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艾滋病新型疫苗在泰国首次出现成功预防案例
生物谷 来源 医药网 2010-12-22 8:37:17
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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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近日，科学家宣布，一种实验性疫苗令感染艾滋病毒的风险减低了三分之一。在泰国进行的这项医疗试验唤起了公众寄予对抗艾滋病取得重大突破的希望。
据美国陆军透露，这项由美国陆军与美国国家过敏症及传染病研究所（NationalInstituteofAllergyandInfectiousDiseases）一同赞助的艾滋病疫苗测试，堪称全球历来规模最大的一次。他们对16000多名志愿者进行了测试，结果首次出现成功预防艾滋病毒感染的案例。
接受测试的志愿者都是年龄介于18岁至30岁、艾滋病毒抗体检测呈阴性、受感染风险为中等的泰国男性和女性。所有的志愿者接受咨询，并配发避孕套，以帮助他们避免感染艾滋病。然后，随机选择一半志愿者接受两种疫苗组合注射的测试，而另一半志愿者接受安慰剂的注射。直到试验结束，没人知道哪个志愿者是属于其中哪个小组的。
结果相对较少的志愿者感染上艾滋病毒，其中在接受疫苗注射的8197名参与者中，感染艾滋病毒的有51人；在接受安慰剂注射的8198名参与者中，感染艾滋病毒的有74人。但是两者之间的差异具有统计学意义，这也就是说，科学家确信这个差异不是由于偶然因素引起的。经计算得出的结论是，对于接受疫苗的那一组志愿者来说，艾滋病毒感染风险降低了31%。
美国陆军负责领导这项耗资达1.05亿美元（合6400万英镑）研究的杰罗姆?金（JeromeKim）上校说，这是“我们可以研发出一种安全有效的艾滋病毒预防性疫苗的首个证据。”
最近一系列研制艾滋病毒预防性疫苗的试验接连失败，致使许多科学家认为这种疫苗可能无法实现。在2007年，默沙东制药公司（Merk）在试验结果令人失望之后，放弃了当时看似最有前途的研究项目。美国国家过敏症及传染病研究所所长安东尼?福西（AnthonyFauci）博士警告说，这“不是研发之路的终极目标”，但也对试验结果表示惊讶，而且也深感满意。
“这让我对改善这个试验结果怀有谨慎乐观的态度，”他说：“这是我们可以做到的。”
每天，全世界有7000名新艾滋病患者；据联合国艾滋病规划署（Unaids）的估计，在2007年，全世界共有2万人死于艾滋病。
一直以来在研发相关疫苗的国际组织——美国艾滋病疫苗倡导联盟（AidsVaccineAdvocacyCoalition）对这项自1983年以来的第三次重大研究的试验结果表示欢迎。“一个历史性的里程碑”的事件是：人类免疫缺陷病毒（HIV，又称艾滋病毒）于1983年被确认为艾滋病的致病原因。
美国艾滋病疫苗倡导联盟的执行理事米切尔?沃伦（MitchellWarren）说：“毫无疑问，这一试验结果将在艾滋病疫苗领域中发挥激励的作用，并重新定位艾滋病疫苗的研发方向。”
英国帝国理工学院的免疫学教授弗朗西斯?高驰（FrancesGotch）表示，这项研究结果似乎有统计学意义，可能是两种不同的疫苗的协同作用，从而产生更为强大的效果。
高驰也是国际艾滋病疫苗行动组织（InternationalAidsVaccineInitiative）的首席调查员，他在接受《卫报》记者采访时说：“使用疫苗后，艾滋病毒感染发生率如此之低，实在令人印象深刻。”
“当然，不是100%的人[得到了保护]，但31%的减低或许会令世界艾滋病治疗的前景大为改观。我觉得这是我们可以接受的。”
泰国公共卫生部进行了这项针对泰国常见艾滋病毒菌株的研究。
科学家强调说，他们并不知道这种疫苗是否能够预防世界其他地方出现的艾滋病毒菌株。该项研究之所以选择在泰国进行，是因为美国陆军的科学家在泰国出现艾滋病流行时，曾在泰国进行了关键性研究，对病毒菌株进行分离，并且向疫苗生产商提供这些艾滋病毒菌株的遗传信息。
这项研究测试了两种疫苗的组合注射，采用“启动—提高”的办法，其中第一种疫苗启动免疫系统攻击艾滋病毒，而第二种疫苗则强化这一反应。
艾滋病毒疫苗Alvac使用一种称为金丝雀痘病毒（canarypox）的禽流感病毒，对该病毒进行改变使它不能引起人体疾病，将三种艾滋病毒基因一同载入体内。而艾滋病毒疫苗Aidsvax则含有艾滋病毒表面的经基因工程改造过的某种蛋白。
目前尚不清楚疫苗制造商是否会寻求获得在泰国生产销售这种双疫苗组合的许可权。在这项试验开始之前，美国食品和药物管理局（FDA）曾指出，在考虑颁发这种双疫苗的美国许可权之前，还需进行一些其他相关的研究。这一试验的全部结果将于10月份在巴黎召开的国际艾滋病疫苗会议上公布于众。
