Safety and effectiveness of RZV in adults ?18 years of age with Systemic lupus erythematosus (SLE) or Multiple sclerosis (MS) (EPI-ZOSTER-041 VS US DB 215104)

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  Shingrix

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:
  48693

Study design details

• Main study objective:
  • To assess the risk of severe flare within 90 days following any RZV dose in adults with pre-existing SLE. • To assess the risk of any relapse within 90 days following any RZV dose in adults with pre-existing MS. • To estimate the VE of 2 doses of RZV in preventing HZ in adults with pre-existing SLE. • To estimate the VE of 2 doses of RZV in preventing HZ in adults with pre-existing MS.
• Outcomes:
  Safety: Risk of severe systemic lupus erythematosus (SLE) flare or risk of any multiple sclerosis (MS) relapse. Effectiveness: Vaccine effectiveness in prevention of herpes zoster (HZ). Safety: Risk of severe systemic lupus erythematosus (SLE) flare or risk of any multiple sclerosis (MS) relapse. Effectiveness: Incidence of post-herpetic neuralgia (PHN).
• Data analysis plan:
  The analysis plan will include descriptive measures to characterize vaccinated and unvaccinated individuals. Cox proportional hazards regression models will be used to compare outcomes in vaccinated and unvaccinated patients using propensity scores to balance potential confounders.To evaluate safety outcomes after any RZV dose, separate cohorts will be created for RZV Dose 1 and Dose 2, each with matched unvaccinated comparators.Severe SLE flares and any MS relapses will be assessed separately in each cohort (Dose 1 and Dose 2) first descriptively, and using time-to-event analysis with Cox proportional hazard models, assessing for violations of the proportional hazards assumptions.A retrospective cohort design with Cox proportional hazards modelling will be used to assess the risks of HZ and incidence of PHN after RZV vaccination. In the primary analysis, patients receiving the RZV Dose 2 at least 28 days after RZV Dose 1 will be compared to patients with no prior RZV vaccination.