Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02034500 | Evaluate a New Shigella Sonnei Vaccine Administered Either by Intradermal, Intranasal or Intramuscular Route in Healthy Adults | PHASE1 | COMPLETED | 52 | — | — | Mar 1, 2014 | Apr 1, 2015 | Jun 21, 2016 | 1 | United Kingdom |
| NCT02017899 | A Phase 1, Dose Escalation Study, to Evaluate a New Shigella Sonnei Vaccine in Healthy Adults. | PHASE1 | COMPLETED | 50 | — | — | Feb 1, 2014 | Mar 1, 2015 | Jan 23, 2019 | 1 | France |
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...