Phase 3
Completed N=197
Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera
Source: ClinicalTrials.gov NCT01895855 ↗Enrolled (actual)
197
Serious AEs
1.0%
Results posted
Apr 2021
Primary outcomePrimary: % of Participants With Moderate to Severe Diarrhea — 5.7; 59.1 percentage of participants
◆ Published Evidence
Highly cited
198citations · ~20 / year
Single-dose Live Oral Cholera Vaccine CVD 103-HgR Protects Against Human Experimental Infection With Vibrio cholerae O1 El Tor.
Summary
The purpose of the study is to determine if PXVX0200 is safe and effective in preventing cholera infection
Linked Publications (5)
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Single-dose Live Oral Cholera Vaccine CVD 103-HgR Protects Against Human Experimental Infection With Vibrio cholerae O1 El Tor.
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Antibody-Based Correlates of Protection Against Cholera Analysis of a Challenge Study in a Cholera-Naïve Population.
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Lipopolysaccharide-specific memory B cell responses to an attenuated live cholera vaccine are associated with protection against Vibrio cholerae infection.
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Anti-O-specific polysaccharide (OSP) immune responses following vaccination with oral cholera vaccine CVD 103-HgR correlate with protection against cholera after infection with wild-type Vibrio cholerae O1 El Tor Inaba in North American volunteers.
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Immune responses to O-specific polysaccharide (OSP) in North American adults infected with Vibrio cholerae O1 Inaba.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY % of Participants With Moderate to Severe Diarrhea |
12.1; 59.1 | — |
| SECONDARY Total Weight of Diarrheal Stools Following the 10 Day Cholera Challenge |
309; 4524 | 0.0073 sig |
| SECONDARY Total Weight of Diarrheal Stools Following the 90 Day Cholera Challenge |
603; 4524 | <0.0001 sig |
| SECONDARY % of Participants With Diarrhea of Any Severity Following a 10 Day Cholera Challenge |
14.3; 92.4 | — |
| SECONDARY % of Participants With Diarrhea of Any Severity Following a 90 Day Challenge |
45.5; 92.4 | — |
| SECONDARY % of Participants With Fever Following the 10 Day Cholera Challenge |
2.9; 27.3 | 0.0025 sig |
| SECONDARY % of Participants With Fever Following the 90 Day Cholera Challenge |
6.1; 27.3 | 0.0159 sig |
| SECONDARY Number of Days With Fecal Shedding Following 10 Day Challenge |
0.0; 3.0 | <0.0001 sig |
| SECONDARY Number of Days With Fecal Shedding Following 90 Day Challenge |
2.0; 3.0 | <0.0001 sig |
| SECONDARY # of Days With Positive Stool Culture Following 10 Day Cholera Challenge |
0.9; 3.3 | <0.0001 sig |
| SECONDARY # of Days With Positive Stool Culture Following 90 Day Cholera Challenge |
2.1; 3.3 | <0.0001 sig |
| SECONDARY % of Participants With Reactogenicity, Diarrhea, Fever or Unsolicited Adverse Events Following Vaccination |
49.5; 50.0; 1.1; 3.0; 2.2; 1.0 | — |
Eligibility Criteria
Inclusion Criteria
- healthy men or women,
- age 18 to 45 years inclusive;
- normal medical history and physical examination; and
- no clinically significant abnormalities from:
- urine dipstick for glucose, protein, and blood
- complete blood count,
- serum hepatic transaminases,
- total bilirubin (direct if abnormal),
- creatinine,
- electrolytes,
- albumin, or
- electrocardiogram.
- Women must have a negative pregnancy test.
Exclusion Criteria
- travel to a cholera endemic area in the previous 5 years;
- abnormal stool pattern or regular use of laxatives;
- history of eating disorders (such as bulimia), anal or rectal disorders, allergy to tetracycline and/or ciprofloxacin;
- history of cholera or enterotoxigenic E. coli challenge or infection;
- current or recent antibiotic use;
- pregnancy or nursing;
- positive serology for HIV, hepatitis B antigen, or hepatitis C;
- any immunosuppressive medical condition;
- history of hospitalization for psychiatric illness or use of specific psychiatric drugs.
Data sourced from ClinicalTrials.gov (NCT01895855) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.