Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Herpes simplex candidate vaccine- adjuvanted GSK 208141 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | - |
| Group B | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Herpes simplex candidate vaccine- adjuvanted GSK 208141 | BIOLOGICAL | Intramuscular injection, 3 doses |
| Placebo | BIOLOGICAL | Intramuscular injection, 3 doses |
| Herpes simplex candidate vaccine- adjuvanted GSK208141 | BIOLOGICAL | Intramuscular injection, 3 doses |
| Placebo injection | BIOLOGICAL | Intramuscular injection, 3 doses |
Inclusion Criteria: * 18 years of age and over at the time of first vaccination * Written informed consent * Females of childbearing potential must have a negative pregnancy test at enrollment and prior to each vaccination and be using an accepted method of birth control Exclusion Criteria: * Any...
It is an investigational vaccine developed by GSK plc for the prevention of herpes simplex infection. It is designed as a prophylactic vaccine, meaning it is intended to prevent genital herpes disease rather than treat existing infection. It has been studied in Phase 3 clinical trials in healthy adult volunteers.
It is being developed for prophylaxis against herpes simplex, specifically to prevent genital herpes disease. The Phase 3 program enrolled healthy volunteers aged 18 years and older, including both HSV seropositive and seronegative subjects, to evaluate whether the vaccine could prevent herpes simplex disease.
GSK plc, which trades under the ticker GSK, is the developer of the herpes simplex candidate vaccine adjuvanted GSK 208141. The vaccine is an adjuvanted formulation containing the gD2t antigen combined with MPL adjuvant, studied in GSK-sponsored Phase 3 trials.
The herpes simplex candidate vaccine adjuvanted GSK 208141 has been studied in Phase 3 clinical development. Both of its Phase 3 trials are listed as completed, and no trials are currently active. It is an investigational vaccine and is not described as approved.
Two completed Phase 3 trials have evaluated the vaccine. NCT00699764 assessed safety of the gD2t vaccine with MPL and its efficacy to prevent genital herpes disease in 2,491 participants. NCT00698568 evaluated safety in HSV seropositive and seronegative subjects across multiple countries, enrolling 7,460 participants.
Yes. Herpes simplex candidate vaccine adjuvanted GSK 208141 and GSK208141 refer to the same investigational vaccine from GSK plc. The two names are alternate forms of the same designation, and both point to the adjuvanted gD2t herpes simplex candidate vaccine studied in Phase 3 trials.