Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HIV Vaccine 732462 · 1 trial · 1 indication
Assessed solicited local symptoms were: pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain causing inability to perform usual social and functional activities. Grade 1 redness/swelling = redness/swelling spreading beyond (\>) 50 millimeters (mm) of injection site.
Assessed solicited general symptoms were abdominal pain, anorexia, diarrhoea, fatigue, headache, myalgia, nausea, sweating, vomiting and temperature \[oral temperature equal to or above (≥) 37.7 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms causing inability to perform usual social and functional activities. Grade 3 anorexia = loss of appetite associated with significant weight loss. Grade 3 diarrhoea = bloody diarrhoea or increase of ≥7 stools per 24 hour period, or IV fluid replacement. Grade 3 nausea/vomiting = persistent nausea/vomiting resulting in minimal oral intake for more (\>) than 48 hours/in orthostatic hypotension or aggressive rehydration indicated. Grade 3 temperature = temperature between 39.4- 40.5 °C
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. Medically attended visits include any kind of medical attention such as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
Study pre-defined HIV-related AEs included: cluster of differentiation-4 (CD4) count decrease \[(≥)25% post vaccination\], viral load increase \[(≥)50 copies per (/) milliliter (mL) of HIV ribonucleic acid (RNA) post-vaccination, for cohort A and at least 0.5 log post-vaccination for cohort B\], initiation of Highly Active Anti-Retroviral Therapy (HAART) for cohort B, or changes in HAART for cohort A, abnormal biochemistry and haematology parameters.
Assessed biochemical and haematological parameters included: Absolute neutrophil count (ANC), Haemoglobin (Hgb), Partial Thromboplastin Time (PTT), Platelets decreased (PLT/D), WBC decreased (WBC/D), Albumin serum low (ALB/SL), Alkaline Phosphatase (ALP), Alanine aminotransferase (SGPT), Aspartate aminotransferase (SGOT), Bilirubin Total (BL/T), Creatinine (CRT), Potassium serum high (K/SH), Potassium serum low (K/SL), Sodium serum high (Na/SH), Sodium serum low (NA/SL), Uric acid (UA).
Time to HAART initiation and/or HAART changes was expressed in days from administration of first dose.
| Arm | Type | Description |
|---|---|---|
| HIV 732462 Group | EXPERIMENTAL | Subjects received 2 doses of the HIV Vaccine 732462 into the deltoid muscle of the dominant arm, on a 0, 1 Month schedule. |
| Placebo Group | PLACEBO_COMPARATOR | Subjects received 2 doses of the placebo vaccine into the deltoid muscle of the dominant arm, on a 0, 1 Month schedule. |
| Name | Type | Description |
|---|---|---|
| HIV Vaccine 732462 | BIOLOGICAL | Two doses reconstituted adjuvanted vaccine, injected intramuscularly, at an interval of approximately one month. |
| Placebo vaccine | BIOLOGICAL | Two doses of placebo, injected intramuscularly, at an interval of approximately one month |
Inclusion Criteria: All subjects must satisfy the following criteria at screening and before vaccination: * A male or female, aged between and including 18-55 years at the time of first vaccination. * Known to be HIV-1 infected and under care of an HIV physician for a minimum of 6 months. However,...
HIV Vaccine 732462 is an investigational vaccine developed by GSK plc for AIDS. It is a Phase 1 candidate that has been studied in a completed clinical trial. It is not an approved product and remains in clinical development.
HIV Vaccine 732462 is being developed for AIDS, the disease caused by HIV infection. Its only recorded clinical study enrolled HIV infected subjects aged 18 to 55 years old, so the program has been evaluated in people already living with HIV rather than as a preventive vaccine in healthy volunteers.
HIV Vaccine 732462 is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor associated with the vaccine's clinical program in AIDS.
HIV Vaccine 732462 is in Phase 1. It is an investigational vaccine and is not approved for any use. One Phase 1 trial has been completed, and no trials are currently active.
HIV Vaccine 732462 has been studied in one completed Phase 1 trial, NCT00814762, titled Safety of the HIV Vaccine 732462 in HIV Infected Subjects Aged 18 to 55 Years Old. It enrolled 41 participants in Germany and was randomized, double blind, and placebo controlled.
Across its clinical program, HIV Vaccine 732462 has enrolled 41 participants in total. That enrollment comes from a single completed Phase 1 trial conducted in Germany, which included adults aged 18 to 55 years old and was placebo controlled.