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

Primary Purpose

Cholera

Status
Completed
Phase
Phase 2
Locations
Vietnam
Study Type
Interventional
Intervention
killed oral cholera vaccine
Sponsored by
International Vaccine Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholera focused on measuring watery diarrhea, cholera vaccine

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Institute of Hygiene and Epidemiology

Outcomes

Primary Outcome Measures

Adverse events
Serum Vibriocidal antibody response

Secondary Outcome Measures

Full Information

First Posted
August 8, 2005
Last Updated
November 8, 2006
Sponsor
International Vaccine Institute
Collaborators
National Institute of Hygiene and Epidemiology, Vietnam, Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT00128011
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
International Vaccine Institute
Collaborators
National Institute of Hygiene and Epidemiology, Vietnam, Göteborg University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholera
Keywords
watery diarrhea, cholera vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
killed oral cholera vaccine
Primary Outcome Measure Information:
Title
Adverse events
Title
Serum Vibriocidal antibody response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dang Duc Anh, PhD
Organizational Affiliation
National Institute of Hygiene and Epidemiology, Vietnam
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Hygiene and Epidemiology
City
Hanoi
ZIP/Postal Code
10000
Country
Vietnam

12. IPD Sharing Statement

Citations:
PubMed Identifier
17055622
Citation
Anh DD, Canh DG, Lopez AL, Thiem VD, Long PT, Son NH, Deen J, von Seidlein L, Carbis R, Han SH, Shin SH, Attridge S, Holmgren J, Clemens J. Safety and immunogenicity of a reformulated Vietnamese bivalent killed, whole-cell, oral cholera vaccine in adults. Vaccine. 2007 Jan 22;25(6):1149-55. doi: 10.1016/j.vaccine.2006.09.049. Epub 2006 Sep 29.
Results Reference
result

Learn more about this trial

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

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