Follow-up of People at Risk of Monkeypox Infection: a Prospective Cohort Study

NCT ID: NCT05438953

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-12
• Study Completion Date: 2024-10-31

Brief 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. 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 :

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.). "

2. 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PEP Vaccinated

Group Type: EXPERIMENTAL

Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®)

Intervention Type: BIOLOGICAL

Participant of these arm will receive 2 doses of MVA vaccine spaced 28 days apart

PrEP Vaccinated

Group Type: EXPERIMENTAL

Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®)

Intervention Type: BIOLOGICAL

Participant of these arm will receive 2 doses of MVA vaccine spaced 28 days apart

Interventions

Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®)

Participant of these arm will receive 2 doses of MVA vaccine spaced 28 days apart

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liem binh LUONG NGUYEN, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

CIC Cochin-Pasteur

Paris, , France

Countries

France

Other Identifiers

2022-002352-39

Identifier Type: OTHER

Identifier Source: secondary_id

APHP220580

Identifier Type: -

Identifier Source: org_study_id