Clinical and Biological Aspects of the MONKEYPOX Disease

NCT05627713 | Recruiting

• 2 other identifiers: 2022-0782022-A01915-38
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Monkey Pox

Keywords

vaccination; infection; monkey pox virus; outbreak; immunization

Outcome Measures

Primary Outcomes (4)

• Characterize the immune responses of the individual to MPXV vaccination

  Seroneutralizing capacity of serum 14 days (+/- 2 days) after the last dose administered

  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

  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

  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

  5 years

Study Arms (1)

Individuals coming to CMIP for MONKEYPOX disease management

OTHER

* 300 individuals eligible for MPXV vaccination and * 30 individuals suspected of MPXV infection.

Other: Blood sample collection; Other: urine sample collection

Interventions

Blood sample collection OTHER

Blood sample collection between inclusion and 12 months after inclusion

Individuals coming to CMIP for MONKEYPOX disease management

urine sample collection OTHER

urine sample collection at inclusion

Individuals coming to CMIP for MONKEYPOX disease management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Pasteur: lead
• Centre Médical de l'Institut Pasteur: collaborator

Study Sites (1)

Centre Médical de l'Institut Pasteur

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Mpox, Monkeypox; Infections

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Primate Diseases; Animal Diseases; Rodent Diseases

Study Officials

• Fabien Taieb, MD

  Institut Pasteur

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabien Taieb, MD

CONTACT

+ 33(0)1 40 61 38 44; fabien.taieb@pasteur.fr

Paul-Henri Consigny, MD

CONTACT

+33(0)1 45 68 81 15; paul-henri.consigny@pasteur.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 28, 2022
• Study Start: December 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

FR (1)