Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials

Background

The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies.

Status of vaccine research and development of vaccines for herpes simplex virus

Herpes simplex virus type-1 (HSV-1) and -2 (HSV-2) are highly prevalent global pathogens which commonly cause recurrent oral and genital ulcerations. Less common but more serious complications include meningitis, encephalitis, neonatal infection, and keratitis. HSV-2 infection is a significant driver of the HIV epidemic, increasing the risk of HIV acquisition 3 fold. As current control strategies for genital HSV-2 infection, including antiviral therapy and condom use, are only partially effective, vaccines will be required to reduce infection. Both preventive and therapeutic vaccines for HSV-2 are being pursued and are in various stages of development. We will provide an overview of efforts to develop HSV-2 vaccines, including a discussion of the clinical need for an HSV vaccine, and status of research and development with an emphasis on recent insights from trials of vaccine candidates in clinical testing. In addition, we will touch upon aspects of HSV vaccine development relevant to low and middle income countries.     

复方倍他米松注射液联合泛昔洛韦胶囊、普瑞巴林胶囊治疗带状疱疹的临床疗效观察

目的 对复方倍他米松注射液联合泛昔洛韦胶囊、普瑞巴林胶囊治疗带状疱疹的临床疗效进行观察并探讨。方法 选取2018 年1 月～2019 年12 月我院收治的118 例带状疱疹患者为研究对象，采用随机抽签的方式将患者分为对照组（泛昔洛韦胶囊+普瑞巴林胶囊+甲钴胺片+维生素B1 片）与观察组（联合复方倍他米松注射液），比较两组治疗总有效率、VAS 评分、QS 评分、C 反应蛋白、无新发皮疹时间、结痂时间及疼痛停止时间、随访2 个月后带状疱疹后遗神经痛发生率以及不良反应发生率。结果 观察组与对照组治疗总有效率分别为94.92%及76.27%，组间对比差异有统计学意义（P＜0.05）；治疗后，观察组VAS 评分显著低于对照组；观察组QS 评分低于对照组（P＜0.05）；治疗后，观察组C 反应蛋白显著低于对照组（P＜0.05）；观察组无新发皮疹时间、结痂时间及疼痛停止时间分别显著短于对照组（P＜0.05）；随访2 个月后，发现观察组带状疱疹后遗神经痛发生率显著低于对照组（P＜0.05）；观察组不良反应发生与对照组比较，差异无统计学意义（P＞0.05）。结论 复方倍他米松注射液联合泛昔洛韦胶囊、普瑞巴林胶囊治疗带状疱疹不仅效果好且安全性高，值得使用。     

单纯疱疹病毒感染与冠心病急性心肌梗死血液流变特性的相关性研究

目的　探讨单纯疱疹病毒 (HSV)感染与冠心病心肌梗死的关系。方法　测定 5 1例急性心肌梗死 (AMI)和 4 2例陈旧性心肌梗死 (OMI)患者及 31例冠脉造影正常者 (NC)的HSV - 1特异性抗体 (HSV - 1IgG、HSV - 1IgM)浓度 ,并同步观察纤维蛋白原 (Fg)、血液流变特性指标变化及其与HSV - 1感染的相关性。结果　AMI组HSV - 1IgG阳性率及平均浓度明显高于NC组 (P <0 0 5 ) ,HSV - 1DNA检测结果与之吻合。校正冠心病危险因素前后HSV - 1IgG阳性与AMI均有相关关系 (OR4 2 6 6 ,P =0 0 19;OR 3 82 1,P =0 0 32 )。AMI组IgG、Fg、血浆黏度、低 /高切全血黏度、红细胞压积、红细胞聚集指数高于 ,而红细胞变形指数低于NC组及OMI组 (P均 <0 0 5 )。AMI组中HSV - 1( )组上述指标 (除HCT外 )的改变与同组中HSV - 1( - )组及与NC、OMI组中HSV - 1( )组比较有显著性差异 (P均 <0 0 5 ) ,AMI组中HSV - 1( )组IgG与Fg、血浆黏度、低 /高切全血黏度、红细胞聚集指数呈正相关 ,而与红细胞变形指数呈负相关 ,调整冠心病的危险因素前后IgG与Fg均呈正相关。结论　HSV - 1感染与CHD(AMI)之间存在明显的相关性 ,与Fg、血液流变特性指标也存在相关性。     

