Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera

Bavarian Nordic197 enrolled

Overview

The purpose of the study is to determine if PXVX0200 is safe and effective in preventing cholera infection

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

197

Conditions

Cholera

Interventions

PXVX0200BIOLOGICAL

Single dose; liquid suspension after reconstitution with buffer; 5x10\^8

placeboBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

University of Maryland Baltimore

Baltimore, Maryland, United States

Cincinnati Children'S Hospital Medical Center

Cincinnati, Ohio, United States

University of Vermont

Burlington, Vermont, United States

Outcomes

Primary Outcomes

% of Participants With Moderate to Severe Diarrhea

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.

Time frame: Ten days after vaccination

% of Participants With Moderate to Severe Diarrhea

Determine whether a single dose of PXVX0200 provides significant greater protection than placebo against a challenge with virulent V. cholerae O1 El Tor Inaba at 3 months after vaccination. The primary endpoint was the occurrence of moderate or severe (\>/= 3 liters) of diarrhea.

Time frame: Ninety days after vaccination

Secondary Outcomes

Total Weight of Diarrheal Stools Following the 10 Day Cholera Challenge

Total weight (converted to volume) per subject of diarrheal stools measured from subjects with diarrhea following the 10 day cholera challenge.

Time frame: Through 10 Days following challenge

Total Weight of Diarrheal Stools Following the 90 Day Cholera Challenge

Total weight (converted to volume) per subject of diarrheal stools measured from subjects with diarrhea following the 90 day cholera challenge.

Time frame: Through 10 Days following challenge

% of Participants With Diarrhea of Any Severity Following a 10 Day Cholera Challenge

Incidence of mild or worse (any severity) diarrhea following the 10 day cholera challenge.

Time frame: Through 10 Days following challenge

% of Participants With Diarrhea of Any Severity Following a 90 Day Challenge

Data from ClinicalTrials.gov

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