Evaluation of a Boosting Regimen With Oral Cholera Vaccine
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
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.
Immunogenicity provided by a two dose boosting regimen of Shanchol™
Immunogenicity provided by a one dose boosting regimen of Shanchol™
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
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)
6 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Suman Kanungo, MBBS, ,
National Institute of Cholera and Enteric Diseases, India
Suman Kanungo, MBBS, Principal Investigator, National Institute of Cholera and Enteric Diseases, India