Gilderman Larry I, Lawless James F, Nolen Thomas M, Sterling Tina, Rutledge Ruth Z, Fernsler Doreen A, Azrolan Neal, Sutradhar Santosh C, Wang William W, Chan Ivan S F, Schlienger Katia, Schödel Florian, Silber Jeffrey L
University Clinical Research, Pembroke Pines, Florida, USA.
Clin Vaccine Immunol. 2008 Feb;15(2):314-9. doi: 10.1128/CVI.00310-07. Epub 2007 Dec 12.
The vaccine Zostavax has been shown to prevent herpes zoster (HZ) and postherpetic neuralgia and is recommended for individuals > or =60 years of age. This study compared the safety and the immunogenicity of a refrigerator-stable formulation (Zostavax refrigerated) with those of the current formulation (Zostavax frozen) in subjects > or =50 years of age. Subjects with a negative history for HZ were randomized 1:1 to receive one dose of either formulation. Enrollment was stratified 1:2 by age (50 to 59 years and > or =60 years). Safety was evaluated for 28 days postvaccination. Varicella-zoster virus (VZV) antibody responses were measured by a glycoprotein enzyme-linked immunosorbent assay (gpELISA). The primary endpoints were the VZV antibody geometric mean titer (GMT; day 28), the VZV antibody geometric mean rise (GMR; days 1 to 28), and the incidence of vaccine-related serious adverse experiences (AEs) over 28 days. The refrigerated (n = 182) and frozen (n = 185) formulations induced similar GMTs (727.4 and 834.4 gpELISA units/ml, respectively); the estimated GMT ratio (refrigerated formulation/frozen formulation) was 0.87 (95% confidence interval, 0.71 to 1.07). The GMRs were 2.6- and 2.9-fold, respectively. No vaccine-related serious AEs were reported in either group, and the safety profiles of the formulations were generally similar. The frequencies of injection-site AEs during follow-up were 35.6% and 46.4% in the refrigerated and the frozen formulation groups, respectively, and were generally mild. The frequencies of systemic AEs were similar in the two groups, and those of vaccine-related AEs were approximately 6% in both groups. The refrigerator-stable formulation of Zostavax has an acceptable safety profile and is as immunogenic as the frozen formulation; thus, the vaccine may be used in clinical settings where freezer availability is limited.
疫苗Zostavax已被证明可预防带状疱疹（HZ）和带状疱疹后神经痛，推荐用于年龄≥60岁的人群。本研究比较了冰箱稳定剂型（冷藏的Zostavax）与现行剂型（冷冻的Zostavax）在年龄≥50岁受试者中的安全性和免疫原性。HZ病史阴性的受试者按1:1随机分组，接受一剂上述任一剂型。入组按年龄（50至59岁和≥60岁）1:2分层。在接种疫苗后28天评估安全性。通过糖蛋白酶联免疫吸附测定（gpELISA）测量水痘-带状疱疹病毒（VZV）抗体反应。主要终点为VZV抗体几何平均滴度（GMT；第28天）、VZV抗体几何平均上升值（GMR；第1天至第28天）以及28天内与疫苗相关的严重不良事件（AE）发生率。冷藏剂型（n = 182）和冷冻剂型（n = 185）诱导的GMT相似（分别为727.4和834.4 gpELISA单位/ml）；估计的GMT比值（冷藏剂型/冷冻剂型）为0.87（95%置信区间，0.71至1.07）。GMR分别为2.6倍和2.9倍。两组均未报告与疫苗相关的严重AE，且两种剂型的安全性概况总体相似。随访期间，冷藏剂型组和冷冻剂型组注射部位AE的发生率分别为35.6%和46.4%，且通常为轻度。两组全身AE的发生率相似，两组中与疫苗相关AE的发生率均约为6%。Zostavax的冰箱稳定剂型具有可接受的安全性概况，且免疫原性与冷冻剂型相同；因此，该疫苗可用于冷冻设备有限的临床环境。
