Systemic sclerosis & Raynaud's

Prospective evaluation of recombinant Herpes zoster vaccine in SSc: immunogenicity, safety and disease outcomes

Rheumatology (Oxford)Published Secondary analysis of a randomised controlled trial

Authors' conclusion

RZV was well tolerated. Despite the high seroconversion rate, the immune response was significantly lower in magnitude compared with the controls, without triggering DA or worsening PROMs.

Study context

Population
Immunosuppressed patients with SSc (47.4% diffuse/52.6% limited) and healthy controls
Participants
76 vs 304
Comparison
Immunosuppressed SSc patients vs healthy controls, both receiving two recombinant zoster vaccine (RZV) doses
  • SScn = 76
  • CGn = 304reference
Primary endpoint
Humoral immune response to RZV (anti-glycoprotein-E antibodies)
Follow-up
6 weeks post-second dose
Methodological detailsdouble-blind, placebo-controlled, sub-analysis
  • Double-blind
  • Placebo-controlled
  • Sub-analysis

Primary result

As reported in the abstract

Humoral response

P = 0.001

Further findings

OutcomeSScCGP value
GMC of anti-glycoprotein-E antibodies · 6 weeks post-second dose5.8112.6P < 0.001
Factor increase (FI) · 6 weeks post-second dose31.059.4P < 0.001

Cell-mediated immunogenicity

Comparable cell-mediated immunogenicity (CMI)
P > 0.05

Predictors of vaccine response

Disease subtypes, demographic factors, immunosuppressive therapies or nutritional status did not predict impaired vaccine response
P > 0.05

Disease activity (DA) and patient-reported outcome measures (PROMs)

DA and PROMs outcomes remained stable
P > 0.05

Safety

Local adverse events

P = 0.024

Systemic reactions

P = 0.712

Original publication

Prospective evaluation of recombinant Herpes zoster vaccine in SSc: immunogenicity, safety and disease outcomes. Rheumatology (Oxford). Published 8 June 2026. doi:10.1093/rheumatology/keag294

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