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中国启动首次艾滋病疫苗Ⅱ期临床研究
2009年03月21日 19:59:55 来源：新华网
新华网南宁３月２１日电（记者 张周来）我国首次艾滋病疫苗Ⅱ期临床研究３月２１日在广西南宁宣布正式启动，研究人员希望在此前基础上继续招募志愿者开展新的临床实验，以进一步检验我国自主研制的首支艾滋病疫苗的安全有效性。
艾滋病在全球流行蔓延的趋势尚未得到根本控制，我国艾滋病防治形势也较为严峻。“鸡尾酒疗法”被公认为艾滋病疗效最好的一种疗法，但只能稳定或减缓艾滋病病状，不能彻底消灭人体内的病毒，各国普遍认为，研制出疫苗是解决这一难题的根本途径。
我国艾滋病疫苗研究始于１９９６年，科研人员在国内艾滋病高发区进行了大量流行病学调查，并从患者血液中分离出ＨＩＶ－１中国流行株，据此构建了由ＤＮＡ疫苗及重组病毒载体疫苗组成的复合型艾滋病疫苗，可以说是专为中国人设计的。
２００４年１１月２５日，国家食品药品监督管理局批准我国自主研制的首支艾滋病疫苗进入Ⅰ期临床研究，２００５年３月１２日，首批志愿者在广西南宁接种了艾滋病疫苗。Ⅰ期临床研究一共招募了４９名志愿者，年龄跨度为１８岁－５０岁。志愿者们分为８组接种疫苗，研究人员对他们进行跟踪监测，以便对疫苗进行有效性、安全性评价。
２００６年６月，Ⅰ期临床研究在广西完成。２００６年８月１８日，科技部、国家食品药品监督管理局在北京宣布，我国自主研制的首支艾滋病疫苗已经顺利完成Ｉ期临床试验。
项目负责人之一、吉林大学教授孔维透露，从实际结果来看，参与Ⅰ期临床实验４９名接种疫苗的志愿者均未出现明显不良反应，研究人员还在高剂量组９０％的受试者体内检测到对艾滋病病毒的特异性免疫应答反应。孔维说：“这种艾滋病疫苗已具备一定的安全性，其免疫应答反应也达到了国际同类疫苗的水平。”
此次国家食品药品监督管理局批准进行的Ⅱ期研究，主要目标是在Ⅰ期临床研究的基础上，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，并为能否继续进行评价疫苗效力的临床实验提供依据。
广西壮族自治区疾病预防控制中心主任董柏清透露，Ⅱ期临床研究启动后，第一阶段将再次面向社会招募３０名志愿者，在知情同意、保护受试者合法权益的情况下稳步开展系列实验研究。
Ⅱ期临床研究将由广西壮族自治区疾病预防控制中心、中国药品生物制品检定所、吉林大学艾滋病疫苗国家工程实验室和长春百克药业有限责任公司联合完成，研究现场设在广西，广西壮族自治区疾病预防控制中心作为临床研究现场负责单位。
“这是我国启动首次艾滋病疫苗Ⅱ期临床研究。”广西壮族自治区卫生厅艾滋病防治处副处长陈杰称，“它填补了我国艾滋病疫苗Ⅱ期临床研究的空白。”一些专家表示相信，如果这种疫苗能够顺利完成Ⅱ期临床研究，必将成为我国艾滋病防治技术与产品科技攻关的一项标志性重大进展，为今后艾滋病疫苗的进一步研发奠定坚实的基础。
Chinese AIDS vaccine to start the first phase Ⅱ clinical study
March 21, 2009 19:59:55 Source: Xinhuanet
Nanning Xinhua March 21 (Xinhua weeks) our country first AIDS vaccine Phase Ⅱ clinical trial of March 21 in Nanning, Guangxi, announced the official start, the researchers hope to build on the previous recruiting volunteers to carry out new clinical trials to further test our country's first independently developed the safety of the effectiveness of an AIDS vaccine.
AIDS epidemic at the global trend of the spread has not been the fundamental control, AIDS prevention and control situation in our country is also more severe. "Cocktail therapy" has been recognized as one of the best AIDS treatment efficacy, but only to stabilize or slow the symptoms of AIDS, people should not eliminate the virus, countries generally believe that vaccines are developed to solve the fundamental approach to this problem.
China's AIDS vaccine research began in 1996, researchers conducted a high incidence of AIDS in China a large number of epidemiological investigations, and blood from patients with isolated HIV-1 Chinese epidemic strains, which constructed by the DNA vaccine and recombinant virus vector vaccine compound composed of an AIDS vaccine can be said to be designed specifically for the Chinese people.
November 25, 2004, State Food and Drug Administration approval of China's independently developed the first AIDS vaccine to enter Phase Ⅰ clinical research, March 12, 2005, the first batch of volunteers in Nanning, Guangxi AIDS vaccine inoculation. Phase Ⅰ clinical study recruited a total of 49 volunteers, age-span is 18 years old -50 years old. Volunteers were divided into 8 groups vaccinated, the researchers tracked their monitoring, in order to conduct vaccine effectiveness, safety evaluation.
June 2006, Ⅰ phase I clinical study completed in Guangxi. August 18, 2006, Science and Technology, the State Food and Drug Administration announced in Beijing that China has independently developed the first AIDS vaccine has successfully completed Phase I clinical trials.
One project leader, Jilin University professor KONG Wei disclosed that from the actual results, to participate in Phase Ⅰ clinical trial of the 49 vaccinated volunteers had no obvious adverse reactions, researchers are still high-dose group 90% of the subjects From the body to detect the AIDS virus-specific immune response. KONG Wei said: "The AIDS vaccine must have the safety, the immune response also reached a similar level of vaccine."
The State Food and Drug Administration approved Phase Ⅱ study, the main goal is to phase Ⅰ clinical research, based on further evaluation of AIDS vaccines at the health of the population to expand the safety and immunogenicity, and ability to continue to evaluate the effectiveness of vaccine clinical trials to provide a basis.
Guangxi Zhuang Autonomous Region, director of the Center for Disease Control and Prevention revealed董柏ching, Ⅱ start phase I clinical study, the first stage of society will once again recruiting for 30 volunteers, in the informed consent, protection of legitimate rights and interests of subjects under a steady series of experiments carried out research .
Phase Ⅱ clinical study will be conducted by the Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Chinese medicines by testing biological products, Jilin University AIDS vaccine and the National Engineering Laboratory, Changchun 100 grams Pharmaceutical Co., Ltd. United finish, research site located in Guangxi, Guangxi Zhuang Autonomous Region, the disease Prevention and Control Center as a clinical research unit in charge of the scene.
"This is the first time in our country to start Phase Ⅱ clinical trial of AIDS vaccine research." Guangxi Zhuang Autonomous Region, Health Department Deputy Director AIDS Chen Jie said, "It fills our country Phase Ⅱ clinical trial of AIDS vaccine research gaps." Some experts expressed the belief that If such a vaccine be able to successfully finish phase Ⅱ clinical research, AIDS prevention and control our country will become a technology and products of scientific and technological progress in a major landmark for future AIDS vaccine research and development to further lay a solid foundation.
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