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Safety and tolerability of a high-potency zoster vaccine in adults > or years of age

机译：成人或以上年龄的高能带状疱疹疫苗的安全性和耐受性

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BACKGROUND: Herpes zoster (HZ) incidence rises with age, especially after 50 years of age, probably due to waning varicella-zoster virus (VZV)-specific immunity. The Shingles Prevention Study [Oxman MN, Levin MJ, Johnson GR, Schmader KE, Straus SE, Gelb LD, et al. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults, N Engl J Med 2005;352:2271-84], enrolled people > or years of age and showed that zoster vaccine prevents HZ and postherpetic neuralgia (PHN), presumably through boosting VZV-specific immunity. This study of people > or years of age compared the safety and tolerability of two zoster vaccine potencies. METHODS: Adults > or years old enrolled in a randomized, double-blind, multicenter study to compare the safety and tolerability of one dose of two zoster vaccine potencies, approximately 58,000 and approximately 207,000 plaque-forming units/dose. Adverse experiences (AEs) were recorded on a standardized Vaccination Report Card for 42 days postvaccination. For assessment of injection-site AEs, clinically acceptable tolerability was predefined based on experience with PNEUMOVAX 23, a licensed vaccine recommended for use in older people. RESULTS: Six hundred and ninety-eight subjects (age 50-90 years, median 64 years) were enrolled. No serious vaccine-related AEs were reported. Similar AE rates were observed in the higher and lower potency groups (overall systemic AEs: 37.5 and 39.3%, vaccine-related systemic AEs: 10.9 and 13.2%, injection-site AEs: 63.0 and 59.8%). Rates for a combined endpoint of moderate or severe injection-site pain/tenderness/soreness and swelling were 17.2% (95% CI 13.9, 21.0) and 9.0% (95% CI 5.6, 13.4), respectively. Most combined endpoint events were reported as moderate in intensity. CONCLUSIONS: Both vaccine potencies were generally well tolerated in this study of people > or years of age. Although rates of some moderate or severe injection-site AEs were greater in the higher potency group, all rates met the prespecified criteria for clinically acceptable tolerability.
机译：背景：带状疱疹（HZ）的发生率随年龄增加，尤其是在50岁以后，可能是由于水痘带状疱疹病毒（VZV）特异性免疫力下降所致。带状疱疹预防研究[牛津大学MN，莱文·麦杰恩，约翰逊GR，施马德·柯，施特劳斯·SE，吉尔布·LD等。预防老年人带状疱疹和带状疱疹后神经痛的疫苗，N Engl J Med 2005; 352：2271-84]，年龄大于或等于年龄的人群，表明带状疱疹疫苗可以通过加强免疫力来预防HZ和带状疱疹后神经痛（PHN） VZV特定的免疫力。这项对年龄大于或等于几岁的人的研究比较了两种带状疱疹疫苗效力的安全性和耐受性。方法：≥岁的成年人参加了一项随机，双盲，多中心研究，以比较一剂两种带状疱疹疫苗效力，约58,000和约207,000斑块形成单位/剂量的安全性和耐受性。疫苗接种后42天，将不良经历（AEs）记录在标准化疫苗接种报告卡上。为了评估注射部位的AE，根据PNEUMOVAX 23（建议用于老年人的许可疫苗）的经验，预先定义了临床可接受的耐受性。结果：招募了698名受试者（年龄50-90岁，中位年龄64岁）。没有严重的疫苗相关不良事件的报道。在较高和较低效力组中观察到相似的AE率（总体全身AE：37.5％和39.3％，疫苗相关全身AE：10.9和13.2％，注射部位AE：63.0和59.8％）。中度或重度注射部位疼痛/压痛/疼痛和肿胀的综合终点率分别为17.2％（95％CI 13.9，21.0）和9.0％（95％CI 5.6，13.4）。据报道大多数合并的终点事件强度中等。结论：在这项研究中，人们对两种或多种疫苗的耐受力均良好。尽管在较高效力组中某些中度或重度注射部位AE的发生率更高，但所有发生率均符合临床可接受的耐受性的预定标准。

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