Effectiveness and safety of MVA-BN vaccination against Mpox in at-risk individuals in the United States (USMVAc) (USMVAC study)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105127
• EU PAS number:
  EUPAS104386
• Study ID:
  105127
• Official title and acronym:
  Effectiveness and safety of MVA-BN vaccination against Mpox in at-risk individuals in the United States (USMVAc) (USMVAC study)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The USMVAc (United States Mpox Vaccination) study is a retrospective, observational longitudinal study using U.S. healthcare data aggregated from HealthVerity. The study aims to evaluate the vaccine effectiveness and safety of the MVA-BN (Jynneos/Imvanex) vaccine in a cohort population of men who sex with men (MSM) and transgender women. Vaccine effectiveness outcomes include mpox infection, hospitalisation related to mpox, all-cause hospitalisation or death, all potential mpox, and all potential hospitalisation for mpox. Safety outcomes of interest include myocarditis, pericarditis, encephalitis, and anaphylaxis.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Aetion

Spain

Study timelines

Date when funding contract was signed

Planned: 22/11/2022

Actual: 22/11/2022

Study start date

Planned: 02/05/2023

Actual: 02/05/2023

Data analysis start date

Actual: 17/10/2023

Date of final study report

Planned: 24/11/2023

Sources of funding

EU institutional research programme

Other

More details on funding

EMA, Aetion

Study protocol

Initial protocol

[CLEAN] USMVac-Protocol_V0.4

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable