Evaluation of a Boosting Regimen With Oral Cholera Vaccine

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Brief Title

Evaluation of a Boosting Regimen With Oral Cholera Vaccine

Official Title

A Open Labeled Controlled Trial to Evaluate the Immune Response of a Boosting Regimen With Shanchol™, a Killed Whole Cell Oral Cholera Vaccine (WC-OCV), in Previously Immunized Adults and Children in Eastern Kolkata, India

Brief Summary

      Data demonstrates that Shanchol™ (killed bivalent oral cholera vaccine) provides protection
      over 3 years and data regarding the protective efficacy over five years is anticipated for
      2012. Regardless at the end of five years, it may still be necessary to provide a booster
      dose or reimmunize with two doses to maintain protection in previously immunized populations.
      This study examines the immune protection and safety of providing a one and two dose boosting
      regimen of Shanchol™ given five years after the initial dose.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Immunogenicity provided by a two dose boosting regimen of Shanchol™

Secondary Outcome

 Immunogenicity provided by a one dose boosting regimen of Shanchol™

Condition

Cholera

Intervention

Shanchol™, oral cholera vaccine

Study Arms / Comparison Groups

 Vaccine to past vaccinated participants
Description:  The first arm includes subjects, who were immunized with two Shanchol™ doses, five years prior. In this study, arm one will receive one Shanchol™ booster dose at baseline and one booster dose on day fourteen.

Publications

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

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

426

Start Date

December 2012

Completion Date

July 2013

Primary Completion Date

July 2013

Eligibility Criteria

        Inclusion Criteria:

        All subjects must be presently enrolled in the Phase 3 NICED RCT of Shanchol™ and satisfy
        the following criteria at study entry:

          1. Male or female adults aged 6 years and above, who are available for follow-up visits
             and specimen collection.

               -  The subject should be able to continue in the study for the next 6 weeks

               -  The subject (or parent/guardian) should be willing to provide 3 blood samples

          2. Written informed consent obtained from the subjects or their parents/guardians, and
             written assent obtained from children aged 12 - 17 years.

          3. Healthy subjects as determined by:

               -  Medical history

               -  Physical examination

               -  Clinical judgment of the investigator

        Exclusion Criteria:

          1. individuals who are too weak to get out of bed to receive the vaccine

          2. pregnant women (identified through verbal screening)

          3. those less than 6 years of age

          4. Receipt of cholera vaccine following 2009 (time of licensure and availability of
             Shanchol™ in India)

Gender

All

Ages

6 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Suman Kanungo, MBBS, ,

Location Countries

India

Location Countries

India

Administrative Informations

NCT ID

NCT01579448

Organization ID

CR-WC-11

Responsible Party

Sponsor-Investigator

Study Sponsor

Sachin Desai

Collaborators

 National Institute of Cholera and Enteric Diseases, India

Study Sponsor

Suman Kanungo, MBBS, Principal Investigator, National Institute of Cholera and Enteric Diseases, India

Verification Date

September 2013