Cholera Clinical Trial
Official title:
Pilot Introduction of the Modified Bivalent Killed Whole Cell Oral Cholera Vaccine in Orissa
The purpose of this study is to provide evidence for policymakers and key opinion leaders on the pilot implementation of cholera vaccination using the newly licensed Oral Cholera Vaccine (OCV) in India. The pilot introduction will provide the evidence for the feasibility, costs and population acceptance of large-scale cholera vaccination using the Indian vaccine (using vaccination coverage rates and other measures).
Severe diarrhoeal disease caused by Vibrio cholerae O1 and O139 has long been an important
cause of mortality and morbidity in India. The availability and recent licensure of the
modified bivalent killed whole cell OCV in India provides hope that the disease may be
controlled in areas where the disease is a problem. On April 10, 2009, a meeting was
organized by the Indian Council of Medical Research (ICMR), the Department of Biotechnology
and the IVI. The recommendations from the meeting are as follows:
- As the modified WC vaccine is safe, effective, and cost-effective, it was suggested
that the National Technical Advisory Group on Immunization (NTAGI) should consider
recommending introduction of the vaccine in public health programs targeted to
appropriate populations in India.
- Vaccination should be initiated in selected highly endemic and/or slum areas such as
known areas in West Bengal or Orissa. The pilot vaccination programs will be monitored
and evaluated. Further expansion to other areas and wider policy changes will be made
in a step-by-step fashion based on the pilot programs. Logistical and operational
issues need to be defined.
The aim of the study is to conduct a pilot introduction of the modified killed oral cholera
vaccine in a public health setting in a population of ~50,000 before implementing in a
larger scale.
Primary objective:
To determine the feasibility, acceptability and costs associated with pilot introduction of
the modified killed whole cell oral cholera vaccine in India when given in a public health
setting.
Secondary objective:
To identify challenges to mass oral cholera vaccine implementation.
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Observational Model: Ecologic or Community
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