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

NCT05438953 | Unknown

• 2 other identifiers: APHP2205802022-002352-39
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Monkey Pox; Monkey Diseases

Keywords

Monkeypox; Vaccines; Prevention; Post exposure vaccination (PEP); Pre exposure vaccination (PrEP)

Outcome Measures

Primary Outcomes (1)

• Proportion of failure of MVA vaccine

  Positive PCR MKPXV

  D28 after the first injection for PEP and between 14 days and 3 month for PrEP

Secondary Outcomes (12)

• Assess early vaccine humoral immunogenicity

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

• Estimate the short-term vaccine failure rate after a risky contact

  28 days after the first injection

• Estimate long-term vaccine failure rate (among PrEP or PEP participants)

  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

  Day 0, Day 7, Day 14, Day 28, 1 month, Day 43 and 3 months

• Effectiveness of MVA vaccination (PEP vs PrEP)

  Day 0, Day 7; Day 14, Day 28, Month 1, 43 Days and 3 Months

Study Arms (2)

PEP Vaccinated

EXPERIMENTAL

Biological: Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®)

PrEP Vaccinated

EXPERIMENTAL

Biological: Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®)

Interventions

Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®) BIOLOGICAL

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

PEP Vaccinated; PrEP Vaccinated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

CIC Cochin-Pasteur

Paris, France

Location

MeSH Terms

Conditions

Mpox, Monkeypox; Monkey Diseases

Interventions

Vaccination; MVA vaccine; smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Intervention Hierarchy (Ancestors)

Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Liem binh LUONG NGUYEN, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 30, 2022
• Study Start: July 12, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)