Impact Study of Cholera Vaccination in Endemic Areas – Clinical Surveillance

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Brief Title

Impact Study of Cholera Vaccination in Endemic Areas - Clinical Surveillance

Official Title

Cholera Control in Endemic Regions of Africa: Clinical Surveillance and Cholera Shedding Study in the Context of Mass Vaccination Campaigns, Democratic Republic of the Congo

Brief Summary

      This project aims to fill this essential knowledge gap by assessing the impact of oral
      cholera vaccine mass campaigns in 2 sites (urban and rural) in DRC, described in this
      protocol. The evidence generated from this project will be key to develop future strategies
      regarding cholera vaccine use in endemic settings, including places with higher burden in
      terms of cholera mortality.
    

Detailed Description

      The project will comprise three different components:

        1. Clinical cholera surveillance to measure cholera diseases incidence in selected African
           hotspots targeted by vaccination.

        2. Serial serological surveys to measure the prevalence of recent cholera infection (within
           the last 12 months).

        3. Identification and follow up of individuals with positive V. cholerae shedding
           (symptomatic or asymptomatic) among sero-survey participants and among household members
           of cholera confirmed cases.

      The present protocol relates to the setup of clinical surveillance and the follow up of
      individuals with positive V. cholerae shedding identified through clinical surveillance, in
      DRC.

      This protocol will allow us to assess if a large vaccination campaign reaching high coverage
      in cholera hotspot in Africa can allow sustained control of cholera for at least two years,
      by fulfilling the following specific objectives:

        -  To measure cholera incidence rates following the mass vaccination campaign in two
           cholera hotspots in Africa.

        -  To assess the duration of shedding among vaccinated and unvaccinated individuals and the
           duration of viable V. cholerae in the peri-household environment.

        -  To measure the secondary cholera attack rates (symptomatic and asymptomatic) at
           household level among vaccinated and unvaccinated individuals following the
           identification of an index case in a given household.

        -  To describe the global genetic diversity of V. cholerae strains in the study areas and
           within households affected by cholera.

        -  To develop sustainable surveillance methods that could be applied in other hotspots in
           Africa and elsewhere aiming to monitor the impact of the cholera control program.
    


Study Type

Observational


Primary Outcome

To better characterize cholera transmission in cholera hotspot in Africa and assess the impact of a large vaccination campaign reaching high coverage on sustained control of cholera transmission for at least two years.

Secondary Outcome

 1. To retrospectively study surveillance data, and prospectively measure cholera incidence rates of medically-attended confirmed cases following the mass vaccination campaign in two cholera hotspots in Africa.

Condition

Cholera



Publications

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

Recruitment Information



Estimated Enrollment

3000

Start Date

May 11, 2021

Completion Date

December 2022

Primary Completion Date

December 2022

Eligibility Criteria

        For Surveillance in study CTCs

        Inclusion Criteria:

          -  All patients presenting at the time of the study to any selected Cholera Treatment
             Center/Cholera Treatment Unit (CTC/CTU), matching the case definition and giving
             his/her consent (or assent for children 8 to 17 years old) to participate in the study
             will be eligible.

        Exclusion Criteria:

          -  Patients who decline to participate will be excluded from the study.

        Follow up of individuals with active cholera shedding:

        Inclusion Criteria:

          1. present to any selected CTC/CTU, match the case definition, participate to the
             clinical surveillance activity and test positive to RDT OR

          2. Be a household member of a person respecting inclusion criteria 1. AND for whom the
             head of the household has provided verbal consent to participate AND giving his/her
             consent (or assent for children 8 to 17 years old) to participate in the study will be
             eligible.

        Exclusion Criteria:

        - Individuals who decline to participate will be excluded from the study, as well as
        households for whom the head of the household (and his or her representative) decline the
        participation of his/her household.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Klaudia PORTEN, +33140215429, [email protected]

Location Countries

Congo, The Democratic Republic of the

Location Countries

Congo, The Democratic Republic of the

Administrative Informations


NCT ID

NCT04853186

Organization ID

2104-WT

Secondary IDs

215689/Z/19/Z

Responsible Party

Sponsor

Study Sponsor

Epicentre

Collaborators

 Wellcome Trust

Study Sponsor

Klaudia PORTEN, Study Director, Epicentre


Verification Date

April 2021