Cholera Clinical Trial - Impact Study of Cholera Vaccination in Endemic

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Cholera

Clinical Trial Details

NCT number	NCT04853186
Study type	Observational
Source	Epicentre
Contact	Anais BROBAN
Phone	+33140215429
Email	anais.broban@epicentre.msf.org
Status	Recruiting
Phase
Start date	May 11, 2021
Completion date	June 2024

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Impact Study of Cholera Vaccination in Endemic Areas - Clinical Surveillance

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms