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

• Sponsor: International Vaccine Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00128011
• Collaborator: National Institute of Hygiene and Epidemiology, Vietnam (Other), Göteborg University (Other)
• Enrollment: 150
• Location: 1
• Duration (Months): 1
• Patients Per Site Per Month: 147.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cholera	Biological: killed oral cholera vaccine	Phase 2

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double
• Primary Purpose: Prevention
• 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 Start Date: May 1, 2005
• Study Completion Date: Jun 1, 2005

Outcome Measures

Primary Outcome Measures

1. Adverse events []

2. Serum Vibriocidal antibody response []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute of Hygiene and Epidemiology	Hanoi		Vietnam	10000

Sponsors and Collaborators

• International Vaccine Institute
• National Institute of Hygiene and Epidemiology, Vietnam
• Göteborg University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00128011
• Other Study ID Numbers: C-12
• First Posted: Aug 9, 2005
• Last Update Posted: Nov 10, 2006
• Last Verified: Nov 1, 2006

• Keywords provided by , ,: watery diarrhea; cholera vaccine
• Additional relevant MeSH terms: Cholera

Study Results

No Results Posted as of Nov 10, 2006