Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
S.sonnei vaccine · 1 trial · 1 indication
Attack rate of shigellosis expressed as percentage of subjects with at least one episode of shigellosis after challenge, and 90% confidence interval (CI) (Clopper-Pearson method). Episodes of shigellosis fulfilling primary case definition: Shedding of S. sonnei 53G accompanied by moderate or severe diarrhea OR shedding with oral temperature greater than or equal to (≥) 38.5°C. Moderate diarrhea consists of 4 to 5 loose or watery (Grade \[G\]3 to 5) stools or 400 to 800 grams of G3 to 5 stools within 24 hours. Severe diarrhea consists of 6 or more loose or watery (G3 to 5) stools or \> 800 grams of G3 to 5 stools within 24 hours or required medical intervention. In case of severe diarrhea, medical intervention is defined as intravenous fluids administration or anticipation of antibiotic treatment before the 5th day after challenge. G3 = viscous opaque liquid or semi-liquid which assumes the shape of the bowl; G4 = watery opaque liquid; G5 = clear watery or mucoid liquid.
| Arm | Type | Description |
|---|---|---|
| S. sonnei Group | EXPERIMENTAL | Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally. |
| Placebo Group | PLACEBO_COMPARATOR | Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally. |
| Name | Type | Description |
|---|---|---|
| S.sonnei vaccine | BIOLOGICAL | Subjects receiving 2 doses of the study vaccine by intramuscular route, 28 days apart (at Day 1 and Day 29). |
| Placebo | DRUG | Subjects receiving 2 doses of placebo by intramuscular route, 28 days apart (at Day 1 and Day 29). |
| S. sonnei 53G challenge strain | BIOLOGICAL | Subjects receiving the challenge dose of S. sonnei 53G strain, orally, at Day 57. |
Inclusion Criteria: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject prior to performing any study specific procedure. * Individuals who, after the nature of the study has been explain...
The S. sonnei vaccine is used for bacillary dysentery, an infectious disease caused by Shigella sonnei. It is designed to protect against infection with this bacterium in healthy adults. The vaccine is currently in Phase 2 clinical development and is being studied for its efficacy, safety, and immunogenicity.
The S. sonnei vaccine is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the vaccine's potential to protect against Shigella sonnei infection, which causes bacillary dysentery.
The S. sonnei vaccine is in Phase 2 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The Phase 2 trial has been completed, and the vaccine is being evaluated for efficacy, safety, and immunogenicity.
The S. sonnei vaccine has one completed clinical trial, identified as NCT03527173. This Phase 2 study evaluated the efficacy, safety, and immunogenicity of the vaccine in healthy adults in the United States. The trial enrolled 71 participants and was randomized, double-blind, and placebo-controlled.
The S. sonnei vaccine is specifically designed to protect against Shigella sonnei, one of the species that causes bacillary dysentery. It is a vaccine targeting this particular pathogen, and while it is a type of Shigella vaccine, it is not a broad-spectrum vaccine covering all Shigella species.