Clinical trial NCT01365442: Pilot Introduction of Oral Cholera Vaccine in Orissa, India
Official title: Pilot Introduction of the Modified Bivalent Killed Whole Cell Oral Cholera Vaccine in Orissa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholera
Keywords: Cholera
Vaccination
Oral cholera vaccine
Mass vaccination
Oral whole cell cholera vaccine
Lead sponsor: International Vaccine Institute
Sponsor class: OTHER
Collaborators: name: Department of Health and Family Welfare, Orissa
name: Indian Council of Medical Research
name: National Institute of Cholera and Enteric Diseases, India
name: Shantha Biotechnics Limited
First posted: 2011-06-03
Enrollment: 31552
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be conducted in \~100 selected villages with approximate population of 50,000 in Satyabadi block of Puri district, Orissa

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To determine the feasibility
timeFrame: The numerator (number of people who received the vaccine doses within the target population) will be counted during the 30 days following the last dose of vaccination.
Secondary outcomes:
measure: Assessment of acceptability and costs of vaccination program
timeFrame: For a thirty days starting from the 30 days following the last dose of vaccination
Other outcomes:
Locations:
city: Chandrashekharpur, Bhubaneswar
country: India
facility: Regional Medical Research Center
state: Orissa
Study officials:
affiliation: Director, Regional Medical Research Center, Bhubaneswar, Orissa, India
name: Shantanu K Kar, MD
role: PRINCIPAL_INVESTIGATOR
References: