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CholeraCVISNCT02727855

Cholera Vaccine Investment Strategy in Bangladesh

An observational study of Cholera, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 year to 14 yearsHealthy volunteers can take part
Conditions the study is for
Cholera
What is being tested?
Shanchol
How many people
75,170 participants
Where
1 siteBangladesh
Study dates
1 Jan 2016to 31 Oct 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: The study population will be recruited from different wards of Dhaka city corporation (wards 42, 43, 45, 46, 47, 48, 58, 91 and 92 which are now numbered as 29,30,32,33,34 of Dhaka North City Corporation and 14,22,55,56,57 of Dhaka South City Corporation respectively).

Who may be able to join

  • 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.

Who cannot join

  • Aged less than 1 year and more than 14 years
  • History of intake of any cholera vaccine
  • Pregnant women (identified through verbal screening)

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    Dhaka, 1212

Other trials in Bangladesh

About this study

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

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.

Read the 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).

Conditions
Cholera
Being tested
Shanchol
Keywords
Cholera, Vaccine, Strategy
Medical subject headings
Cholera

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ShancholBiological

    Oral Cholera Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Shanchol vaccine will be given to healthy , non pregnant residents aged 1-14 years in Dhaka, Bangladesh against culture proven vibrio cholerae O1 diarrhoea which has been detected in all treatment settings serving the catchment population.

    Measured: 2 years from dosing

Secondary outcomes (4)

  1. Cholera vaccine coverage

    Vaccination status of children by age, sex, socioeconomic characteristics of the household evaluation

    Measured: 10 months

  2. Vaccine acceptability

    Exit interviews with caregivers, direct observation of vaccination sessions, in-depth interviews and focus groups with guardians of vaccine recipients and of children not receiving vaccine will be conducted using qualitative guidelines to evaluate the taste of the vaccine, the convenience of the vaccine delivery program, willingness to participate in similar future vaccination programmes,general concerns about the vaccine and the vaccine program

    Measured: 17 months

  3. Vaccine feasibility

    Quantitative survey with a structured questionnaire administered to vaccination team members, and in depth interviews of purposefully selected vaccine supervisors and programme managers and focus group discussions with vaccination teams to evaluate the barriers faced in implementing the programme, availability of infrastructural supports, logistics and human resources, the adequacy of the vaccine transportation system, adequacy of cold chain and vaccine storage management, suitability of vaccination session management

    Measured: 17 months

  4. Incidence of cholera among vaccinated individuals in vaccination area

    Vaccine induced protective immunity and the indirect protection ( Herd immunity) will be estimated from comparing the incidence of cholera among vaccine recipients in the vaccination area and the incidence of cholera among vaccine non recipients in the same area.

    Measured: Two years after completion of vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2016 (estimated)
  2. Study start1 Jan 2016
  3. Primary completion31 Oct 2019
  4. Study completion31 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
75,170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02727855
Sponsor's protocol ID
PR-15091
Acronym
CVIS
Status last verified
Dec 2019
First submitted
16 Jan 2016
Last updated
20 Dec 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Individual participant data will not be shared to anybody.

Publications

  • Ali M, Lopez AL, You YA, Kim YE, Sah B, Maskery B, Clemens J. The global burden of cholera. Bull World Health Organ. 2012 Mar 1;90(3):209-218A. doi: 10.2471/BLT.11.093427. Epub 2012 Jan 24.

    PubMed 22461716

  • 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.

    PubMed 19819004

  • Glass RI, Becker S, Huq MI, Stoll BJ, Khan MU, Merson MH, Lee JV, Black RE. Endemic cholera in rural Bangladesh, 1966-1980. Am J Epidemiol. 1982 Dec;116(6):959-70. doi: 10.1093/oxfordjournals.aje.a113498.

    PubMed 7148820

Questions about this trial

What is this clinical trial studying?

An observational study of Cholera, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with two doses of oral cholera vaccine (Shanchol) will get protection (time frame: 2 years from dosing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02727855, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.

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