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

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Bavarian Nordic

Status and phase

Completed
Phase 3

Conditions

Cholera

Treatments

Biological: placebo
Biological: PXVX0200

Study type

Interventional

Funder types

Industry

Identifiers

NCT01895855
PXVX-VC-200-003

Details and patient eligibility

About

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

Full 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

Enrollment

197 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

197 participants in 2 patient groups, including a placebo group

PXVX0200
Experimental group
Description:
Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 5x10\^8 CFU
Treatment:
Biological: PXVX0200
Placebo
Placebo Comparator group
Description:
Biological: Placebo physiological saline
Treatment:
Biological: placebo

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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