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