POS1107 IMMUNOGENICITY, REACTOGENICITY AND SAFETY OF 2 DOSES OF AN ADJUVANTED HERPES ZOSTER SUBUNIT VACCINE IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS: A RANDOMIZED CLINICAL TRIAL
Authors: J. K. Park, M. Kim, J. I. Jung, J. Y. Kim, H. Jeong, J. W. Park, K. L. Winthrop, E. B. Lee
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> Patients with systemic lupus erythematosus (SLE) are at an increased risk for herpes zoster (HZ) due to underlying immune dysfunction and treatment-associated immune suppression (1, 2). While HZ vaccine is recommended, the safety and efficacy of the novel adjuvanted herpes zoster subunit (HZ/su) vaccine in SLE patients remain uncertain (3, 4). <h3>Objectives:</h3> This study aims to evaluate the immunogenicity and safety of the HZ/su vaccine in SLE patients receiving standard of care in a clinical trial. <h3>Methods:</h3> In this randomized placebo controlled clinical trial, 65 patients with SLE were randomized in a 4:1 ratio to receive two doses of either HE/su vaccine or placebo 8 weeks apart. Anti-gE antibody titers and gE-specific cell-mediated immune responses at baseline and after vaccination were evaluated using an enzyme-linked fluorescence assay (ELISA) and flow cytometry, respectively. Reactogenicity, SLE disease activity, including SLEDAI-2K, and BILAG-flare rate were examined. The study was registered with www.clinicaltrials.gov (trial registration number: NCT06001606). <h3>Results:</h3> 49 patients in the HE/su vaccine and 11 patients in the placebo group were included in the modified intention-to-treat (mITT) population, comprising subjects who received the two doses and had available antibody titers at baseline and 4 weeks after the second dose (post-dose 2). Baseline characteristics, including age, sex, and SLE disease activity, were comparable between the groups (Table 1). The fold change in anti-gE antibody levels after the second dose was significantly higher in the HZ/su vaccine group than placebo (22.3 [12.1 - 29.3] vs. 1.0 [0.8 - 1.1] folds, P &lt;0.001). The frequencies of gE-specific CD4 T cells after the second dose were significantly higher in the HZ/su vaccine group compared to the placebo group (1098.2 [460.0 - 1775.8] vs. 125.0 [0.7 - 301.8] gE-specific CD4 cells/10<sup>6</sup> CD4 cells, P = 0.001) (Figure 1). More patients in the HZ/su vaccine group reported reactogenicity, including injection site reaction, fever, and fatigue. There were no differences in SLEDAI-2K, Physician Global Assessment, and BILAG-flare rates between the HE/su and placebo groups. <h3>Conclusion:</h3> The HE/su vaccine induces both humoral and cellular immunity with a good safety profile in SLE patients. A larger study is warranted to assess the effectiveness of the HE/su vaccines to prevent a HE in SLE patients. <h3>REFERENCES:</h3> [1] Cohen JI. Clinical practice: Herpes zoster. N Engl J Med. 2013 Jul 18; 369(3):255-263. [2] Kwan A, Rayes HA, Lazova T, Anderson N, Bonilla D, Su J, et al. Herpes zoster in SLE: prevalence, incidence and risk factors. Lupus Sci Med. 2022 Jan; 9(1). [3] Furer V, Rondaan C, Heijstek MW, Agmon-Levin N, van Assen S, Bijl M, et al. 2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis. 2020 Jan; 79(1):39-52. [4] Lal H, Cunningham AL, Godeaux O, Chlibek R, Diez-Domingo J, Hwang SJ, et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015 May 28; 372(22):2087-2096. <b>Table 1.</b> Baseline characteristics <h3>Acknowledgements:</h3> <b>NIL.</b> <h3>Disclosure of Interests:</h3> <b>None declared.</b>