Cholera Vaccine Investment Strategy in Bangladesh

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Brief Title

Cholera Vaccine Investment Strategy in Bangladesh

Official Title

Targeted Vaccination of Children in Urban Slums Against Cholera: Evaluation of a Potentially Cost-effective and Impactful Strategy for Deploying Oral Cholera Vaccine in Bangladesh

Brief Summary

      To evaluate the preventive impact, demand, acceptability, uptake, feasibility, and
      cost-effectiveness of a two-dose regimen of the OCV Shanchol in children living in urban
      slums in Bangladesh, Investigators will conduct a targeted mass immunization programme, using
      an innovative approach successfully deployed by the Bangladesh government in its recent
      countrywide campaign of MR vaccination of 52 million children aged 9 months to 14 years (<15
      years). Investigators will undertake a census of a geographic population of approximately
      300,000 persons, with GIS locations of each household. This census will be updated every 6
      months during the follow-up period to permit tracking of births, deaths, and migrations,
      including changes in location of each individual's residence. Following the initial census,
      the OCV will be offered to all non-pregnant individuals aged 1 to 14 years. Operational
      research and economic studies will evaluate the coverage, feasibility, acceptability, demand,
      costs and cost-effectiveness of this vaccination programme.
    

Detailed Description

      Burden: Cholera remains a major global problem, resulting in more than 100,000 deaths and
      several million cases annually , mostly children. Vaccination has been reconsidered as a key
      component of the public health response to cholera. Bangladesh has one of the world's highest
      burdens of endemic cholera, with an estimated 300,000 cholera cases and over 4,500 deaths
      annually, and with high caseloads and frequent outbreaks in more than half of the country.
      The endemicity of cholera in Bangladesh is demonstrated by the predictable yearly occurrence
      of the disease in the country's high-risk districts and the repetitive seasonal pattern of
      cholera outbreaks, either in spring or autumn, or both .

      Knowledge gap: More evidence is needed to address uncertainties around the cholera disease
      burden, as well as the impact, feasibility, and cost-effectiveness of various vaccination
      strategies against cholera, to add to the existing knowledge base. A special need for
      acquiring field evidence of these vaccine attributes in settings with endemic cholera, which
      account for a very large fraction of the global cholera disease burden, is also recognized .

      Relevance: Nonetheless, the assertion that selective vaccination of children with OCV is an
      impactful approach to controlling cholera at the population level rests on unproven
      assumptions, since there are no studies that directly address this vaccination strategy.
      Therefore, further study on whether targeted mass immunization can create efficiencies that
      general mass immunization would not, is warranted. The Investigators therefore believe that
      the most compelling question for the control of endemic cholera in Bangladesh is how
      targeting 1-14 year olds in urban slums, using the established platform of targeted mass
      childhood immunization recently deployed by the GOB for measles-rubella (MR) vaccine, impacts
      on the overall burden of cholera in the population and how feasible and cost-effective this
      strategy is. Addressing these questions will add to the evidence base on the most cost
      efficient and effective settings and strategies for use of OCV to control endemic disease and
      optimize health impact.

      Hypothesis : Vaccination of children under 15 years of age in urban slums of Dhaka will
      confer at least 50% overall protection to the entire population through combined direct and
      indirect protective effects and it will be cost effective.

      Objectives:To evaluate the feasibility, efficiency, and impact of a two-dose regimen of the
      oral cholera vaccine (OCV) Shanchol delivered to children aged 1-14 years residing in urban
      slums, leveraging a targeted mass immunization delivery platform used for other vaccines in
      Bangladesh.

      Methods: Observational design based on the contrast of persons who do and do not get
      vaccinated according to public health practice(Age-targeted mass immunization program).
    


Study Type

Observational


Primary Outcome

Number of participants with two doses of oral cholera vaccine (Shanchol) will get protection

Secondary Outcome

 Cholera vaccine coverage

Condition

Cholera

Intervention

Shanchol


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

75170

Start Date

January 1, 2016

Completion Date

October 31, 2019

Primary Completion Date

October 31, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  All healthy, consenting, non-pregnant (as ascertained by history) residents of a high
             risk group, 1 to 14 years of age, of the study area will be included in the study.

        Exclusion Criteria:

          -  Aged less than 1 year and more than 14 years

          -  History of intake of any cholera vaccine

          -  Pregnant women (identified through verbal screening)
      

Gender

All

Ages

1 Year - 14 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Dr. Firdausi Qadri, PhD, , 

Location Countries

Bangladesh

Location Countries

Bangladesh

Administrative Informations


NCT ID

NCT02727855

Organization ID

PR-15091


Responsible Party

Sponsor

Study Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborators

 Gavi, The Vaccine Alliance

Study Sponsor

Dr. Firdausi Qadri, PhD, Principal Investigator, International Centre for Diarrhoeal Disease Research, Bangladesh


Verification Date

December 2019