Pilot Introduction of Oral Cholera Vaccine in Orissa, India

Cholera Clinical Trial

Official title:

Pilot Introduction of the Modified Bivalent Killed Whole Cell Oral Cholera Vaccine in Orissa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365442
• Other study ID #: CR-WC-03
• Status: Completed
• Phase: N/A
• First received: March 10, 2010
• Last updated: May 21, 2013
• Start date: May 2011
• Est. completion date: September 2012

Study information

• Verified date: May 2013
• Source: International Vaccine Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31552
• Est. completion date: September 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months and older

Eligibility

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 Design

Observational Model: Ecologic or Community

Related Conditions & MeSH terms

• Cholera

Locations

Country	Name	City	State
India	Regional Medical Research Center	Chandrashekharpur, Bhubaneswar	Orissa

Sponsors (5)

Lead Sponsor	Collaborator
International Vaccine Institute	Department of Health and Family Welfare, Orissa, Indian Council of Medical Research, India, National Institute of Cholera and Enteric Diseases, India, Shantha Biotechnics Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No