Department of Epidemiology, Faculty of Military Health Sciences, University of Defence, Hradec Kralove, Czech Republic.
J Infect Dis. 2013 Dec 15;208(12):1953-61. doi: 10.1093/infdis/jit365. Epub 2013 Jul 31.
An adjuvanted varicella-zoster virus glycoprotein E (gE) subunit vaccine candidate for herpes zoster is in development. In this trial we compared the safety, reactogenicity, and immunogenicity of the vaccine antigen combined with different adjuvant doses.
This was a phase II, observer-blind, randomized, multinational study. Adults ≥50 years old were randomized 4:4:2:1 to be vaccinated at months 0 and 2 with gE combined with a higher (AS01B) or lower (AS01E) dose adjuvant, unadjuvanted gE, or saline. Following each dose, solicited events were recorded for 7 days and unsolicited adverse events for 30 days. Serious adverse events were collected for 1 year. Cell-mediated and humoral immune responses were assessed at baseline and following each dose.
No vaccine-related severe adverse events were reported. Solicited adverse events were generally mild to moderate and transient. For all gE-based vaccines, pain was the most common local symptom and fatigue the most common general symptom. Immune responses were significantly enhanced by AS01B and AS01E compared to unadjuvanted gE and were significantly stronger for gE/AS01B than for gE/AS01E.
AS01 improved the immunogenicity of gE while retaining acceptable safety and reactogenicity profiles. The enhancement of gE-specific cellular and humoral responses was adjuvant dose dependent.
NCT00802464.
一种带状疱疹病毒糖蛋白 E（gE）亚单位佐剂疫苗候选物正在开发中。在这项试验中，我们比较了疫苗抗原与不同佐剂剂量组合的安全性、反应原性和免疫原性。
这是一项 II 期、观察者盲法、随机、多国研究。年龄≥50 岁的成年人按 4:4:2:1 的比例随机分组，在 0 月和 2 月接种 gE 与高（AS01B）或低（AS01E）剂量佐剂、无佐剂 gE 或生理盐水联合疫苗。每次接种后，记录 7 天的症状和 30 天的不良事件。严重不良事件收集 1 年。在基线和每次接种后评估细胞介导和体液免疫反应。
没有报告与疫苗相关的严重不良事件。症状通常为轻度至中度和短暂。对于所有 gE 疫苗，疼痛是最常见的局部症状，疲劳是最常见的全身症状。与无佐剂 gE 相比，AS01B 和 AS01E 显著增强了 gE 的免疫原性，gE/AS01B 比 gE/AS01E 更强。
AS01 提高了 gE 的免疫原性，同时保持了可接受的安全性和反应原性。gE 特异性细胞和体液反应的增强与佐剂剂量有关。
NCT00802464。
