Recombinant herpes zoster vaccine in patients with autoimmune rheumatic diseases in Brazil: a double-blind, randomised, placebo-controlled, phase 4, non-inferiority study
Primary result · Flare (worsening of disease activity)Result — go to the resultDifference in flare rate −1.2 % 95% CI −4.7 to 2.2Authors' conclusion
Recombinant zoster vaccine had an acceptable safety profile in patients with autoimmune rheumatic diseases who are immunosuppressed, and had no significant effect on short-term disease activity.
Study context
- Population
- Patients aged ≥18 years with an autoimmune rheumatic disease managed with GC, immunosuppressives or DMARDs at stable doses, tertiary centre in Brazilplus 393 healthy controls
- Participants
- 590 / 602 / 393
- Comparison
- Two doses of recombinant zoster vaccine 6 weeks apart vs placebo in patients with autoimmune rheumatic diseases; healthy controls received the vaccine
- Recombinant zoster vaccinen = 590
- Placebon = 602reference
- Healthy controlsn = 393
- Primary endpoint
- Patients with autoimmune rheumatic diseases with worsening of disease activity (flare), vaccine vs placebo, double-blind phase; non-inferiority if upper boundary of one-sided 95% CI of the difference <5%
- Follow-up
- Up to day 84 after the first dose
Methodological detailssingle-centre, double-blind, placebo-controlled, phase 4, non-inferiority, open-label phase for placebo recipients after double-blind phase, healthy control group
- Single-centre
- Double-blind
- Placebo-controlled
- Phase 4
- Non-inferiority
- Open-label phase for placebo recipients after double-blind phase
- Healthy control group
Primary result
Flare (worsening of disease activity) · up to day 84
Difference in flare rate
−1.2 %
95% CI −4.7 to 2.2
P = 0.0018 for non-inferiority
Events by treatment group
Recombinant zoster vaccinevs Placebo
difference in flare rate −1.2 % (95% CI −4.7 to 2.2); P for non-inferiority = 0.0018
As reported in the abstract
Safety
Adverse events after first dose
Adverse events after second dose
Serious adverse events after second dose · similar across the groups
| Outcome | Recombinant zoster vaccine | Placebo | Healthy controls |
|---|---|---|---|
| Serious adverse events after first doseSimilar across the groups | 1% | 1% | 0 events |
Original publication
Recombinant herpes zoster vaccine in patients with autoimmune rheumatic diseases in Brazil: a double-blind, randomised, placebo-controlled, phase 4, non-inferiority study. Lancet Rheumatol. Published 9 February 2026. doi:10.
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