Oral Cholera Vaccine Delivery in Rural Bangladesh (ROCV)

This study is currently recruiting participants.
Verified September 2012 by International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor:
Collaborator:
Government of Bangladesh
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT01811771
First received: March 13, 2013
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

Background:

Vibrio cholerae is one of the major causes of severe diarrheal disease in Bangladesh. It is estimated that there are about 450,000 cholera cases each year in Bangladesh. Cholera is prevalent in both urban and rural settings in the country. Policy decisions about how best a new public health tool can be incorporated into the system requires evidence. We have recently carried out a feasibility study of oral cholera vaccine in urban Dhaka in Mirpur (Protocol #10061). However, whether a similar system can also be utilized in a rural area in Bangladesh needs to be studied.

The hospital disease surveillance data from icddr,b reveals a substantial burden of cholera from Keraniganj upazila. We propose a feasibility study of oral cholera vaccination by using the existing national immunization service delivery mechanism in Keraniganj. This study will help to provide evidence for the policy makers in introducing oral cholera vaccine in preventing cholera in high risk rural areas in Bangladesh.

Hypothesis:

That icddr,b in collaboration with the Government of Bangladesh will be able to implement an oral cholera vaccine program that;

  1. reaches residents of rural union of Keraniganj
  2. reduces the incidence of diarrhea due to Vibrio cholerae

Objectives:

  1. Carry out cholera vaccination in one rural union in Keraniganj.
  2. Evaluate the impact of vaccination in reducing cholera in the study area

Methods:

Two unions in Keraniganj will be selected; around 30,000 individuals in one union will be vaccinated and impact evaluated by comparison with another similar union. After vaccination, passive cholera surveillance at the Upazila hospital will be conducted for two years on the patients from the two unions.

Outcome measures/variables:

Cholera vaccination programme will be assessed by the number of doses administered, drop-out rates between the two rounds, the proportion of vaccine wastage, and the vaccine coverage.

Proportion of diarrheal hospitalizations that are due to V. cholerae O1 between the vaccinated and non vaccinated union will be calculated and compared to assess the impact of intervention.


Condition Intervention
Cholera
Biological: Shanchol vaccine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact Evaluation of Oral Cholera Vaccination in a Rural Setting Using the National Immunization System of Bangladesh

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Proportion of diarrheal hospitalizations that are due to V. cholerae O1 between the vaccinated and non vaccinated union will be calculated and compared to assess the impact of intervention [ Time Frame: within 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60000
Study Start Date: August 2012
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 vaccine
Around 30,000 individuals will be vaccinated with two doses of oral cholera vaccine at least 14 days apart.All male and non-pregnant female residents above one year age will be targeted for vaccination.
Biological: Shanchol vaccine
Shanchol vaccine contains whole cell inactivated heat killed and formalin killed bacteria consisting of 600 ELISA Units (EU) of lipopolysaccharide (LPS). It consists of formalin-killed V. cholerae Inaba, El Tor biotype (strain Phil 6973). It also contains 300 EU LPS of heat-killed V. cholerae Ogawa classical biotype (Cairo 50); 300 EU LPS of formalin killed V. cholerae Ogawa classical biotype (Cairo 50); 300 EU LPS of heat-killed V. cholerae Inaba, classical biotype (Cairo 48); and 600 EU LPS of formalin killed V. cholerae O139 (4260B) (9). The vaccine has no detectable cholera toxin. Vaccine is packaged as liquid formulations in 1.5-ml doses. No buffer is needed for administered.This vaccine is licensed in India and WHO prequalified.
No Intervention: Non-intervention
No intervention will be given. Health education will be provided to the study participants.

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  Eligibility

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

Inclusion Criteria:

  1. Apparently healthy residents
  2. Aged 1 year and above
  3. Non Pregnant women -

Exclusion Criteria:

  1. Age less than 1 year
  2. Pregnant women -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01811771

Contacts
Contact: Firdausi Qadri, PhD +88-028860525-32 ext 2431 fqadri@icddrb.org
Contact: Iqbal Ansary Khan, Msc +88-028860525-32 ext 3459 iak@icddrb.org

Locations
Bangladesh
International Centre for Diarrhoeal Disease Research,Bangladesh Recruiting
Dhaka, Bangladesh, 1212
Contact: Firdausi Qadri, PhD    880-2-9840525 ext 2431    fqadri@icddrb.org   
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Government of Bangladesh
  More Information

Publications:
Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01811771     History of Changes
Other Study ID Numbers: PR-12041
Study First Received: March 13, 2013
Last Updated: March 13, 2013
Health Authority: Bangladesh: Ethical Review Committee

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

ClinicalTrials.gov processed this record on April 17, 2014