Monkey PoxMonkeyVaxNCT05438953
Follow-up of People at Risk of Monkeypox Infection: a Prospective Cohort Study
A study testing Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®) in people with Monkey Pox and Monkey Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Since one month (first case confirmed the 05/06/2022), some cases of non-imported were reported by Portuguese and British authorities then in several Europeans countries, the US and the Canada. The 05/19/2022, a first case of Monkeypox was confirmed in France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Monkey Pox, Monkey Diseases
- What is being tested?
- Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2022to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PEP group : Be a contact at risk of exposure to the Monkeypox virus as recommended by the HAS within at less 14 days and not vaccinated OR Be a contact at risk of exposure to the Monkeypox virus as recommended by the HAS within at less 14 days and who received the first injection of PEV less than 28 days ago
- PrEP group : Be identified as belonging to the groups most exposed to MPXV, as defined by HAS, but not be a contact person at risk and not have received an MVA vaccine
- Signature of informed consent
Who cannot join
- Be under guardianship or curatorship
- No covered by social security
- Subject to a legal protection measure
- Have a contraindication to Monkeypox vaccination
- Have a known or suspected allergy to one of the components of the vaccine- Diagnosis of Monkeypox
Trial locations and contacts
1 site in 1 country.
About this study
Since one month (first case confirmed the 05/06/2022), some cases of non-imported were reported by Portuguese and British authorities then in several Europeans countries, the US and the Canada. The 05/19/2022, a first case of Monkeypox was confirmed in France. The 06/01/2022, "Santé Publique France" (SPF) declared 33 confirmed cases of Monkeypox without a direct interaction with people returning from endemic area. No deaths are currently recorded.
Currently, data on efficiency of modified vaccinia Ankara virus (MVA) used in post-exposure prophylaxis are few. The Centers for Disease Control and Prevention (CDC) consider that 2 doses of MVA vaccine used in post-exposure vaccination do not prevent totally the infection but consider that one rapid vaccination of high-risk contacts could reduce the severity of symptoms.
Read more
In order to clarify clinical impact and safety of PEV, it is proposed to set up a national cohort including people at risk of Monkeypox infectionfalling within the indications for vaccination, i.e. seen within 14 days of last contact for post-exposition (PEP) cases and also in prevention :pre-exposition ( PrEP)cases.
The purpose of this study is to estimate the failure rate of the vaccinationby the VMA vaccine in PEP or PrEP administration in people at risk of Monkeypox infection after one dose.
Read the detailed description
Indication for Post-Exposure vaccination (PEP) :
PEP has demonstrated its interest in different situations, in particular rabies, tetanus or hepatitis B, as recalled in the report "Guide for post-exposure immunization: vaccination and immunoglobulin" of the High Committee for Public Health in 2016.
For Monkeypox, the PEV was used in 2018 and 2019 in UK, when several import cases were discovered. In 2018, 3 cases were diagnosed and 154 contact cases identified (including 147 healthcare professionals). In total, 131 people have accepted the PEV (including 126 healthcare professionals) and 1 single case among healthcare professionals, having been exposed for 6 to 7 days. In 2019, following an imported case, 17/18 contacts (including children) accepted EPV. No secondary cases or serious adverse effects have been reported.
Several countries have recommended EPV as part of Monkeypox.
Indication for Pre-Exposure vaccination (PrEP):
Since 2022/07/07, in addition to PEP vaccination, HAS recommends vaccination (PrEP) to people at very high risk of infection:
- Men who have sex with men (MSM) reporting multiple partners and trans people reporting multiple sexual partners
- People in prostitution
- Professionals in places of sexual consumption, regardless of the status of these places.
In France, the Haute Autorité de Santé (HAS) recommends that pre-exposure vaccination with 3rd generation MVA-BN vaccines (Imvanex and Jynneos) be offered to female partners who are occasional or who share the same living environment as people at very high risk of exposure, including MSM reporting multiple sexual partners and trans people reporting multiple sexual partners, people in a situation of prostitution and professionals in places of sexual consumption, regardless of the status of these places.
HAS also recommends the implementation of a reactive vaccine strategy with the 3rd generation vaccine administered in 2 doses spaced 28 days apart. For people who received smallpox vaccination with a 1st generation vaccine before 1980, only one dose of MVA vaccine should be administered. For immunocompromised subjects, regardless of their vaccination status, a three-dose schedule, each 28 days apart, is recommended. In post-exposure (PEP) the first dose being ideally administered within 4 days after the risky contact and at most 14 days after the risky contact.
