Impact Study of Cholera Vaccination in Endemic Areas - Seroprevalence

NCT05829772 | Completed

• 1 other identifier: 2146-WT
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 2

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; Serial seroprevalence

Outcome Measures

Primary Outcomes (1)

• To better characterize cholera immunization in the population of cholera hotspot in Africa and assess the impact of a large vaccination campaign reaching high coverage

  Cholera-specific antibody levels will be measured in all participants for each surveys. Serial surveys will allow monitoring level of antibodies over time following the vaccination campaign

  2 years

Secondary Outcomes (6)

• Calculate proportion of individuals infected with cholera (previous year or last 2 months) before the campaign distribution or in non-vaccinated zones or following the massOCV campaign and before the start of cholera season:pre-season survey, urban site.

  2 years

• Assess proportion of individuals infected (the last 2 months or previous year) during the expected peak-week of cholera in the area and at the end of the expected cholera season (post-season survey), as compared to baseline or pre-season survey.

  2years

• To assess the intra-household transmission and correlation in cholera recent infections among vaccinated and non-vaccinated households (post-season survey)

  2 years

• To compare mortality linked to diarrheal diseases and potential cholera in the community of rural site before and after vaccination

  2 years

• To assess the duration of shedding among vaccinated and unvaccinated individuals and the duration of viable V. cholerae in the peri-household environment.

  2 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are selected randomly in the community. GPS point selection is made on mapping of roofs from the area, and some roofs are randomly selected with appropriate GIS software. Persons living under the randomly selected roof are proposed to participate in the surveys, or close neighboors in case of refusal.

You may qualify if:

• All persons,
• Living in the randomly-selected households in targeted area AND
• Giving his/her consent (or assent for children 13 to 17 years old) to participate in the study

You may not qualify if:

• People who decline to participate will be excluded from the study. For 2nd survey in Goma only: members of the household who cannot be reached after 2 attempts will be excluded.

Sponsors & Collaborators

• Epicentre: lead
• Wellcome Trust: collaborator
• Institut Pasteur: collaborator
• Institut National de Recherche Biomédicale. Goma, République Démocratique du Congo: collaborator
• Ministry of Public Health, Democratic Republic of the Congo: collaborator
• Medecins Sans Frontieres, France: collaborator

Study Sites (2)

Epicentre/Médecins Sans Frontières

Bukama, Haut-Lomami, Democratic Republic of the Congo

Location

Médecins Sans Frontières France

Goma, North Kivu, Democratic Republic of the Congo

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Full blood serum samples are collected for all participants in each surveys, 4 in Goma and 3 in Bukama. An additional EDTA tube is also collected in 2 surveys (1st in Goma and 1st in Bukama). They will be analyzed for cholera antibody levels (Luminex and/or vibriocidal assay). In addition, stool samples will be collected in 1 survey in Goma and RDT-tested. Participants with positive samples will be proposed to participate in home follow-up study. During home follow-up, a stool sample will be collected from all household members upon household visits.On day 90and180, stool samples will only be collected from participants who tested positive for cholera shedding during the previous visits.Samples from peri-household environment (drinking water, kitchen swab, latrine swab and latrine sludge), will be taken during the first 3 household visits and sent to laboratory.Environment samples collection will be stopped afterwards if all of them tested negative for at least 2 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

• Francisco Luquero

  Gavi

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: April 26, 2023
• Study Start: September 20, 2021
• Primary Completion: March 31, 2024
• Study Completion: April 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)