Monkeypox Virus InfectionAFRIPOXNCT05058898
A One Health Study of Monkeypox Human Infection
An observational study of Monkeypox Virus Infection, run by Institut Pasteur at 1 site in Central African Republic.
Trial summary
This multidisciplinary project aim to understand the epidemiology of the monkeypox in Central African Republic through the identification of the animal reservoir, the clinical and epidemiological description of the human outbreak, through an ethnological approach around risk factors of the disease and through an… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Monkeypox Virus Infection
- What is being tested?
- blood samples and Scabs and pus samples
- How many people
- 280 participants
- Where
- 1 siteCentral African Republic
- Study dates
- 9 Sep 2021to 31 Dec 2023
- 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: The populations concerned by the study correspond to the sedentary populations known as "Bantus" and the more mobile populations known as "pygmies. These populations belong to different ethno-linguistic groups with more or less specific forest uses and subsistence practices: some are slash-and-burn farmers (Ngbaka, Bagando, Monzombo), others are more mobile and traditionally hunter-gatherers, but now practice agriculture (Bayaka "Pygmies"). Translated with www.DeepL.com/Translator (free version)
Who may be able to join
- Human population in villages affected by monkeypox epidemics: patients who developed monkeypox and their contacts
- Health care personnel (paramedics, nurses, doctors) who work or have worked in affected villages
- Traditional healers, diviners
- Members of villages affected by past monkeypox epidemics
Who cannot join
- area not accessible to investigation
- refusal to participate
- inability to obtain consent
Trial locations and contacts
1 site in 1 country.
Central African Republic1 site
Institut Pasteur Bangui
Bangui
About this study
Official title: A One Health Study of Monkeypox Human Infection, Animal Reservoir, Disease Ecology and Diagnostic Tools
This multidisciplinary project aim to understand the epidemiology of the monkeypox in Central African Republic through the identification of the animal reservoir, the clinical and epidemiological description of the human outbreak, through an ethnological approach around risk factors of the disease and through an ecological approach of the ecological context of emergence, and the improvement of biological diagnosis.
Read the detailed description
This project is composed by monkyepox disease outbreak investigation in the CAR following national surveillance framework.
- Conditions
- Monkeypox Virus Infection
- Being tested
- blood samples, Scabs and pus samples
- Keywords
- epidemiology, outbreak investigation, anthropology,, animal reservoir, zoonotic disease, field diagnosis
- Medical subject headings
- Mpox, Monkeypox, Zoonoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesOther
5 mL
Scabs and pus samplesOther
if available
| Study group | Role | What they receive |
|---|---|---|
| Risk factors transmission cases | Human cases of monkeypox confirmed by PCR Receives: Other: blood samples; Other: Scabs and pus samples | |
| Risk factors transmission contacts and co-exposures | Human contact of confirmed monkeypox cases Receives: Other: blood samples | |
| Serological follow up cases | Human cases of monkeypox confirmed by PCR from Lobaye region Receives: Other: blood samples; Other: Scabs and pus samples | |
| Serological follow up contacts and co-exposures | Human contact of confirmed monkeypox cases from Lobaye region adjusted for age, month of the year and village of origin Receives: Other: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of monkeypox cases occuring following interhuman exposures
through a quantitative case-control study with an odds ratio of >3 for an exposure factor for human-to-human transmission.
Measured: 36 months
Proportion of monkeypox cases occuring following zoonotic exposures
through a quantitative case-control study with an odds ratio of >3 for an exposure factor for zoonotic transmission.
Measured: 36 months
Secondary outcomes (5)
Measurement of the Effective reproduction rate R in CAR according to the level of immunity (smallpox vaccine immunity or orthopoxvirus-related post disease immunity).
measurement of the level of population natural immunity and post vaccinal immunity to determine the Effective reproduction rate R and changes in R between 2000-2020 according to the evolution of immunity (smallpox vaccine immunity or orthopoxvirus-related post disease immunity).
Measured: 36 months
measurement of the sensitivity and the specificity of the existing diagnostic tests and those developed within the framework of the project
sensitivity and specificity of the existing diagnostic tests and those developed within the framework of the project, as well as the reproducibility of measurements in relation to reference tests.
Measured: 36 months
Identification and interpretation of genomic viral mutations from the viral sequences isolated from humans and animals in CAR for Phylogenetic and phylogeographic study of the monkeypox virus
identification and interpretation of mutations, search for the common ancestor.
Measured: 36 months
Comparison of genetic proximities between different viral strains isolated in humans and animals in CAR and neighboring countries since 1980.
Comparison of genetic proximities
Measured: 36 months
Identification of the characteristics associated with the environments in which human cases of monkeypox virus infection have occurred
ecosystems and their recent modifications, land use, associated climatic/meteorological elements in the tropical zone (CAR, Northern DRC...).
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start9 Sep 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Monkeypox Virus InfectionStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur de Bangui
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058898
- Sponsor's protocol ID
- 2019-047
- Acronym
- AFRIPOX
- Status last verified
- Dec 2023
- First submitted
- 24 Sep 2021
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Besombes C, Gonofio E, Konamna X, Selekon B, Grant R, Gessain A, Berthet N, Manuguerra JC, Fontanet A, Nakoune E. Intrafamily Transmission of Monkeypox Virus, Central African Republic, 2018. Emerg Infect Dis. 2019 Aug;25(8):1602-1604. doi: 10.3201/eid2508.190112. Epub 2019 Aug 17.
