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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Observational study (secondary data collection)

Study drug and medical condition

• Name of medicine:
  IMVANEX
• Name of medicine, other:
  Jynneos
• Medical condition to be studied:
  Monkeypox immunisation

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  978

Study design details

• Main study objective:
  To assess the vaccine effectiveness and safety profile of MVA-BN vaccine against mpox disease among a population of MSM and transgender women in the U.S.
• Outcomes:
  To compare the incidence of mpox disease, hospitalization or death among the MVA-BN fully vaccinated population (two doses at least 28 days apart), vs. unvaccinated population (no evidence of any dose) in an at-risk population of MSM and transgender women, and HIV (treated and untreated with antiretroviral treatments) subgroups. To compare the incidence of pre-specified adverse events of special interest (AESIs), namely, pericarditis, myocarditis, encephalitis, and anaphylaxis among those who were vaccinated with at least one dose of MVA-BN vs. matched unvaccinated subjects (no evidence of any dose) in an at-risk population of MSM and transgender women.
• Data analysis plan:
  A risk set sampling of vaccinated and unvaccinated MSM and transgender women matched on age, region and insurance provider will be implemented. Additional PS matching on pre-defined covariates will be used to further manage confounding between vaccinated vs. unvaccinated MSM and transgender women. Incidence rate ratios and rate differences will be provided to compare vaccine effectiveness and safety outcomes between vaccinated and unvaccinated subjects. For safety assessment, a self-controlled design will be implemented as a sensitivity analysis to assess potential impact of (unmeasured) time-invariant confounders.

Documents

Study results

[CLEAN] USMVac Study Report v3.0.