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The author:(作者)归海一刀published in(发表于) 2014/2/11 10:03:01 H7N9 avian flu experts said vaccine clinical evaluation needs at least 6 years
Xu Yanyan
H7N9 avian flu DNA vaccine for new research and development, and reproduction made by the new Institute of infectious diseases in Shanghai yesterday, Professor Xu Jianqing told the newspaper reporters, clinical evaluation of a three-phase, you need at least six years, there are still certain risks in the process.
Attached to Shanghai's new Shanghai Public Health Clinical Center and recreate the infectious diseases Institute 7th flotilla, H7N9 avian flu DNA vaccine has completed preliminary research and development in Shanghai, now entering the stage of clinical trials reporting.
Xu Jianqing told this newspaper, the team developed a vaccine using gene technology. Specific method is to try H7 implant H7N9 main ImmunoGen gene vaccine to mature on the carrier or placed in the cells of the body in storage in the safe, because of the structure of membrane proteins of the virus will not be damaged, can be effective in stimulating the human body produces protective antibodies. 30 experimental infection of mice after vaccination H7N9 avian flu viruses, within 30 days of non-pathogenic.
But the effectiveness and safety of vaccines would also further validation through clinical evaluation.
"Clinical evaluation period was mainly on vaccine safety, the second phase is for safety and immunogenicity, third-phase is immunogenicity and protective. "Xu Jianqing said that phase III clinical trial is completed, will it be possible to enter the market.
Xu Jianqing said that is the biggest advantage of gene vaccine safety, genetic vaccine using a universal vaccine vector, which had been adopted at the international level has proved to be safe in clinical trials. "The safety of the vaccine itself, theoretically there is no problem, specific to our own vaccines still need to go to preclinical and clinical validation. ”
DNA Vaccine immunogenicity of the main risk is in larger animals, such as humans, monkeys seem weak. "Clinically, can overcome this weakness by complementary technologies, we are doing another set of fake virus lab techniques, can be used as a complementary technology to enhance immunogenicity of DNA vaccine. ”
In addition, H7N9 in constant mutation of the virus, "depends on the variation in which part, we choose the parts of membrane proteins, from the current level of work done and data, we have vaccines for more than in 1996, 2003 and 2007 H7 viruses, has a protective effect. "Xu Jianqing said.
H7N9 avian flu vaccine research and development, domestic and foreign companies and institutions a number of breakthroughs. For example Taiwan bio-tech Corporation H7N9 avian flu vaccine, expected in March, enters clinical trials; last May, the United States Greffex and Protein Science has announced that engineered adenovirus developed H7N9 virus candidate vaccine; in addition, United States Novavax, and Canada Medicago, sinopharm group, China's biological technology company limited, Under sinovac Beijing sinovac, hualan biological companies, as well as China's Taiwan bio-tech company limited have also declared a stage of vaccine development, none of the above companies now entering clinical phases.
(Original title: H7N9 avian flu vaccine needed six years)
徐燕燕
针对新研发的H7N9禽流感基因疫苗，上海市新发与再现传染病研究所教授徐建青昨日告诉《第一财经日报》记者，临床评价分为三期，至少需要六年，过程中仍存在一定风险。
上海市公共卫生临床中心附设上海市新发与再现传染病研究所7日发布消息称，H7N9禽流感基因疫苗已在上海初步完成研发，目前进入临床试验申报阶段。
徐建青告诉本报，该团队研发的疫苗采用基因技术。具体方法是，尝试把H7N9的主要免疫原基因H7植入到成熟的疫苗载体上，相当于存进保险柜里再放到人体细胞中，由于病毒的膜蛋白结构不会被破坏，可以有效激发人体产生保护性中和抗体。30只实验小鼠在接种疫苗后再感染H7N9禽流感病毒，30天内无一致病。
但疫苗的有效性和安全性还要进一步通过临床评价来验证。
“临床评价一期主要是针对疫苗安全性，二期是安全性和免疫原性，三期是免疫原性和保护性。”徐建青说，三期临床完成后，才有可能进入市场。
徐建青称，基因疫苗最大的优势是安全性，因为基因疫苗使用的是通用型的基因疫苗载体，这在国际上已经通过临床试验证明是安全的。“疫苗本身的安全性，从理论上讲是没有问题的，具体到我们自己的疫苗，还是要到临床前及临床上去验证。”
但基因疫苗最主要的风险是其免疫原性在人、猴子等较大的动物身上显得较弱。“临床上可以通过互补技术来克服这一弱点，我们实验室也在做另外一套假病毒技术，可以作为互补技术提高基因疫苗免疫原性。”
此外，H7N9病毒也在不断变异，“要看变异在哪个部位，我们选择的部位是膜蛋白，从目前所做的工作和数据来看，我们疫苗对1996年、2003年与2007年的多个H7病毒，都有保护作用。”徐建青表示。
针对H7N9禽流感病毒疫苗的研发，境内外多家公司及机构已有不少突破性进展。例如台湾地区国光生物科技股份有限公司研制的H7N9禽流感疫苗，预计3月进入临床试验；去年5月，美国Greffex和Protein Science也先后宣布，采用经过改造的腺病毒载体研发H7N9病毒候选疫苗；此外，美国的Novavax、加拿大的Medicago、国药集团旗下中国生物技术股份有限公司、科兴控股下属的北京科兴生物制品有限公司、华兰生物公司，以及中国台湾的国光生物科技股份有限公司也都相继宣布进入疫苗研制阶段，目前上述公司均未进入临床阶段。
(原标题：H7N9禽流感疫苗上市还需六年)
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