At 9:56 on February 10, 2014Source: First Financial Daily
For the newly developed H7N9 avian influenza DNA vaccine , Professor , Shanghai Institute of Emerging Infectious Diseases Xu Jianqing reproduction yesterday told the " First Financial Daily" reporters , clinical evaluation is divided into three phases , at least six years , there are still some risks during the .
Shanghai Institute of Infectious Diseases , Shanghai Public Health Clinical Center has a new hair and reproduce the 7th news release , H7N9 avian influenza DNA vaccine has completed initial development in Shanghai , has now entered clinical trials reporting stage.
Xu Jianqing told the newspaper, the team developed a vaccine using gene technology. The specific method is to try the main immunogen gene H7N9 is implanted into a mature H7 vaccine vector , equivalent to deposit into the safe and then into human cells , the membrane protein structure of the virus will not be destroyed, can effectively stimulate body to produce protective neutralizing antibodies. 30 mice were vaccinated and then infected with H7N9 avian influenza virus , 30 days without a disease.
However, the effectiveness and safety of vaccines should be verified by further clinical evaluation .
" Phase I clinical evaluation is mainly for vaccine safety , the second phase is the safety and immunogenicity , three are immunogenic and protective ."徐建青said that after the completion of Phase III clinical , be possible to enter the market.
Xu Jianqing said the biggest advantage of DNA vaccine is safe , because the gene vaccine using gene universal vaccine carrier , which has been internationally proven through clinical trials to be safe . " The safety of the vaccine itself , in theory there is no problem , specific to our own vaccine , or pre-clinical and clinical going to go verify ."
However, the main risk is genetic vaccine immunogenicity in humans, monkeys and other larger animals seem weak. " Can be complementary techniques to overcome this weakness on clinical , laboratory we are doing another set of fake virus technology can be used as a complementary technology to enhance the immunogenicity of DNA vaccine ."
In addition , H7N9 viruses are constantly variation, "It depends on which part of the variation , we chose the site of the membrane protein , and the work done from the current data, we have a number of vaccines for 1996 , 2003 and 2007 of H7 viruses have a protective effect . " Xu Jianqing said .
For R & D H7N9 avian influenza virus vaccine , a number of companies and organizations inside and outside there are many breakthroughs . For example in Taiwan Guoguang Biotechnology Co., Ltd. developed the H7N9 bird flu vaccine is expected to enter clinical trials in March ; last May , the U.S. Greffex and Protein Science has also announced the adoption of modified adenovirus vectors through research H7N9 virus vaccine candidates ; addition American Novavax, Canada, Medicago, Sinopharm Group, China biotechnology Co., Ltd. , a subsidiary of Beijing Sinovac Sinovac Biotech Ltd. , Hualan companies, and China Taiwan 's Guoguang biotechnology Co., Ltd. also have declared vaccine development stage , none of these companies are currently entering clinical phase.http://fashion.ifeng.com/health/yiyao/chanjing/detail_2014_02/10/33653020_0.shtml
For the newly developed H7N9 avian influenza DNA vaccine , Professor , Shanghai Institute of Emerging Infectious Diseases Xu Jianqing reproduction yesterday told the " First Financial Daily" reporters , clinical evaluation is divided into three phases , at least six years , there are still some risks during the .
Shanghai Institute of Infectious Diseases , Shanghai Public Health Clinical Center has a new hair and reproduce the 7th news release , H7N9 avian influenza DNA vaccine has completed initial development in Shanghai , has now entered clinical trials reporting stage.
Xu Jianqing told the newspaper, the team developed a vaccine using gene technology. The specific method is to try the main immunogen gene H7N9 is implanted into a mature H7 vaccine vector , equivalent to deposit into the safe and then into human cells , the membrane protein structure of the virus will not be destroyed, can effectively stimulate body to produce protective neutralizing antibodies. 30 mice were vaccinated and then infected with H7N9 avian influenza virus , 30 days without a disease.
However, the effectiveness and safety of vaccines should be verified by further clinical evaluation .
" Phase I clinical evaluation is mainly for vaccine safety , the second phase is the safety and immunogenicity , three are immunogenic and protective ."徐建青said that after the completion of Phase III clinical , be possible to enter the market.
Xu Jianqing said the biggest advantage of DNA vaccine is safe , because the gene vaccine using gene universal vaccine carrier , which has been internationally proven through clinical trials to be safe . " The safety of the vaccine itself , in theory there is no problem , specific to our own vaccine , or pre-clinical and clinical going to go verify ."
However, the main risk is genetic vaccine immunogenicity in humans, monkeys and other larger animals seem weak. " Can be complementary techniques to overcome this weakness on clinical , laboratory we are doing another set of fake virus technology can be used as a complementary technology to enhance the immunogenicity of DNA vaccine ."
In addition , H7N9 viruses are constantly variation, "It depends on which part of the variation , we chose the site of the membrane protein , and the work done from the current data, we have a number of vaccines for 1996 , 2003 and 2007 of H7 viruses have a protective effect . " Xu Jianqing said .
For R & D H7N9 avian influenza virus vaccine , a number of companies and organizations inside and outside there are many breakthroughs . For example in Taiwan Guoguang Biotechnology Co., Ltd. developed the H7N9 bird flu vaccine is expected to enter clinical trials in March ; last May , the U.S. Greffex and Protein Science has also announced the adoption of modified adenovirus vectors through research H7N9 virus vaccine candidates ; addition American Novavax, Canada, Medicago, Sinopharm Group, China biotechnology Co., Ltd. , a subsidiary of Beijing Sinovac Sinovac Biotech Ltd. , Hualan companies, and China Taiwan 's Guoguang biotechnology Co., Ltd. also have declared vaccine development stage , none of these companies are currently entering clinical phase.http://fashion.ifeng.com/health/yiyao/chanjing/detail_2014_02/10/33653020_0.shtml
