Brief Title
Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata
Official Title
Safety and Immunogenicity of a Killed, Oral Cholera Vaccine in Indian Subjects in Eastern Kolkata, West Bengal
Brief Summary
The purpose of the study is to confirm the safety and immunogenicity of the oral killed bivalent cholera vaccine in adult and pediatric volunteers in Eastern Kolkata, West Bengal, India.
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. Through IVI, an agreement between VABIOTECH in Hanoi and Shantha Biotechnics PVT, LTD in India has been reached that will make the bivalent vaccine available in India. A double-blind randomized phase III trial in a cholera-endemic area would be necessary to demonstrate the efficacy of this vaccine in other settings. This would pave the way for the introduction of the vaccine into the national immunization programme in India and the internationalization of this vaccine and licensure in other countries where it is needed. Prior to the phase III trial, a phase II study will be performed among adults and children.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
adverse events
Secondary Outcome
serum vibriocidal antibody response
Condition
Cholera
Intervention
killed whole cell oral cholera vaccine
Study Arms / Comparison Groups
1
Description: Killed Whole Cell 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
200
Start Date
August 2005
Completion Date
July 2006
Primary Completion Date
June 2006
Eligibility Criteria
Inclusion Criteria: - Healthy non-pregnant adults aged 18-40 years and children aged 1-17 years Exclusion Criteria: - Diarrhea during the past week - Antibiotic and anti-diarrheal medicine use during 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
12 Months - 40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Sujit K Bhatttacharya, MD, ,
Location Countries
India
Location Countries
India
Administrative Informations
NCT ID
NCT00119197
Organization ID
C-8-ph2
Study Sponsor
International Vaccine Institute
Collaborators
National Institute of Cholera and Enteric Diseases, India
Study Sponsor
Sujit K Bhatttacharya, MD, Principal Investigator, National Institute of Cholera and Enteric Diseases, India
Verification Date
June 2008