Description of the Kinetics of the Clinical and Biological Aspects of the Persons Consulting in the Framework of the Management of the MONKEYPOX Disease

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Adult,

• 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

Locations
Other Locations
France
Centre Médical de l'Institut Pasteur
RECRUITING
Paris
Contact Information
Primary
Fabien Taieb, MD
fabien.taieb@pasteur.fr
+ 33(0)1 40 61 38 44
Backup
Paul-Henri Consigny, MD
paul-henri.consigny@pasteur.fr
+33(0)1 45 68 81 15
Time Frame
Start Date: 2022-12-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 330
Treatments
Other: Individuals coming to CMIP for MONKEYPOX disease management
* 300 individuals eligible for MPXV vaccination and~* 30 individuals suspected of MPXV infection.
Related Therapeutic Areas
Sponsors
Collaborators: Centre Médical de l'Institut Pasteur
Leads: Institut Pasteur

This content was sourced from clinicaltrials.gov