NCT01579448

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 426 (actual)
• Sponsor: Sachin Desai · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cholera

Interventions

Type	Name	Description
BIOLOGICAL	Shanchol™, oral cholera vaccine	This killed, whole cell, bivalent vaccine will be presented as a creamish white suspension. Upon storage, a white sediment and clear supernatant may be observed. The recommended dose (1.5ml) of the vaccine must be administered orally. The primary vaccination schedule consists of two doses given at an interval of two weeks. After vigorous shaking of the vial, 1.5 ml should be poured into the mouth of the recipient, followed by water ad libitum. The vaccine can alternatively be administered with a disposable syringe (without needle) after removing the contents from the vial and squirted into the mouth of the recipient. Vaccine is administered in 1.5 mL vials by mouth in 2 doses, given 2 weeks apart. The vaccine appears as a creamy white suspension.
BIOLOGICAL	Shanchol™, killed, whole cell, bivalent, oral cholera vaccine	This killed, whole cell, bivalent vaccine will be presented as a creamish white suspension. Upon storage, a white sediment and clear supernatant may be observed. The recommended dose (1.5ml) of the vaccine must be administered orally. The primary vaccination schedule consists of two doses given at an interval of two weeks. After vigorous shaking of the vial, 1.5 ml should be poured into the mouth of the recipient, followed by water ad libitum. The vaccine can alternatively be administered with a disposable syringe (without needle) after removing the contents from the vial and squirted into the mouth of the recipient. Vaccine is administered in 1.5 mL vials by mouth in 2 doses, given 2 weeks apart. The vaccine appears as a creamy white suspension.
OTHER	no intervention	No intervention will be given to this arm of past placebo recipients. To ensure that boosting was not due to natural exposure to Vibrio cholera, we will compare subjects in the boosting arm to this no intervention arm.

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-04-18
• Last updated: 2013-09-25

Locations

1 site across 1 country: India