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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 426
- Locations
- 1
- Primary Endpoint
- Immunogenicity provided by a two dose boosting regimen of Shanchol™
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All subjects must be presently enrolled in the Phase 3 NICED RCT of Shanchol™ and satisfy the following criteria at study entry:
- •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
- •Written informed consent obtained from the subjects or their parents/guardians, and written assent obtained from children aged 12 - 17 years.
- •Healthy subjects as determined by:
- •Medical history
- •Physical examination
- •Clinical judgment of the investigator
Exclusion Criteria
- •individuals who are too weak to get out of bed to receive the vaccine
- •pregnant women (identified through verbal screening)
- •those less than 6 years of age
- •Receipt of cholera vaccine following 2009 (time of licensure and availability of Shanchol™ in India)
Outcomes
Primary Outcomes
Immunogenicity provided by a two dose boosting regimen of Shanchol™
Time Frame: 28 days
To determine whether two doses of Shanchol™ administered to a previously immunized cohort elicits similar immune responses (greater than fourfold rise in serum vibriocidal antibody titers through IgM) to those achieved by a primary immunization series in an unimmunized cohort stratified by age (6-14 and ≥15 years old),
Secondary Outcomes
- Immunogenicity provided by a one dose boosting regimen of Shanchol™(28 days)
- Rises in serum IgA and IgG following boosting regimens(28 days)
- Proportion of subjects with adverse events(42 days)
Investigators
Sachin Desai
ASSOCIATE RESEARCH SCIENTIST
International Vaccine Institute