OP0117 Safety and immune response of a live attenuated herpes zoster vaccine in patients with systemic lupus erythematosus: a randomised placebo-controlled trial
Authors: C.C. Mok, K.H. Chan, L.Y. Ho, Y.F. Fung, W.F. Fung, P.C. Woo
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Objectives</h3> To evaluate the safety and immune response of a live attenuated herpes zoster (HZ) vaccine in patients with systemic lupus erythematosus (SLE) in a randomised placebo-controlled trial. <h3>Methods</h3> Adult patients who fulfilled ≥4 ACR criteria for SLE and had a SLEDAI score &lt;6 with stable immunosuppressive treatment for 6 m were recruited. Exclusion criteria were: active infection; lymphocyte &lt;500/mm<sup>2</sup>; reduced serum IgG/A/M level; serum creatinine &gt;200 umol/L; a history of cancer; and high-dose immunosuppressive treatment (prednisone &gt;15 mg/day, azathioprine &gt;100 mg/day, MMF &gt;500 mg/day, cyclosporin &gt;100 mg/day, tacrolimus &gt;3 mg/day, CYC and biologics). Participants were randomly assigned to receive HZ vaccine (Zostavax) or placebo (same volume of normal saline) given subcutaneously. Anti-VZV IgG reactivity (baseline and 6 weeks post-vaccination) was measured by an ELISA coated with inactivated varicella-zoster viral antigen (Vidas VZV IgG, bioMerieux, Marcy I'Etoile, France). Cell-mediated response to HZ was assessed by a specific VZV-stimulated IFNγ enzyme linked immunospot (ELISPOT) assay. Disease activity of SLE was assessed by the SLEDAI and PGA. Adverse events (AEs) and immune responses to HZ of the two groups were compared. <h3>Results</h3> 90 SLE patients were recruited (age 45.6±14.1 years; 93% women): 45 assigned to HZ vaccine and 45 to placebo. All participants had a history of HZ/chickenpox infection. The baseline clinical profile of the two groups of patients was similar. Only 3 patients in the vaccine and 1 patient in the placebo group had mild SLE activity (all mild thrombocytopenia). Baseline SLEDAI and PGA scores of the two groups were not significantly different (1.58±1.8 vs 1.64±1.7; p=0.86 and 0.21±0.18 vs 0.27±0.25; p=0.18, respectively). The proportion of patients receiving various immunosuppressive agents, lymphocyte count, serum creatinine, IgG/A/M levels were also similar in the two groups. The mean 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&lt;0.001), lymphocyte count, Ig levels, SLEDAI, and other clinical variables. The% increase in VZV IgG antibody was significantly higher in the vaccinated than control patients (+59.8% vs −2.1%; p=0.01), indicating an effect of vaccine. 21 and 6 AEs were reported in the vaccinated and control patients, respectively, but none were serious. Significantly more vaccinated patients reported pain and erythema at the injection site than controls (31% vs 7%; p&lt;0.01) (mild in all and subsided in a few days). Other AEs more commonly reported with vaccination included dizziness (2%), arthralgia (2%) and subjective fever (4%). Two vaccinated patients (4.4%) had mild flare of skin/joint disease, and one control patients (2.2%) had mild increase in proteinuria between week 0 and 6. None of the patients had clinical HZ infection post-vaccination. <h3>Conclusions</h3> In patients with stable SLE who were not receiving intensive immunosuppression, the live attenuated HZ vaccine was well tolerated and provoked an expected antibody response. Study of the cell-mediated response to HZ post-vaccination is in progress. <h3>Disclosure of Interest</h3> None declared