Currently, data on the efficacy of the MVA vaccine used in post-exposure prophylaxis are few. The Centers for Disease Control and Prevention considers it unlikely that 2 doses of MVA vaccine used in PEV will completely prevent infection but believes that rapid vaccination of at-risk contacts could reduce the severity of symptoms.
In France, the definitions for identifying contact persons are :
- Contact at risk:
- Anyone who has had unprotected direct physical contact, i.e. without wearing surgical masks and FFP2, without using hygiaphones and vis-à-vis direct physical contact, without wearing waterproof gloves (latex, nitrile, rubber) with damaged skin or biological fluids of a probable or confirmed symptomatic case, whatever the circumstances, including acts of medical or paramedical care, or sharing of toilet utensils, or contact with textiles (clothing , bath linen, bedding) or dirty dishes used by the probable or confirmed symptomatic case.
- Anyone who has had unprotected contact at less than 2 meters for 3 hours with a probable or confirmed symptomatic case (e.g. close or intimate friend, transport neighbour, office neighbour, people sharing the same living space with no intimate ties, act of care or hygiene, school and university environment, sports club, etc.). "
- Confirmed case:
- A positive qPCR or RT-PCR result specific for the MKPXV virus
- A positive result in generic qPCR of the genus Orthopoxvirus, in a person presenting recent risks of exposure to the MKPXV virus in the 3 weeks preceding the onset of the signs (returning from a trip to an endemic zone or where the virus is circulating or at-risk contact of a person returning from a trip to an endemic zone or where the virus is circulating, contact person at risk of a probable or confirmed case).
In order to specify the clinical interest and the safety of MVA vaccination administered in PEP or PrEP in people at risk of infection, it is proposed to set up a national cohort including contact cases falling within the indications for vaccination, i.e. seen within 14 days after the last contact but also people vaccinated with PrEP representing the majority of vaccinations currently.
- Conditions
- Monkey Pox, Monkey Diseases
- Being tested
- Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®)
- Keywords
- Monkeypox, Vaccines, Prevention, Post exposure vaccination (PEP), Pre exposure vaccination (PrEP)
- Medical subject headings
- Mpox, Monkeypox, Monkey Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®)Biological
Participant of these arm will receive 2 doses of MVA vaccine spaced 28 days apart
| Study group | Role | What they receive |
|---|---|---|
| PEP Vaccinated | Experimental | Not described Receives: Biological: Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®) |
| PrEP Vaccinated | Experimental | Not described Receives: Biological: Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of failure of MVA vaccine
Positive PCR MKPXV
Measured: D28 after the first injection for PEP and between 14 days and 3 month for PrEP
Secondary outcomes (12)
Assess early vaccine humoral immunogenicity
Poxvirus antibody titer serological and neutralizing
Measured: Day 0, Day 7; Day 14 after the first injection (Day 0)
Estimate the short-term vaccine failure rate after a risky contact
Cumulative incidence of probable cases or confirmed cases within 28 days after the 1st dose of vaccine: among participants vaccinated in PEP
Measured: 28 days after the first injection
Estimate long-term vaccine failure rate (among PrEP or PEP participants)
Cumulative incidence of probable cases or confirmed cases occurring at least 14 days and up to 1 year after the 1 redose of vaccine in participants vaccinated with PEP or PrEP
Measured: up to 1 year after the first injection
Evaluate the proportion of failures and their clinical presentations according to the time between exposure and vaccination
Proportion of failure and clinical presentation in vaccinated group <4days after exposure, 4 to 14 days and >14 days
Measured: Day 0, Day 7, Day 14, Day 28, 1 month, Day 43 and 3 months
Effectiveness of MVA vaccination (PEP vs PrEP)
Comparison of the number of infections in PEP vaccinated versus PrEP
Measured: Day 0, Day 7; Day 14, Day 28, Month 1, 43 Days and 3 Months
Effectiveness of MVAvaccination (PEP and PrEP)
Comparison of the number of infections in PEP and PrEP vaccinated and the number of infections in unvaccinated
Measured: D0, D7; D14, D28, Month 1, 43 Days et 3 Months
Assess vaccine reactogenicity after each dose of vaccines
Any adverse effects, local and systemic reactions occurring
Measured: up to 1 year after the first injection of PEV
Assess the acceptability of post-exposure vaccination
Proportion of people accepting vaccination and reasons for non-acceptance
Measured: Day 0 (inclusion)
Prevalence of sexually transmitted infections
Seropositivity HIV, VHA (IgM), VHB (Ac-Hbs positive + Ac-Hbc positive), HCV, Syphilis
Measured: Day 0
Assess the transmissibility of asymptomatic forms
Detection of monkeypox virus in biological samples, Monkeypox PCR
Measured: D0, D7, D14, D28, D43 , M3, M6 and M12 after the first injection (D0)
Titre of antibodies directed against the Monkeypox virus
Study the humoral immunogenicity of the vaccine and the factors associated with the humoral immune response
Measured: D7, D14, D28, D43 and M3 after the first injection (D0)
Cellular immunity to PEP and PrEP vaccination
Study of cellular immunity to MVA vaccination
Measured: D0, D10, M3 after the first injection (D0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start12 Jul 2022
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (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 Assistance Publique - Hôpitaux de ParisThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liem binh LUONG NGUYEN, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438953
- Sponsor's protocol ID
- APHP220580
- Other IDs
- 2022-002352-39
- Acronym
- MonkeyVax
- Status last verified
- Oct 2023
- First submitted
- 27 Jun 2022
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of People at Risk of Monkeypox Infection: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05438953
- Acronym / sponsor ID
- MonkeyVax / APHP220580
- Conditions
- Monkey Pox, Monkey Diseases
- Keywords
- Monkeypox, Vaccines, Prevention, Post exposure vaccination (PEP), Pre exposure vaccination (PrEP)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 30 Jun 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.
