To Determine the Safety and Immunogenicity of an Oral Whole Cell ShanChol Cholera Vaccine in Bangladesh

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2010 by International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor:
Collaborators:
International Vaccine Institute
Government of Bangladesh
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT01042951
First received: January 5, 2010
Last updated: December 3, 2012
Last verified: January 2010
  Purpose

Background: Severe dehydrating cholera due to V. cholerae O1 is an important public health problem in Bangladesh and many other developing countries. V. cholerae O1 is a major bacterial pathogen causing around 5 million cases and at least 200,000 deaths in adults and children each year. It can be assumed that there are at least 300,000 severe cases and 1.2 million infections in people in Bangladesh alone. The rate of cholera varies from around 1 to 8 per 1000 population and the highest attack rate is in children 2- to 9-year years of age . Cholera is now also being documented in very young children. Currently enteric vaccine approaches are regarded as the most accessible short term and practical means to prevent and control such illnesses to prevent disease and epidemics in resource poor settings with limited public health and sanitary facilities.

An effective inactivated whole cell bivalent cholera vaccine against Vibrio cholerae O1 and O139 was produced and implemented for public health purposes in Vietnam since the 1990s. This bivalent vaccine has been found to be safe and to confer significant protection against El Tor cholera in both children and adults and has over the last decade being used in the Vietnam to protect against cholera. This vaccine has further been reformulated by the IVI to meet WHO requirements and is now being produced in WHO prequalified vaccine company in India.

The reformulated vaccine has been shown to be safe and immunogenic in Indian children as well as adults. A large Phase III study of the vaccine, has recently been carried out in Kolkata, India in over 120,000 participants aged from one year and above. Results of the study are encouraging and the vaccine gives over 60% protection against cholera. The vibriocidal antibody response rate was 80% in children and 53% in adults. Following this study, the vaccine, designated as ShanChol has been licensed in India in April 2009. The vaccine is now being marketed in India and is available at a cost affordable for developing country settings.

Objective: The aim of the proposed study is to assess if the orally administered, killed, bivalent whole-cell cholera vaccine, ShanChol will be safe and immunogenic in different age groups in Bangladesh in children and adults.

Study design: This will be a randomized, double blind, placebo-controlled study on a total of 330 subjects, 165 vaccine and 165 placebo recipients. The specific aims will be to determine: i) safety and determine adverse events if any (ii) determine immune responses.

Relevance: The study of ShanChol on Bangladeshi children and adults will be able to give information regarding the safety and immunogenicity of the vaccine in Bangladeshi subjects. This information will be important for proceeding with larger studies in Bangladesh and if proven useful for introduction the cholera vaccine in the country in the future.


Condition Intervention Phase
Healthy
Biological: ShanChol Cholera Vaccine
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: Randomized, Double-blind, Placebo-controlled Trial, to Evaluate the Safety and Immunogenicity of Orally Administered, Killed, Bivalent Whole-cell, Cholera Vaccine, ShanChol in Bangladeshi Adults and Children

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Safety and Reactogenicity: of orally administered killed, bivalent whole-cell cholera vaccine cholera vaccine, ShanChol [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunogenicity: of cholera vaccine assessed by serum vibriocidal antibody responses as well as serological and mucosal responses to vaccine antigens and compare it with those obtained with placebo recipients. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 330
Study Start Date: January 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ShanChol Cholera Vaccine Biological: ShanChol Cholera Vaccine
55 adults (18-45 year old) will be given 2 doses of the bivalent whole-cell cholera vaccine 55 Toddlers(2-5 years) will be given 2 doses of the bivalent whole-cell cholera vaccine 55 Younger children(12-23 months)will be given 2 doses of the bivalent whole-cell cholera vaccine
Other Name: ShanCholCholera Vaccine
Placebo Comparator: Placebo Other: Placebo
55 adults (18-45 year old) will be given 2 doses placebo, 55 Toddlers(2-5 years) will be given 2 doses of placebo, and 55 Younger children(12-23 months)will be given 2 doses of placebo
Other Name: Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Months to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age: 12-23 months for younger children group, 2-5 years for the toddler group and 18-45 years for the adult group.
  2. Sex: Either
  3. Consent: Written informed consent from study participants and parents in case of children.
  4. Compliance to study procedures: e.g. available for follow-up visits and agrees to specimen collection.
  5. Apparently healthy: as determined by medical history, physical examination findings, and clinical judgment of the study physician.

Exclusion Criteria:

  1. Chronic disease: history or evidence of chronic illness.
  2. Gastrointestinal symptoms such as abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours or abdominal pain lasting for more than 2 weeks in the past 6 months
  3. Intake of any anti-diarrheal medicine or antimicrobial therapy the past week.
  4. Acute disease one week prior to enrollment, with or without fever ≥38ºC .
  5. Receiving of cholera vaccine any time in the past, and any other live or killed enteric vaccine in the last 4 weeks.
  6. Diarrhea within 6 week period at screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042951

Contacts
Contact: Firdausi Qadri, PhD 88028860523 to 32 ext 2431 fqadri@icddrb.org

Locations
Bangladesh
Dr. Firdausi Qadri Recruiting
Mirpur, Dhaka, Bangladesh, 1230
Contact: Dr F Qadri, PhD    088-2-8819419-20 ext 2431    fqadri@icddrb.org   
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
International Vaccine Institute
Government of Bangladesh
Investigators
Principal Investigator: Firdausi Qadri, PhD International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

Publications:
Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01042951     History of Changes
Other Study ID Numbers: PR-09047
Study First Received: January 5, 2010
Last Updated: December 3, 2012
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
safety
immunogenicity
Healthy Participants

Additional relevant MeSH terms:
Cholera
Vibrio Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 28, 2014