Syed Yahiya Y
Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
Drugs Aging. 2018 Dec;35(12):1031-1040. doi: 10.1007/s40266-018-0603-x.
Shingrix is a recombinant zoster vaccine (RZV) that contains a varicella zoster virus glycoprotein E antigen and the AS01 adjuvant system. The subunit vaccine is approved for the prevention of herpes zoster (HZ) [EU, USA, Japan, Canada and Australia] and postherpetic neuralgia (PHN) [EU and Australia] in adults aged ≥ 50 years. In the pivotal trials in adults aged ≥ 50 years (ZOE-50) and ≥ 70 years (ZOE-70), RZV significantly reduced the risk of HZ and PHN. Its protective efficacy waned minimally over 4 years and was well preserved in adults aged ≥ 70 years. In patients with breakthrough disease, RZV reduced HZ-related pain severity, burden of illness and burden of interference with activities of daily living. RZV was more reactogenic than placebo, with injection-site reactions, myalgia and fatigue being the most common solicited adverse reactions. However, most solicited adverse reactions were transient and were mild to moderate in severity. RZV represents a novel, highly effective and well-tolerated vaccine option for HZ and PHN in adults aged ≥ 50 years. RZV is not contraindicated in immunocompromised individuals, and is preferred over a live attenuated HZ vaccine in immunocompetent individuals, according to the US and Canadian guidelines.
欣安立适是一种重组带状疱疹疫苗(RZV),其含有水痘带状疱疹病毒糖蛋白E抗原和AS01佐剂系统。该亚单位疫苗已获批用于预防≥50岁成人的带状疱疹(HZ)[欧盟、美国、日本、加拿大和澳大利亚]以及带状疱疹后神经痛(PHN)[欧盟和澳大利亚]。在≥50岁成人(ZOE - 50)和≥70岁成人(ZOE - 70)的关键试验中,RZV显著降低了HZ和PHN的风险。其保护效力在4年期间仅有轻微下降,并且在≥70岁的成人中得到了良好维持。在发生突破性疾病的患者中,RZV减轻了与HZ相关的疼痛严重程度、疾病负担以及对日常生活活动的干扰负担。RZV比安慰剂的反应原性更强,注射部位反应、肌痛和疲劳是最常见的主动报告的不良反应。然而,大多数主动报告的不良反应是短暂的,严重程度为轻至中度。对于≥50岁成人的HZ和PHN,RZV是一种新型、高效且耐受性良好的疫苗选择。根据美国和加拿大的指南,RZV在免疫功能低下的个体中并非禁忌,并且在免疫功能正常的个体中比减毒活HZ疫苗更受青睐。