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Also known as Shigella sonnei vaccine
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 shigellosis, the diarrheal disease caused by Shigella sonnei bacteria. It is a Phase 1 candidate from GSK plc (ticker GSK) and has been studied in healthy adult volunteers in the United Kingdom and France.
S. sonnei 1790GAHB is being developed for the prevention of shigellosis, the infection caused by Shigella sonnei. The two completed Phase 1 trials enrolled healthy adult volunteers rather than patients with active disease, which is typical for early vaccine testing.
S. sonnei 1790GAHB is being developed by GSK plc, which trades under the ticker GSK. GSK sponsored both of the completed Phase 1 trials of the candidate, one conducted in the United Kingdom and one in France.
S. sonnei 1790GAHB is in Phase 1. Both of its clinical trials were Phase 1 studies, and both are now completed. There are no active trials of the candidate, and it has not been approved for any indication.
S. sonnei 1790GAHB has been studied in two completed Phase 1 trials. NCT02034500 evaluated intradermal, intranasal, and intramuscular administration in 52 healthy adults in the United Kingdom. NCT02017899 was a dose escalation study in 50 healthy adults in France.
The two completed Phase 1 trials of S. sonnei 1790GAHB enrolled 102 participants in total. NCT02034500 enrolled 52 healthy adults in the United Kingdom, and NCT02017899 enrolled 50 healthy adults in France. Both studies were randomized, double blind, and placebo controlled.