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Lower magnitude of humoral response to recombinant herpes zoster vaccine in immunocompromised Sjögren's disease patients: evidence from a randomized double-blinded placebo-controlled trial
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DOI：10.1016/j.semarthrit.2026.152974.png)
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Abstract
En 中文
Background: Immunocompromised Sjo & uml;gren's disease-(SjD) patients are susceptible to herpes zoster reactivated infection-(HZ/shingles), yet data on the recombinant zoster vaccine-(Shingrix (R)/RZV) in these patients are limited. Objectives: To assess RZV humoral/cellular immunogenicity and safety in immunocompromised SjD patients. Methods: Randomized double-blind placebo-controlled study comprising 67 immunocompromised SjD patients and 201 age-/sex-balanced non-immunosuppressed controls. SjD patients were randomized to receive vaccine(SjD-V) or placebo-(SjD-P) on day-0-(D0) and D42. SjD-P were immunized after unblinding on D84 and D126. Controls were vaccinated on D0 and D42. Adverse events-(AEs) and disease activity were monitored. Humoral immunogenicity was assessed by anti-gE concentrations, with seroconversion defined as >= 4-fold increase from baseline to 6-weeks after the 2nd RZV dose. gE-specific CD4+ T cells were counted in congruent to 10% of participants. Vaccine impact on SjD symptoms/biological parameters was explored. Results: SjD and controls were comparable regarding age [55.0 (48.3-63.8) vs. 55.0 (52.0-64.0) years; P = 0.087] and sex (P = 0.303). Seroconversion rate was lower in SjD than controls (90.6% vs. 99.5%; P < 0.001), with reduced geometric-mean-titer-(GMT) [7.1 (5.3-9.6) vs. 12.6 (11.4-13.9) mIU/mL; P < 0.001] and factor-increase-GMT [23.9 (16.0-35.8) vs. 70.4 (58.8-84.4); P < 0.001] in SjD. The cellular response was comparable between SjD patients and controls (P > 0.05). Disease activity, SjD symptoms/biological parameters remained stable (P > 0.05). No serious vaccine-related AEs occurred. Conclusion: RZV showed a favorable safety profile in immunocompromised SjD patients. Despite the high seroconversion rate, the response was significantly lower in magnitude compared to controls. This may compromise long-term immunity, underscoring the need for optimizing immune responses in this population (ClinicalTrials. gov-NCT05879419).
Keywords:
Herpes zoster
Shingles
Recombinant herpes zoster vaccine
Sj & ouml
gren's disease
Sj & ouml
gren'ssyndrome
Safety
Immunogenicity
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