Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
S. sonnei 1790GAHB · 2 trials · 1 indication
Any erythema/induration/swelling refers to: ≥25 mm in diameter. Grade 3 (severe) refers to erythema/induration/swelling \>100 mm in diameter. Grade 3 (severe) for injection site pain/nasal pain/facial edema/rhinorrhea refers to: prevents daily activity
Any= Incidence of any symptom regardless of intensity grade. Grade 3 = symptom that prevented daily activities
Day 8: VISIT 2 (D7 post 1st vac)
Day 36: VISIT 3.1 (D7 post 2nd vac)
| Arm | Type | Description |
|---|---|---|
| S. sonnei 1790GAHB - 0.1 mcg - ID | EXPERIMENTAL | Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 0.1 mcg intradermally (ID) |
| S. sonnei 1790GAHB - 1 mcg - ID | EXPERIMENTAL | Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 1 mcg intradermally (ID) |
| S. sonnei 1790GAHB - 10 mcg - ID | EXPERIMENTAL | Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 10 mcg intradermally (ID) |
| S. sonnei 1790GAHB - 5 mcg - IN | EXPERIMENTAL | Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 5 mcg intranasally (IN) |
| S. sonnei 1790GAHB - 20 mcg - IN | EXPERIMENTAL | Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 20 mcg intranasally (IN) |
| S. sonnei 1790GAHB - 80 mcg - IN | EXPERIMENTAL | Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 80 mcg intranasally (IN) |
| S. sonnei 1790GAHB - 5 mcg - IM | EXPERIMENTAL | Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 5 mcg intramuscularly (IM) |
| Placebo - ID | PLACEBO_COMPARATOR | 2 subjects enrolled in each COHORT A, B and C receiving 3 injections of Placebo intradermally (ID). These were pooled in one Placebo group in the analyses |
| Placebo - IN | PLACEBO_COMPARATOR | 2 subjects enrolled in each COHORT A, B and C receiving 3 injections of Placebo intranasally (IN). These were pooled in one Placebo group in the analyses |
| Placebo - IM | PLACEBO_COMPARATOR | 2 subjects enrolled in COHORT C receiving 3 injections of Placebo intramuscularly (IM) |
| S. sonnei 1790GAHB - 1 mcg | EXPERIMENTAL | Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg |
| S. sonnei 1790GAHB - 5 mcg | EXPERIMENTAL | Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg |
| S. sonnei 1790GAHB - 25 mcg | EXPERIMENTAL | Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg |
| S. sonnei 1790GAHB - 50 mcg | EXPERIMENTAL | Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg |
| S. sonnei 1790GAHB - 100 mcg | EXPERIMENTAL | Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg |
| Placebo | PLACEBO_COMPARATOR | 2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses |
| Name | Type | Description |
|---|---|---|
| S. sonnei 1790GAHB | BIOLOGICAL | - |
| Placebo | BIOLOGICAL | - |
Inclusion Criteria: 1. Males and females of age ≥18 years to ≤45 years. 2. Individuals who, after the nature of the study have been explained to them, have given written consent according to local regulatory requirements. 3. Individuals in good health as determined by the outcome of medical history...
S. sonnei 1790GAHB is an investigational vaccine being developed for the prevention of shigellosis, a bacterial infection caused by Shigella sonnei. It is currently in Phase 1 clinical development and is not yet approved for use.
S. sonnei 1790GAHB is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in healthy adults.
S. sonnei 1790GAHB is in Phase 1 clinical development. Two Phase 1 trials have been completed, enrolling a total of 102 healthy adult participants. The vaccine remains investigational and has not received regulatory approval.
S. sonnei 1790GAHB has been studied in two completed Phase 1 trials. NCT02017899 was a dose escalation study in 50 healthy adults in France, and NCT02034500 evaluated intradermal, intranasal, and intramuscular administration in 52 healthy adults in the United Kingdom.
S. sonnei 1790GAHB has been evaluated via three routes of administration in clinical trials: intradermal, intranasal, and intramuscular. The Phase 1 trial NCT02034500 compared these delivery methods in healthy adults to assess safety and immune responses.