Study identification

PURI

https://redirect.ema.europa.eu/resource/50282

EU PAS number

EUPAS50093

Study ID

50282

Official title and acronym

Safety and Effectiveness of MVA-BN vaccination against MPXV infection in at-risk individuals in Germany (SEMVAc) (DRKS ID: DRKS00029638 (SEMVAc))

DARWIN EU® study

No

Study countries

Germany

Study description

The SEMVAc study is a multi-centric prospective, non-interventional observational cohort study, which aims to investigate the following hypotheses: ● Vaccination with MVA-BN reduces the likelihood of infection with MPXV and symptomatic monkeypox disease (MPX) compared to non-vaccinated individuals.  ● Pre-existing medical conditions and medication influence the risk of contracting monkeypox as a vaccinated person.

Study status

Planned
Research institution and networks

Institutions

Med. Klinik m.S. Infektiologie und Pneumologie
Aetion
Spain
First published:
16/07/2024
Institution
OtherENCePP partner
Harvard Pilgrim Health Care, Inc. Boston, Massachussets, USA, CVS Health Clinical Trial Services Woonsocket, Rhode Island, USA, HealthCore Wilmington, DE, USA, Humana Louisville, Kentucky, USA

Contact details

Leif Erik Sander

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

EMA, Intramural funds of the Charité - Universitätsmedizin Berlin and Berlin Institute of Health (BIH)
Study protocol
Initial protocol

20221202_SEMVAc_V1.3 final_shared version

English (534.65 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable