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

Cholera Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128011
• Other study ID #: C-12
• 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
• 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

• Cholera

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