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CompletedNCT05829772Updated Sep 19, 2024

Impact Study of Cholera Vaccination in Endemic Areas - Seroprevalence

An observational study in Cholera, sponsored by Epicentre. Completed at 2 sites in Congo, The Democratic Republic of the. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Epicentre · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
7,000
Sex
All
01

Study 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

Read the detailed description

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 seroprevalence surveys and the follow up of individuals with positive V. cholerae shedding identified through seroprevalence surveys, 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:

  1. To calculate the proportion of individuals infected with cholera recently (i.e. previous year or last 2 months) before the campaign distribution or in non-vaccinated zones (baseline survey, rural site) or following the mass OCV campaign and before the start of the usual cholera season (pre-season survey, urban site).
  2. To assess proportion of individuals recently infected (i.e. infected in the last two months or in the last year) during the expected peak-week of cholera in the area (peak survey, urban site) and at the end of the expected cholera season (post-season survey), as compared to baseline or pre-season survey.
  3. To assess the intra-household transmission and correlation in cholera recent infections among vaccinated and non-vaccinated households (post-season survey)
  4. To compare mortality linked to diarrheal diseases and potential cholera in the community of rural site before and after vaccination
  5. To assess the duration of shedding among vaccinated and unvaccinated individuals and the duration of viable V. cholerae in the peri-household environment.
  6. 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.
02

Conditions studied

  • Cholera

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Keywords

  • Cholera incidence rates
  • Mass vaccination campaign
  • V.Cholerae
  • Serial seroprevalence
03

In context

Cholera

83 studies on the registry are indexed under Cholera; 16 are open to participants now.

Browse Cholera studies →

Lead sponsor

Epicentre is the lead sponsor of 49 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
7,000 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

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

    Time frame: 2 years

Secondary outcomes

  1. 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.

    Time frame: 2 years

  2. 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.

    Time frame: 2years

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

    Time frame: 2 years

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

    Time frame: 2 years

  5. 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: 2 years

  6. 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: 2 years

07

Study locations

2 sites
  • Epicentre/Médecins Sans Frontières
    Bukama, Haut-Lomami, Congo, The Democratic Republic of the
  • Médecins Sans Frontières France
    Goma, Nord Kivu, Congo, The Democratic Republic of the
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2021 to primary completion in Mar 2024, 30 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 13, 2023
First posted
Apr 26, 2023
StartActual
Sep 20, 2021
Primary completionActual
Mar 31, 2024
CompletionActual
Apr 1, 2024
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05829772
Lead sponsor
Epicentre
Collaborators
Wellcome Trust, Institut Pasteur, Institut National de Recherche Biomédicale. Goma, République Démocratique du Congo, Ministry of Public Health, Democratic Republic of the Congo, Medecins Sans Frontieres, France
Responsible party
Sponsor
First posted
Apr 26, 2023
Start date
Sep 20, 2021
Primary completion
Mar 31, 2024
Completion
Apr 1, 2024
Last update
Sep 19, 2024

Study contacts

Klaudia Porten
study director · Epicentre
Francisco Luquero
study chair · Gavi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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