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NCT Number: NCT04853186

Impact Study of Cholera Vaccination in Endemic Areas - Clinical Surveillance

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Anais Broban

Goma, Democratic Republic of the Congo

Location status: Recruiting

Location contact

Anais BROBAN

CONTACT

[email protected]

0140215429

About this study

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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: 2 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".

Secondary outcomes

  1. 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.

    Time frame: 2 years

  2. 2. 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: one year

  3. 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.

    Time frame: one year

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

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Anais BROBAN

CONTACT

[email protected]

+33140215494

Flavio Finger

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Epicentre

Other

Collaborators

  • Grand Labo de Lubumbashi
  • Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
  • Ministry of Public Health, Democratic Republic of the Congo
  • Médecins Sans Frontières, France
  • Wellcome Trust

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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