Trial record 3 of 15 for:    Open Studies | "Cholera"

Single Dose Oral Cholera Vaccine Study in Dhaka, Bangladesh (SCVB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 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:
NCT02027207
First received: December 23, 2013
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

Bangladesh remains endemic for cholera, which experiences biannual outbreaks with additional epidemics seen during times of floods, cyclones or any natural disaster. It affects all age groups with the majority of fatal cases occurring in children . Therefore, immunization against cholera remains an important public health component in the prevention and control of the disease .The current two-dose regimen of the internationally available oral cholera vaccines (OCV) create a logistical and programmatic challenge for use in national programs or during epidemics ,so it is important to determine if a single dose vaccine will be protective in regions where cholera is endemic. If the vaccine is found to be efficacious following a single dose, this will have profound implications for the use of the vaccine in areas with limited resources particularly in complex emergencies where a multiple dose regimen is difficult to deploy. A single-dose regimen of this vaccine will improve its 'field ability' and allow the vaccine to be used for outbreak control, especially in difficult settings where the risk of cholera is extremely high and provisions for clean water and sanitation are not available. With low OCV production rates, larger populations could be immunized against cholera if a single dose is found to be efficacious. A single-dose schedule could facilitate the inclusion of a global stockpile strategy.

The study design is a two-arm individually randomized double-blind placebo-controlled trial. The primary outcome of the study is the proportion of persons receiving 1 dose of vaccine or placebo who are detected with diarrhea with faecal excretion of V. cholera O1 in the study treatment centres from 7 days to 6 months after dosage and whose identity is confirmed through home visit.


Condition Intervention Phase
Cholera
Biological: Shanchol
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: An Individually Randomized, Placebo-controlled Trial to Measure the Protection Conferred by a Single Dose Regimen of Bivalent, Killed, Whole Cell Oral Cholera Vaccine (Shanchol™) in Dhaka, Bangladesh

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of participants with a single dose regimen oral cholera vaccine Shanchol will get protection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Shanchol vaccine will be given to healthy, non-pregnant residents aged one and above in Dhaka, Bangladesh, against culture-proven V. cholerae O1 diarrhea which has been detected in all treatment settings serving the catchment population.


Secondary Outcome Measures:
  • Number of participants with a single dose Shanchol with onset of 7 days to to 24 months after dosing, against culture-proven V. cholerae O1 diarrhea, V. Cholerae O1 along and with severe dehydration get protection [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Number of participants with the single dose regimen of Shanchol against acute watery diarrhea and AWD with severe dehydration with onset of 7 days to 24 months after dosing get protection [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Serum vibriocidal antibody responses to a single dose regimen of the bivalent, killed, whole cell-based oral cholera vaccine Shanchol in healthy,non-pregnant residents, aged one year and older in a subset of population [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Safety up to 28 days following a single dose of the bivalent, killed, whole cell oral cholera vaccine Shanchol™ administered to healthy, non-pregnant residents one year and older. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 204438
Study Start Date: December 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Shanchol Biological: Shanchol

We will use the killed whole cell oral cholera vaccine, Shanchol that will be manufactured by Shantha Biotechnics, in Hyderabad, India for the study. The vaccine is registered in India and is prequalified by the WHO. Shanchol is available in a single dose vial. Vaccine will be maintained at 2-8oC. Each participant over the age of one year and non pregnant females living in communities will be individually randomized to receive vaccine.Pregnancy status will be enquired verbally for all married women of child bearing age during the census update as well as before vaccination to exclude them from the study.

Prior to vaccination, informed consent will be taken from the adults and guardians of minor participants .Each dose of vaccine will be 1.5 ml in volume.

Placebo Comparator: Placebo Biological: Placebo
Placebo will be transported from the manufacturer and will be maintained at 2-8oC. Each participant over the age of one year and non pregnant females living in communities will be individually randomized to receive placebo.Each dose of placebo will be 1.5 ml in volume.Placebo will be dispensed in liquid form in identical vials.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy subjects > 1 year of age and above Living in high risk area for cholera Provision of Informed consent for participating in the study by participant /parent or guardian as well as verbal assent for children 11-17 years.

Exclusion Criteria:

Pregnant women Aged less than 1 year History of taking cholera vaccine

  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: NCT02027207

Contacts
Contact: Dr. Firdausi Qadri, PhD 88-02-9840525 ext 2431 fqadri@icddrb.org

Locations
Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) Recruiting
Dhaka, Bangladesh, 1212
Contact: Dr. Firdausi Qadri, PhD    88-02-9840525 ext 2431    fqadri@icddrb.org   
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
International Vaccine Institute
Government of Bangladesh
  More Information

Publications:
Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT02027207     History of Changes
Other Study ID Numbers: PR-12090
Study First Received: December 23, 2013
Last Updated: January 2, 2014
Health Authority: Bangladesh: Ethical Review Committee
Bangladesh: Data and Safety Monitoring Board (DSMB), icddr,b

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Cholera
Oral cholera vaccine
Shanchol
Protective efficacy
Bangladesh

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

ClinicalTrials.gov processed this record on July 22, 2014