Monkey PoxPoxVac22NCT05627713
Clinical and Biological Aspects of the MONKEYPOX Disease
A study testing Blood sample collection and urine sample collection in people with Monkey Pox, run by Institut Pasteur at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Monkey Pox
- What is being tested?
- Blood sample collection and urine sample collection
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2022to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Médical de l'Institut Pasteur
Paris, 75015
Fabien Taieb, MD, +33(0)1 40 61 38 44, fabien.taieb@pasteur.fr
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Monkey Pox
- Being tested
- Blood sample collection, urine sample collection
- Keywords
- vaccination, infection, monkey pox virus, outbreak, immunization
- Medical subject headings
- Mpox, Monkeypox, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionOther
Blood sample collection between inclusion and 12 months after inclusion
urine sample collectionOther
urine sample collection at inclusion
| Study group | Role | What they receive |
|---|---|---|
| Individuals coming to CMIP for MONKEYPOX disease management | Other | * 300 individuals eligible for MPXV vaccination and
* 30 individuals suspected of MPXV infection. Receives: Other: Blood sample collection; Other: urine sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the immune responses of the individual to MPXV vaccination
Seroneutralizing capacity of serum 14 days (+/- 2 days) after the last dose administered
Measured: 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
Measured: 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
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start1 Dec 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monkey PoxStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Médical de l'Institut Pasteur
- Responsible party
- Sponsor
- Investigators
- Fabien Taieb, MD, Principal investigator, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627713
- Sponsor's protocol ID
- 2022-078
- Other IDs
- 2022-A01915-38
- Acronym
- PoxVac22
- Status last verified
- Dec 2023
- First submitted
- 16 Nov 2022
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05627713
- Acronym / sponsor ID
- PoxVac22 / 2022-078
- Conditions
- Monkey Pox
- Keywords
- vaccination, infection, monkey pox virus, outbreak, immunization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Centre Médical de l'Institut Pasteur
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 28 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals coming to CMIP for MONKEYPOX disease management | Other | Other: Blood sample collection, Other: urine sample collection* 300 individuals eligible for MPXV vaccination and * 30 individuals suspected of MPXV infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionBlood sample collection between inclusion and 12 months after inclusion | Other | Individuals coming to CMIP for MONKEYPOX disease management |
| urine sample collectionurine sample collection at inclusion | Other | Individuals coming to CMIP for MONKEYPOX disease management |
Primary outcome
Characterize the immune responses of the individual to MPXV vaccination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5 years
Transcriptomic analysis of gene expression of immunological markers in individuals after MPXV vaccination and MPXV
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabien Taieb, MD principal investigator
Institut Pasteur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample collection and urine sample collection in people with Monkey Pox, run by Institut Pasteur at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabien Taieb, MD (+ 33(0)1 40 61 38 44, fabien.taieb@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the immune responses of the individual to MPXV vaccination (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.