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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00029638

Enrollment

15000

Registered

2022-07-21

Start date

2022-07-07

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety and Effectiveness of MVA-BN vaccination against MPXV infection in at-risk individuals in Germany B04

Interventions

Group 1: Vaccination group - receives one or two doses of MVA-BN vaccine according to indication Group 2: Control group - receives no MVA-BN vaccine dose, potential switch (crossover) to vaccination g

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Germany

Contacts

Public ContactFlorian Kurth

Charité Universitätsmedizin Berlin, Klinik m.S. Infektiologie und Pneumologie

semvac@charite.de+4930450553052

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 5, 2026