CD4+ T-cells and F4co-Computed [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD40L+CD4+ T-cells expressing at least interleukin- 2 (IL-2), as assessed by Intracellular Cytokine Staining (ICS).

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Posted

Median

Inter-Quartile Range

CD40L+CD+ T-cells/million cells

During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Secondary

Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine

Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD40L+CD4+ T-cells and F4co-Computed [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD40L+CD4+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).

Posted

Median

Inter-Quartile Range

CD40L+CD4+ T-cells/million T-cells

During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group

Secondary

Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.

Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD40L-CD4+ T-cells and F4co-Computed [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD40L-CD4+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Posted

Median

Inter-Quartile Range

CD40L-CD4+ T-cells/million T-cells

During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group

Secondary

Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine

Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD4+ T-cells and F4co-Computed [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD4+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).

Posted

Median

Inter-Quartile Range

CD4+ T-cells/million cells

During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Secondary

Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine

Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD8+ T-cells and F4co-Computed [frequency of CD8+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD8+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD8+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).

Posted

Median

Inter-Quartile Range

CD8+ T-cells/million cells

During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Secondary

Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens

Breadth was assessed only for the CD4+ T-cells and was measured by evaluating response to at least 1, 2, 3 or all 4 antigens: proteins 17, 24, Nef, reverse transcriptase (RT).

Posted

Count of Participants

Participants

During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Secondary

Cytokine Expression Profile of F4co-Computed CD4+ T Cells

The cytokine co-expression profile was defined by the frequency of F4co-Computed CD4+ T-cells [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).

Posted

Median

Inter-Quartile Range

F4co-computed CD4+ T-cells/million cells

During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Secondary

Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells

The cytokine co-expression profile was defined by the frequency of Nef-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).

Posted

Median

Inter-Quartile Range

Nef-specific CD4+ T-cells/million cells

During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Secondary

Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells

The cytokine co-expression profile was defined by the frequency of P17-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).

Posted

Median

Inter-Quartile Range

P17-specific CD4+ T-cells/million T-cell

During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Secondary

Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells

The cytokine co-expression profile was defined by the frequency of P24-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).

Posted

Median

Inter-Quartile Range

P24-specific CD4+ T-cells/million cells

During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Secondary

Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells

The cytokine co-expression profile was defined by the frequency of reverse transcriptase (RT)-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).

Posted

Median

Inter-Quartile Range

RT-specific CD4+ T-cells/million cells

During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Secondary

Cytokine Expression Profile of F4co-Computed CD8+ T Cells

The cytokine co-expression profile was defined by the frequency of F4co-Computed CD8+ T-cells [Frequency of CD8+ T cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD8+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Posted

Median

Inter-Quartile Range

F4co-Computed CD8+ T-cells/million cells

During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Secondary

Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells

The cytokine co-expression profile was defined by the frequency of Nef-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.

Posted

Median

Inter-Quartile Range

Nef-specific CD8+ T-cells/million cells

During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Secondary

Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells

The cytokine co-expression profile was defined by the frequency of P17-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.

Posted

Median

Inter-Quartile Range

P17-specific CD8+ T-cells/million cells

During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Secondary

Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells

The cytokine co-expression profile was defined by the frequency of P24-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.

Posted

Median

Inter-Quartile Range

P24-specific CD8+ T-cells/million cells

During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Secondary

Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells

The cytokine co-expression profile was defined by the frequency of reverse transcriptase (RT)-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.

Posted

Median

Inter-Quartile Range

RT-specific CD8+ T-cells/million cells

During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Secondary

Number of Seropositive Subjects for Anti-P17 Antibodies

Seropositivity rates for antibodies against P17 antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 187 milli-ELISA units per milliliter (mEL.U/mL).

Posted

Count of Participants

Participants

During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Secondary

Number of Seropositive Subjects for Anti-P24 Antibodies

Seropositivity rates for antibodies against P24 antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 119 milli-ELISA units per milliliter (mEL.U/mL).

