Post-Marketing Observational Surveillance Study to Evaluate the Incidence of New-Onset Immune-Mediated Diseases, Herpes Zoster, and Anaphylaxis in Adults 18 Years of Age and Older Who Receive HEPLISAV B® Compared with Another Hepatitis B Vaccine (DV2-HBV-26)

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

  Vasculitis

  Alopecia areata

  Graves' disease

  Bell's palsy

  Erythema nodosum

  Giant cell arteritis

  Guillain-Barre syndrome

  Lichen planus

  Polyarteritis nodosa

  Polymyalgia rheumatica

  Rheumatoid arthritis

  Scleroderma

  Systemic lupus erythematosus

  Takayasu's arteritis

  Colitis ulcerative

  Tolosa-Hunt syndrome

  Vitiligo

Population studied

• Short description of the study population:
  The study population included patients aged 18 years or older received hepatitis B vaccination registered in the KPSC research data warehouse.; Inclusion criteria:; 1. Received at least 1 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 (more than 9 dialysis sessions in the past 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:
  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)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  69625

Study design details

• Main study objective:
  The primary objective of this post-marketing observational surveillance study was to describe and compare the incidence of new-onset immune-mediated diseases, herpes zoster, and anaphylaxis in recipients of HEPLISAV B with recipients of another hepatitis B vaccine.
• Outcomes:
  The outcome of interest was the incidence of selected new-onset immune-mediated diseases, herpes zoster, and anaphylaxis events following the index dose of hepatitis B vaccine. Please see relevant medical condition section 7.0 to have a list of new-onset immune-mediated diseases of interest in this study.
• Data analysis plan:
  Baseline demographic and medical factors compared using standardized difference scores; Poisson regression employing inverse probability of treatment weighting (IPTW) for the analysis of immune-mediated diseases, herpes zoster, and anaphylaxis events, where there was at least 80% power to detect a relative risk of 5 for anaphylaxis or at least 80% power to detect a relative risk of 3 for herpes zoster and immune-mediated diseases for a 5% two-sided alpha level and without multiplicity consideration.