[转移贴]-美国传染病研究中心与Medicago获FDA批准开展H5N1疫苗I期临床试验

rojjer

原帖由ipsvirus发表于19/8/2012 11:04

位于西雅图的非营利组织美国传染病研究中心（IDRI）及Medicago生物制药公司宣布，获FDA批准以启动H5N1亚型高致病性禽流感病毒样颗粒（VLP）候选疫苗（简称H5N1疫苗）的I期临床试验。

IDRI表示，该试验旨在评价添加经肌肉或皮下注射的吡喃葡萄糖基脂（GLA）佐剂的H5N1疫苗的安全性及免疫原性。试验中的每位受试者将接受两个剂量的疫苗以收集并比较数据。

该试验是皮下注射佐剂的第一个临床试验，若应用于临床，可使人们在流感大流行中自行注射。

该H5N1候选疫苗包括IDRI的GLA佐剂，及由Medicago生产的植物表达系统，该生产工艺比传统的鸡胚法疫苗生产路线快得多。

IDRI表示，该I期临床试验将在今年9月开始实施，预计招募100位年龄在18-49岁的健康志愿者，在美国境内三地进行试验以评价疫苗安全性及免疫反应。试验预计进行15个月，2013年第一季度会完成初期的安全性及免疫学数据。

试验由美国国防部下属国防高级研究计划局（DARPA）拨款给IDRI支持，旨在为大流行流感研发疫苗。
http://www.bioon.com/industry/drug/528235.shtml

(RTTNews) - The Infectious Disease Research Institute or IDRI, a Seattle-based non-profit research organization, and Medicago Inc.  announce that they have been cleared by the U.S. Food and Drug Administration or FDA to initiate a Phase 1 clinical trial for an H5N1 Avian Influenza Virus-Like Particles vaccine candidate or "H5N1 vaccine".

The IDRI said that the trial is focused on evaluating the safety and immunogenicity of the H5N1 vaccine, combined with IDRI's Glucopyranosyl Lipid A or "GLA" adjuvant, which will be administered intramuscularly or intradermally. Each study participant in the trial will receive two doses of a given formulation in order to collect and compare data.

The H5N1 vaccine candidate includes IDRI's GLA adjuvant and is produced in Medicago's plant-based expression system, which is speedier than the traditional route of producing flu vaccines in eggs.

The IDRI said it expects that the Phase 1 clinical trial will start in September 2012, and will enroll 100 healthy adult volunteers, ages 18-49 years, at three locations in the U.S., testing for safety and immune response. The trial is anticipated to take 15 months to complete, and initial safety and immunology data are expected in the first quarter of 2013.
http://www.rttnews.com/1949132/i ... r-h5n1-vaccine.aspx

rojjer

杨子~ ：
学习了，谢谢！！！！

deepblue：
最新更新：美国FDA已经批准和接受了GSK公司生产的带AS03佐剂的H5N1疫苗作为储备疫苗，已应对H5的可能流行。

Anny

学习了