PoxVac22: Clinical and Biological Aspects of the MONKEYPOX Disease

Sponsor

Institut Pasteur (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05627713

Collaborator

Centre Médical de l'Institut Pasteur (Other)

330

Enrollment

Location

Arm

Anticipated Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Monkey Pox	Other: Blood sample collection Other: urine sample collection	N/A

Detailed Description

Descriptive, prospective, monocentric, longitudinal study. Subjects will be enrolled during their consultation at CMIP as part of their curative or preventive management of MPXV disease.

At the time of the appointment dedicated to vaccination or as part of the diagnosis of the infection, the clinician will explain the study in progress and will propose to the individual to participate if he/she is eligible.

If so, after signing the informed consent form, the individual will be included in the study.

The collection of socio-demographic, clinical and treatment data will be done on an eCRF at each study visit.

Biological samples (blood and/or urine samples and/or swabs for viruses) will also be taken at each study visit.

The samples will be used for the following biological analyses

serological analyses
sero-neutralization analysis by different techniques
cytometric analyses and biomarker measurements
virological analyses
genetic analysis.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

330 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Individuals coming to CMIP for MONKEYPOX disease management 300 individuals eligible for MPXV vaccination and 30 individuals suspected of MPXV infection.	Other: Blood sample collection Blood sample collection between inclusion and 12 months after inclusion Other: urine sample collection urine sample collection at inclusion

Arm

Intervention/Treatment

Other: Individuals coming to CMIP for MONKEYPOX disease management

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

Other: Blood sample collection

Blood sample collection between inclusion and 12 months after inclusion

Other: urine sample collection

urine sample collection at inclusion

Outcome Measures

Primary Outcome Measures

Characterize the immune responses of the individual to MPXV vaccination [5 years]
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 [5 years]
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 [5 years]
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 [5 years]
Transcriptomic analysis of gene expression of immunological markers in individuals after MPXV vaccination and MPXV

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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