国产艾滋病疫苗临床研究进展顺利

国产艾滋病疫苗临床研究进展顺利
　　本报讯 (记者莫雪)近日，广西壮族自治区卫生厅艾防处副处长陈杰透露，参与国产艾滋病疫苗临床研究Ⅱ期一阶段的最后一组10名志愿者已在该自治区疾控中心完成了疫苗接种工作，经过72小时观察，无一出现不良反应。至此，这一阶段共30名广西志愿者接受了疫苗接种，无一例发生严重不良反应，国产艾滋病疫苗的安全性再次得到验证。

　　据介绍，2005年3月开始进入临床研究的我国自主研发的艾滋病疫苗，于2006年顺利完成了Ⅰ期临床试验，49名志愿者参与试验，无一例出现严重不良反应，提示疫苗有一定的安全性，在高剂量组中有较好的刺激机体产生免疫应答的能力。今年3月，国产艾滋病疫苗临床研究Ⅱ期在广西正式启动。按照设计，Ⅱ期试验将进一步考察疫苗的安全性并观察疫苗的有效性。Ⅱ期又分为3个阶段。在第一阶段研究中，考察的是疫苗在人体中的耐药剂量，以优化疫苗的最佳剂量。第二、第三阶段为随机、盲法、安慰剂对照研究，对免疫程序和联合免疫剂量进行探索，检验疫苗的免疫能力有多强，能否为人体提供保护。

　　在Ⅱ期研究中，共需要招募200名志愿者，第一、第二阶段为低危的健康人群。2011年，研究将进入第三阶段，高危人群届时也将参与到这项研究工作中。

稿源：健康报网编辑：杨晨雨
Domestic AIDS vaccine clinical studies are well underway
(Reporter Mo snow) Recently, the Guangxi Zhuang Autonomous Region Health Department Deputy Director of Anti-Ai Chen Jie said the participation of China-made AIDS vaccine Phase Ⅱ clinical research phase of a final group of 10 volunteers already in the Autonomous Region CDC completion of vaccination, after 72 hours of observation, not an adverse reaction. Thus, at this stage a total of 30 volunteers received the vaccine in Guangxi, with no serious adverse reactions, the safety of Chinese-made AIDS vaccine again be verified.

According to reports, in March 2005 has begun to enter clinical studies of our self-developed AIDS vaccine in 2006 successfully completed the Phase Ⅰ clinical trial, 49 volunteers participate in the pilot, with no serious adverse reactions, suggesting a certain degree of safety of the vaccine sex, in the high-dose group had better stimulate the body's immune response capabilities. In March of this year, China-made AIDS vaccine Phase Ⅱ clinical study was officially launched in Guangxi. By design, Ⅱ Phase I trials will further examine the safety of the vaccine and to observe the effectiveness of the vaccine. Phase Ⅱ is divided into three stages. In the first phase of the study, examining a vaccine dose of drug resistance in the body in order to optimize the best dose of the vaccine. The second and third phase of a randomized, blinded, placebo-controlled study on the immunization dose of immunization procedures and joint exploration, testing how strong immunity vaccines, can provide protection for the human body.

In Phase Ⅱ study, a total recruitment of 200 volunteers, the first and second stage of the health of low-risk populations. By 2011, the study will enter the third stage, high-risk groups will also be involved in this research work.

Draft Source: Health News Web Editor: Yang Chenyu