Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PXVX0200 10E8 · 1 trial · 1 indication
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...
PXVX0200 10E8 is an investigational monoclonal antibody being developed for cholera, an infectious disease. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
PXVX0200 10E8 is being developed by Emergent BioSolutions Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol EBS.
PXVX0200 10E8 is in Phase 2 clinical development for cholera. It is an investigational monoclonal antibody and has not been approved for commercial use.
PXVX0200 10E8 has one completed Phase 2 clinical trial, NCT02145377, which compared it to Shanchol in Mali. The trial enrolled 150 participants, was randomized, double-blind, and active-controlled, and included healthy volunteers aged 18 years and older.
PXVX0200 10E8 is also known as CVD103-HgR. The clinical trial NCT02145377 lists the drug as PXVX0200 (CVD103-HgR), indicating these names refer to the same investigational product.