65 岁及以上曾接种过减毒活带状疱疹疫苗的成年人中，含佐剂的重组带状疱疹疫苗。
The Adjuvanted Recombinant Zoster Vaccine in Adults Aged ≥65 Years Previously Vaccinated With a Live-Attenuated Herpes Zoster Vaccine.
机构信息
GSK, Rockville, Maryland, USA.
Kaiser Permanente Vaccine Study Center, Oakland, California, USA.
出版信息
J Infect Dis. 2021 Oct 13;224(7):1139-1146. doi: 10.1093/infdis/jiaa083.
BACKGROUND
Efficacy of the live-attenuated herpes zoster (HZ) vaccine (ZVL) wanes substantially over time. We evaluated immunogenicity and safety of the adjuvanted recombinant zoster vaccine (RZV) in previous ZVL recipients.
METHODS
Adults aged ≥65 years who were previously vaccinated with ZVL ≥5 years earlier (n = 215) were group-matched with ZVL-naive individuals (n = 215) and vaccinated with RZV. Glycoprotein E (gE)-specific humoral and cell-mediated immune responses and the correlation between them, polyfunctional gE-specific CD4 T-cell responses, safety, and confirmed HZ cases were assessed.
RESULTS
Through 12 months after dose 2, anti-gE antibody concentrations, gE-specific CD4 T-cell frequencies, and activation marker profiles were similar between groups. Safety outcomes were also similar. No HZ episodes were confirmed.
CONCLUSIONS
RZV induced strong humoral and polyfunctional cell-mediated immune responses that persisted above prevaccination levels through 1 year after dose 2 in adults aged ≥65 years irrespective of previous ZVL vaccination. The RZV safety profile was not affected.
CLINICAL TRIALS REGISTRATION
NCT02581410.
背景
减毒活带状疱疹（HZ）疫苗（ZVL）的效力随时间推移而大幅减弱。我们评估了佐剂重组带状疱疹疫苗（RZV）在先前接受过 ZVL 疫苗接种者中的免疫原性和安全性。
方法
年龄≥65 岁且先前接种 ZVL 疫苗超过 5 年的成年人（n=215）与 ZVL 初免者（n=215）分组匹配，并接种 RZV。评估了糖蛋白 E（gE）特异性体液和细胞介导免疫应答及其相关性、gE 特异性多功能 CD4 T 细胞应答、安全性和确诊的带状疱疹病例。
结果
在接种第 2 剂后 12 个月，两组之间的抗 gE 抗体浓度、gE 特异性 CD4 T 细胞频率和激活标志物谱相似。安全性结局也相似。未确认带状疱疹发作。
结论
RZV 诱导了强烈的体液和多功能细胞介导免疫应答，在接种第 2 剂后 1 年内，无论先前是否接种过 ZVL 疫苗，这些应答均持续高于接种前水平。RZV 的安全性特征不受影响。
临床试验注册
NCT02581410。
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