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

Phase 3

Completed

• Conditions: Cholera
• Interventions: Biological: PXVX0200; Biological: placebo

• Registration Number: NCT01895855
• Lead Sponsor: Bavarian Nordic

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 Timeline

• Study First Submitted: 2013-07-05
• Study First Submitted QC: 2013-07-10
• Study First Posted: 2013-07-11
• Study Start: 2013-09
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Results First Submitted: 2018-07-05
• Results First Submitted QC: 2021-03-05
• Results First Posted: 2021-04-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-26
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PXVX0200	PXVX0200	Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 5x10\^8 CFU
Placebo	placebo	Biological: Placebo physiological saline

Primary Outcome Measures

Name	Time	Method
% of Participants With Moderate to Severe Diarrhea	Ninety days after vaccination	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.

Secondary Outcome Measures

Name	Time	Method
% of Participants With Diarrhea of Any Severity Following a 10 Day Cholera Challenge	Through 10 Days following challenge	Incidence of mild or worse (any severity) diarrhea following the 10 day cholera challenge.
# of Days With Positive Stool Culture Following 90 Day Cholera Challenge	Through 10 Days following challenge	Total number of days with a positive stool culture following 90 Day Cholera Challenge
% of Participants With Diarrhea of Any Severity Following a 90 Day Challenge	Through 10 Days following challenge	Incidence of mild or worse (any severity) diarrhea following the 90 day cholera challenge.
Total Weight of Diarrheal Stools Following the 90 Day Cholera Challenge	Through 10 Days following challenge	Total weight (converted to volume) per subject of diarrheal stools measured from subjects with diarrhea following the 90 day cholera challenge.
# of Days With Positive Stool Culture Following 10 Day Cholera Challenge	Through 10 Days following challenge	Total number of days with a positive stool culture following the 10 Day Cholera challenge.
% of Participants With Fever Following the 90 Day Cholera Challenge	Through 10 Days following challenge	Incidence of mild or worse fever following the 90 day cholera challenge.
Total Weight of Diarrheal Stools Following the 10 Day Cholera Challenge	Through 10 Days following challenge	Total weight (converted to volume) per subject of diarrheal stools measured from subjects with diarrhea following the 10 day cholera challenge.
% of Participants With Fever Following the 10 Day Cholera Challenge	Through 10 Days following challenge	Incidence of mild or worse fever following the 10 day cholera challenge.
Number of Days With Fecal Shedding Following 10 Day Challenge	Through 10 Days post challenge	Number of days of fecal shedding of wild type V. cholerae following 10 Day Challenge.
Number of Days With Fecal Shedding Following 90 Day Challenge	Through 10 days following challenge	Number of days of fecal shedding of wild type V. cholerae following 90 Day Challenge
% of Participants With Reactogenicity, Diarrhea, Fever or Unsolicited Adverse Events Following Vaccination	Following vaccination (Days 1 - 8) and to Day 29	Incidence and severity of signs and symptoms of reactogenicity such as diarrhea, and fever following vaccination (through Day 8).; Incidence and severity of unsolicited adverse events following vaccination (through Day 29).

Trial Locations

Locations (3)

Cincinnati Children'S Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

University of Maryland Baltimore; 🇺🇸 Baltimore, Maryland, United States

University of Vermont; 🇺🇸 Burlington, Vermont, United States