Immunogenicity, Safety, and Determinants of Recombinant Zoster Vaccine Response in Idiopathic Inflammatory Myopathies: A Phase 4 Randomized Trial
Authors' conclusion
RZV was safe and induced seroconversion in most immunosuppressed patients with IIM, without evidence of vaccine-related disease activation.
Study context
- Population
- Immunocompromised adult patients with idiopathic inflammatory myopathies (IIM) (2017 ACR/EULAR criteria) and healthy controls
- Participants
- 70 vs 280
- Comparison
- Immunosuppressed IIM vs healthy controls receiving two recombinant zoster vaccine (RZV) doses; RZV vs placebo during blinded phase for disease activity
- IIMn = 70
- CGn = 280reference
- Primary endpoint
- Seroconversion (≥4-fold increase in anti-gE antibodies)
Methodological detailsdouble-blind, placebo-controlled, phase 4
- Double-blind
- Placebo-controlled
- Phase 4
Primary result
As reported in the abstract
Seroconversion rate
P < 0.001
Further findings
Post-vaccination GMT
P = 0.001
| Outcome | IIM | CG | P value |
|---|---|---|---|
| FI-GMT | 21.8 | 53.0 | P = 0.001 |
Factors associated with reduced seroconversion (multivariable)
- MMF use, higher baseline cutaneous activity and higher baseline geometric mean titers (GMT) independently associated with reduced seroconversion
- P < 0.05
Disease activity scores, vaccine vs placebo
- No differences in activity scores between vaccine and placebo groups
- P > 0.05
Safety
Adverse events (mostly mild)
P < 0.001
Original publication
Immunogenicity, Safety, and Determinants of Recombinant Zoster Vaccine Response in Idiopathic Inflammatory Myopathies: A Phase 4 Randomized Trial. Arthritis Care Res (Hoboken). Published 15 June 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →