Clinical and Biological Aspects of the MONKEYPOX Disease

ConditionMonkey Pox
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Pasteur

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Blood sample collection

    Other intervention

    Blood sample collection between inclusion and 12 months after inclusion

  • urine sample collection

    Other intervention

    urine sample collection at inclusion

Treatment groups

330 Participants
are divided into 1 treatment group
Group A: Individuals coming to CMIP for MONKEYPOX disease managementOther 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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Institut Pasteur

Lead sponsor

Centre Médical de l'Institut Pasteur

Collaborator