An interventional study of Blood sample collection and urine sample collection in Monkey Pox, sponsored by Institut Pasteur. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-19.
Sponsored by Institut Pasteur · Not applicable, Interventional, and Basic science
Monkey pox virus (MPXV), of the genus Orthopoxvirus, regularly causes epidemics in endemic areas of central and western Africa.
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.
Descriptive, prospective, monocentric, longitudinal study. Subjects will be enrolled during their consultation at CMIP as part of their curative or preventive management of MPXV disease.
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
Institut Pasteur is the lead sponsor of 96 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* 300 individuals eligible for MPXV vaccination and * 30 individuals suspected of MPXV infection.
Other: Blood sample collection · Other: urine sample collection
Blood sample collection between inclusion and 12 months after inclusion
urine sample collection at inclusion
Characterize the immune responses of the individual to MPXV vaccination
Seroneutralizing capacity of serum 14 days (+/- 2 days) after the last dose administered
Time frame: 5 years
Characterize the developed cellular immunity and circulating levels of immune signaling molecules in individuals after MPXV vaccination and MPXV infection
Measurement of activation of dendritic cells, NK cells, B cells and various T cells and levels of involved cytokines in individuals after MPXV vaccination and MPXV infection
Time frame: 5 years
Map the presence of MPXV in infectious sites of infected patients by qualitative and quantitative analyses comparing primary lesions, secondary lesions and healthy skin
Measurement of the number of clinical sites in which MPXV is demonstrated, the level of associated viral load, the cellular distribution of lesional viral load on biopsies of ulcerated areas
Time frame: 5 years
Characterize gene expression profiling in the peripheral blood of the individual after MPXV vaccination and the individual after MPXV infection
Transcriptomic analysis of gene expression of immunological markers in individuals after MPXV vaccination and MPXV
Time frame: 5 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Mpox (monkeypox)
Institut Pasteur