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

NCT ID: NCT01895855

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-11-30

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

Conditions

Cholera

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

PXVX0200

Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 5x10\^8 CFU

Group Type: EXPERIMENTAL

PXVX0200

Intervention Type: BIOLOGICAL

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

Placebo

Biological: Placebo physiological saline

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: BIOLOGICAL

Interventions

PXVX0200

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

Intervention Type: BIOLOGICAL

placebo

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emergent BioSolutions

INDUSTRY

Sponsor Role: collaborator

Bavarian Nordic

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James McCarty, MD

Role: STUDY_DIRECTOR

Emergent BioSolutions

Locations

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

Countries

United States

References

Chen WH, Cohen MB, Kirkpatrick BD, Brady RC, Galloway D, Gurwith M, Hall RH, Kessler RA, Lock M, Haney D, Lyon CE, Pasetti MF, Simon JK, Szabo F, Tennant S, Levine MM. Single-dose Live Oral Cholera Vaccine CVD 103-HgR Protects Against Human Experimental Infection With Vibrio cholerae O1 El Tor. Clin Infect Dis. 2016 Jun 1;62(11):1329-1335. doi: 10.1093/cid/ciw145. Epub 2016 Mar 21.

Reference Type: RESULT

PMID: 27001804 (View on PubMed)

Haney DJ, Lock MD, Gurwith M, Simon JK, Ishioka G, Cohen MB, Kirkpatrick BD, Lyon CE, Chen WH, Sztein MB, Levine MM, Harris JB. Lipopolysaccharide-specific memory B cell responses to an attenuated live cholera vaccine are associated with protection against Vibrio cholerae infection. Vaccine. 2018 May 11;36(20):2768-2773. doi: 10.1016/j.vaccine.2018.04.011. Epub 2018 Apr 11.

Reference Type: RESULT

PMID: 29655627 (View on PubMed)

Haney DJ, Lock MD, Simon JK, Harris J, Gurwith M. Antibody-Based Correlates of Protection Against Cholera Analysis of a Challenge Study in a Cholera-Naive Population. Clin Vaccine Immunol. 2017 May 31;24(8):e00098-17. doi: 10.1128/CVI.00098-17. Online ahead of print.

Reference Type: RESULT

PMID: 28566334 (View on PubMed)

Hossain M, Islam K, Kelly M, Mayo Smith LM, Charles RC, Weil AA, Bhuiyan TR, Kovac P, Xu P, Calderwood SB, Simon JK, Chen WH, Lock M, Lyon CE, Kirkpatrick BD, Cohen M, Levine MM, Gurwith M, Leung DT, Azman AS, Harris JB, Qadri F, Ryan ET. Immune responses to O-specific polysaccharide (OSP) in North American adults infected with Vibrio cholerae O1 Inaba. PLoS Negl Trop Dis. 2019 Nov 19;13(11):e0007874. doi: 10.1371/journal.pntd.0007874. eCollection 2019 Nov.

Reference Type: DERIVED

PMID: 31743334 (View on PubMed)

Islam K, Hossain M, Kelly M, Mayo Smith LM, Charles RC, Bhuiyan TR, Kovac P, Xu P, LaRocque RC, Calderwood SB, Simon JK, Chen WH, Haney D, Lock M, Lyon CE, Kirkpatrick BD, Cohen M, Levine MM, Gurwith M, Harris JB, Qadri F, Ryan ET. Anti-O-specific polysaccharide (OSP) immune responses following vaccination with oral cholera vaccine CVD 103-HgR correlate with protection against cholera after infection with wild-type Vibrio cholerae O1 El Tor Inaba in North American volunteers. PLoS Negl Trop Dis. 2018 Apr 6;12(4):e0006376. doi: 10.1371/journal.pntd.0006376. eCollection 2018 Apr.

Reference Type: DERIVED

PMID: 29624592 (View on PubMed)

Other Identifiers

PXVX-VC-200-003

Identifier Type: -

Identifier Source: org_study_id