Post-Marketing Observational Surveillance Study to Evaluate the Occurrence of Acute Myocardial Infarction in Adults 18 Years of Age and Older Who Receive HEPLISAV-B® Compared with Another Hepatitis B Vaccine (DV2-HBV-25)

Study type

• Study topic:
  Disease /health condition

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

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cluster design

  Cohort

  Other
• Non-interventional study design, other:
  Non-randomized cluster design

Study drug and medical condition

• Name of medicine:
  HEPLISAV B
• Study drug International non-proprietary name (INN) or common name:
  HEPATITIS B SURFACE ANTIGEN
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BC01) hepatitis B, purified antigen

  hepatitis B, purified antigen
• Medical condition to be studied:
  Hepatitis B virus test

  Acute myocardial infarction

Population studied

• Short description of the study population:
  The study population included patients with acute myocardial infarction, aged 18 years or older, received HEPLISAV-B vaccine, registered in KPSC research data warehouse.; Inclusion Criteria:; 1. Received at least one dose of hepatitis B vaccine (either HEPLISAV-B in HEPLISAV-B arm, or non-dialysis formulation hepatitis B comparator vaccine in comparator arm) at KPSC during study vaccination period.; 2. Enrolled as a KPSC member at time of hepatitis B vaccination during the study vaccination period.; 3. Age 18 years or older at time of hepatitis B vaccination during study vaccination period.; 4. Received hepatitis B vaccine at KPSC family practice or internal medicine departments, or in urgent care or nurse clinics affiliated with those departments.; ; Exclusion Criteria: ; 1. Received peritoneal dialysis or chronic hemodialysis in the 3 months prior to index hepatitis B vaccination; 2. Received all doses of their hepatitis B vaccine series in KPSC departments other than family practice or internal medicine or their affiliated departments as described above
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Immunocompromised

  Other
• Special population of interest, other:
  Patients with myocardial infarction and hepatitis B virus
• Estimated number of subjects:
  69625

Study design details

• Main study objective:
  The primary objective of this post-marketing observational surveillance study was to compare the occurrence (rate) of confirmed acute myocardial infarctions between patients who received HEPLISAV-B and those who received Engerix-B.
• Outcomes:
  The outcome of interest was the first occurrence of Acute Myocardial Infarction (AMI) during the 13-month follow-up period for each patient. Confirmed AMI was defined as definite plus probable type 1 AMI., Unconfirmed type 1 AMI events using a historical comparator. This outcome was used for the final analysis of unconfirmed type 1 AMI events as well as the secondary analysis using a historical comparator. Type 1 AMI events in the historical comparator analysis were not adjudicated.
• Data analysis plan:
  Baseline demographic and medical factors compared using standardized difference scores; multivariable Cox proportional hazards model applying inverse probability of treatment weighting (IPTW) for the analysis of AMI.