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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02145377 | PXVX0200 (CVD103-HgR) vs Shanchol in Mali | PHASE2 | COMPLETED | 150 | — | — | Jul 1, 2014 | Mar 1, 2015 | Sep 26, 2019 | 1 | Mali |
A comparison of the ability of a single ≥2 x10E9 cfu oral dose versus a single ≥2 x10E8 cfu oral dose of PXVX0200 (CVD 103-HgR) versus placebo to elicit a significant (\> 4-fold) rise in serum Inaba vibriocidal antibody 14 days after vaccination, compared to baseline
| Arm | Type | Description |
|---|---|---|
| PXVX0200 10E8 then placebo | EXPERIMENTAL | PXVX0200 10E8 on day 0; Placebo on day 14 |
| Placebo, then PXVX0200 10E8 | EXPERIMENTAL | Placebo on day 0; PXVX0200 10E8 on day 14 |
| PXVX0200 10E9 then Placebo | EXPERIMENTAL | PXVX0200 10E9 on day 0; Placebo on day 14 |
| Placebo then PXVX0200 10E9 | EXPERIMENTAL | Placebo on day 0; PXVX0200 10E9 on day 14 |
| Shanchol | ACTIVE_COMPARATOR | Two doses of Shanchol, on day 0 and day 14 |
| Name | Type | Description |
|---|---|---|
| PXVX0200 10E8 | BIOLOGICAL | Oral dose of PXVX0200 10E8 |
| PXVX0200 10E9 | BIOLOGICAL | Oral dose of PXVX0200 10E9 |
| Placebo | BIOLOGICAL | Oral dose of sodium bicarbonate buffer |
| Shanchol | BIOLOGICAL | Licensed comparator |
Inclusion Criteria: * Able to understand the study and give consent (either written or through a process that involves audio tapes explaining all aspects of the study and the consent form in local languages \[Bambara and French\] followed by making a mark and signature by a literate witness) * Heal...