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