Safety profile of the adjuvanted recombinant zoster vaccine (RZV) in immunocompromised populations: an overview of 6 Trials

Abstract Background Immunocompromised (IC) populations are at increased risk of herpes zoster (HZ) and its related complications. RZV demonstrated > 68% efficacy against HZ in autologous hematopoietic stem cell transplant (HSCT) recipients ≥ 18 years of age (YOA). Here we present the safety data across 6 clinical trials in IC populations: autologous HSCT recipients, HIV-infected adults, renal transplant recipients, patients with solid tumor and patients with hematological malignancies. Methods All 6 studies (Table 1) enrolled IC adults ≥ 18 YOA in RZV and Placebo groups. Safety was evaluated in the total vaccinated cohort (TVC). Solicited adverse events (AEs) were collected for 7 days and unsolicited AEs for 30 days after each dose. Serious AEs (SAEs), and potential immune-mediated diseases (pIMDs) were collected from dose 1 until 1 year post-last dose or study end (for causally related [assessed by investigator] and fatal SAEs). Data are presented by age group: 18–49 YOA and ≥ 50 YOA. Reactogenicity data are pooled across the 6 studies and other safety data are presented by study. Table 1. Clinical trials with immunocompromised populations included in our analysis Results 1587 (RZV) and 1529 (Placebo) adults were included in the pooled TVC. Solicited AEs were more frequently reported in the RZV than Placebo group. Pain, fatigue, headache, myalgia, shivering and fever were reported more frequently in the RZV 18–49 YOA than in the RZV ≥ 50 YOA (Figure 1). Solicited AEs were mostly mild/moderate and lasted ≤3 days and grade 3 solicited AEs lasted ≤ 2 days (median duration). Across studies, the percentage of adults reporting ≥ 1 unsolicited AE was similar between RZV (18–49 YOA: 37.4–80.6%; ≥ 50 YOA: 36.9–87.2%) and Placebo (18–49 YOA: 31.4–90.0%; ≥ 50 YOA: 30.1–89.4%) (Figure 2). Overall, the percentage of adults with ≥ 1 SAE (Figure 3), causally related SAEs, fatal SAEs and pIMDs was similar between RZV and Placebo and between age groups. Overall, no safety concern was identified. Conclusion Reactogenicity symptoms were more frequent after RZV than placebo, and in younger age groups but no safety concern was identified. Most of the reported AEs and SAEs were in the context of underlying diseases and therapies. Overall our data support a favorable benefit-risk profile of vaccination with RZV in IC adults. Funding GlaxoSmithKline Biologicals SA Disclosures Marta Lopez Fauqued, PhD, GSK group of companies (Employee) Maribel Miranda Co, MD, GSK group of companies (Employee) Adriana Bastidas, MD, GSK group of companies (Shareholder, Former employee) Pierre Beukelaers, PhD, GSK group of companies (Employee) Alemnew F. Dagnew, MD, GSK group of companies (Employee, Shareholder) Juan Jose Fernandez Garcia, MSc, GSK group of companies (Independent Contractor) Anne Schuind, MD, GSK (Employee, Other Financial or Material Support, own GSK stock options or restricted shares as part of renumeration) Fernanda Tavares da Silva, MD, GSK group of companies (Employee, Shareholder)