Cholera Vaccine Investment Strategy in Bangladesh

Cholera Clinical Trial

— CVIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727855
• Other study ID #: PR-15091
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: October 31, 2019

Study information

• Verified date: December 2019
• Source: International Centre for Diarrhoeal Disease Research, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75170
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 14 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cholera

Intervention

Biological:
• Shanchol
Oral Cholera Vaccine

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh	Dhaka

Sponsors (3)

Lead Sponsor	Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh	Gavi, The Vaccine Alliance, Government of Bangladesh

Country where clinical trial is conducted

Bangladesh, 

References & Publications (3)

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. — View Citation

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. — View Citation

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-who — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years from dosing
Secondary	Cholera vaccine coverage	Vaccination status of children by age, sex, socioeconomic characteristics of the household evaluation	10 months
Secondary	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	17 months
Secondary	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	17 months
Secondary	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.	Two years after completion of vaccination