|
|
|
|
|
|
Sponsors and Collaborators: |
International Vaccine Institute National Institute of Cholera and Enteric Diseases, India Indian Council of Medical Research Shantha Biotechnics Limited |
Information provided by: | International Vaccine Institute |
ClinicalTrials.gov Identifier: | NCT00119197 |
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.
Condition | Intervention | Phase |
Cholera |
Biological: killed whole cell oral cholera vaccine Biological: Heat Killed E. coli |
Phase II |
ChemIDplus related topics: | Cholera Vaccine |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Safety and Immunogenicity of a Killed, Oral Cholera Vaccine in Indian Subjects in Eastern Kolkata, West Bengal |
Enrollment: | 200 |
Study Start Date: | August 2005 |
Study Completion Date: | July 2006 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Killed Whole Cell Oral Cholera Vaccine
|
Biological: killed whole cell oral cholera vaccine
Bivalent oral killed cholera vaccine: each dose of this vaccine contains:
each 1.5 mL dose given orally, two doses given 14 days apart |
2: Placebo Comparator
Heat-killed E. coli
|
Biological: Heat Killed E. coli
Escherichia coli K12 strain placebo: each dose of placebo contains heat-killed E. coli K12 strain in an amount whose optical turbidity is identical to that for the cholera vaccine. Each 1.5 mL dose given orally, two doses given 14 days apart |
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.
Ages Eligible for Study: | 12 Months to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
India, West Bengal | |||||
National Institute of Cholera and Enteric Diseases | |||||
Kolkata, West Bengal, India |
International Vaccine Institute |
National Institute of Cholera and Enteric Diseases, India |
Indian Council of Medical Research |
Shantha Biotechnics Limited |
Principal Investigator: | Sujit K Bhatttacharya, MD | National Institute of Cholera and Enteric Diseases, India |
Responsible Party: | International Vaccine Institute ( Director General ) |
Study ID Numbers: | C-8-ph2 |
First Received: | July 4, 2005 |
Last Updated: | June 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00119197 |
Health Authority: | India: Ministry of Health |
|
|