研究机构及资助机构（比如盖茨基金会）联盟组织——全球艾滋病疫苗企业计划（GlobalHIVVaccineEnterprise）的执行董事阿兰?伯恩斯坦（AlanBernstein）表示，这项研究的结果显示，研发艾滋病毒疫苗是一个可以实现的目标。“这是寻求研制艾滋病疫苗的26年来最具历史性的一天，”伯恩斯坦博士说，“这项试验首次证明了，人类通过更多的研究，将会有可能研制出一种完全可以预防艾滋病毒的疫苗。”
英国的全国爱滋信托基金会总裁德博拉?杰克（DeborahJack）表示，目前，迫切需要艾滋病毒疫苗，因为疫苗是迄今为止治疗重大传染性疾病的最有效方法。还需进行更多的研究工作，但这个颇有希望的结果“验证了一点，那就是包括英国政府在内的国际社会继续投资并致力于研制艾滋病毒疫苗是完全合适的。”
英国主要的艾滋病慈善机构——特伦斯希金斯信托组织（TerranceHigginsTrust）表示对此研究结果持“谨慎乐观”的态度。该组织的政策经理维姬?希尔德（VickySheard）说：“这是在漫漫长路上跨出的第一步。”
“对于疫苗的推出、所需付出的昂贵费用以及是否对不同艾滋病毒菌株也有效等方面，还需进行许多研究。”
New AIDS vaccine in Thailand for the first time cases of successful prevention
Sources of biological Valley Medical Network 2010-12-22 8:37:17
Recently, scientists announced that an experimental vaccine that reduced the risk of HIV infection in the third. In the clinical trials conducted in Thailand to arouse the public has placed a major breakthrough in the fight against AIDS hope.
According to the U.S. Army revealed that the U.S. Army and the United States by the National Institute of Allergy and Infectious Diseases (NationalInstituteofAllergyandInfectiousDiseases) jointly sponsored AIDS vaccine test, called the world's largest one ever. They tested more than 16,000 volunteers, the results for the first time successful prevention of HIV infection cases.
The volunteers were tested between the ages of 18 to 30 years old, HIV antibody test was negative, the risk of infection for the middle of the Thai men and women. All volunteers receive counseling, and dispensing of condoms, to help them avoid HIV infection. Then, randomly select half of the volunteers were injected with the test combination of both vaccines, while the other half of the volunteers received placebo injections. Until the end of the trial, no one knows which volunteers belong to which group of them.
The results of relatively few HIV-infected volunteers, including the vaccination of the 8197 participants, 51 HIV-infected person; placebo injections in 8198 participants, 74 HIV-infected people. However, the difference between the two was statistically significant, which means that scientists believe the difference is not due to chance factors. The calculation was concluded that, for the volunteer group that received the vaccine, the risk of HIV infection by 31%.
