Effectiveness of Adjuvanted Recombinant Zoster Vaccine (RZV) Against Postherpetic Neuralgia (PHN) and Against Cardiovascular Disease (CVD) Events After Herpes Zoster (HZ) in United States Adults in Medicare Fee-for-Service (FFS) + Inovalon’s MORE2 Registry (307298 - EPI-ZOSTER-116 VE DB US)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  SHINGRIX
• Medicinal product name, other:
  Recombinant Zoster Vaccine
• Study drug International non-proprietary name (INN) or common name:
  HERPES ZOSTER VACCINE (RECOMBINANT, ADJUVANTED)
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BK03) zoster, purified antigen

  zoster, purified antigen
• Medical condition to be studied:
  Herpes zoster
• Additional medical condition(s):
  Postherpetic Neuralgia, Cardiovascular Disease

Population studied

• Short description of the study population:
  Eligible adults in 100% Medicare FFS and in MORE2 Registry between 01 October 2015 and 31 December 2024.
• 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

Study design details

• Study design:
  This is a retrospective, matched cohort study.
• Main study objective:
  • To estimate the VE of 2 doses of RZV (2-6 months apart) in preventing PHN in adults aged ≥50 years, overall and by follow-up year since vaccination.; • To estimate the VE of 2 doses of RZV (2-6 months apart) in preventing 3-point MACE (composite of hospitalized AMI, hospitalized stroke, or cardiovascular death) occurring within 3 months after HZ diagnosis in adults aged ≥50 years, overall.
• Comparators:
  RZV unvaccinated comparator: individuals will be selected for the ‘no RZV’ unvaccinated comparator group from individuals with a preventive care visit who have no record of RZV vaccination prior to or on the preventive care visit date.
• Outcomes:
  Vaccine effectiveness of RZV against:; • PHN; • HZ-associated hospitalization; • Other HZ complications (HZO); • 3-point MACE within 3 months after HZ - composite of hospitalized AMI, hospitalized stroke, or cardiovascular death; • 3-point MACE within 3 months after HZ - components: hospitalized AMI within 3 months after HZ, hospitalized stroke within 3 months after HZ, cardiovascular death within 3 months after HZ; • 3-point MACE within [timeframe] after HZ – composite and components; Adjusted hazard ratio of:; • All-cause 3-point MACE – composite; • All-cause hospitalized AMI; • All-cause hospitalized stroke (ischemic or hemorrhagic); • All-cause cardiovascular death
• Data analysis plan:
  A series of matched, multivariable, and weighted analyses will be conducted to address the research objectives focused on assessing the VE (including incidence rate and hazard ratio) of new diagnosis of PHN and 3-point MACE after HZ as well as other HZ complications.
• Summary results:
  The summary of results will be available within 12 months since end of study date.