Impact Study of Cholera Vaccination in Endemic Areas - Clinical Surveillance

Cholera Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04853186
• Other study ID #: 2104-WT
• Secondary ID: 215689/Z/19/Z
• Status: Recruiting
• Start date: May 11, 2021
• Est. completion date: June 2024

Study information

• Verified date: April 2023
• Source: Epicentre
• Contact: Anais BROBAN
• Phone: +33140215429
• Email: anais.broban[@]epicentre.msf.org
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholera

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	Anais Broban	Goma

Sponsors (6)

Lead Sponsor	Collaborator
Epicentre	Grand Labo de Lubumbashi, Institut National de Recherche Biomédicale. Goma, République Démocratique du Congo, Médecins Sans Frontières, France, Ministry of Public Health, Democratic Republic of the Congo, Wellcome Trust

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Specific objectives 1 and 4 will be answered through the clinical surveillance activity, below referred to as "Surveillance in study CTCs", while 2 and 3 relate to the follow-up activity, below referred to as "Follow-up of individuals with active cholera shedding".	2 years
Secondary	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.		2 years
Secondary	2. To assess the duration of shedding among vaccinated and unvaccinated individuals and the duration of viable V. cholerae in the peri-household environment.		one year
Secondary	3. 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.		one year
Secondary	4. To describe the global genetic diversity of V. cholerae strains in the study areas and within households affected by cholera.		2 years