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

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Brief Title

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

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

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.

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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Adverse events

Condition

Cholera

Intervention

killed oral cholera vaccine

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

150

Start Date

May 2005

Completion Date

June 2005

Eligibility 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

Gender

All

Ages

18 Years - 40 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Dang Duc Anh, PhD, ,

Location Countries

Vietnam

Location Countries

Vietnam

Administrative Informations

NCT ID

NCT00128011

Organization ID

C-12

Study Sponsor

International Vaccine Institute

Collaborators

 National Institute of Hygiene and Epidemiology, Vietnam

Study Sponsor

Dang Duc Anh, PhD, Principal Investigator, National Institute of Hygiene and Epidemiology, Vietnam

Verification Date

November 2006