Impact Study of Cholera Vaccination in Endemic Areas - Seroprevalence

May 2, 2023 updated by: Epicentre

Community-based Monitoring of Cholera Antibodies' Seroprevalence, and Home Follow-up of Positive Cases, in the Context of Cholera Vaccination Campaign, Democratic Republic of the Congo

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

Study Overview

Status

Recruiting

Conditions

Detailed Description

The project will comprise three different components:

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

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

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 seroprevalence surveys and the follow up of individuals with positive V. cholerae shedding identified through seroprevalence surveys, 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:

  1. To calculate the proportion of individuals infected with cholera recently (i.e. previous year or last 2 months) before the campaign distribution or in non-vaccinated zones (baseline survey, rural site) or following the mass OCV campaign and before the start of the usual cholera season (pre-season survey, urban site).
  2. To assess proportion of individuals recently infected (i.e. infected in the last two months or in the last year) during the expected peak-week of cholera in the area (peak survey, urban site) and at the end of the expected cholera season (post-season survey), as compared to baseline or pre-season survey.
  3. To assess the intra-household transmission and correlation in cholera recent infections among vaccinated and non-vaccinated households (post-season survey)
  4. To compare mortality linked to diarrheal diseases and potential cholera in the community of rural site before and after vaccination
  5. To assess the duration of shedding among vaccinated and unvaccinated individuals and the duration of viable V. cholerae in the peri-household environment.
  6. 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.

Study Type

Observational

Enrollment (Anticipated)

7000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants are selected randomly in the community. GPS point selection is made on mapping of roofs from the area, and some roofs are randomly selected with appropriate GIS software. Persons living under the randomly selected roof are proposed to participate in the surveys, or close neighboors in case of refusal.

Description

Inclusion Criteria:

  • All persons,

    1. Living in the randomly-selected households in targeted area AND
    2. Randomly selected among household members. Inclusions will be limited to 1 participant per household, except for one survey AND
    3. Giving his/her consent (or assent for children 13 to 17 years old) to participate in the study

Exclusion Criteria:

  • People who decline to participate will be excluded from the study. For 2nd survey in Goma only: members of the household who cannot be reached after 2 attempts will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To better characterize cholera immunization in the population of cholera hotspot in Africa and assess the impact of a large vaccination campaign reaching high coverage
Time Frame: 2 years
Cholera-specific antibody levels will be measured in all participants for each surveys. Serial surveys will allow monitoring level of antibodies over time following the vaccination campaign
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Calculate proportion of individuals infected with cholera (previous year or last 2 months) before the campaign distribution or in non-vaccinated zones or following the massOCV campaign and before the start of cholera season:pre-season survey, urban site.
Time Frame: 2 years
2 years
Assess proportion of individuals infected (the last 2 months or previous year) during the expected peak-week of cholera in the area and at the end of the expected cholera season (post-season survey), as compared to baseline or pre-season survey.
Time Frame: 2years
2years
To assess the intra-household transmission and correlation in cholera recent infections among vaccinated and non-vaccinated households (post-season survey)
Time Frame: 2 years
2 years
To compare mortality linked to diarrheal diseases and potential cholera in the community of rural site before and after vaccination
Time Frame: 2 years
2 years
To assess the duration of shedding among vaccinated and unvaccinated individuals and the duration of viable V. cholerae in the peri-household environment.
Time Frame: 2 years
2 years
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.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epicentre

Collaborators

Wellcome Trust
Institut Pasteur
Ministry of Public Health, Democratic Republic of the Congo
Médecins Sans Frontières, France
Institut National de Recherche Biomédicale. Goma, République Démocratique du Congo

Investigators

  • Study Chair: Francisco Luquero, Gavi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2021

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

April 13, 2023

First Submitted That Met QC Criteria

April 13, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Estimate)

May 4, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2146-WT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Methods and findings will be compiled into a report and will be sent to the Health Zone, the province authorities (DPS), the Ministry of Public Health of DRC, the PNECHOL, the involved laboratory institutions, the WHO, the Wellcome Trust foundation, and the other MSF sections present in the DRC.

Datasets gathered during this study are susceptible to be made available to other research groups which are currently actively collaborating with Epicentre in the cholera research projects. In that case, data sharing agreements will be made with the relevant research groups.

IPD Sharing Access Criteria

Partners of the study / Data Sharing Agreement and/or Memorandum of Understanding signed

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cholera

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe