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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

France1 site
  • CIC Cochin-Pasteur

    Paris

Other trials in France

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 :

  1. 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.). "
  1. 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.

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 groups in NCT05438953
Study groupRoleWhat they receive
PEP VaccinatedExperimentalNot described
Receives: Biological: Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®)
PrEP VaccinatedExperimentalNot 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.

  1. 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)
  1. Assess early vaccine humoral immunogenicity

    Poxvirus antibody titer serological and neutralizing

    Measured: Day 0, Day 7; Day 14 after the first injection (Day 0)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Assess the acceptability of post-exposure vaccination

    Proportion of people accepting vaccination and reasons for non-acceptance

    Measured: Day 0 (inclusion)

  9. Prevalence of sexually transmitted infections

    Seropositivity HIV, VHA (IgM), VHB (Ac-Hbs positive + Ac-Hbc positive), HCV, Syphilis

    Measured: Day 0

  10. 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)

  11. 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)

  12. 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.

  1. First posted30 Jun 2022
  2. Study start12 Jul 2022
  3. Primary completionOct 2024 (estimated)
  4. Study completionOct 2024 (estimated)

Resources

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)
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

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.

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