To Determine the Safety and Immunogenicity of an Oral Whole Cell ShanChol Cholera Vaccine in Bangladesh
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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 |
- Safety and Reactogenicity: of orally administered killed, bivalent whole-cell cholera vaccine cholera vaccine, ShanChol [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- 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 |
Inclusion Criteria:
- Age: 12-23 months for younger children group, 2-5 years for the toddler group and 18-45 years for the adult group.
- Sex: Either
- Consent: Written informed consent from study participants and parents in case of children.
- Compliance to study procedures: e.g. available for follow-up visits and agrees to specimen collection.
- Apparently healthy: as determined by medical history, physical examination findings, and clinical judgment of the study physician.
Exclusion Criteria:
- Chronic disease: history or evidence of chronic illness.
- 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
- Intake of any anti-diarrheal medicine or antimicrobial therapy the past week.
- Acute disease one week prior to enrollment, with or without fever ≥38ºC .
- Receiving of cholera vaccine any time in the past, and any other live or killed enteric vaccine in the last 4 weeks.
- Diarrhea within 6 week period at screening.
Contacts and Locations| Contact: Firdausi Qadri, PhD | 88028860523 to 32 ext 2431 | fqadri@icddrb.org |
| Bangladesh | |
| Dr. Firdausi Qadri | Recruiting |
| Mirpur, Dhaka, Bangladesh, 1230 | |
| Contact: Dr F Qadri, PhD 088-2-8819419-20 ext 2431 fqadri@icddrb.org | |
| 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 May 16, 2013