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Clinical and Biological Aspects of the MONKEYPOX Disease (PoxVac22)

Primary Purpose

Monkey Pox

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample collection
urine sample collection
Sponsored by
Institut Pasteur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Monkey Pox focused on measuring vaccination, infection, monkey pox virus, outbreak, immunization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre Médical de l'Institut PasteurRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Individuals coming to CMIP for MONKEYPOX disease management

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 16, 2022
Last Updated
May 24, 2023
Sponsor
Institut Pasteur
Collaborators
Centre Médical de l'Institut Pasteur
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1. Study Identification

Unique Protocol Identification Number
NCT05627713
Brief Title
Clinical and Biological Aspects of the MONKEYPOX Disease
Acronym
PoxVac22
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 1, 2026 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Pasteur
Collaborators
Centre Médical de l'Institut Pasteur

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monkey Pox
Keywords
vaccination, infection, monkey pox virus, outbreak, immunization

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individuals coming to CMIP for MONKEYPOX disease management
Arm Type
Other
Arm Description
300 individuals eligible for MPXV vaccination and 30 individuals suspected of MPXV infection.
Intervention Type
Other
Intervention Name(s)
Blood sample collection
Intervention Description
Blood sample collection between inclusion and 12 months after inclusion
Intervention Type
Other
Intervention Name(s)
urine sample collection
Intervention Description
urine sample collection at inclusion
Primary Outcome Measure Information:
Title
Characterize the immune responses of the individual to MPXV vaccination
Description
Seroneutralizing capacity of serum 14 days (+/- 2 days) after the last dose administered
Time Frame
5 years
Title
Characterize the developed cellular immunity and circulating levels of immune signaling molecules in individuals after MPXV vaccination and MPXV infection
Description
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
Title
Map the presence of MPXV in infectious sites of infected patients by qualitative and quantitative analyses comparing primary lesions, secondary lesions and healthy skin
Description
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
Title
Characterize gene expression profiling in the peripheral blood of the individual after MPXV vaccination and the individual after MPXV infection
Description
Transcriptomic analysis of gene expression of immunological markers in individuals after MPXV vaccination and MPXV
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabien Taieb, MD
Phone
+ 33(0)1 40 61 38 44
Email
fabien.taieb@pasteur.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Paul-Henri Consigny, MD
Phone
+33(0)1 45 68 81 15
Email
paul-henri.consigny@pasteur.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabien Taieb, MD
Organizational Affiliation
Institut Pasteur
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Médical de l'Institut Pasteur
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabien Taieb, MD
Phone
+33(0)1 40 61 38 44
Email
fabien.taieb@pasteur.fr

12. IPD Sharing Statement

Learn more about this trial

Clinical and Biological Aspects of the MONKEYPOX Disease

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