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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 by Emergent BioSolutions Inc. (ticker: EBS) for cholera, an infectious disease. It is in Phase 2 clinical development and has been studied in a completed trial in Mali.
PXVX0200 10E8 is being developed for cholera, an infectious disease. It is an investigational monoclonal antibody and has not been approved for any indication. The only reported clinical trial evaluated it in healthy adult volunteers in Mali.
PXVX0200 10E8 is developed by Emergent BioSolutions Inc., which trades under the ticker EBS. The company is the sponsor of the clinical program for this monoclonal antibody candidate.
PXVX0200 10E8 is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA for any use.
PXVX0200 10E8 has been studied in one completed Phase 2 trial, NCT02145377, titled PXVX0200 (CVD103-HgR) vs Shanchol in Mali. It enrolled 150 healthy adult volunteers, was randomized, double-blind, and active-controlled, and was conducted in Mali.