Clinical and Biological Aspects of the MONKEYPOX Disease
NCT ID: NCT05627713
Last Updated: 2023-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
330 participants
INTERVENTIONAL
2022-12-01
2026-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Since January 1, 2022, cases of Monkey pox have been reported to WHO by 96 Member States in the 6 WHO regions. As of 22 August 2022, a total of 41,664 laboratory-confirmed cases and 192 probable cases, including 12 deaths, have been reported to WHO. Since May 13, 2022, a high proportion of these cases have been reported from countries where monkey pox transmission had not previously been documented. For the first time, cases and sustained chains of transmission are being reported in countries without direct or immediate epidemiological links to areas in West or Central Africa (WHO 2022). France is one of the most affected countries with 2889 cases reported as of August 22, 2022.
This situation led the WHO Director General to declare, on July 23, 2022, that the monkeypox epidemic currently affecting several countries constitutes a Public Health Emergency of International Concern.
To address this epidemic, the WHO has recommended Post Exposure Vaccination (PEP) and Pre Exposure Vaccination (PrEP) for at risk groups with 2nd and 3rd generation vaccines. In France, the Haute Autorité de Santé (French National Authority for Health) recommended on May 20, 2022, vaccination for PEP and on July 7, 2022, for PrEP with a 3rd generation MVA-BN vaccine (Imvanex® or Jynneos®). The European Medicines Agency (EMA) has approved the use of Imvanex® on July 22, 2022 for immunization against MPXV.
The objective of the present study is to describe the clinical, biological, virological, pathophysiological and immunological aspects in the short and medium term of persons vaccinated against and infected with MPXV.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
At the time of the appointment dedicated to vaccination or as part of the diagnosis of the infection, the clinician will explain the study in progress and will propose to the individual to participate if he/she is eligible.
If so, after signing the informed consent form, the individual will be included in the study.
The collection of socio-demographic, clinical and treatment data will be done on an eCRF at each study visit.
Biological samples (blood and/or urine samples and/or swabs for viruses) will also be taken at each study visit.
The samples will be used for the following biological analyses
* serological analyses
* sero-neutralization analysis by different techniques
* cytometric analyses and biomarker measurements
* virological analyses
* genetic analysis.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Individuals coming to CMIP for MONKEYPOX disease management
* 300 individuals eligible for MPXV vaccination and
* 30 individuals suspected of MPXV infection.
Blood sample collection
Blood sample collection between inclusion and 12 months after inclusion
urine sample collection
urine sample collection at inclusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blood sample collection
Blood sample collection between inclusion and 12 months after inclusion
urine sample collection
urine sample collection at inclusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* eligible for MPXV vaccination according to HAS criteria or suspected of MPXV infection
* whose health status is compatible with a 45 ml single blood sample
* who have consented to participate in the study
* who are covered by a Social Health Insurance plan
Exclusion Criteria
* For persons presenting for MPXV vaccination: presence of a contraindication to vaccination other than a current infection.
* Pregnant and lactating women
* Person unable to give informed consent to participate
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Médical de l'Institut Pasteur
UNKNOWN
Institut Pasteur
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fabien Taieb, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Pasteur
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre Médical de l'Institut Pasteur
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Fabien Taieb, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-A01915-38
Identifier Type: OTHER
Identifier Source: secondary_id
2022-078
Identifier Type: -
Identifier Source: org_study_id