NCT05438953: MonkeyVax

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

Status unknown NA Last updated 18 October 2023

What this trial tests

NA trial testing Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®) in Monkey Pox in 164 participants. Status unknown.

Timeline

12 July 2022

Primary endpoint
1 October 2024

1 October 2024

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	164
Start date	12 July 2022
Primary completion	1 October 2024
Estimated completion	1 October 2024
Sites	1 location across France

Drugs / interventions tested

• Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®) — full drug profile →

Conditions studied

• Monkey Pox — all drugs for Monkey Pox →
• Monkey Diseases — all drugs for Monkey Diseases →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Monkey Pox or Monkey Diseases. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Monkeypox, a Literature Review: What Is New and Where Does This concerning Virus Come From?
   Tiecco G, Degli Antoni M, Storti S, Tomasoni LR, et al · · 2022 · cited 54× · PMID 36146705 · DOI 10.3390/v14091894
2. Progress and prospects on vaccine development against monkeypox infection.
   Saadh MJ, Ghadimkhani T, Soltani N, Abbassioun A, et al · · 2023 · cited 45× · PMID 37201635 · DOI 10.1016/j.micpath.2023.106156
3. Advancements in monkeypox vaccines development: a critical review of emerging technologies.
   Garcia-Atutxa I, Mondragon-Teran P, Huerta-Saquero A, Villanueva-Flores F. · · 2024 · cited 18× · PMID 39464881 · DOI 10.3389/fimmu.2024.1456060
4. Mpox vaccination in global perspective: priorities and challenges.
   Rana J, Patel SK, Agrawal A, Channabasappa NK, et al · · 2023 · cited 13× · PMID 37228971 · DOI 10.1097/ms9.0000000000000550
5. A brief on new waves of monkeypox and vaccines and antiviral drugs for monkeypox.
   Hung YP, Lee CC, Lee JC, Chiu CW, et al · · 2022 · cited 11× · PMID 36115792 · DOI 10.1016/j.jmii.2022.08.016
6. Emerging evidence on Monkeypox: resurgence, global burden, molecular insights, genomics and possible management.
   Sharma R, Chen KT, Sharma R. · · 2023 · cited 9× · PMID 37153147 · DOI 10.3389/fcimb.2023.1134712
7. Comprehensive Genomic, Mutation, Phylogenetic, and Statistical Analysis of the Monkeypox Virus Across Multiple Countries.
   Zafar I, Kanwal F, Azmat M, Unar A, et al · · 2025 · cited 1× · PMID 40655364 · DOI 10.1007/s12088-025-01447-2
8. Emerging threats of monkeypox virus in 2024: current insights and future directions.
   L S D, R D, A M, N H, et al · · 2025 · PMID 41173508 · DOI 10.1080/20565623.2025.2577069