【drug-news】【资讯翻译】新流感疫苗对H1N1的9个关键菌株有效，包括1918年西班牙大流感
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http://www.drugs.com/clinical_trials/inovio-pharmaceuticals-takes-major-stride-toward-universal-influenza-vaccine-14239.html
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BLUE BELL, Pa., Sept. 6, 2012 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that the interim analysis of its SynCon® universal H1N1 influenza vaccine showed that it generated protective HAI titers against some of the most prevalent strains of H1N1 influenza from the past 100 years in a phase I clinical trial. Because the SynCon® approach incorporates sequence information from multiple divergent strains, the vaccine is not matched to any of the historical flu strains. The achievement of protective titers against multiple unmatched strains represents a major step towards Inovio's ultimate goal to develop a universal influenza vaccine to protect against known and newly emerging strains of influenza.
"With respect to influenza, our ultimate objective is to develop a universal vaccine capable of providing years of true preemptive protection across subtypes and strains," said Dr. J. Joseph Kim, Inovio's President and CEO. "This is a challenging goal but this proof-of-principle H1N1 data demonstrates the potential of our SynCon® approach to generate cross-protective HAI titers against multiple unmatched influenza strains. These results are an important addition to our previously reported H5N1 phase I data and a validating achievement on our ongoing effort to develop a safe vaccine that provides immunity against the ever-changing influenza virus."
The current open label phase I study evaluated two synthetic H1N1 hemagglutinin (HA) plasmids designed to broadly protect against unmatched influenza strains within different branches of the H1N1 subtype. These plasmids were delivered in healthy adults with Inovio's CELLECTRA® intradermal electroporation device up to three times. The delivered vaccine was well tolerated; reported adverse events and injection site reactions were mild to moderate and required no treatment.
Researchers exposed blood samples from the vaccinated subjects to each of the nine key H1N1 viruses in circulation over the last 100 years: eight were H1N1 strains used to formulate the seasonal vaccines of the last 25 years; one was the H1N1 strain that caused the 1918 Spanish flu, which killed over 40 million people. These unmatched influenza strains were used to assess the generation of hemagglutination inhibition (HAI) titers meeting or exceeding 1:40. An HAI titer of 1:20 is generally regarded as a positive vaccine response, while 1:40 is the level recognized as a protective immune response against influenza in humans. Demonstrating Inovio's synthetic vaccine's broad cross-reactive coverage, a significant percentage of subjects immunized with Inovio's SynCon® vaccine had an HAI titer of 1:40 or higher against each of the nine H1N1 strains tested, ranging from a 30% response rate to the A/Brisbane/59/07 strain to a 100% response rate to the A/Beijing/262/95 strain. The benchmark for the current licensed seasonal flu vaccines, which are based on matching the vaccine HA sequence to that of the circulating strain, is to have greater than 65% of the vaccines generate an HAI titer of 1:40 or higher against the matched vaccine strain.
By design, Inovio's SynCon® universal flu vaccine is not matched to any single virus and was not matched to any of the strains tested in this study. The vaccine recipients generated protective HAI responses against the H1N1 A/South Carolina/1/18 strain from the 1918 Spanish flu as well as all the H1N1 strains which were part of the annual seasonal trivalent inactivated flu vaccines (TIV) since 1986, including: A/Taiwan/1/86, A/Texas/36/91, A/Bayern/07/95, A/Beijing/262/95, A/New Caledonia/20/99, A/Solomon Islands/03/06, A/Brisbane/59/07, A/California/07/09. The HAI titers in the positive responders ranged from 1:40 to greater than 1:1280.
Compared to the seasonal TIV (trivalent influenza vaccine)-immunized control group, which is matched to the current H1N1 seasonal flu strain (A/California/07/09), those immunized with Inovio's vaccine generated a higher or similar percentage of positive HAI titer responders against all of the strains except for A/California/07/09. As anticipated, the TIV recipients generated the best HAI titers against the matched strain, but did not generate vaccine-induced response rates against the unmatched strains.
This phase I study is ongoing, with additional results from a higher dose group expected in 2013. Inovio is also conducting optimization studies in animal models to further strengthen its H1N1 vaccine's potency against all strains, especially the current circulating strain, A/California/07/09, as well as to reduce the number of injections needed to generate protective responses against multiple strains.
Today's announced results and prior achievements provide further evidence of the capability of Inovio's synthetic consensus design approach to create vaccines capable of providing universal protection against changing strains of a pathogen. Inovio's intent is to leverage the greater breadth of immune responses achievable using its SynCon® vaccine design to revolutionize the flu vaccine market. Inovio has a two-pronged development strategy targeting the pandemic and seasonal influenza vaccine market segments. Within this strategy, we have a particular focus on the elderly market segment, which has the greatest unmet need.
First, we are attempting to better guard against future flu pandemic strains. Inovio recently reported that its SynCon® H5N1 plasmid construct generated high levels of antigen-specific binding antibodies and exhibited a four-fold or greater rise in geometric mean titers and HAI titers ranging from 1:20 to 1:80 against six different H5N1 virus strains. A four-fold rise in HAI titers, compared to pre-vaccination, is considered an important indicator of immune activation. Our plan with this product is to access the pandemic stockpiling market, which is dominated by government buyers.
Second, we aim to develop a universal seasonal vaccine to protect us from future H1N1, H3N2, and the Type B influenza strains, the subtypes comprising today's TIV. In addition to the ongoing animal and human studies for H1N1, the Company is completing tests in animal models of its vaccine constructs for A/H3N2 and Type B influenza. Our goal is to develop vaccines that can also generate HAI titers exceeding 1:40 against unmatched strains within the H3N2 and Type B subtypes.
