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国产艾滋病疫苗临床试验 接种后无不良反应
2010年01月25日 15:39中国广播网
中广网北京1月25日消息 据中国之声《央广新闻》14时40分报道，记者从相关部门了解到，目前，我国国产艾滋病疫苗II期临床试验进展顺利，30名志愿者接种疫苗后没有不良反应。详细情况我们连线中央台记者刘天思。
主持人：先给我们介绍一下，我国国产艾滋病疫苗是在哪里研制的？
记者：我国的艾滋病疫苗Ⅱ期临床研究是由中国药品生物制品检定所、吉林大学、长春百克药业以及广西疾病预防控制中心共同开展的，这个项目去年3月在广西南宁启动。此前，Ⅰ期研究已经表明我国自主研制的艾滋病疫苗是有良好的安全性，Ⅱ期临床研究将进一步评价艾滋病疫苗在扩大的健康人群中的安全性和免疫原性，为临床试验提供依据。
主持人：这个疫苗的效果是如何得到验证的，目前临床试验的志愿者招募情况怎么样？
记者：据广西壮族自治区卫生厅有关负责人介绍，自从去年3月，国产艾滋病疫苗Ⅱ期临床研究正式启动以来，全程大约需要200名志愿者的参与。目前广西疾控中心研究部门已经顺利招募到第一阶段所需的30名志愿者，并对他们开展了疫苗接种。这批志愿者来自社会各行各业，包括医务人员、保安等。目前来看，这30名已经完成了国产艾滋病疫苗接种的临床研究志愿者，都没有不良反应。疫苗Ⅰ期临床试验的安全性再次得到了验证。据了解，在国产Ⅱ期艾滋病疫苗临床研究中，第一、第二阶段招募的志愿者都是艾滋病的风险人群，也就是健康人群。到了第三阶段，出于研究需要，将有一部分高危人群参与到研究工作中来。
Domestic AIDS vaccine clinical trials, no adverse reactions after vaccination
At 15:39 on January 25, 2010 China Radio Network
Zhong Guangwang Beijing January 25, according to Voice of China, "Yang Guang news" 14:40 report, the reporter learned from relevant departments, at present, China-made AIDS vaccine Phase II clinical trials progressing well, 30 volunteers vaccinated After the no adverse reactions. Details we connect a CCTV reporter Liu days thinking.
Moderator: give us introduce our domestic AIDS vaccine is developed, where?
Reporter: China's AIDS vaccine Phase Ⅱ clinical study was conducted by pharmaceutical and biological products in China, Jilin University, Changchun, 100 grams medicine, as well as the Guangxi Center for Disease Control and Prevention jointly undertaken this project in March last year, launched in Nanning, Guangxi. Previously, Ⅰ-year research has shown that China has independently developed an AIDS vaccine is a good safety, Ⅱ clinical studies will further evaluation of AIDS vaccine in healthy populations to expand the safety and immunogenicity, in order to provide a basis for clinical trials.
Moderator: This is how the effect of the vaccine been tested, the current situation of clinical trials, how to recruit volunteers like?
Reporter: According to Guangxi Zhuang Autonomous Region Health Department, the person in charge, since last March, made an AIDS vaccine Phase Ⅱ clinical research since the formal initiation whole requires about 200 volunteers involved. Guangxi CDC research department has been successfully recruited to the first stages of the 30 volunteers, and they carried out vaccinations. This group of volunteers from every walk of life, including medical personnel, security and so on. The current situation, it has completed 30 home-made AIDS vaccine clinical study of volunteers, no adverse reactions. Phase Ⅰ clinical trial vaccine safety has been verified again. It is understood that, in the domestic AIDS vaccine Phase Ⅱ clinical studies, the first and second phase of the recruitment of volunteers were HIV-risk groups, that is, healthy people. To the third stage, for research needs, there will be a part of high-risk populations to participate in research work.
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