213825-Non-interventional (observational) post-licensure study to assess the vaccine effectiveness and safety of recombinant zoster vaccine (RZV) in the rheumatoid arthritis (RA) and inflammatory bowel disease (IBD) patient populations in adults 18 years of age and older (EPI-ZOSTER-044 VE US)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Self-controlled case series

Study drug and medical condition

• Name of medicine:
  SHINGRIX
• Medical condition to be studied:
  Herpes zoster

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)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  21500

Study design details

• Main study objective:
  To estimate the VE of 2 doses of RZV, given 4 weeks to 6 months apart, in preventing HZ in adults ≥18 years of age with RA and IBD.; To assess the risk of RA and IBD flares within 30 days following any RZV vaccination as compared to the risk in self-controlled comparison periods, in adults ≥18 years of age with RA and IBD respectively.
• Outcomes:
  Number of incident HZ cases in participants with RA and IBD; Incidence rate of HZ in participants with RA and IBD; Number of incident RA and IBD flare cases; Number of incident HZ cases in participants with: ; -IBD stratified by condition and age; -RA, stratified by age; -RA or IBD, stratified by condition (in those receiving second dose >=4 weeks after first dose and those receiving second dose >6 months after first dose); -RA and IBD (from 1st dose); Incidence rate of HZ in participants with: ; -IBD, stratified by condition and age ; -RA, stratified by age; -RA or IBD, stratified by condition (in those receiving second dose >=4 weeks after first dose and those receiving second dose >6 months after first dose); -RA and IBD (from 1st dose); Number of incident IBD flare cases stratified by condition;
• Data analysis plan:
  For the VE analyses, the number and characteristics of individuals in each cohort will be described and compared. Overall incidence rates of HZ for the 2-dose (4 weeks to 6 months) RZV vaccinated cohort and the matched unvaccinated cohort will be calculated by dividing the number of HZ cases by the total number of person-years. Adjusted HRs and 95% confidence intervals (CIs) comparing HZ incidence rates in the 2-dose (4 weeks to 6 months) RZV cohort, and the matched unvaccinated cohort will be estimated by Cox proportional hazards regression models adjusting for potential confounders. VE will be calculated from the hazard ratio (HR) obtained from Cox regression analysis. ; For the primary safety analyses, characteristics of individuals with RA or IBD who meet inclusion criteria will be described. ; Incidence rates for RA or IBD (UC or CD) flare for risk periods and comparison periods will be calculated by dividing the number of flares by person-time. Relative risks (95% CI) for flare comparing risk and comparison periods overall and by first dose and second dose will be estimated using conditional Poisson regression.