我国艾滋病疫苗研究一期临床成功
来源:金黔在线-贵州日报 2010年12月09日09:29
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图示∶2010年12月即将出版的《中国特色医疗金鉴》登载的刘君主任及其机构 |
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我国1993年就开始参与艾滋病疫苗临床试验,自主开展的艾滋病疫苗研制从2005年左右开始,采取自己创新的技术路线。使用中国的天花疫苗“天坛株”作为艾滋病疫苗的载体,同时使用活的病毒载体。按照这样创新的技术路线,我国研制的艾滋病疫苗在三年前启动了临床试验。刚刚结束的第一期临床试验充分证明,疫苗非常安全,接种者没有任何严重的不良反应。
据了解,传染病疫苗的临床试验一般要经过三期:第一期叫安全性评价,选择完全健康、没有任何危险性感染的人进行临床试验;第二期,用于有危险性感染的人群,重点评价其免疫原性,检测设计的免疫指标、对抗病毒等是否可以实现;第三期是在更大的高危人群中直接测试这个疫苗,检测其能否保护接种人群不被细菌和病毒感染。一期临床试验成功后,目前二期疫苗已经生产出来并得到国家药监部门的技术审批,现正报送二期临床试验方案。作者:王 邻来源金黔在线-贵州日报)
China AIDS vaccine research a clinical success
Source: Jinqianzaixian - Guizhou Daily at 09:29 on December 9 2010
1993 China began to participate in AIDS vaccine for clinical trials of AIDS vaccine development independently carried out around 2005, to take their own line of innovative technology. The smallpox vaccine used in China, "the Temple of Heaven strain" as the carrier of an AIDS vaccine, while the use of live viral vectors. According to this line of innovative technology, developed AIDS vaccine in China three years ago launched a clinical trial. The just concluded first phase of clinical trials proved the vaccine is very safe, no inoculation serious adverse reactions.
It is understood that clinical trials of vaccines against infectious diseases common to go through three phases: Phase I safety evaluation is called, select the perfectly healthy, there is no risk of infection, people who conduct clinical trials; the second for a dangerous infection of the crowd focus on evaluation of its immunogenicity, the immune detection of design indicators, it can be achieved against the virus; the third period in a larger high-risk groups to test the vaccine directly, testing its ability to protect the vaccinated group was not bacterial and viral infections . After the success of Phase I clinical trials, the current two vaccines have been produced and the technology department of the State Drug Administration approval of phase II clinical trials are being submitted to the program. Of: o Source Jinqianzaixian Wang - Guizhou Daily)
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