Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.

The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].

The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].

The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].

The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [RBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].

The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].

The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].

The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].

Antigen-specific CD4+ T-cells can express cluster of differentiation 40-ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). The frequency of antigen specific CD4+T-cells was calculated as the difference between the frequency of CD4+T-cells producing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L), upon in vitro stimulation with the peptide pools derived from the antigen minus the frequency of CD4+T-cells producing at least 2 cytokines upon in vitro stimulation in medium only.A responder was a subject with an antigen-stimulated CD4+T cells response greater than or equal to the cut-off value. The same cut-off value was used for all subjects and all antigen responses post-vaccination. It was calculated from the pre-vaccination CD4+T cell responses (the frequency of antigen-stimulated CD4+T cells expressing at least two markers; i.e. all doubles) for all subjects.

Antigen-specific CD4+ T-cells can express CD40 ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). Frequency of CD4+ T-cells expressing markers in response to the F4co fusion protein (all antigens) was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (p17, p24, Nef, RT). Results are presented as determined by Intracellular Cytokine Staining (ICS).

Anti-p17, -p24, -Nef, -RT and -F4co antibody titers were measured by Enzyme Linked Immunosorbent Assay (ELISA) and presented as geometric mean titers (GMTs).

Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.

Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.

Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.

Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.

Total of all reporting groups

Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.

Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.

Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.

Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.

Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.

Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, sweating, gastrointestinal symptoms(nausea, vomiting, diarrhea, and/or abdominal pain). Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

The analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.

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 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 vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.

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 vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.

The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].

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

The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].

The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.

The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].

The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.

The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [RBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].

The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.

The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].

The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.

The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].

The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.

The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].

The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccination administration documented for whom data were available and who had their symptom sheets filled in.

Antigen-specific CD4+ T-cells can express cluster of differentiation 40-ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). The frequency of antigen specific CD4+T-cells was calculated as the difference between the frequency of CD4+T-cells producing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L), upon in vitro stimulation with the peptide pools derived from the antigen minus the frequency of CD4+T-cells producing at least 2 cytokines upon in vitro stimulation in medium only.A responder was a subject with an antigen-stimulated CD4+T cells response greater than or equal to the cut-off value. The same cut-off value was used for all subjects and all antigen responses post-vaccination. It was calculated from the pre-vaccination CD4+T cell responses (the frequency of antigen-stimulated CD4+T cells expressing at least two markers; i.e. all doubles) for all subjects.

Analysis was performed on the According-to-Protocol cohort for Immunogenicity that included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with procedures and intervals defined in protocol, with no elimination criteria during study) for whom data concerning immunogenicity outcome measures were available.

Antigen-specific CD4+ T-cells can express CD40 ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). Frequency of CD4+ T-cells expressing markers in response to the F4co fusion protein (all antigens) was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (p17, p24, Nef, RT). Results are presented as determined by Intracellular Cytokine Staining (ICS).

Analysis was performed on the According-to-Protocol cohort for Immunogenicity that included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with procedures and intervals defined in protocol, with no elimination criteria during study) for whom data concerning immunogenicity outcome measures were available.

Antigen-specific CD4+ T-cells can express CD40 ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). Frequency of CD4+ T-cells expressing markers in response to the F4co fusion protein (all antigens) was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (p17, p24, Nef, RT). Results are presented as determined by Intracellular Cytokine Staining (ICS).

Analysis was performed on the According-to-Protocol cohort for Immunogenicity that included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with procedures and intervals defined in protocol, with no elimination criteria during study) for whom data concerning immunogenicity outcome measures were available.

Anti-p17, -p24, -Nef, -RT and -F4co antibody titers were measured by Enzyme Linked Immunosorbent Assay (ELISA) and presented as geometric mean titers (GMTs).

Analysis was performed on the According-to-Protocol cohort for Immunogenicity that included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with procedures and intervals defined in protocol, with no elimination criteria during study) for whom data concerning immunogenicity outcome measures were available.

Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.

Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.

Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.

Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.

Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.