不同剂量和疗程伐昔洛韦治疗带状疱疹的多中心随机双盲对照研究

目的：比较不同剂量和疗程伐昔洛韦治疗带状疱疹的疗效和安全性。方法：选择带状疱疹患者为研究对象，采用多中心、随机、双盲、对照的临床试验。试验组患者采用伐昔洛韦1000mg每日3次口服，共服7d；对照组患者采用伐昔洛韦300mg每日2次口服，共服10d。用药后第3、6和10天观察疗效和不良反应。结果：共入组128例，全分析集（FAS）分析128例，符合方案集（PPS）分析118例。治疗后第3、6和10天，试验组和对照组患者的症状、体征积分下降值及有效率比较差异无统计学意义（P〉0．05）；疼痛视觉模拟评分法（visnal analogue scale，VAS）值比较，两组间差异无统计学意义（P〉0．05），但入组时疼痛VAS值≥8的患者，FAS集分析显示，在治疗后第6、10天VAS值下降两组均存在统计学差异（P〈0．05）；PPS集分析显示治疗后第10天VAS值下降，两组间存在统计学差异俨〈0．05）。试验组和对照组不良反应发生率分别为17．18％和12．50％．主要为嗜睡和恶心。结论：增加伐昔洛韦用量治疗带状疱疹安全、有效，与较低剂量伐昔洛韦组相比，对疼痛程度较严重的患者能更显著地减轻疼痛。     

Herpes zoster ophthalmicus and the orbital apex syndrome

Herpes zoster ophthalmicus (HZO) commonly causes isolated ophthalmoplegic syndromes. Visual loss caused by optic neuritis secondary to HZO can be reversible or irreversible. HZO rarely presents as an orbital apex syndrome, when an association with meningo-encephalitis has been reported. We report a case of orbital apex syndrome secondary to HZO treated with systemic steroids and acyclovir. Our patient suffered no systemic complications and displayed a rapid resolution of optic neuropathy. We discuss this case in the light of previous reports and explore the possible pathogenic mechanisms involved.     

Electroencephalographic changes in patients with herpes zoster

EEGs of 42 patients with herpes zoster and 6 with herpes zoster-associated encephalitis were studied to characterize the nature and prevalence of EEG abnormalities in apparently uncomplicated herpes zoster. Thirty-one percent of herpes zoster patients had EEG changes with reduced rhythm frequency ranging from 7 to 2 Hz activity. Frontotemporal localization was observed in 54% of the abnormal EEGs. When compared to EEG in herpes zoster associated encephalitis, the findings were qualitatively the same, but tended to be more severe in the encephalitis cases. No effect of acyclovir on the EEG could be demonstrated.     

Naturally occuring antibodies against nerve growth factor in human and rabbit sera: comparison between control and herpes simplex virus-infected patients

Antibodies against nerve growth factor (NGF) in sera were detected by enzyme-linked immunosorbent assays (ELISA), by their isolation after passage of sera through NGF immunoadsorbent columns and by their specificity to bind and immunoprecipitate mouse NGF as well as to stain by immunohistochemical methods cellular sites of NGF synthesis. Increased levels of anti-NGF antibodies were found in sera of herpes simplex virus (HSV)-infected patients but not in HSV-inoculated rabbits. As HSV latency is known to be promoted by NGF in vitro, these results may suggest that anti-NGF antibodies modulate the cytokine function of NGF and thus might play a role in HSV infection. The biological function of circulating antibodies against NGF, in general, is now open to future investigation.     

中西医联合治疗单纯疱疹性角膜炎的疗效观察

目的 :探讨单纯疱疹性角膜炎是中西医联合用药的治疗方法。方法 :本组 10 0例 ( 10 6只眼 )单纯疱疹性角膜炎患者应用抗病毒药物联合清热解毒中药的疗效观察。结果 :本组病例治疗后总有效率 82 .0 8%。结论 :中西医联合治疗措施是我们对单纯疱疹性角膜炎治疗的一项新的探讨。