Randomized Controlled Trial of Killed Oral Cholera Vaccine in Kolkata

July 30, 2014 updated by: International Vaccine Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

69329

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • West Bengal
      • Kolkata, West Bengal, India
        • National Institute of Cholera and Enteric Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Placebo
Biological: Placebo
Heat Killed E. coli K12 in an optical turbidity identical to killed oral cholera vaccine, in 1.5 mL oral dose given twice, at least 14 days apart.
EXPERIMENTAL: 1
Cholera Vaccine
Biological: bivalent killed whole cell oral cholera vaccine

Given as 1.5 mL dose, given orally in 2 doses 14 days apart, each dose contains:

V. cholerae O1 Inaba El Tor strain Phil 6973 formalin killed 600 Elisa units (EU) LPS V. cholerae O1 Ogawa classical strain Cairo 50 heat killed 300 EU LPS V. cholerae O1 Ogawa classical strain Cairo 50 formalin killed 300 EU LPS V. cholerae O1 Inaba classical strain Cairo 48 heat killed 300 EU LPS V. cholerae O139 strain 4260B formalin killed 600 EU LPS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
culture-proven V. cholerae O1 diarrhoea episodes severe enough to require treatment in a health care facility.
Time Frame: 1095 days
1095 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Episodes of acute watery diarrhoea severe enough to require treatment in a health care facility
Time Frame: 1095 days
1095 days
Serum vibriocidal responses, compared to baseline
Time Frame: 14 days and 365 days after second dose
14 days and 365 days after second dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Vaccine Institute

Collaborators

National Institute of Cholera and Enteric Diseases, India
Shantha Biotechnics Limited

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

February 7, 2006

First Submitted That Met QC Criteria

February 7, 2006

First Posted (ESTIMATE)

February 9, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 31, 2014

Last Update Submitted That Met QC Criteria

July 30, 2014

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C8phIII

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diarrhea

Clinical Trials on bivalent killed whole cell oral cholera vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe