减毒活水痘带状疱疹病毒疫苗（ZOSTAVAX™）在印度健康成年人中的免疫原性、安全性和耐受性
Immunogenicity, Safety, and Tolerability of Live Attenuated VaricellaZoster Virus Vaccine (ZOSTAVAX™) in Healthy Adults in India.
作者信息
Sreenivasamurthy L, Pandey Sudhanshu, Chandra Bharija Subhash, Sharma Monisha, Ranganathaiah S R, Vaidya P, Naik Rajiv
机构信息
Lifecare Clinic and Research Center, Bangalore, Karnataka;Corresponding Author.
MSD, Mumbai, Maharashtra.
出版信息
J Assoc Physicians India. 2018 Jul;66(7):50-54.
BACKGROUND
Herpes zoster (HZ) is caused by varicella-zoster virus ( VZV ) reactivation. In the United States, Zoster vaccine (ZOSTAVAX) is indicated for HZ prevention in patients ≥50 years.
AIMS
To evaluate the immunogenicity, safety, and tolerability of ZOSTAVAX in healthy Indian subjects, to support its registration in India.
METHODS
This open-label, single-arm study was conducted at 10 sites in India. Healthy Indians (≥50 years) received a single ZOSTAVAX dose. Immunogenicity was assessed by VZV-specific antibody titer using gpELISA assay. VZV-specific antibody geometric mean titers (GMT; Day 1 pre-vaccination, Week 6 post-vaccination) and geometric mean fold-rise (GMFR; Week 6 post-vaccination) were assessed. Safety was evaluated by the incidence of adverse events (AEs) and serious adverse events (SAEs) within 42 days of vaccination. Two-sided 95% confidence intervals (CIs) were evaluated using t-distribution with natural log-transformed values.
RESULTS
Of the 250 subjects (mean age, 58.6 years) enrolled and vaccinated, 244 subjects completed the 6-week follow-up. Overall, subjects in the per-protocol population had GMT of 149.8 gpELISA units/mL (n=250; 95% CI: 132.6, 169.2) at Day 1 pre-vaccination, and 410.8 gpELISA units/mL (n=243; 95% CI: 373.0, 452.6) at Week 6 post-vaccination. GMFR of VZV-specific antibody from Day 1 pre-vaccination to Week 6 post-vaccination was 2.8 (95% CI: 2.5, 3.1). Overall, 67 subjects (26.8%) experienced AEs, with 48 (19.2%) reporting injection-site AEs and 38 (15.2%) reporting non-injection-site AEs. SAE-abdominal pain and bronchitis-was reported in one (0.4%) patient each. There was one death, which was unrelated to the vaccine.
LIMITATIONS
Since ZOSTAVAX introduces a new live attenuated virus, clinical reactivation of ZOSTAVAX virus and wild-type VZV will need to be differentiated.
CONCLUSIONS
In healthy Indians ≥50 years, ZOSTAVAX was well tolerated and resulted in expected VZV-specific antibody titer levels at 6 weeks post-vaccination.
背景
带状疱疹（HZ）由水痘-带状疱疹病毒（VZV）再激活引起。在美国，带状疱疹疫苗（ZOSTAVAX）适用于预防50岁及以上患者的带状疱疹。
目的
评估ZOSTAVAX在健康印度受试者中的免疫原性、安全性和耐受性，以支持其在印度注册。
方法
这项开放标签、单臂研究在印度的10个地点进行。健康的印度人（≥50岁）接受一剂ZOSTAVAX。使用gpELISA测定法通过VZV特异性抗体滴度评估免疫原性。评估VZV特异性抗体几何平均滴度（GMT；接种疫苗前第1天、接种疫苗后第6周）和几何平均上升倍数（GMFR；接种疫苗后第6周）。通过接种疫苗后42天内不良事件（AE）和严重不良事件（SAE）的发生率评估安全性。使用对自然对数转换值的t分布评估双侧95%置信区间（CI）。
结果
在250名入组并接种疫苗的受试者（平均年龄58.6岁）中，244名受试者完成了6周的随访。总体而言，符合方案人群中的受试者在接种疫苗前第1天的GMT为149.8 gpELISA单位/mL（n = 250；95% CI：132.6，169.2），在接种疫苗后第6周为410.8 gpELISA单位/mL（n = 243；95% CI：373.0，452.6）。从接种疫苗前第1天到接种疫苗后第6周，VZV特异性抗体的GMFR为2.8（95% CI：2.5，3.1）。总体而言，67名受试者（26.8%）经历了AE，其中48名（19.2%）报告了注射部位AE，38名（15.2%）报告了非注射部位AE。分别有1名（0.4%）患者报告了SAE-腹痛和支气管炎。有1例死亡，与疫苗无关。
局限性
由于ZOSTAVAX引入了一种新的减毒活病毒，需要区分ZOSTAVAX病毒和野生型VZV的临床再激活。
结论
在50岁及以上的健康印度人中，ZOSTAVAX耐受性良好，接种疫苗后6周产生了预期的VZV特异性抗体滴度水平。
Zotero 插件