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OpenTrials
Completed

NCT Number: NCT01579448

Evaluation of a Boosting Regimen With Oral Cholera Vaccine

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.

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Key information

Conditions

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

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Institute of Cholera and Enteric Diseases

Kolkata, West Bengal, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Immunogenicity provided by a two dose boosting regimen of Shanchol™

    Time frame: 28 days

    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 outcomes

  1. Immunogenicity provided by a one dose boosting regimen of Shanchol™

    Time frame: 28 days

    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)

  2. Rises in serum IgA and IgG following boosting regimens

    Time frame: 28 days

    Measure rises in serum IgA and IgG as an adjunct measure of immunogenic response to the Shanchol™ boosting regimens

  3. Proportion of subjects with adverse events

    Time frame: 42 days

    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.

Sponsors and collaborators

Lead sponsor

Sachin Desai

Other

Collaborators

  • Indian Council of Medical Research
  • National Institute of Cholera and Enteric Diseases, India

Registry information

Official study 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

Acronym: Boost

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 18, 2012
Registry last updated
Sep 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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