Evaluation of a Boosting Regimen With Oral Cholera Vaccine

NCT01579448 | Completed Phase 4 DMC

• 1 other identifier: CR-WC-11
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholera

Keywords

killed oral cholera vaccine; boosting vaccine regimen; safety and immunogenicity

Outcome Measures

Primary Outcomes (1)

• Immunogenicity provided by a two dose boosting regimen of Shanchol™

  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),

  28 days

Secondary Outcomes (3)

• 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

Study Arms (3)

Vaccine to past vaccinated participants

EXPERIMENTAL

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.

Biological: Shanchol™, oral cholera vaccine

Vaccine to past placebo recipients

ACTIVE COMPARATOR

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

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

No intervention to past placebo recipients

PLACEBO COMPARATOR

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.

Other: no intervention

Interventions

Shanchol™, oral cholera vaccine BIOLOGICAL

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.

Vaccine to past vaccinated participants

Shanchol™, killed, whole cell, bivalent, oral cholera vaccine BIOLOGICAL

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.

Vaccine to past placebo recipients

no intervention OTHER

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.

No intervention to past placebo recipients

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sachin Desai: lead
• National Institute of Cholera and Enteric Diseases, India: collaborator
• Indian Council of Medical Research: collaborator

Study Sites (1)

National Institute of Cholera and Enteric Diseases

Kolkata, West Bengal, India

Location

MeSH Terms

Conditions

Cholera

Interventions

shanchol; Cholera Vaccines

Condition Hierarchy (Ancestors)

Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Suman Kanungo, MBBS

  National Institute of Cholera and Enteric Diseases, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ASSOCIATE RESEARCH SCIENTIST

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: April 18, 2012
• Study Start: December 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 25, 2013

Record last verified: 2013-09

Locations

IN (1)