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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03576183 | Study Confirming A Human Challenge Model and Investigating The Safety Of VLA1701 | PHASE2 | COMPLETED | 34 | — | — | Jun 4, 2018 | Nov 30, 2018 | Apr 23, 2021 | 1 | United States |
within 120 hours of challenge with ETEC strain LSN03-016011/A.
| Arm | Type | Description |
|---|---|---|
| VLA1701 | ACTIVE_COMPARATOR | VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli) The vaccine is administered orally in 2 doses about 1 week apart. |
| Placebo | PLACEBO_COMPARATOR | The buffer component of VLA1701 will be used as Placebo. The vaccine is administered orally in 2 doses about 1 week apart. |
| Name | Type | Description |
|---|---|---|
| VLA1701 | BIOLOGICAL | VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli) |
| Placebo | BIOLOGICAL | buffer component of VLA1701 |
| Challenge Strain | OTHER | LSN03-016011/A |
Inclusion Criteria: 1. Healthy male and non-pregnant female subjects aged 18 to \<50 years; 2. BMI of 19.0 to 35.0 kg/m2 3. Willingness to participate after informed consent has been obtained from the subject prior to any study related procedures. 4. Completion of a training session and demonstrati...