Since one month (first case confirmed the 05/06/2022), some cases of non-imported were reported by Portuguese and British authorities then in several Europeans countries, the US and the Canada. The 05/19/2022, a first case of Monkeypox was confirmed in France. The 06/01/2022, "Santé Publique France" (SPF) declared 33 confirmed cases of Monkeypox without a direct interaction with people returning from endemic area. No deaths are currently recorded.
Currently, data on efficiency of modified vaccinia Ankara virus (MVA) used in post-exposure prophylaxis are few. The Centers for Disease Control and Prevention (CDC) consider that 2 doses of MVA vaccine used in post-exposure vaccination do not prevent totally the infection but consider that one rapid vaccination of high-risk contacts could reduce the severity of symptoms.
In order to clarify clinical impact and safety of PEV, it is proposed to set up a national cohort including people at risk of Monkeypox infectionfalling within the indications for vaccination, i.e. seen within 14 days of last contact for post-exposition (PEP) cases and also in prevention :pre-exposition ( PrEP)cases.
The purpose of this study is to estimate the failure rate of the vaccinationby the VMA vaccine in PEP or PrEP administration in people at risk of Monkeypox infection after one dose.
Detailed description
Indication for Post-Exposure vaccination (PEP) :
PEP has demonstrated its interest in different situations, in particular rabies, tetanus or hepatitis B, as recalled in the report "Guide for post-exposure immunization: vaccination and immunoglobulin" of the High Committee for Public Health in 2016.
For Monkeypox, the PEV was used in 2018 and 2019 in UK, when several import cases were discovered. In 2018, 3 cases were diagnosed and 154 contact cases identified (including 147 healthcare professionals). In total, 131 people have accepted the PEV (including 126 healthcare professionals) and 1 single case among healthcare professionals, having been exposed for 6 to 7 days. In 2019, following an imported case, 17/18 contacts (including children) accepted EPV. No secondary cases or serious adverse effects have been reported.
Several countries have recommended EPV as part of Monkeypox.
Indication for Pre-Exposure vaccination (PrEP):
Since 2022/07/07, in addition to PEP vaccination, HAS recommends vaccination (PrEP) to people at very high risk of infection:
- Men who have sex with men (MSM) reporting multiple partners and trans people reporting multiple sexual partners
- People in prostitution
- Professionals in places of sexual consumption, regardless of the status of these places.
In France, the Haute Autorité de Santé (HAS) recommends that pre-exposure vaccination with 3rd generation MVA-BN vaccines (Imvanex and Jynneos) be offered to female partners who are occasional or who share the same living environment as people at very high risk of exposure, including MSM reporting multiple sexual partners and trans people reporting multiple sexual partners, people in a situation of prostitution and professionals in places of sexual consumption, regardless of the status of these places.
HAS also recommends the implementation of a reactive vaccine strategy with the 3rd generation vaccine administered in 2 doses spaced 28 days apart. For people who received smallpox vaccination with a 1st generation vaccine before 1980, only one dose of MVA vaccine should be administered. For immunocompromised subjects, regardless of their vaccination status, a three-dose schedule, each 28 days apart, is recommended. In post-exposure (PEP) the first dose being ideally administered within 4 days after the risky contact and at most 14 days after the risky contact.
Currently, data on the efficacy of the MVA vaccine used in post-exposure prophylaxis are few. The Centers for Disease Control and Prevention considers it unlikely that 2 doses of MVA vaccine used in PEV will completely prevent infection but believes that rapid vaccination of at-risk contacts could reduce the severity of symptoms.