Posted

Count of Participants

Participants

During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Secondary

Number of Seropositive Subjects for Anti-Nef Antibodies

Seropositivity rates for antibodies against Nef antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 494 milli-ELISA units per milliliter (mEL.U/mL).

Posted

Count of Participants

Participants

During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Secondary

Number of Seropositive Subjects for Anti-RT Antibodies

Seropositivity rates for antibodies against RT antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 125 milli-ELISA units per milliliter (mEL.U/mL).

Posted

Count of Participants

Participants

During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Secondary

Number of Seropositive Subjects for Anti-F4co Antibodies

Seropositivity rates for antibodies against F4co antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 42 milli-ELISA units per milliliter (mEL.U/mL).

Posted

Count of Participants

Participants

During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

ID	Title	Description
OG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
OG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	62	1	62	60	62
EG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	64	3	64	60	64
EG002	Control Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	64	2	64	42	64

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0010 events0 affected64 at risk EG0021 events1 affected64 at risk
Appendicitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected64 at risk EG0020 events0 affected64 at risk
Gastroenteritis shigella	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected64 at risk EG0020 events0 affected64 at risk
Hepatitis c	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected64 at risk EG0020 events0 affected64 at risk
Lymph node tuberculosis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected64 at risk EG0020 events0 affected64 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0010 events0 affected64 at risk EG0021 events1 affected64 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0010 events0 affected64 at risk EG0021 events1 affected64 at risk
Hydrocephalus	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0010 events0 affected64 at risk EG0021 events1 affected64 at risk
Pre-eclampsia	Pregnancy, puerperium and perinatal conditions	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0010 events0 affected64 at risk EG0021 events1 affected64 at risk
Anxiety	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected64 at risk EG0020 events0 affected64 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0010 events0 affected64 at risk EG0021 events1 affected64 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected64 at risk EG0020 events0 affected64 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG00018 events13 affected62 at risk EG00113 events10 affected64 at risk EG0026 events4 affected64 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG00013 events11 affected62 at risk EG00111 events10 affected64 at risk EG0027 events7 affected64 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG00023 events18 affected62 at risk EG00129 events20 affected64 at risk EG00219 events15 affected64 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG00023 events18 affected62 at risk EG00119 events14 affected64 at risk EG0020 events0 affected64 at risk
Fatigue	General disorders	MedDRA 16.0	Systematic Assessment	EG00083 events43 affected62 at risk EG00166 events39 affected64 at risk EG00234 events20 affected64 at risk
Headache	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG00057 events32 affected62 at risk EG00157 events33 affected64 at risk EG00232 events22 affected64 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG00021 events11 affected62 at risk EG00127 events20 affected64 at risk EG00211 events10 affected64 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG00061 events33 affected62 at risk EG00155 events33 affected64 at risk EG00221 events13 affected64 at risk
Nasopharyngitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0004 events4 affected62 at risk EG0014 events4 affected64 at risk EG0024 events4 affected64 at risk
Nausea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG00024 events17 affected62 at risk EG00118 events15 affected64 at risk EG0028 events8 affected64 at risk
Pain	General disorders	MedDRA 16.0	Systematic Assessment	EG000146 events58 affected62 at risk EG001115 events57 affected64 at risk EG00220 events14 affected64 at risk
Pyrexia	General disorders	MedDRA 16.0	Systematic Assessment	EG00018 events14 affected62 at risk EG00111 events9 affected64 at risk EG0028 events7 affected64 at risk
Swelling	General disorders	MedDRA 16.0	Systematic Assessment	EG0006 events4 affected62 at risk EG00110 events8 affected64 at risk EG0020 events0 affected64 at risk

ID	Term
D000163	Acquired Immunodeficiency Syndrome
D015658	HIV Infections

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012897	Slow Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Title	Description
BG000	3D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
BG001	2D_HIV Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
BG002	Control Group	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
BG003	Total	Total of all reporting groups