Pilot Introduction of Oral Cholera Vaccine in Orissa, India

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).

Study Overview

• Status: Completed
• Conditions: Cholera

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.

• Study Type: Observational
• Enrollment (Actual): 31552

Contacts and Locations

Study Locations

• India
  • Orissa
    • Chandrashekharpur, Bhubaneswar, Orissa, India, 751023
      • Regional Medical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Consenting, eligible participants; All consenting eligible participants in the study area will receive the oral cholera vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the feasibility	Feasibility will be determined by the vaccine coverage (%), defined as the number of subjects who received the vaccine doses divided by the number of subjects who are targeted for mass vaccination.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of acceptability and costs of vaccination program	Costs of vaccination program will be defined as the sum of the cost items required for social mobilization, mass vaccination, and post-vaccination actiities. This includes 1) vaccine price, 2) shipment and insurance costs, 3) personnel(FTEs), 4) supplies including coldboxes and vaccine carriers, 5) transportation. Acceptability will be evaluated by; vaccine coverage rate; survey results which will be qualtitaviely and quantitatively summarized by the sociobehavioral scientists based on in-person interviews.	For a thirty days starting from the 30 days following the last dose of vaccination

Collaborators and Investigators

• Sponsor: International Vaccine Institute
• Collaborators: Indian Council of Medical Research; National Institute of Cholera and Enteric Diseases, India; Shantha Biotechnics Limited; Department of Health and Family Welfare, Orissa
• Investigators: Principal Investigator: Shantanu K Kar, MD, Director, Regional Medical Research Center, Bhubaneswar, Orissa, India

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: March 10, 2010
• First Submitted That Met QC Criteria: June 1, 2011
• First Posted (Estimate): June 3, 2011

Study Record Updates

• Last Update Posted (Estimate): May 23, 2013
• Last Update Submitted That Met QC Criteria: May 21, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Vaccination; Cholera; Mass vaccination; Oral cholera vaccine; Oral whole cell cholera vaccine
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vibrio Infections; Cholera
• Other Study ID Numbers: CR-WC-03