Palmetto Medical Research, Mount Pleasant, SC, United States.
Vaccine. 2010 Jun 7;28(25):4204-9. doi: 10.1016/j.vaccine.2010.04.003. Epub 2010 Apr 21.
Prior clinical studies of zoster vaccine enrolled subjects without a history of herpes zoster (HZ), so there are limited data on safety and immunogenicity in vaccinees with a prior history of HZ. This study was conducted to evaluate the safety and immunogenicity of zoster vaccine recipients who had a prior episode of HZ.
A total of 101 subjects > or = 50 years of age with a prior history of HZ were enrolled. They were stratified by number of years since their HZ (5 to 9 years and > or = 10 years, in an approximate 2:1 ratio), and randomized 1:1 to one of two vaccination groups. On day 1, Group I was administered zoster vaccine and Group II received placebo. At week 4, Group I received placebo and Group II received zoster vaccine. Subjects were followed for adverse experiences (AEs), exposure to varicella or HZ, and development of any varicella/varicella-like or HZ/HZ-like rashes, for 28 days after each injection. Blood samples were obtained prior to study injection on day 1 and week 4, and at week 8. Serum was assessed for varicella-zoster virus (VZV) antibody concentration by glycoprotein enzyme-linked immunosorbent assay.
No serious AEs were reported within the 28-day safety follow-up period following any vaccination. Although a higher percentage of subjects reported injection-site AEs after receiving zoster vaccine than did placebo recipients, the proportion of subjects reporting systemic clinical AEs was similar in both groups. Zoster vaccine induced a VZV antibody response at 4 weeks post-vaccination. The estimated geometric mean titer (GMT) ratio (vaccine/placebo) was 2.07 (95% CI: 1.48, 2.88). The geometric mean fold-rise (GMFR) from prevaccination to week 4 post-vaccination was 2.1 in zoster vaccine recipients, versus 1.0 in placebo recipients.
In HZ history-positive adults > or = 50 years of age, zoster vaccine: (1) was well tolerated; and (2) significantly boosted the level of VZV antibody from baseline to 4 weeks post-vaccination as measured by GMT and GMFR. These data support the Advisory Committee on Immunization Practices' recommendation for routine zoster vaccination for all immunocompetent persons >/=60 years of age irrespective of HZ history.
先前的带状疱疹疫苗临床试验纳入了没有带状疱疹（HZ）病史的受试者，因此对于有 HZ 病史的疫苗接种者，疫苗的安全性和免疫原性数据有限。本研究旨在评估有 HZ 病史的带状疱疹疫苗接种者的安全性和免疫原性。
共纳入 101 例年龄≥50 岁、有 HZ 病史的受试者。根据 HZ 发生时间（5 至 9 年和≥10 年，大致为 2：1 比例）进行分层，然后按照 1：1 的比例随机分配到两组中的一组。第 1 天，I 组接种带状疱疹疫苗，II 组接种安慰剂。第 4 周，I 组接种安慰剂，II 组接种带状疱疹疫苗。在每次注射后 28 天内，对受试者进行不良事件（AE）、水痘或 HZ 暴露以及任何水痘/水痘样或 HZ/HZ 样皮疹的发生情况进行随访。在研究注射前的第 1 天和第 4 周采集血样，并在第 8 周采集。采用糖蛋白酶联免疫吸附试验检测血清中水痘带状疱疹病毒（VZV）抗体浓度。
在任何一次疫苗接种后的 28 天安全性随访期间，均未报告严重的 AE。尽管接种带状疱疹疫苗后，更多的受试者报告了注射部位 AE，但两组报告全身临床 AE 的比例相似。带状疱疹疫苗在接种后 4 周诱导 VZV 抗体应答。接种疫苗后 4 周的估计几何平均滴度（GMT）比值（疫苗/安慰剂）为 2.07（95%可信区间：1.48，2.88）。与安慰剂组相比，接种疫苗组从接种前到接种后 4 周的几何平均倍数增加（GMFR）为 2.1。
在 HZ 病史阳性的年龄≥50 岁成人中，带状疱疹疫苗：（1）具有良好的耐受性；（2）在接种后 4 周内显著提高了 VZV 抗体水平，GMT 和 GMFR 均有升高。这些数据支持免疫实践咨询委员会的建议，即对于所有免疫功能正常的≥60 岁人群，无论 HZ 病史如何，均应常规接种带状疱疹疫苗。
