Study identification

PURI

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

EU PAS number

EUPAS50093

Study ID

50282

Official title and acronym

Prospective Cohort Study and Emulated Target Trial to Estimate the Safety and Effectiveness of MVA-BN vaccination against MPXV infection in at-risk individuals in Germany (SEMVAc/TEMVAc)

DARWIN EU® study

No

Study countries

Germany

Study description

The SEMVAc study is a prospective, non-interventional, multicentric cohort study of the safety and effectiveness of the MVA-BN vaccine in a population of MSM and transgender persons. SEMVAc aimed to assess effectiveness of the MVA-BN vaccine and to describe the incidence of safety events (SAR, AR, AESIs) and reactogenicity (tolerability) of mpox vaccination. It also aimed to describe the influence of sexual behaviour, HIV status, PrEP use, and history of smallpox vaccination (HSMV) on the safety and effectiveness of mpox vaccination. The additional analysis, TEMVAc, used a retrospective, target trial emulation approach only for the primary objective of vaccine effectiveness.

Study status

Finalised
Research institutions and networks

Institutions

Aetion
Spain
First published:
16/07/2024
InstitutionOtherENCePP partner

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:
Actual:

Date of final study report

Planned:
Actual:
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)?

EU RMP category 3 (required)