Background/Purpose: To evaluate the safety and immune response of a live attenuated herpes zoster (HZ) vaccine in patients with SLE by a randomized placebo-control trial (RCT).

Methods: Adult patients (age >18 years) who fulfilled ≥4 ACR criteria for SLE and had a SLEDAI score <6 with stable immunosuppressive treatment in the preceding 6 months were recruited. Exclusion criteria were: active infection, lmphocyte count <500/mm², reduced IgG/A/M level, a history of malignancies, and current treatment with high-dose immunosuppression (eg. prednisone >15mg/day, azathioprine >100mg/day, mycophenolate mofetil >500mg/day, cylophosphamide and biological agents etc.). Participants were randomly assigned to either HZ vaccine (®Zostavax) or placebo given subcutaneously. Anti-VZV IgG reactivity was measured by a two-step enzyme linked fluorescence assay (VIDAS [Biomeriux]). An index value was computed and higher values reflect increased anti-VZV titers. Cell-mediated response to HZ was assessed by a specific VZV-stimulated IFNγ release ELISPOT assay. Disease activity of SLE was assessed by the SLEDAI. Unsolicited adverse events (AEs) at week 6 were compared between the two groups.

Results:

90 SLE patients were recruited (age 45.6±14.1 years; 93% women): 45 assigned to vaccine and 45 to placebo. Baseline clinical characteristics and SLEDAI scores (1.58±1.8 vs 1.64±1.7; p=0.86) of the vaccine and placebo groups of patients were similar. Proportion of patients who were using various immunosuppressive agents, and the baseline lymphocyte count, serum creatinine and IgG/A/M levels were also similar in the two groups. The baseline VZV IgG index value was 3.28±1.19 and 3.45±1.07 in the vaccine and control group of patients, respectively (p=0.48). The paired VZV IgG titer at week 6 was significantly higher in the vaccine than control group, even after adjustment for baseline value (4.16±1.26 vs 3.32±1.01; p<0.001), clinical characteristics, SLEDAI and other risk factors for HZ infection. The increase in VZV IgG antibody was significantly higher in the vaccinated than control patients (+59.8% vs -2.1%; p=0.01). In 10 patients (5 vaccine; 5 placebo) who had undergone ELISPOT assay so far (the work is ongoing), the number of IFNγ-secreting CD4+ T cell colonies dropped from 32.8±17 to 28.4±12 in the placebo-treated patients but increased from 29.6±4.5 to 55.0±11.4 in vaccinated patients from week 0 to week 6. Twenty-one and 6 unsolicited AEs were reported in the vaccinated and control patients, respectively. Significantly more vaccinated patients reported pain and erythema at the injection site than controls (31% vs 7%; P<0.01), and in all cases, symptoms were mild and self-limiting. Other AEs were minor and did not differ between the two groups. Two vaccinated patients (4.4%) had mild flare of skin/joint disease, and one control patients (2.2%) had mildly increase in proteinuria between week 0 and 6. No patients had evidence of HZ infection 6 weeks after vaccination.

Conclusion: In patients with stable SLE who were not receiving intensive immunosuppression, vaccination with the live attenuated HZ vaccine provoked an expected cell-mediated and humoral response. The HZ vaccine was well tolerated.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-and-immune-response-of-a-live-attenuated-herpes-zoster-vaccine-in-patients-with-systemic-lupus-erythematosus-sle-a-randomized-placebo-controlled-trial/