Evaluation of a Boosting Regimen With Oral Cholera Vaccine (Boost)
Cholera
About this trial
This is an interventional prevention trial for Cholera focused on measuring killed oral cholera vaccine, boosting vaccine regimen, safety and immunogenicity
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:
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)
Sites / Locations
- National Institute of Cholera and Enteric Diseases
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Placebo Comparator
Vaccine to past vaccinated participants
Vaccine to past placebo recipients
No intervention to past placebo recipients
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.
The second arm includes subjects, who received two placebo doses, five years prior. Arm two will receive a primary immunization series consisting of one Shanchol™ dose at baseline and one at day fourteen
The third arm includes subjects, who received two placebo doses, five years prior. This third arm will not receive any intervention and will serve to represent a baseline immune response by vaccine naïve individuals exposed to natural exposure.