Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT05627713

Clinical and Biological Aspects of the MONKEYPOX Disease

Led by Institut Pasteur · Updated on 2023-12-19

330

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

Sponsors

I

Institut Pasteur

Lead Sponsor

C

Centre Médical de l'Institut Pasteur

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Clinical and Biological Aspects of the MONKEYPOX Disease

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult
  • Eligible for MPXV vaccination according to HAS criteria or suspected of MPXV infection
  • Health status compatible with a 45 ml single blood sample
  • Consent to participate in the study
  • Covered by a Social Health Insurance plan
Not Eligible

You will not qualify if you...

  • Person vaccinated against MPXV without proof of vaccination
  • Contraindication to vaccination other than current infection for those presenting for vaccination
  • Pregnant and lactating women
  • Unable to give informed consent to participate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centre Médical de l'Institut Pasteur

Paris, France, 75015

Actively Recruiting

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Research Team

F

Fabien Taieb, MD

CONTACT

P

Paul-Henri Consigny, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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