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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02100631 | A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults | PHASE3 | COMPLETED | 398 | — | — | May 1, 2014 | Jun 1, 2015 | Jun 28, 2023 | 16 | United States |
| NCT01895855 | Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera | PHASE3 | COMPLETED | 197 | — | — | Sep 1, 2013 | Nov 1, 2014 | Jun 28, 2023 | 3 | United States |
| NCT01585181 | Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200 | PHASE1 | COMPLETED | 66 | — | — | Apr 1, 2012 | Jan 1, 2013 | Jun 27, 2023 | 2 | United States |
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
Determine whether a single dose of PXVX0200 provides significantly greater protection than placebo against a challenge with virulent V. cholerae O1 El Tor Inaba at 10 days after vaccination. The primary endpoint was the occurrence of moderate or severe (\>/= 3 liters) diarrhea.
Safety defined as frequency and severity of vaccine-related reactogenicity events and reported AEs
Immunogenicity as defined as rate of seroconversion (4-fold rise) of serum Inaba vibriocidal antibody and initial estimates of between subject variability of vibriocidal antibody response
| Arm | Type | Description |
|---|---|---|
| PXVX0200 in Older Adults | EXPERIMENTAL | PXVX0200 Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension |
| Placebo in Older Adults | PLACEBO_COMPARATOR | Placebo physiological saline |
| Historical Control: Adults Aged 18-45 | OTHER | This arm consists of historical data from subjects who received a single dose of PXVX0200 in study PXVX-VC-200-004. The data was included in study PXVX-VC-200-005 as a comparator bridging population for the Day 11 seroconversion. NCT02094586 PubMed ID:29317118 |
| PXVX0200 | EXPERIMENTAL | Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 5x10\^8 CFU |
| Placebo | PLACEBO_COMPARATOR | Biological: Placebo physiological saline |
| Name | Type | Description |
|---|---|---|
| PXVX0200 | BIOLOGICAL | - |
| Placebo | BIOLOGICAL | - |
Inclusion Criteria: 1. Able to understand the study and give written consent. 2. Healthy male and female adults, age 46-64 years (inclusive) without significant medical history, physical, or abnormal screening laboratory test results at screening. 3. Women of childbearing potential must have had a ...