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

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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