Cholera Clinical Trial
Official title:
Community-based Monitoring of Cholera Antibodies' Seroprevalence, and Home Follow-up of Positive Cases, in the Context of Cholera Vaccination Campaign, Democratic Republic of the Congo
NCT number | NCT05829772 |
Other study ID # | 2146-WT |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 20, 2021 |
Est. completion date | April 2024 |
Verified date | May 2023 |
Source | Epicentre |
Contact | Anais Broban |
Phone | +33140215429 |
anais.broban[@]epicentre.msf.org | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Recruiting |
Enrollment | 7000 |
Est. completion date | April 2024 |
Est. primary completion date | April 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - All persons, 1. Living in the randomly-selected households in targeted area AND 2. Randomly selected among household members. Inclusions will be limited to 1 participant per household, except for one survey AND 3. Giving his/her consent (or assent for children 13 to 17 years old) to participate in the study Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Congo, The Democratic Republic of the | Epicentre/Médecins Sans Frontières | Bukama | Haut-Lomami |
Congo, The Democratic Republic of the | Médecins Sans Frontières France | Goma | Nord Kivu |
Lead Sponsor | Collaborator |
---|---|
Epicentre | Institut National de Recherche Biomédicale. Goma, République Démocratique du Congo, Institut Pasteur, Medecins Sans Frontieres, France, Ministry of Public Health, Democratic Republic of the Congo, Wellcome Trust |
Congo, The Democratic Republic of the,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | ||
Secondary | 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 | ||
Secondary | To assess the intra-household transmission and correlation in cholera recent infections among vaccinated and non-vaccinated households (post-season survey) | 2 years | ||
Secondary | To compare mortality linked to diarrheal diseases and potential cholera in the community of rural site before and after vaccination | 2 years | ||
Secondary | 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 | ||
Secondary | 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. | 2 years |
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