Long-term Protection Against Herpes Zoster (HZ) by the Adjuvanted Recombinant Zoster Vaccine (RZV): Interim Efficacy, Immuno and Safety Results at Approximately 10 Years after Initial Vaccination.

배경: The recombinant zoster vaccine (RZV) has demonstrated high vaccine efficacy (VE) against herpes zoster (HZ) in adults ≥50 years of age (YOA) in 2 phase 3 clinical trials (ZOE-50, NCT01165177; ZOE 70, NCT01165229). VE persisted up to year (Y)2 in the interim analysis of the extension study (ZOSTER-049, NCT02723773). Here, we describe the interim analysis for Y4 of the extension study. Understanding VE persistence and long-term protection against HZ can help optimize RZV use in adults ≥50 YOA. 방법: The study design is detailed in Fig. 1. Primary objective included VE against HZ during ZOSTER-049. Secondary objectives included VE against HZ from 1 month post-dose 2 in the ZOE-50/-70 studies until the end of Y4 of ZOSTER-049 (Y10 post-vacci- nation), persistence of vaccine-induced humoral immunogenicity in terms of anti-glycoprotein E (gE) antibody and cell-mediated immune response in terms of frequency of gE-specific CD4[2+] T-cells and safety. VE analysis for ZOSTER-049 used historical control estimates from the ZOE-50/-70 placebo groups. 결과: ZOSTER-049 enrolled 7,413 participants and 7,277 were included in VE analyses (Fig. 2). During 4 years of follow-up in ZOSTER-049, overall VE against HZ was 81.6% (95% confidence interval [CI]: 75.2-86.6). From 1 month post-dose 2 in ZOE-50/-70 until Y4 of ZOSTER-049, overall VE was 89.0% (95% CI: 85.6-91.3). In ZOSTER-049, anti-gE antibody concentrations persisted >5 times above pre-vaccination up to Y10 post-vaccination (Fig. 3A). Frequency of gE-specific CD4[2+] T-cells remained above pre-vaccination from Y6 to Y10 post-vaccination (Fig. 3B). No safety signals were identified until the end of ZOSTER-049 Y4. 결론: VE against HZ and immune responses to RZV remained high until the end of the observation period for this Y4 interim analysis, suggesting sustained clinical benefit of RZV in adults ≥50 YOA for at least 10 years after vaccination. RZV safety profile remained clinically acceptable. [ABSTRACT FROM AUTHOR]