Safety and Immunogenicity of a New Formulation of a Bivalent Killed, Whole-Cell Oral Cholera Vaccine

This study has been completed.
Sponsor:
Collaborators:
National Institute of Hygiene and Epidemiology, Vietnam
Göteborg University
Information provided by:
International Vaccine Institute
ClinicalTrials.gov Identifier:
NCT00128011
First received: August 8, 2005
Last updated: November 8, 2006
Last verified: November 2006
  Purpose

The purpose of this study is to evaluate the safety and immunogenicity of a new formulation of a locally-produced bivalent, (O-1 and O-139) killed whole cell oral cholera vaccine among Vietnamese adults.


Condition Intervention Phase
Cholera
Biological: killed oral cholera vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Safety and Immunogenicity Study of a New Formulation of the Locally-Produced Bivalent Killed, Whole-Cell Oral Cholera Vaccine in Vietnamese Subjects

Resource links provided by NLM:


Further study details as provided by International Vaccine Institute:

Primary Outcome Measures:
  • Adverse events
  • Serum Vibriocidal antibody response

Estimated Enrollment: 150
Study Start Date: May 2005
Estimated Study Completion Date: June 2005
Detailed Description:

Cholera remains to be a serious public health problem worldwide. In the mid-1980s following technology transfer from Sweden, Vietnamese scientists developed and produced an oral killed monovalent cholera vaccine for Vietnam’s public health programs. A 2-dose regimen of this vaccine has been shown to be safe and efficacious. Subsequently, a bivalent vaccine was developed containing the newly emergent O139 V. cholerae. This vaccine has several advantages over the existing Swedish vaccine. It confers protection against the El Tor biotype in younger children, is considerably less expensive, does not require a buffer during administration and does not require strict cold chain requirements. However, this vaccine is not licensed for use in countries other than Vietnam. In order to make this vaccine available to other countries, the IVI has provided technical assistance to produce this vaccine following the WHO Good Manufacturing Practices standards. A new formulation of the current oral cholera vaccine was produced following these guidelines. Since this vaccine is slightly different from the previous vaccine, a study is necessary to demonstrate safety and immunogenicity for local licensure and larger Phase III studies in other countries.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy non-pregnant adults
  • Available in the study area for 1 month

Exclusion Criteria:

  • Diarrhea for the past week
  • Antibiotic use in the past week
  • Intake of anti-diarrheal medicines in the past week
  • One or more episodes of diarrhea or abdominal pain lasting for 2 weeks during the past 6 months
  • Abdominal pain, nausea, vomiting, loss of appetite or generalized ill feeling for the past 24 hours
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128011

Locations
Vietnam
National Institute of Hygiene and Epidemiology
Hanoi, Vietnam, 10000
Sponsors and Collaborators
International Vaccine Institute
National Institute of Hygiene and Epidemiology, Vietnam
Göteborg University
Investigators
Principal Investigator: Dang Duc Anh, PhD National Institute of Hygiene and Epidemiology, Vietnam
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00128011     History of Changes
Other Study ID Numbers: C-12
Study First Received: August 8, 2005
Last Updated: November 8, 2006
Health Authority: Vietnam: Ministry of Health

Keywords provided by International Vaccine Institute:
watery diarrhea
cholera vaccine

Additional relevant MeSH terms:
Cholera
Vibrio Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 23, 2014