CholeraNCT05829772
Impact Study of Cholera Vaccination in Endemic Areas - Seroprevalence
An observational study of Cholera, run by Epicentre at 2 sites in Democratic Republic of the Congo.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cholera
- How many people
- 7,000 participants
- Where
- 2 sitesDemocratic Republic of the Congo
- Study dates
- 20 Sep 2021to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- All persons,
- Living in the randomly-selected households in targeted area AND
- Randomly selected among household members. Inclusions will be limited to 1 participant per household, except for one survey AND
- Giving his/her consent (or assent for children 13 to 17 years old) to participate in the study
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Democratic Republic of the Congo2 sites
Epicentre/Médecins Sans Frontières
Bukama, Haut-Lomami
Médecins Sans Frontières France
Goma, North Kivu
About this study
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
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:
- 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).
- 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.
- To assess the intra-household transmission and correlation in cholera recent infections among vaccinated and non-vaccinated households (post-season survey)
- To compare mortality linked to diarrheal diseases and potential cholera in the community of rural site before and after vaccination
- 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.
- Conditions
- Cholera
- Keywords
- Cholera incidence rates, Mass vaccination campaign, V.Cholerae, Serial seroprevalence
- Medical subject headings
- Cholera
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 2years
To assess the intra-household transmission and correlation in cholera recent infections among vaccinated and non-vaccinated households (post-season survey)
Measured: 2 years
To compare mortality linked to diarrheal diseases and potential cholera in the community of rural site before and after vaccination
Measured: 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.
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start20 Sep 2021
- Primary completion31 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholeraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, Institut Pasteur, Institut National de Recherche Biomedicale (INRB), Ministry of Public Health, Democratic Republic of the Congo, Medecins Sans Frontieres, France
- Responsible party
- Sponsor
- Investigators
- Klaudia Porten, Study director, EpicentreFrancisco Luquero, Study chair, Gavi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829772
- Sponsor's protocol ID
- 2146-WT
- Status last verified
- Sep 2024
- First submitted
- 13 Apr 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05829772
- Acronym / sponsor ID
- 2146-WT
- Conditions
- Cholera
- Keywords
- Cholera incidence rates, Mass vaccination campaign, V.Cholerae, Serial seroprevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,000 participants (actual)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Wellcome Trust, Institut Pasteur, Institut National de Recherche Biomedicale (INRB), Ministry of Public Health, Democratic Republic of the Congo, Medecins Sans Frontieres, France
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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).
- 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.
- To assess the intra-household transmission and correlation in cholera recent infections among vaccinated and non-vaccinated households (post-season survey)
- To compare mortality linked to diarrheal diseases and potential cholera in the community of rural site before and after vaccination
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- All persons,
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 2 years
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
6 secondary outcomes
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
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
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
To compare mortality linked to diarrheal diseases and potential cholera in the community of rural site before and after vaccination
Time frame: 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.
Time frame: 2 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaudia Porten study director
Epicentre
Francisco Luquero study chair
Gavi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholera, run by Epicentre at 2 sites in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.