Randomized Controlled Trial of Killed Oral Cholera Vaccine in Kolkata

Brief Title

Randomized Controlled Trial of Killed Oral Cholera Vaccine in Kolkata

Official Title

A Randomized Controlled Trial of the Bivalent Killed Whole Cell Oral Cholera Vaccine in Eastern Kolkata, West Bengal, India

Brief Summary

      The primary purpose of this study is to estimate the efficacy of a two-dose regimen of the
      oral killed bivalent cholera vaccine when administered to individual residing in a
      cholera-endemic area in India.
    

Detailed Description

      Cholera remains a serious public health problem worldwide. Provision of safe water and food,
      establishment of adequate sanitation, and implementation of personal and community hygiene
      constitute the main public health interventions against cholera. These measures cannot be
      implemented fully in the near future in most cholera-endemic areas. A safe, effective, and
      affordable vaccine would be a useful tool for cholera prevention and control.The World Health
      Organization recently recommended that the newer generation cholera vaccines be considered in
      certain endemic and epidemic situations, but indicated that demonstration projects are needed
      to provide more information about the costs, feasibility, and impact of using these vaccines.
      Starting in the mid-1980s, following technology transfer from Prof Jan Holmgren in Sweden,
      Vietnamese scientists at the National Institute of Hygiene and Epidemiology (NIHE) in Hanoi
      developed and produced an oral, killed cholera vaccine for the country's public health
      programs (10). Since licensure of the oral cholera vaccine in Vietnam, more than 5 million
      doses have been administered without any report of serious adverse events.

      The vaccine is produced according to recommended WHO guidelines (6) at the NIHE's newly
      privatized arm, the Company for Vaccine and Biological Production No. 1 (VABIOTECH) in Hanoi.
      Recently the vaccine was reformulated in order to comply with WHO standards to further
      internationalize this vaccine. Phase II trials of this reformulated vaccine have been
      performed among 148 adults in SonLa,Vietnam (18) and among 100 adults and 100 children in
      Kolkata, India. Results from these trials reveal that the vaccine is safe and immunogenic.

      A double-blind randomised phase III trial of the reformulated oral killed bivalent cholera
      vaccine in an urban slum site in Kolkata is proposed by the National Institute of Cholera and
      Enteric Diseases (NICED) in collaboration with the International Vaccine Institute (IVI). The
      IVI has negotiated an agreement between VABIOTECH and Shantha Biotechnics PVT LTD for the
      vaccine and placebo to be used during the trial. VABIOTECH will produce bulk oral killed
      bivalent cholera vaccine under quality control conditions to be supervised by IVI staff.
      Shanta will purchase bulk vaccine from VABIOTECH, fill and finish the bulk vaccine, and
      obtain regulatory clearance for use of the vaccine in the phase III trial. Shanta will
      purchase the bulk placebo agent for use in the trial from IVAC (also in Vietnam) and Shanta
      will fill and finish the placebo and obtain regulatory clearance for use of the placebo in
      the phase III trial. Shanta will later obtain the technology for future production of the
      oral killed bivalent cholera vaccine. The results of this trial will pave the way for the use
      of this vaccine in India and other cholera-endemic areas.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

culture-proven V. cholerae O1 diarrhoea episodes severe enough to require treatment in a health care facility.

Secondary Outcome

 Episodes of acute watery diarrhoea severe enough to require treatment in a health care facility

Condition

Diarrhea

Intervention

bivalent killed whole cell oral cholera vaccine

Study Arms / Comparison Groups

 1

Description:  Cholera Vaccine

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

69329

Start Date

July 2006

Completion Date

May 2013

Primary Completion Date

December 2011

Eligibility Criteria

        Inclusion Criteria:

          -  All healthy, consenting, non-pregnant (as ascertained by history) residents at least 1
             year of age of the study area

        Exclusion Criteria:

          -  individuals who are too weak to get out of bed to receive the vaccine;

          -  pregnant women (identified through verbal screening); and

          -  those less than 1 year of age
      

Gender

All

Ages

12 Months - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Dipika Sur, MD, , 

Location Countries

India

Location Countries

India

NCT ID

NCT00289224

Organization ID

C8phIII

Responsible Party

Sponsor

Study Sponsor

International Vaccine Institute

Collaborators

 National Institute of Cholera and Enteric Diseases, India

Study Sponsor

Dipika Sur, MD, Principal Investigator, National Institute of Cholera and Enteric Diseases, India

Verification Date

March 2012