艾滋病疫苗将闯效果关 AIDS vaccine will burst effect shut

Ⅱ期临床试验启动 Ⅱ period clinical trials start

31名受试者接受第一针注射 31 subjects who accept the first needle injection

　　发现艾滋病31年后，首个用于未受感染人群预防的药物在今年7月16日被美国FDA批准上市。10天后结束的第19届世界艾滋病大会上，首位被治愈者现身，人们看到了控制艾滋病疫情的曙光。

Found that AIDS 31 years later，First used in uninfected crowd prevention drugs in July 16 listed by the United States approved by FDA。10 days after the end of the 19th world AIDS conference，The first is no cure appeared，People see the control HIV/AIDS epidemic in the dawn。

　　记者昨天从北京佑安医院获悉，我国科技重大专项艾滋病疫苗Ⅱ期临床试验已于上周在该院启动，首批31名受试者已接受第一针注射。

Reporters yesterday from Beijing youan hospital, learn，Our country science and technology major special AIDS vaccine Ⅱ period clinical test has been in hospital last week in start，The first 31 subjects who have accepted the first needle injection。

进展 progress

防艾疫苗将验证有效性 AIDS vaccine will verify effectiveness

　　与费用高昂的艾滋病治疗药物相比，打几针之后就不需再打的艾滋病疫苗更经济有效。

And the high cost of AIDS drugs compared，A few needle then don't need to dozens of AIDS vaccine more economical effective。

　　中国疾控中心与国药中生北京生物制品研究所采用新方法，联合研制具有完全自主知识产权的艾滋病疫苗，该疫苗在“十一五”期间完成了Ⅰ期临床试验，显示安全性良好，免疫原性强，可诱导受试者产生抗艾滋病病毒的体液和细胞免疫反应，Ⅱ期试验将进一步验证其免疫原性，即是否有效。这是国际上首次使用复制型活病毒载体研制的艾滋病疫苗进入临床试验阶段。目前已有31人注射第一针。

The Chinese CDC and traditional Chinese medicine have Beijing institute of biological products by the new method，Joint development with completely independent intellectual property rights of the AIDS vaccine，The vaccine in“11th five-year plan”Period completed Ⅰ phase of clinical test，Show better security，Immunogenicity strong，Can induce subjects have resistance to the virus that causes AIDS humoral and cellular immune response，Ⅱ period test will further verify its immunogenicity，Namely, whether effective。This is the first international use copy type live virus carrier of AIDS vaccine research into the clinical test。There are 31 people first needle injection。

　　此次艾滋病疫苗研究的专家组表示，艾滋病是人类目前面临的最严重的公共卫生威胁之一。尽管全球艾滋病的防治经费在逐年增加，HIV感染的药物治疗在不断推广，艾滋病的流行趋势仍然超出了人们的估计。

The AIDS vaccine research group said，AIDS is human are currently facing the most severe public health threats。Although the global HIV/AIDS prevention and control in funds increases year by year，HIV infection in drug treatment for further promotion，The AIDS epidemic trend still beyond people's estimate。

　　据介绍，到2009年底，全球约有3330万艾滋病病毒感染者。截至2010年底，我国现存HIV感染者及艾滋病病人约76万，仅2010年，我国艾滋病新发感染数约为4.8万，死亡1.4万。按照我国防艾计划，到2015年底，存活的感染者和病人数控制在120万左右。专家组表示，目前，我国艾滋病流行增长趋势明显，高危人群中的艾滋病流行没有得到有效控制，且开始向一般人群扩散，局部地区艾滋病发病和死亡的高峰期已来临。

According to introducing，By the end of 2009，Global about 33.3 million HIV infections。By the end of 2010，Our country existing people infected with HIV and AIDS patient about 760000，Only 2010 years，Chinese AIDS new infections number about 48000，Death 14000。According to my defense ai plan，By the end of 2015，Survival of the patients and the third control at around 1.2 million。Expert group said，At present，Our country the HIV/AIDS epidemic growth trend obvious，The high risk population of HIV/AIDS epidemic didn't get effective control，And began to spread in the general population，Local AIDS incidence and death peak has come。

　　专家组坦言，虽然我国自主研发的艾滋病疫苗已入二期临床试验阶段，但与1998年发布的《中国预防和控制艾滋病中长期规划》提出的“在2010年前研制出针对我国流行毒株的艾滋病疫苗并完成临床试验的目标”相比，已经晚了两年。

