Impact Study of Cholera Vaccination in Endemic Areas - Clinical Surveillance

NCT04853186 | Recruiting

• 2 other identifiers: 2104-WT215689/Z/19/Z
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cholera

Keywords

Cholera incidence rates; Mass vaccination campaign; V.Cholerae

Outcome Measures

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.

  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 Outcomes (4)

• 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

• 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

• 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

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

  2 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients presenting to a CTC/UTC with a watery diarrhoea (≥ 3 watery stools per day), with or without vomiting, with or without dehydration. For the follow-up of individuals with active cholera shedding: This activity will take place in the community at included patient's households. Patients will be identified through CTC/CTUs and will therefore be conducted in the catchment area of these structures.

You may qualify if:

• 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.

You may not qualify if:

• Patients who decline to participate will be excluded from the study.
• Follow up of individuals with active cholera shedding:
• present to any selected CTC/CTU, match the case definition, participate to the clinical surveillance activity and test positive to RDT OR
• \- 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.

Sponsors & Collaborators

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

Study Sites (1)

Anais Broban

Goma, Democratic Republic of the Congo

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fresh stool samples will be systematically collected for patients presenting at the CTC and fulfilling the cholera case definition.Samples will first be tested with rapid test, then humid filter papers (for culture) and dry filter papers (for PCR) will be made from fresh sample.Enriched rapid tests could also be tested if appropriate to enhance RDT specificity.A fresh stool sample will be collected from all household members upon household visits.On day 90and180, fresh stool samples will only be collected from household member having tested positive for active cholera shedding during the course of the previous visits.Samples from peri-household environment including drinking water, kitchen swab, latrine swab and latrins sludge, will be taken during the first three household visits and sent to laboratory for testing.Peri-household environment samples collection will be stopped afterwards upon the course of the follow-up if all of them tested negative for at least2 consecutive visits.

MeSH Terms

Conditions

Cholera

Condition Hierarchy (Ancestors)

Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Klaudia PORTEN

  Epicentre

  STUDY DIRECTOR

• Francesco Luquero

  GAVI

  STUDY CHAIR

Central Study Contacts

Anais BROBAN

CONTACT

+33140215494; anais.broban@epicentre.msf.org

Flavio Finger

CONTACT

flavio.finger@epicentre.msf.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 21, 2021
• Study Start: May 11, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

DE (1)