About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Person with MPXV vaccination without proof of vaccination.
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
Trial design
Single group
Treatments tested in this trial
Blood sample collection
Other interventionBlood sample collection between inclusion and 12 months after inclusion
urine sample collection
Other interventionurine sample collection at inclusion
Treatment groups
Trial outcomes
Primary outcomes
Characterize the immune responses of the individual to MPXV vaccination
Seroneutralizing capacity of serum 14 days (+/- 2 days) after the last dose administered
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
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
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
Sponsors and contacts
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Institut Pasteur
Lead sponsor
Centre Médical de l'Institut Pasteur
Collaborator