带状疱疹亚单位佐剂疫苗在老年人中的功效。

Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults.

机构信息

The authors' affiliations are listed in the Appendix.

出版信息

N Engl J Med. 2015 May 28;372(22):2087-96. doi: 10.1056/NEJMoa1501184. Epub 2015 Apr 28.

DOI:10.1056/NEJMoa1501184

PMID:25916341

Abstract

BACKGROUND

In previous phase 1-2 clinical trials involving older adults, a subunit vaccine containing varicella-zoster virus glycoprotein E and the AS01B adjuvant system (called HZ/su) had a clinically acceptable safety profile and elicited a robust immune response.

METHODS

We conducted a randomized, placebo-controlled, phase 3 study in 18 countries to evaluate the efficacy and safety of HZ/su in older adults (≥50 years of age), stratified according to age group (50 to 59, 60 to 69, and ≥70 years). Participants received two intramuscular doses of the vaccine or placebo 2 months apart. The primary objective was to assess the efficacy of the vaccine, as compared with placebo, in reducing the risk of herpes zoster in older adults.

RESULTS

A total of 15,411 participants who could be evaluated received either the vaccine (7698 participants) or placebo (7713 participants). During a mean follow-up of 3.2 years, herpes zoster was confirmed in 6 participants in the vaccine group and in 210 participants in the placebo group (incidence rate, 0.3 vs. 9.1 per 1000 person-years) in the modified vaccinated cohort. Overall vaccine efficacy against herpes zoster was 97.2% (95% confidence interval [CI], 93.7 to 99.0; P<0.001). Vaccine efficacy was between 96.6% and 97.9% for all age groups. Solicited reports of injection-site and systemic reactions within 7 days after vaccination were more frequent in the vaccine group. There were solicited or unsolicited reports of grade 3 symptoms in 17.0% of vaccine recipients and 3.2% of placebo recipients. The proportions of participants who had serious adverse events or potential immune-mediated diseases or who died were similar in the two groups.

CONCLUSIONS

The HZ/su vaccine significantly reduced the risk of herpes zoster in adults who were 50 years of age or older. Vaccine efficacy in adults who were 70 years of age or older was similar to that in the other two age groups. (Funded by GlaxoSmithKline Biologicals; ZOE-50 ClinicalTrials.gov number, NCT01165177.).

摘要

背景

在之前涉及老年人的 1-2 期临床试验中，一种含有水痘带状疱疹病毒糖蛋白 E 和 AS01B 佐剂系统的亚单位疫苗（称为 HZ/su）具有可接受的临床安全性，并引发了强大的免疫反应。

方法

我们在 18 个国家进行了一项随机、安慰剂对照、3 期研究，评估 HZ/su 在年龄在 50 岁及以上的老年人中的疗效和安全性，按年龄组（50-59 岁、60-69 岁和≥70 岁）进行分层。参与者接受两次肌肉内剂量的疫苗或安慰剂，间隔 2 个月。主要目的是评估疫苗与安慰剂相比在降低老年人带状疱疹风险方面的疗效。

结果

共有 15411 名可评估的参与者接受了疫苗（7698 名）或安慰剂（7713 名）治疗。在平均 3.2 年的随访期间，疫苗组有 6 名参与者和安慰剂组有 210 名参与者（发病率，0.3 比 1000 人年 9.1 人）确诊带状疱疹（改良接种人群）。带状疱疹的总体疫苗有效性为 97.2%（95%置信区间[CI]，93.7 至 99.0；P<0.001）。所有年龄组的疫苗有效性均在 96.6%至 97.9%之间。疫苗组在接种后 7 天内注射部位和全身反应的报告更为频繁。疫苗组有 17.0%的接种者和 3.2%的安慰剂组报告有 3 级症状。两组参与者发生严重不良事件或潜在免疫介导疾病或死亡的比例相似。