MonkeyVax: Follow-up of Contact at Risk of Monkeypox Infection: a Prospective Cohort Study
Study Details
Study Description
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 contacts cases falling within the indications for vaccination, i.e. seen within 14 days of last contact.
The purpose of this study is to estimate the failure rate of a PEV by the VMA vaccine in Monkeypox contact case participants at risk after one dose.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Post-exposure vaccination (PVE) 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. In France, the Haute Autorité de Santé (HAS) recommends the implementation of a reactive vaccine strategy in post-exposure with the 3rd generation vaccine administered in 2 doses spaced 28 days apart, 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.
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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
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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 an PEV, 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vaccinated
|
Biological: Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®)
Participant of these arm will receive 2 doses of MVA vaccine spaced 28 days apart
|
| No Intervention: Unvaccinated Theses participants will not receive the post-exposure vaccination |
Outcome Measures
Primary Outcome Measures
- Proportion of failure of MVA vaccine [Day 28 after the first injection]
Positive PCR MKPXV
Secondary Outcome Measures
- Assess early vaccine humoral immunogenicity [Day 0, Day 7; Day 14 after the first injection (Day 0)]
Poxvirus antibody titer serological and neutralizing
- Assess early vaccine humoral immunogenicity after one, two doses [1 month, 43 days and 3 months after the first injection]
Poxvirus antibody titer serological and neutralizing
- Assess factors associated with immune response [1 month, 43 Days and 3 Months after the first injection]
Associated factors find that statistically associated with an immune response or with a failure against Monkeypox
- Evaluate the proportion of failures and their clinical presentations according to the time between exposure and vaccination [Day0, Day 15, Day 28]
Proportion of failure and clinical presentation in vaccinated group <4days after exposure, 4 to 14 days and >14 days
- Effectiveness of post-exposure vaccination (PEV) [Day 0, Day 7; Day 14, Day 28, Month 1, 43 Days and 3 Months]
Comparison of the number of infections in vaccinated and the number of infections in unvaccinated
- Assess vaccine reactogenicity after each dose of vaccines [up to 3 months after the first injection of PEV]
Any adverse effects, local and systemic reactions occurring
- Assess the acceptability of post-exposure vaccination [Day 7, Day 14 and Day 28]
Proportion of people accepting vaccination and reasons for non-acceptance
- Prevalence of sexually transmitted infections [Day 7, Day 14, 1 Month, 43 Days and 3 Months]
Seropositivity HIV, VHA (IgM), VHB (Ac-Hbs positive + Ac-Hbc positive), HCV, Syphilis
- Assess the transmissibility of asymptomatic forms [Day 0, Day 7, Day 14, Day 28, Day 43 , Month 3 after the first injection (Day 0)]
Detection of monkeypox virus in biological samples
- Cellular immunity to PEV vaccination [Day 0, Day 7, Day 14, Day 28, Day 43 , Month 3 after the first injection (Day 0)]
Study of cellular immunity to MVA vaccination
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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Signature of informed consent
Exclusion Criteria:
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Be under guardianship or curatorship
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No covered by social security
-
Subject to a legal protection measure
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Have a contraindication to Monkeypox vaccination
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Have a known or suspected allergy to one of the components of the vaccine- Diagnosis of Monkeypox
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CIC Cochin-Pasteur | Paris | France |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Principal Investigator: Liem binh LUONG NGUYEN, MD, Assistance Publique - Hôpitaux de Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APHP220580
- 2022-002352-39