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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BX01) smallpox and monkeypox vaccines
• Medical condition to be studied:
  Monkeypox

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:
  15000

Study design details

• Main study objective:
  Objectives is to investigate the followiing: -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.
• Outcomes:
  Vaccine effectiveness of MVA-BN against symptomatic PCR-confirmed MPX, defined as reduction in risk of infection/disease in vaccinated versus unvaccinated individuals. For study participants who have received at least one dose of MVA-BN vaccination: -Safety and reactogenicity of the MVA-BN vaccine, assessed by questionnaires -Change in risk behavior after vaccination, assessed by questionnaires -Influence of pre-existing medical conditions (e.g. HIV) and medications (e.g. HIV pre-exposure prophylaxis PrEP) on reactogenicity of the vaccination.
• Data analysis plan:
  In this study, vaccine effectiveness, descriptive and exploratory statistical analyses are performed. The collected data will first be summarized using methods of descriptive statistics. Means and standard deviations or median with interquartile range (depending on distribution) for metric variables and absolute and relative frequencies for categorical variables (with associated 95% CI) will be used to present the results. An unadjusted group comparison will be sought and appears possible if random allocation of vaccines to study facilities results in well-comparable treatment groups. If treatment groups differ significantly by self-selection mechanisms, the framework of an emulated target trial will be used. Relevant baseline confounders (e.g. age, use of PrEP, number of sexual contacts in the past 3 months) will have to be adjusted between groups.This will be done with PS matching, depending on the exact group composition, inverse probability treatment weighting may also be used

Documents

Study report

SEMVAc_Study Report.pdf

Study, other information

Annex 2_Supplementary Material_SEMVAc_Study report.pdf