Safety and Effectiveness of MVA-BN vaccination against MPXV infection in at-risk individuals in Germany

• Conditions: Safety and Effectiveness of MVA-BN vaccination against MPXV infection in at-risk individuals in Germany; B04; Monkeypox

• Registration Number: DRKS00029638
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-21
• Study Completion: 2023-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 15813

Inclusion Criteria

Inclusion criteria for vaccine group:
- Age = 18 years
- Existing informed consent
- Men and trans* persons who have sex with changing men (MSM) and/or trans* persons (according to the STIKO recommendation for indication vaccination with MVA-BN against monkeypox).

Inclusion criteria for control group:
- Age = 18 years
- Informed consent available
- Men and trans* persons who have sex with changing men (MSM) and/or trans* persons (according to the STIKO recommendation for indication vaccination with MVA-BN against monkeypox).

Inclusion criteria for subgroup:
- Inclusion in the vaccine group or control group
- Existing indication for regular blood sampling

Exclusion Criteria

- Inability to consent
- Known exposure to MPXV before 1st vaccination (post-exposure prophylaxis).
- For the subgroup of individuals with serological testing: Presence of medical reasons against the collection of additional blood volume.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaccine effectiveness of MVA-BN against symptomatic PCR-detected monkeypox disease, defined as reduction in risk of disease in vaccinated versus unvaccinated individuals within 12 months after vaccination.

Secondary Outcome Measures

Name	Time	Method
In study participants who have received at least one vaccination with MVA-BN:<br>- Safety and tolerance of MVA-BN vaccination, assessed through questionnaires.<br>- Change in risk behaviour after vaccination, assessed through questionnaires.<br>- Influence of existing medical conditions (e.g. HIV) and medication (e.g. HIV pre-exposure prophylaxis [PrEP]) on the tolerance of the vaccination.