NCT04853186

Impact Study of Cholera Vaccination in Endemic Areas - Clinical Surveillance

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 6,000 (estimated)
• Sponsor: Epicentre · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cholera

Timeline

• Start date: 2021-05-11
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2021-04-21
• Last updated: 2024-09-19

Locations

1 site across 1 country: Democratic Republic of the Congo