Evaluation of a Boosting Regimen With Oral Cholera Vaccine

Sachin Desai

Status and phase: Completed; Phase 4

Conditions: Cholera

Treatments: Biological: Shanchol™, oral cholera vaccine; Other: no intervention; Biological: Shanchol™, killed, whole cell, bivalent, oral cholera vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01579448

CR-WC-11

Details and patient eligibility

About

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.

Enrollment: 426 patients

Sex: All

Ages: 6+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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426 participants in 3 patient groups, including a placebo group

Vaccine to past vaccinated participants

Experimental group

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.

Treatment:

Biological: Shanchol™, oral cholera vaccine

Vaccine to past placebo recipients

Active Comparator group

Description:

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

Treatment:

Biological: Shanchol™, killed, whole cell, bivalent, oral cholera vaccine

No intervention to past placebo recipients

Placebo Comparator group

Description:

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.

Treatment:

Other: no intervention