Brief Title
Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera
Official Title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Efficacy Trial of a Single Dose Live Oral Cholera Vaccine, PXVX0200 CVD 103-HgR, in Preventing Cholera Following Challenge With Vibrio Cholerae 10 Days or 3 Months After Vaccination
Brief Summary
The purpose of the study is to determine if PXVX0200 is safe and effective in preventing cholera infection
Detailed Description
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Efficacy Trial of a Single Dose of Live Oral Cholera Vaccine Candidate, PXVX0200 CVD 103-HgR Strain, in Preventing Cholera following Challenge with Vibrio cholerae O1 El Tor Inaba 10 Days or 3 Months after Vaccination in volunteers aged 18-45 years
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
% of Participants With Moderate to Severe Diarrhea
Secondary Outcome
Total Weight of Diarrheal Stools Following the 10 Day Cholera Challenge
Condition
Cholera
Intervention
PXVX0200
Study Arms / Comparison Groups
PXVX0200
Description: Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 5x10^8 CFU
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
197
Start Date
September 2013
Completion Date
November 2014
Primary Completion Date
November 2014
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.
Gender
All
Ages
18 Years - 45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
James McCarty, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01895855
Organization ID
PXVX-VC-200-003
Responsible Party
Sponsor
Study Sponsor
Emergent BioSolutions
Study Sponsor
James McCarty, MD, Study Director, Emergent BioSolutions
Verification Date
March 2021