In France, the definitions for identifying contact persons are :
- Contact at risk:
- Anyone who has had unprotected direct physical contact, i.e. without wearing surgical masks and FFP2, without using hygiaphones and vis-à-vis direct physical contact, without wearing waterproof gloves (latex, nitrile, rubber) with damaged skin or biological fluids of a probable or confirmed symptomatic case, whatever the circumstances, including acts of medical or paramedical care, or sharing of toilet utensils, or contact with textiles (clothing , bath linen, bedding) or dirty dishes used by the probable or confirmed symptomatic case.
- Anyone who has had unprotected contact at less than 2 meters for 3 hours with a probable or confirmed symptomatic case (e.g. close or intimate friend, transport neighbour, office neighbour, people sharing the same living space with no intimate ties, act of care or hygiene, school and university environment, sports club, etc.). "
- Confirmed case:
- A positive qPCR or RT-PCR result specific for the MKPXV virus
- A positive result in generic qPCR of the genus Orthopoxvirus, in a person presenting recent risks of exposure to the MKPXV virus in the 3 weeks preceding the onset of the signs (returning from a trip to an endemic zone or where the virus is circulating or at-risk contact of a person returning from a trip to an endemic zone or where the virus is circulating, contact person at risk of a probable or confirmed case).
In order to specify the clinical interest and the safety of MVA vaccination administered in PEP or PrEP in people at risk of infection, it is proposed to set up a national cohort including contact cases falling within the indications for vaccination, i.e. seen within 14 days after the last contact but also people vaccinated with PrEP representing the majority of vaccinations currently.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEP Vaccinated | Experimental | Biological: Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®) |
| PrEP Vaccinated | Experimental | Biological: Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- PEP group : Be a contact at risk of exposure to the Monkeypox virus as recommended by the HAS within at less 14 days and not vaccinated OR Be a contact at risk of exposure to the Monkeypox virus as recommended by the HAS within at less 14 days and who received the first injection of PEV less than 28 days ago
- PrEP group : Be identified as belonging to the groups most exposed to MPXV, as defined by HAS, but not be a contact person at risk and not have received an MVA vaccine
- Signature of informed consent
Key exclusion criteria (5 listed)
- Be under guardianship or curatorship
- No covered by social security
- Subject to a legal protection measure
- Have a contraindication to Monkeypox vaccination
- Have a known or suspected allergy to one of the components of the vaccine- Diagnosis of Monkeypox
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 |
|---|---|---|
| Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®)Participant of these arm will receive 2 doses of MVA vaccine spaced 28 days apart | Biological | PEP Vaccinated, PrEP Vaccinated |
Primary outcome
Proportion of failure of MVA vaccine
Time frame: D28 after the first injection for PEP and between 14 days and 3 month for PrEP
Positive PCR MKPXV
12 secondary outcomes
Assess early vaccine humoral immunogenicity
Time frame: Day 0, Day 7; Day 14 after the first injection (Day 0)
Estimate the short-term vaccine failure rate after a risky contact
Time frame: 28 days after the first injection
Estimate long-term vaccine failure rate (among PrEP or PEP participants)
Time frame: up to 1 year after the first injection
Evaluate the proportion of failures and their clinical presentations according to the time between exposure and vaccination
Time frame: Day 0, Day 7, Day 14, Day 28, 1 month, Day 43 and 3 months
Effectiveness of MVA vaccination (PEP vs PrEP)
Time frame: Day 0, Day 7; Day 14, Day 28, Month 1, 43 Days and 3 Months
Effectiveness of MVAvaccination (PEP and PrEP)
Time frame: D0, D7; D14, D28, Month 1, 43 Days et 3 Months
Assess vaccine reactogenicity after each dose of vaccines
Time frame: up to 1 year after the first injection of PEV
Assess the acceptability of post-exposure vaccination
Time frame: Day 0 (inclusion)
Prevalence of sexually transmitted infections
Time frame: Day 0
Assess the transmissibility of asymptomatic forms
Time frame: D0, D7, D14, D28, D43 , M3, M6 and M12 after the first injection (D0)
Titre of antibodies directed against the Monkeypox virus
Time frame: D7, D14, D28, D43 and M3 after the first injection (D0)
Cellular immunity to PEP and PrEP vaccination
Time frame: D0, D10, M3 after the first injection (D0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Liem binh LUONG NGUYEN, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®) in people with Monkey Pox and Monkey Diseases, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of failure of MVA vaccine (time frame: D28 after the first injection for PEP and between 14 days and 3 month for PrEP). 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 Oct 2023.