search
Back to results

Evaluation of a Boosting Regimen With Oral Cholera Vaccine (Boost)

Primary Purpose

Cholera

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Shanchol™, oral cholera vaccine
Shanchol™, killed, whole cell, bivalent, oral cholera vaccine
no intervention
Sponsored by
Sachin Desai
About
Eligibility
Locations
Arms
Outcomes
Full info

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

6 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • National Institute of Cholera and Enteric Diseases

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Vaccine to past vaccinated participants

Vaccine to past placebo recipients

No intervention to past placebo recipients

Arm 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.

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.

Outcomes

Primary Outcome Measures

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),

Secondary Outcome Measures

Immunogenicity provided by a one dose boosting regimen of Shanchol™
To determine if a one dose booster regimen of Shanchol™ administered to a previously immunized cohort can elicit similar immune responses (through serum IgM) to those achieved by primary immunization in an unimmunized cohort stratified by age (6-14 and ≥15 years old)
Rises in serum IgA and IgG following boosting regimens
Measure rises in serum IgA and IgG as an adjunct measure of immunogenic response to the Shanchol™ boosting regimens
Proportion of subjects with adverse events
To confirm the safety of one and two dose boosting regimens Shanchol™ in healthy, non-pregnant subjects stratified by age within 28 days following dosing in each intervention group. Screening for number of adverse events (AEs)and severe adverse events (SAEs) will done on all study visits. Adverse events screened for include: diarrhea, fever, vomiting, abdominal pain, itching, rash, nausea, weakness, cough, vertigo, and dryness of mouth. SAEs are those which are incapacitating, preventing normal activities, including death and hospitalization.

Full Information

First Posted
April 11, 2012
Last Updated
September 24, 2013
Sponsor
Sachin Desai
Collaborators
National Institute of Cholera and Enteric Diseases, India, Indian Council of Medical Research
search

1. Study Identification

Unique Protocol Identification Number
NCT01579448
Brief Title
Evaluation of a Boosting Regimen With Oral Cholera Vaccine
Acronym
Boost
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sachin Desai
Collaborators
National Institute of Cholera and Enteric Diseases, India, Indian Council of Medical Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholera
Keywords
killed oral cholera vaccine, boosting vaccine regimen, safety and immunogenicity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
426 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaccine to past vaccinated participants
Arm Type
Experimental
Arm 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.
Arm Title
Vaccine to past placebo recipients
Arm Type
Active Comparator
Arm 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
Arm Title
No intervention to past placebo recipients
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Shanchol™, oral cholera vaccine
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Shanchol™, killed, whole cell, bivalent, oral cholera vaccine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
no intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Immunogenicity provided by a two dose boosting regimen of Shanchol™
Description
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),
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Immunogenicity provided by a one dose boosting regimen of Shanchol™
Description
To determine if a one dose booster regimen of Shanchol™ administered to a previously immunized cohort can elicit similar immune responses (through serum IgM) to those achieved by primary immunization in an unimmunized cohort stratified by age (6-14 and ≥15 years old)
Time Frame
28 days
Title
Rises in serum IgA and IgG following boosting regimens
Description
Measure rises in serum IgA and IgG as an adjunct measure of immunogenic response to the Shanchol™ boosting regimens
Time Frame
28 days
Title
Proportion of subjects with adverse events
Description
To confirm the safety of one and two dose boosting regimens Shanchol™ in healthy, non-pregnant subjects stratified by age within 28 days following dosing in each intervention group. Screening for number of adverse events (AEs)and severe adverse events (SAEs) will done on all study visits. Adverse events screened for include: diarrhea, fever, vomiting, abdominal pain, itching, rash, nausea, weakness, cough, vertigo, and dryness of mouth. SAEs are those which are incapacitating, preventing normal activities, including death and hospitalization.
Time Frame
42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suman Kanungo, MBBS
Organizational Affiliation
National Institute of Cholera and Enteric Diseases, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Cholera and Enteric Diseases
City
Kolkata
State/Province
West Bengal
Country
India

12. IPD Sharing Statement

Learn more about this trial

Evaluation of a Boosting Regimen With Oral Cholera Vaccine

We'll reach out to this number within 24 hrs