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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00128011
Recruitment Status : Completed
First Posted : August 9, 2005
Last Update Posted : November 10, 2006
National Institute of Hygiene and Epidemiology, Vietnam
Göteborg University
Information provided by:
International Vaccine Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Cholera Biological: killed oral cholera vaccine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
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
Study Start Date : May 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cholera

Primary Outcome Measures :
  1. Adverse events
  2. Serum Vibriocidal antibody response

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00128011

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National Institute of Hygiene and Epidemiology
Hanoi, Vietnam, 10000
Sponsors and Collaborators
International Vaccine Institute
National Institute of Hygiene and Epidemiology, Vietnam
Göteborg University
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Principal Investigator: Dang Duc Anh, PhD National Institute of Hygiene and Epidemiology, Vietnam
Publications of Results:
Layout table for additonal information Identifier: NCT00128011    
Other Study ID Numbers: C-12
First Posted: August 9, 2005    Key Record Dates
Last Update Posted: November 10, 2006
Last Verified: November 2006
Keywords provided by International Vaccine Institute:
watery diarrhea
cholera vaccine
Additional relevant MeSH terms:
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Vibrio Infections
Gram-Negative Bacterial Infections
Bacterial Infections