Expert group said，Although our country's independent research and development of AIDS vaccine already into the second phase of clinical trial stage，But and published in 1998《China's measures to prevent and control AIDS long-term planning》Put forward“In the 2010 years ago in our country developed epidemic strain AIDS vaccine and complete the goal of clinical trials”Compared with，Already late for two years。

方向 direction

中国防艾疫苗打组合拳 National defence in artemisia vaccine play combination

　　为了“对症下药”，DNA疫苗是根据云南省HIV阳性的静脉吸毒者的血液“量身定做”的。

In order to“Suit the remedy to the case”，DNA vaccine is according to yunnan HIV positive vein blood of the drug addicts“tailored”of。

　　此次我国采用的是“核酸疫苗与重组天坛痘苗联合免疫艾滋病疫苗”，作用为“预防HIV感染”。由HIV-1DNA疫苗和重组痘苗病毒(以下简称DNA疫苗和“痘苗”)艾滋病疫苗两个组份组成，前者在人体内建筑免疫屏障作用，后者则对该屏障进行加固。

The our country is used“The nucleic acid vaccine and restructuring the temple of heaven vaccine combined immune AIDS vaccine”，Role for“To prevent HIV infection”。By HIV - 1 DNA vaccine and restructuring vaccine virus(Hereinafter referred to as the DNA vaccines and“vaccine”)AIDS vaccine two component composition，The former in the human body building immune barrier function，The latter to the barrier are strengthened。

　　“不论是艾滋病感染者的抗病毒治疗，还是结核病患者的治疗，都是采用联合用药的”，参与此次试验的北京佑安医院医师夏炜说，为了增强免疫效果，此次艾滋病疫苗采用的也是联合注射，这是我国“国家级”艾滋病疫苗与国外最大的不同之一。受试者先接种3针DNA疫苗，每针间隔一个月，随后根据随机分组，在不同的间隔时间后注射“痘苗”，这样能“显著增强诱导的体液和细胞免疫反应，比单独用DNA疫苗免疫有优势”。

“Whether people infected with HIV anti-viral treatment，Or the treatment of patients with tuberculosis，Is the combination of drugs”，To participate in the test of the Beijing youan hospital doctors, XiaHui said，In order to enhance the effect of immunity，The AIDS vaccine is the combined injection，This is our country“national”AIDS vaccine and foreign one of the biggest different。Subjects first vaccination 3 needle DNA vaccine，Each needle interval a month，Then according to the random grouping，In different interval time injection“vaccine”，This can“Remarkable enhancement induced humoral and cellular immune response，Alone than with DNA vaccine immune have an advantage”。

　　专家组介绍，全球范围内，艾滋病疫苗已经有20余年的研究历史，疫苗形式主要包括传统疫苗(灭活疫苗和减毒活疫苗)、病毒样颗粒、合成肽疫苗、蛋白亚单位疫苗、DNA疫苗、活载体疫苗，但至今未成功的原因是因每种试验都有着明显的劣势。而一支成功、将大范围推广使用的疫苗需要“100%的安全，100%的有效”。

Expert group is introduced，The global scope，HIV vaccine has more than 20 years of research history，Vaccine form mainly includes traditional vaccine(Inactivated vaccine and attenuated live vaccine)、Virus sample particle、Synthetic peptide vaccine、Protein subunit vaccine、DNA vaccine、Live carrier vaccine，But has not successful reason is because each test has obvious disadvantages。And a successful、Will a wide range to promote the use of the vaccine need“100% of the security，100% of the effective”。

　　我国此次试验的艾滋病疫苗正是站在“前人的肩膀上”，摒除了其他方法的缺点。为了“对症下药”，其中DNA疫苗是根据云南省HIV阳性的静脉吸毒者的血液“量身定做”的，从实验感染的外周血单核细胞中提取前病毒DNA，经过扩增基因组并测序后得到。

Our country the test AIDS vaccine is standing in“Predecessors' shoulders”，The exclusion of other methods of faults。In order to“Suit the remedy to the case”，The DNA vaccine is according to yunnan HIV positive vein blood of the drug addicts“tailored”of，From the experiment infection of peripheral blood mononuclear cells, former virus DNA，After amplification genome sequencing and get。