Effectiveness of a Bivalent Killed Whole Cell Based Oral Cholera Vaccine

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Brief Title

Effectiveness of a Bivalent Killed Whole Cell Based Oral Cholera Vaccine

Official Title

Effectiveness of a Bivalent, Killed Whole-cell Based Oral Cholera Vaccine(Shanchol®) Delivered Through Community-based Mass Vaccination Campaign in a High-risk Population in India: Matched Case-control Studies

Brief Summary

      Various field studies has found that the modified , bivalent, whole cell - based oral cholera
      vaccine (OCV) to be safe, immunogenic and effective with protective efficacy of 67 % in
      earlier clinical trials. However, the effectiveness of the vaccine in "real" life situation
      using the public health system is unknown. It is critical to follow up in the same
      population, where pilot introduction of OCV was introduced and evaluate vaccine proactive
      effectiveness at individual as well as at population level. The follow - up and determination
      of effectiveness of mass OCV vaccination was requested by State Government.

Detailed Description

      The overall goal of this study is to evaluate the protective effectiveness of one or two
      doses of modified, bivalent, killed whole cell based OCV, given at least 14 days apart, when
      delivered through community - based mass vaccination campaign using existing public health
      infrastructure in a high - risk population in Satyabadi block of Puri district, Orissa,
      India.

      This study has following objectives

      Primary objectives:

      * To evaluate the individual level protective effectiveness of one or two doses of OCV
      against culture confirmed cholera episodes, severe enough to seek a formal health care.

      Secondary objectives:

        -  To evaluate population - level effectiveness (herd effects)of OCV delivered through a
           community based mass vaccination when the vaccine is delivered to more than half of
           population at risk.

        -  To determine inverse correlation between vaccine coverage and cholera incidence among
           diverse geographical clusters.

Study Type

Observational

Primary Outcome

Vaccine protective effectiveness at individual level

Secondary Outcome

 Population level effectiveness (herd effect)

Condition

Cholera

Study Arms / Comparison Groups

 Cholera cases group
Description:  "Any diarrheal cases or suspected cholera cases from study area, whose stool specimen collected in study health center and examined in reference laboratory, reveals V. cholerae serotype O1/O139 is defined as cholera case"

Publications

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

Recruitment Information

Estimated Enrollment

240

Start Date

March 2013

Completion Date

March 2014

Primary Completion Date

February 2014

Eligibility Criteria

        Inclusion criteria for cases of the main case-control study are as follows:

          -  Giving verbal informed consent/assent, or in the case of minors, a parent or guardian
             give informed consent to participate in the study

          -  Living in the study area since the start of the mass vaccination

          -  Submitted a faecal specimen

          -  Whose residence could be located

          -  Whose stool specimens yield V. cholera O1 or O139

          -  Belonging to study population through census database

        Exclusion criteria:

          -  Not giving verbal informed consent/assent, or in the case of minors, a parent or
             guardian does not give informed consent to participate in the study

          -  Not living in the study area since the start of the mass vaccination

          -  No faecal specimen

          -  Whose residence could not be located

          -  Whose stool specimens does not yield V. cholera O1 or O139

          -  Not belonging to study population through census database

Gender

All

Ages

1 Year - N/A

Accepts Healthy Volunteers

No

Contacts

Shantanu K Kar, MD, +822 - 8811 442, [email protected]

Location Countries

India

Location Countries

India

Administrative Informations

NCT ID

NCT01508507

Organization ID

CR-WC-10

Responsible Party

Sponsor

Study Sponsor

International Vaccine Institute

Collaborators

 Department of Health and Family Welfare, Orissa

Study Sponsor

Shantanu K Kar, MD, Principal Investigator, Director, Regional Medical Research Center, Bhubanewar, Orissa, India

Verification Date

June 2013