PHASE I EVALUATION OF RECOMBINANT INFLUENZA VIRUS H5 HEMAGGLUTININ VA

重组流感病毒 H5 血凝素 VA 的 I 期评估

• 批准号: 6309796
• 负责人: DAVID I DORSKY
• 金额: $ 1.91万
• 依托单位: UNIVERSITY OF CONNECTICUT SCH OF MED/DNT
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6309796
• 关键词: active immunization; clinical research; clinical trial phase I; disease /disorder proneness /risk; health care personnel; hemagglutinin; human subject; human therapy evaluation; influenza vaccines; influenzavirus A; occupational health /safety; vaccine development; vector vaccine

This Phase I proptocol for the evaluation of safety and immunogenicity of a recombinant, serum-free, influenza hemagglutinin (rHA0) vaccine is designed to generate immunity to the new H5N1 strain of avian influenza recently reported in 18 confirmed cases in humans in Hong Kong, including 6 fatalities as of January 14, 1998. The H5N1 strain is thought to have been transmitted from the avian species directly to humans, and could become a source of epidemic influenza if efficiently transmitted between humans. From a public health perspective, the development of a H5N1 vaccine which can be used to protect laboratory and public health personnel currently at occupational risk is of the highest priority. The objective of this protocol is to immunize laboratory and public health personnel currently manipulating the H5N1 influenza virus or working with potentially infected secretions, with an experimental, purified influenza H5 hemagglutinin (rHA0) vaccine produced in the baculovirus expression system, administered as a two-dose vaccine. A common protocol will be used at multiple sites to administer the vaccine and safety and immunogenicity data will be collected in a standardized manner.

该 I 期方案用于评估重组无血清流感血凝素 (rHA0) 疫苗的安全性和免疫原性，旨在产生对最近在香港 18 例确诊病例中报告的新型 H5N1 禽流感病毒株的免疫力，截至 1998 年 1 月 14 日，已造成 6 人死亡。H5N1 毒株被认为是从禽类物种直接传播给人类的，如果在人与人之间有效传播，则可能成为流行性流感的来源。人类。 从公共卫生角度来看，开发可用于保护目前处于职业风险的实验室和公共卫生人员的H5N1疫苗是当务之急。 该方案的目的是使用杆状病毒表达系统中生产的实验性纯化流感 H5 血凝素 (rHA0) 疫苗，对目前操作 H5N1 流感病毒或处理潜在感染分泌物的实验室和公共卫生人员进行免疫，作为两种疫苗施用剂量疫苗。 将在多个地点使用通用方案来管理疫苗，并将以标准化方式收集安全性和免疫原性数据。