PubMed 31216261Berthet N, Descorps-Declere S, Besombes C, Curaudeau M, Nkili Meyong AA, Selekon B, Labouba I, Gonofio EC, Ouilibona RS, Simo Tchetgna HD, Feher M, Fontanet A, Kazanji M, Manuguerra JC, Hassanin A, Gessain A, Nakoune E. Genomic history of human monkey pox infections in the Central African Republic between 2001 and 2018. Sci Rep. 2021 Jun 22;11(1):13085. doi: 10.1038/s41598-021-92315-8.
PubMed 34158533
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A One Health Study of Monkeypox Human Infection, Animal Reservoir, Disease Ecology and Diagnostic Tools
- ClinicalTrials.gov ID
- NCT05058898
- Acronym / sponsor ID
- AFRIPOX / 2019-047
- Conditions
- Monkeypox Virus Infection
- Keywords
- epidemiology, outbreak investigation, anthropology,, animal reservoir, zoonotic disease, field diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur de Bangui
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Sep 2021 (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 multidisciplinary project aim to understand the epidemiology of the monkeypox in Central African Republic through the identification of the animal reservoir, the clinical and epidemiological description of the human outbreak, through an ethnological approach around risk factors of the disease and through an ecological approach of the ecological context of emergence, and the improvement of biological diagnosis.
Detailed description
This project is composed by monkyepox disease outbreak investigation in the CAR following national surveillance framework.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Risk factors transmission cases | – | Other: blood samples, Other: Scabs and pus samplesHuman cases of monkeypox confirmed by PCR |
| Risk factors transmission contacts and co-exposures | – | Other: blood samplesHuman contact of confirmed monkeypox cases |
| Serological follow up cases | – | Other: blood samples, Other: Scabs and pus samplesHuman cases of monkeypox confirmed by PCR from Lobaye region |
| Serological follow up contacts and co-exposures | – | Other: blood samplesHuman contact of confirmed monkeypox cases from Lobaye region adjusted for age, month of the year and village of origin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The populations concerned by the study correspond to the sedentary populations known as "Bantus" and the more mobile populations known as "pygmies. These populations belong to different ethno-linguistic groups with more or less specific forest uses and subsistence practices: some are slash-and-burn farmers (Ngbaka, Bagando, Monzombo), others are more mobile and traditionally hunter-gatherers, but now practice agriculture (Bayaka "Pygmies"). Translated with www.DeepL.com/Translator (free version)
Key inclusion criteria (4 listed)
- Human population in villages affected by monkeypox epidemics: patients who developed monkeypox and their contacts
- Health care personnel (paramedics, nurses, doctors) who work or have worked in affected villages
- Traditional healers, diviners
- Members of villages affected by past monkeypox epidemics
Key exclusion criteria (3 listed)
- area not accessible to investigation
- refusal to participate
- inability to obtain consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samples5 mL | Other | Risk factors transmission cases, Risk factors transmission contacts and co-exposures, Serological follow up cases, Serological follow up contacts and co-exposures |
| Scabs and pus samplesif available | Other | Risk factors transmission cases, Serological follow up cases |
Primary outcome
Proportion of monkeypox cases occuring following interhuman exposures
Time frame: 36 months
through a quantitative case-control study with an odds ratio of >3 for an exposure factor for human-to-human transmission.
Proportion of monkeypox cases occuring following zoonotic exposures
Time frame: 36 months
through a quantitative case-control study with an odds ratio of >3 for an exposure factor for zoonotic transmission.
5 secondary outcomes
Measurement of the Effective reproduction rate R in CAR according to the level of immunity (smallpox vaccine immunity or orthopoxvirus-related post disease immunity).
Time frame: 36 months
measurement of the sensitivity and the specificity of the existing diagnostic tests and those developed within the framework of the project
Time frame: 36 months
Identification and interpretation of genomic viral mutations from the viral sequences isolated from humans and animals in CAR for Phylogenetic and phylogeographic study of the monkeypox virus
Time frame: 36 months
Comparison of genetic proximities between different viral strains isolated in humans and animals in CAR and neighboring countries since 1980.
Time frame: 36 months
Identification of the characteristics associated with the environments in which human cases of monkeypox virus infection have occurred
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Background: PubMed 31216261Besombes C, Gonofio E, Konamna X, Selekon B, Grant R, Gessain A, Berthet N, Manuguerra JC, Fontanet A, Nakoune E. Intrafamily Transmission of Monkeypox Virus, Central African Republic, 2018. Emerg Infect Dis. 2019 Aug;25(8):1602-1604. doi: 10.3201/eid2508.190112. Epub 2019 Aug 17.
- Background: PubMed 34158533Berthet N, Descorps-Declere S, Besombes C, Curaudeau M, Nkili Meyong AA, Selekon B, Labouba I, Gonofio EC, Ouilibona RS, Simo Tchetgna HD, Feher M, Fontanet A, Kazanji M, Manuguerra JC, Hassanin A, Gessain A, Nakoune E. Genomic history of human monkey pox infections in the Central African Republic between 2001 and 2018. Sci Rep. 2021 Jun 22;11(1):13085. doi: 10.1038/s41598-021-92315-8.
- Institut Pasteur AfripoxLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monkeypox Virus Infection, run by Institut Pasteur at 1 site in Central African Republic.
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 3 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: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Central African Republic. 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?
Results are not available in the source record.
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?
Proportion of monkeypox cases occuring following interhuman exposures (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05058898, which also lists 2 linked publications.
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 20 Dec 2023.