Pilot Introduction of Oral Cholera Vaccine in Orissa, India
Pilot Introduction of Oral Cholera Vaccine in Orissa, India
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.
Inclusion Criteria:

 -  aged 12 months and older

 -  non-pregnant

 Exclusion Criteria:

 -  age less than 12 months

 -  pregnant

 -  too ill/old to get out of bed