The U.S. Army is responsible for leading the cost of 1.05 billion dollars (64 million pounds) of the Jerome? Gold (JeromeKim) Colonel said it was "we can develop a safe and effective HIV preventive vaccine first evidence. "
A series of recent development of HIV preventive vaccine trial after another failed, leaving many scientists believe that the vaccine may not be realized. In 2007, pharmaceutical company Merck (Merk), after disappointing results in the test, gave up at that time seems the most promising research projects. U.S. National Institute of Allergy and Infectious Diseases Anthony? Fauci (AnthonyFauci) Dr. warned that it "is not the ultimate goal of research and development of the road" but also expressed surprise at the test results, but also deeply satisfied.
"It makes me cherish the results of this test to improve the attitude of cautious optimism," he said: "This is what we can do."
Every day, worldwide, 7,000 new AIDS; according to UNAIDS (Unaids) estimated that in 2007, a total of 2 million people worldwide died of AIDS.
Vaccine has been in research and development related to international organizations - the United States AIDS Vaccine Advocacy Coalition (AidsVaccineAdvocacyCoalition) since 1983 for the third major study results welcome. "A historic milestone" events are: human immunodeficiency virus (HIV, also known as HIV) in 1983 was recognized as a cause of AIDS.
U.S. AIDS Vaccine Advocacy Coalition executive director of the Mitchell? Warren (MitchellWarren) said: "There is no doubt that the AIDS vaccine test results will be inspired to play the role of the field, and re-positioning the direction of AIDS vaccine research and development."
Imperial College London professor of immunology Francis? High Chi (FrancesGotch) said the findings appear to have statistical significance, two different vaccines may be synergies, resulting in a more powerful effect.
High Chi International AIDS Vaccine Initiative is (InternationalAidsVaccineInitiative) chief investigator, he told "The Guardian" interview, said: "The use of vaccine, the HIV infection rate is so low, it is impressive."
"Of course, not 100% of the people [are protected], but perhaps 31% would reduce the prospect of the world greatly improved AIDS treatment. I think this is acceptable to us."
Thailand Ministry of Public Health conducted the HIV strains common in Thailand for the research.
Scientists stressed that they did not know whether the vaccine appears to prevent other parts of the world of HIV strains. The study chose Thailand because the U.S. Army scientists when the AIDS epidemic in Thailand has a critical study in Thailand, the virus strains were isolated, and vaccine manufacturers to provide the genetic strains of HIV information.
This study tested the combination of injection of the two vaccines, the use of "Start - to improve" approach, in which the immune system starts the first vaccine against HIV, while the second is to strengthen the response to the vaccine.
Alvac HIV vaccine using a virus called canarypox (canarypox) avian influenza virus, the virus changes so that it can not cause disease in humans, will be loaded with three HIV genes in vivo. The HIV vaccine Aidsvax the surface of HIV which have been genetically engineered in a protein.
It is not clear whether the vaccine manufacturers in Thailand will seek the vaccine production and sales of this dual combination of permissions. Before the start of the trial, the U.S. Food and Drug Administration (FDA) has pointed out that in considering this dual vaccine issued license before the United States, the need for some other related research. The full results of this trial will be held in October in Paris, meeting of the International AIDS Vaccine public.
Research institutions and funding agencies (such as the Gates Foundation) Alliance - Global AIDS Vaccine Enterprise Scheme (GlobalHIVVaccineEnterprise) executive director Alan? Bernstein (AlanBernstein), said the study results suggest that HIV vaccine research and development an achievable goal. "This is the development of an AIDS vaccine for 26 years to the most historic day," Dr. Bernstein said, "This trial was the first proof of human through more research, will be possible to develop a fully vaccines for HIV prevention. "
British president of the National AIDS Trust, Deborah? Jack (DeborahJack) said that at present, the urgent need of HIV vaccine because the vaccine is so far the treatment of major communicable diseases, the most effective way. More research is needed, but the promising results "validate the point that the British Government, including the international community to continue to invest and is committed to develop an HIV vaccine is entirely appropriate."
Britain's leading AIDS charities - Terrence Higgins Trust (TerranceHigginsTrust) said the results of this study was "cautiously optimistic" attitude. The organization's policy manager Vicky? Heald (VickySheard) said: "This is the first step on the long journey."
"For the introduction of the vaccine required to pay the high cost and whether different strains of HIV are also effective, etc., needed for many studies."
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