Evaluation of a Boosting Regimen With Oral Cholera Vaccine

Cholera Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579448
• Other study ID #: CR-WC-11
• Status: Completed
• Phase: Phase 4
• First received: April 11, 2012
• Last updated: September 24, 2013
• Start date: December 2012
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• Source: International Vaccine Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: KOREA: INTERNATIONAL VACCINE INSTITUTE IRBINDIA: NATIONAL INSTITUTE OF CHOLERA AND ENTERIC DISEASESIndia: Indian Council of Medical ResearchINDIA: SHANTHA BIOTECHNICS LTD
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cholera

Intervention

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.
• 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.

Locations

Country	Name	City	State
India	National Institute of Cholera and Enteric Diseases	Kolkata	West Bengal

Sponsors (3)

Lead Sponsor	Collaborator
Sachin Desai	Indian Council of Medical Research, National Institute of Cholera and Enteric Diseases, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	28 days	No
Secondary	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	28 days	No
Secondary	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.	42 days	Yes