带状疱疹亚单位疫苗在 70 岁及以上成人中的疗效。
Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older.
机构信息
From Westmead Institute for Medical Research, Westmead, NSW (A.L.C.), University of Sydney, Sydney (A.L.C.), the Department of Infectious Disease, Barwon Health, Deakin University, Geelong, VIC (E.A.), AusTrials and the Discipline of General Practice, School of Medicine, University of Queensland, Brisbane (F.L.), and Illawarra Health and Medical Research Institute, Graduate School of Medicine, University of Wollongong, Wollongong, NSW (W.Y.) - all in Australia; GSK Vaccines, King of Prussia, PA (H.L., T.C.H.); GSK Vaccines, Wavre, Belgium (M.K., O.G., C.V.A., T.Z., L.C., L.O.); Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic (R.C., J.S.); the Department of Family Medicine, Taipei Veterans General Hospital, and National Yang Ming University School of Medicine, Taipei, Taiwan (S.-J.H.); the Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain (J.D.-D., J.P.-B.); the Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.J.L.); Health Sciences North Research Institute, Sudbury, ON (J.E.M.), the Section of Infectious Diseases, University of British Colombia, Victoria (W.G.), PrimeHealth Clinical Research, Toronto (I.G.), and the Canadian Center for Vaccinology, IWK Health Center and Nova Scotia Health Authority, Dalhousie University, Halifax (S.A.M.) - all in Canada; Vaccine Research Center, University of Tampere, Tampere, Finland (T.V., A.A., T.K.); the Department of Dermatology, Aichi Medical University, Nagakute, Japan (D.W.); Instituto Dermatologico de Jalisco Dr. José Barba Rubio, Zapopan, Mexico (J.F.B.-G.); Jacksonville Center for Clinical Research, Jacksonville, FL (H.J.D.); the Division of Geriatric Medicine, Department of Medicine and Geriatrics, United Christian Hospital, Hong Kong (E.L.); Center for Clinical Research, Sörmland County Council, Eskilstuna, and Uppsala University, Uppsala - both in Sweden (L.R.); and
出版信息
N Engl J Med. 2016 Sep 15;375(11):1019-32. doi: 10.1056/NEJMoa1603800.
BACKGROUND
A trial involving adults 50 years of age or older (ZOE-50) showed that the herpes zoster subunit vaccine (HZ/su) containing recombinant varicella-zoster virus glycoprotein E and the AS01B adjuvant system was associated with a risk of herpes zoster that was 97.2% lower than that associated with placebo. A second trial was performed concurrently at the same sites and examined the safety and efficacy of HZ/su in adults 70 years of age or older (ZOE-70).
METHODS
This randomized, placebo-controlled, phase 3 trial was conducted in 18 countries and involved adults 70 years of age or older. Participants received two doses of HZ/su or placebo (assigned in a 1:1 ratio) administered intramuscularly 2 months apart. Vaccine efficacy against herpes zoster and postherpetic neuralgia was assessed in participants from ZOE-70 and in participants pooled from ZOE-70 and ZOE-50.
RESULTS
In ZOE-70, 13,900 participants who could be evaluated (mean age, 75.6 years) received either HZ/su (6950 participants) or placebo (6950 participants). During a mean follow-up period of 3.7 years, herpes zoster occurred in 23 HZ/su recipients and in 223 placebo recipients (0.9 vs. 9.2 per 1000 person-years). Vaccine efficacy against herpes zoster was 89.8% (95% confidence interval [CI], 84.2 to 93.7; P<0.001) and was similar in participants 70 to 79 years of age (90.0%) and participants 80 years of age or older (89.1%). In pooled analyses of data from participants 70 years of age or older in ZOE-50 and ZOE-70 (16,596 participants), vaccine efficacy against herpes zoster was 91.3% (95% CI, 86.8 to 94.5; P<0.001), and vaccine efficacy against postherpetic neuralgia was 88.8% (95% CI, 68.7 to 97.1; P<0.001). Solicited reports of injection-site and systemic reactions within 7 days after injection were more frequent among HZ/su recipients than among placebo recipients (79.0% vs. 29.5%). Serious adverse events, potential immune-mediated diseases, and deaths occurred with similar frequencies in the two study groups.
CONCLUSIONS
In our trial, HZ/su was found to reduce the risks of herpes zoster and postherpetic neuralgia among adults 70 years of age or older. (Funded by GlaxoSmithKline Biologicals; ZOE-50 and ZOE-70 ClinicalTrials.gov numbers, NCT01165177 and NCT01165229 .).
背景
一项涉及 50 岁及以上成年人的试验（ZOE-50）表明，含有重组水痘带状疱疹病毒糖蛋白 E 和 AS01B 佐剂系统的带状疱疹亚单位疫苗（HZ/su）与安慰剂相比，带状疱疹的风险降低了 97.2%。同时在同一地点进行了第二项试验，研究了 HZ/su 在 70 岁及以上成年人中的安全性和有效性（ZOE-70）。
方法
这是一项在 18 个国家进行的随机、安慰剂对照、3 期临床试验，涉及 70 岁及以上的成年人。参与者接受两次 HZ/su 或安慰剂（按 1:1 比例分配）肌肉注射，间隔 2 个月。在 ZOE-70 中的参与者和 ZOE-70 和 ZOE-50 中的参与者汇总中评估了针对带状疱疹和带状疱疹后神经痛的疫苗效力。
结果
在 ZOE-70 中，13900 名可评估的参与者（平均年龄 75.6 岁）接受了 HZ/su（6950 名参与者）或安慰剂（6950 名参与者）治疗。在平均 3.7 年的随访期间，HZ/su 组有 23 名参与者和安慰剂组有 223 名参与者发生带状疱疹（每 1000 人年 0.9 例和 9.2 例）。针对带状疱疹的疫苗效力为 89.8%（95%置信区间[CI]，84.2 至 93.7；P<0.001），在 70 至 79 岁的参与者（90.0%）和 80 岁及以上的参与者（89.1%）中相似。在 ZOE-50 和 ZOE-70 中 70 岁及以上参与者汇总数据的分析中（16596 名参与者），针对带状疱疹的疫苗效力为 91.3%（95%CI，86.8 至 94.5；P<0.001），针对带状疱疹后神经痛的疫苗效力为 88.8%（95%CI，68.7 至 97.1；P<0.001）。在注射后 7 天内注射部位和全身反应的自发报告在 HZ/su 组中比安慰剂组更常见（79.0% vs. 29.5%）。两组研究中发生严重不良事件、潜在的免疫介导性疾病和死亡的频率相似。
结论
在我们的试验中，HZ/su 被发现可降低 70 岁及以上成年人患带状疱疹和带状疱疹后神经痛的风险。（由葛兰素史克生物公司资助；ZOE-50 和 ZOE-70 临床试验.gov 编号，NCT01165177 和 NCT01165229）。
Zotero 插件