Novel Therapies for Herpes Simplex Virus Infections

单纯疱疹病毒感染的新疗法

• 批准号: 6099147
• 负责人: ADRIANA R MARQUES
• 金额: --
• 依托单位: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6099147
• 关键词: Alphaherpesvirinae; Herpes simplex disease; antiviral agents; chemoprevention; clinical research; clinical trial phase I; congenital infection; disease /disorder prevention /control; human subject; human therapy evaluation; infant human (0-1 year); infectious encephalitis; microorganism disease chemotherapy; monoclonal antibody; passive immunization; pharmacokinetics; sexually transmitted diseases

1. The major current focus of this project is a randomized, multicenter, double-blind, placebo-controlled Phase III study to evaluate the effect of valaciclovir in preventing the transmission of herpes simplex virus (HSV) in heterosexual couples discordant for the presence of herpes simplex type 2 virus (HSV-2) antibody. The seropositive source partner is randomized to receive valaciclovir 500 mg once daily or placebo for 8 months, and the susceptible seronegative partner is monitored for clinical and subclinical (serological) acquisition of HSV. A total of 1500 couples will be randomized into the study, at approximately 35 outpatient centers in the United States, Canada and Europe. This study is open for accrual and at this point, 18 patients have been screened for treatment at the NIH site. 2. HSV 863 is a human monoclonal antibody against herpes simplex virus. In vitro and in vivo studies showed that HSV 863 is effective both prophylactically and therapeutically against herpes simplex viruses. In a second study being designed now, we plan to assess the safety, potency and pharmacokinetics of HSV 863 preparation in an adult population before it is tested as adjunct therapy for neonatal herpes. This study will be followed by a phase I/II study of HSV 863 in babies with encephalitis and disseminated neonatal HSV infection to further determine the dose to be used in a phase III controlled trial for babies with neonatal HSV infection. During these initial months of this project, the clinical research protocol was developed and the monoclonal antibody is being produced at the Biological Resources Branch at the National Cancer Institute facility in Frederick, Maryland.

1.该项目目前的主要重点是 随机、多中心、双盲、安慰剂对照III期 评价万乃洛韦预防糖尿病的作用 单纯疱疹病毒（HSV）在异性恋夫妇中的传播 2型单纯疱疹病毒（HSV-2）的存在不一致 抗体的血清阳性的源伴侣随机接受 伐昔洛韦500 mg，每日一次或安慰剂，持续8个月， 监测易感血清阴性伴侣的临床和 HSV的亚临床（血清学）获得。总共1500 在大约35岁时， 美国、加拿大和欧洲的门诊中心。这 研究开放招募，目前已有18例患者 在国家卫生研究院接受治疗。2. HSV 863是一种人类 抗单纯疱疹病毒单克隆抗体。体外和 体内研究表明，HSV 863是有效的， 和治疗性地对抗单纯疱疹病毒。在第二 目前正在设计一项研究，我们计划评估安全性，效力和 成年人群中HSV 863制剂的药代动力学 然后才能作为新生儿疱疹的辅助疗法进行测试本研究 随后将进行一项HSV 863在婴儿中的I/II期研究， 脑炎和播散性新生儿HSV感染， 确定用于III期对照试验的剂量， 新生儿HSV感染的婴儿。在最初的几个月里， 该项目制定了临床研究方案，并 生物资源公司正在生产单克隆抗体 弗雷德里克国家癌症研究所设施的分支， 马里兰州。