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

NCT01042951 | Completed Phase 2 DMC

• 1 other identifier: PR-09047
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

safety; immunogenicity; Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Safety and Reactogenicity: of orally administered killed, bivalent whole-cell cholera vaccine cholera vaccine, ShanChol

  1 year

Secondary Outcomes (1)

• 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.

  1 year

Study Arms (2)

ShanChol Cholera Vaccine

ACTIVE COMPARATOR

Biological: ShanChol Cholera Vaccine

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

ShanChol Cholera Vaccine BIOLOGICAL

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

Also known as: ShanCholCholera Vaccine

ShanChol Cholera Vaccine

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 12 Months - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• International Vaccine Institute: collaborator
• Government of Bangladesh: collaborator

Study Sites (1)

Dr. Firdausi Qadri

Mirpur, Dhaka, 1230, Bangladesh

Location

Related Publications (3)

• Sur D, Lopez AL, Kanungo S, Paisley A, Manna B, Ali M, Niyogi SK, Park JK, Sarkar B, Puri MK, Kim DR, Deen JL, Holmgren J, Carbis R, Rao R, Nguyen TV, Donner A, Ganguly NK, Nair GB, Bhattacharya SK, Clemens JD. Efficacy and safety of a modified killed-whole-cell oral cholera vaccine in India: an interim analysis of a cluster-randomised, double-blind, placebo-controlled trial. Lancet. 2009 Nov 14;374(9702):1694-702. doi: 10.1016/S0140-6736(09)61297-6. Epub 2009 Oct 8.

  PMID: 19819004 BACKGROUND

• Kanungo S, Paisley A, Lopez AL, Bhattacharya M, Manna B, Kim DR, Han SH, Attridge S, Carbis R, Rao R, Holmgren J, Clemens JD, Sur D. Immune responses following one and two doses of the reformulated, bivalent, killed, whole-cell, oral cholera vaccine among adults and children in Kolkata, India: a randomized, placebo-controlled trial. Vaccine. 2009 Nov 16;27(49):6887-93. doi: 10.1016/j.vaccine.2009.09.008. Epub 2009 Sep 15.

  PMID: 19761838 BACKGROUND

• Mahalanabis D, Lopez AL, Sur D, Deen J, Manna B, Kanungo S, von Seidlein L, Carbis R, Han SH, Shin SH, Attridge S, Rao R, Holmgren J, Clemens J, Bhattacharya SK. A randomized, placebo-controlled trial of the bivalent killed, whole-cell, oral cholera vaccine in adults and children in a cholera endemic area in Kolkata, India. PLoS One. 2008 Jun 4;3(6):e2323. doi: 10.1371/journal.pone.0002323.

  PMID: 18523643 BACKGROUND

Study Officials

• Firdausi Qadri, PhD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 6, 2010
• Study Start: January 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: November 1, 2010
• Last Updated: October 30, 2014

Record last verified: 2010-01

Locations

BA (1)