Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HIV vaccine 732461 · 1 trial · 2 indications
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.
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.
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.
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 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.
| Arm | Type | Description |
|---|---|---|
| SB732461 adjuvanted_LD Group | EXPERIMENTAL | 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. |
| SB732461 adjuvanted_MD Group | EXPERIMENTAL | 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. |
| SB732461 adjuvanted_HD Group | EXPERIMENTAL | 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. |
| SB732461 non-adjuvanted_LD Group | EXPERIMENTAL | Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30. |
| SB732461 non-adjuvanted_MD Group | EXPERIMENTAL | 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. |
| SB732461 non-adjuvanted_HD Group | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| HIV vaccine 732461 | BIOLOGICAL | - |
Inclusion Criteria: * A male or female between and including 18-40 years at the time of first vaccination. * Written informed consent obtained from the subject prior to any study procedure. * Subjects who the investigator believes that they can and will comply with the requirements of the protocol....
HIV vaccine 732461 is an investigational vaccine developed by GSK plc for the prevention of HIV infection and AIDS. It is a Phase 2 candidate that has been studied in healthy HIV seronegative volunteers. The vaccine is designed to elicit immune responses against HIV, but it is not approved for use.
HIV vaccine 732461 is being developed for the prevention of HIV infection and AIDS. It is intended for use in healthy HIV seronegative individuals to induce protective immunity. The vaccine is investigational and has not been approved for any indication.
HIV vaccine 732461 is developed by GSK plc, a global pharmaceutical company traded on the New York Stock Exchange under the ticker GSK. GSK is responsible for the research and clinical development of this vaccine candidate.
HIV vaccine 732461 is in Phase 2 clinical development. It has completed one Phase 2 trial but is not yet approved for any indication. Further studies would be needed to advance the vaccine toward potential regulatory review.
HIV vaccine 732461 has been evaluated in one completed Phase 2 clinical trial, NCT00434512, titled "Dose-ranging Study to Evaluate the Safety & Immunogenicity of a HIV Vaccine 732461 in Healthy HIV Seronegative Volunteers." The trial enrolled 180 participants in Belgium and was randomized, double-blind, and controlled.