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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00128011
Other study ID # C-12
Secondary ID
Status Completed
Phase Phase 2
First received August 8, 2005
Last updated November 8, 2006
Start date May 2005
Est. completion date June 2005

Study information

Verified date November 2006
Source International Vaccine Institute
Contact n/a
Is FDA regulated No
Health authority Vietnam: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
killed oral cholera vaccine


Locations

Country Name City State
Vietnam National Institute of Hygiene and Epidemiology Hanoi

Sponsors (3)

Lead Sponsor Collaborator
International Vaccine Institute Göteborg University, National Institute of Hygiene and Epidemiology, Vietnam

Country where clinical trial is conducted

Vietnam, 

References & Publications (1)

Anh DD, Canh do G, 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 adult — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events
Primary Serum Vibriocidal antibody response
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