More specifically, our goal is to develop a more effective flu vaccine for those over 65 years of age, who currently account for about 90% of seasonal flu-related deaths. Inovio recently launched a third influenza study, called FLUPRIME, using its H1N1 construct alone and in combination with the 2012 seasonal influenza vaccine (TIV) to evaluate the results of these regimens in this population. We expect immunogenicity data in 2013.
认领翻译的战友请跟帖注明“认领本文翻译，48小时内未完成，请其他战友认领！”
请根据自己专业背景选择认领，如使用翻译软件翻译，被发现者扣分1-2分
请根据自己的专业背景选择相应的资讯认领，经常认领而不能及时提供优质稿件者将被列入黑名单，取消认领资格，请大家注意！
新近参与本次活动的会员请查看：【公告】动态版重启资讯翻译计划：我为人人，人人为我，共同提高
寻找最近的翻译贴请查看：http://search.dxy.cn/?words=%E8%B5%84%E8%AE%AF%E7%BF%BB%E8%AF%91&bid=116&t=1&c=1&age=7&bid=116&limit=30&o=1
翻译时请参照版规 【版务】科技动态版版规及加分细则（ 2014-02-21 更新）
希望参与动态版其他活动的会员请查看版面右边栏的置顶部分
BLUE BELL, Pa., Sept. 6, 2012 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that the interim analysis of its SynCon® universal H1N1 influenza vaccine showed that it generated protective HAI titers against some of the most prevalent strains of H1N1 influenza from the past 100 years in a phase I clinical trial. Because the SynCon® approach incorporates sequence information from multiple divergent strains, the vaccine is not matched to any of the historical flu strains. The achievement of protective titers against multiple unmatched strains represents a major step towards Inovio's ultimate goal to develop a universal influenza vaccine to protect against known and newly emerging strains of influenza.
"With respect to influenza, our ultimate objective is to develop a universal vaccine capable of providing years of true preemptive protection across subtypes and strains," said Dr. J. Joseph Kim, Inovio's President and CEO. "This is a challenging goal but this proof-of-principle H1N1 data demonstrates the potential of our SynCon® approach to generate cross-protective HAI titers against multiple unmatched influenza strains. These results are an important addition to our previously reported H5N1 phase I data and a validating achievement on our ongoing effort to develop a safe vaccine that provides immunity against the ever-changing influenza virus."
The current open label phase I study evaluated two synthetic H1N1 hemagglutinin (HA) plasmids designed to broadly protect against unmatched influenza strains within different branches of the H1N1 subtype. These plasmids were delivered in healthy adults with Inovio's CELLECTRA® intradermal electroporation device up to three times. The delivered vaccine was well tolerated; reported adverse events and injection site reactions were mild to moderate and required no treatment.
Researchers exposed blood samples from the vaccinated subjects to each of the nine key H1N1 viruses in circulation over the last 100 years: eight were H1N1 strains used to formulate the seasonal vaccines of the last 25 years; one was the H1N1 strain that caused the 1918 Spanish flu, which killed over 40 million people. These unmatched influenza strains were used to assess the generation of hemagglutination inhibition (HAI) titers meeting or exceeding 1:40. An HAI titer of 1:20 is generally regarded as a positive vaccine response, while 1:40 is the level recognized as a protective immune response against influenza in humans. Demonstrating Inovio's synthetic vaccine's broad cross-reactive coverage, a significant percentage of subjects immunized with Inovio's SynCon® vaccine had an HAI titer of 1:40 or higher against each of the nine H1N1 strains tested, ranging from a 30% response rate to the A/Brisbane/59/07 strain to a 100% response rate to the A/Beijing/262/95 strain. The benchmark for the current licensed seasonal flu vaccines, which are based on matching the vaccine HA sequence to that of the circulating strain, is to have greater than 65% of the vaccines generate an HAI titer of 1:40 or higher against the matched vaccine strain.
By design, Inovio's SynCon® universal flu vaccine is not matched to any single virus and was not matched to any of the strains tested in this study. The vaccine recipients generated protective HAI responses against the H1N1 A/South Carolina/1/18 strain from the 1918 Spanish flu as well as all the H1N1 strains which were part of the annual seasonal trivalent inactivated flu vaccines (TIV) since 1986, including: A/Taiwan/1/86, A/Texas/36/91, A/Bayern/07/95, A/Beijing/262/95, A/New Caledonia/20/99, A/Solomon Islands/03/06, A/Brisbane/59/07, A/California/07/09. The HAI titers in the positive responders ranged from 1:40 to greater than 1:1280.
Compared to the seasonal TIV (trivalent influenza vaccine)-immunized control group, which is matched to the current H1N1 seasonal flu strain (A/California/07/09), those immunized with Inovio's vaccine generated a higher or similar percentage of positive HAI titer responders against all of the strains except for A/California/07/09. As anticipated, the TIV recipients generated the best HAI titers against the matched strain, but did not generate vaccine-induced response rates against the unmatched strains.
This phase I study is ongoing, with additional results from a higher dose group expected in 2013. Inovio is also conducting optimization studies in animal models to further strengthen its H1N1 vaccine's potency against all strains, especially the current circulating strain, A/California/07/09, as well as to reduce the number of injections needed to generate protective responses against multiple strains.
Today's announced results and prior achievements provide further evidence of the capability of Inovio's synthetic consensus design approach to create vaccines capable of providing universal protection against changing strains of a pathogen. Inovio's intent is to leverage the greater breadth of immune responses achievable using its SynCon® vaccine design to revolutionize the flu vaccine market. Inovio has a two-pronged development strategy targeting the pandemic and seasonal influenza vaccine market segments. Within this strategy, we have a particular focus on the elderly market segment, which has the greatest unmet need.
First, we are attempting to better guard against future flu pandemic strains. Inovio recently reported that its SynCon® H5N1 plasmid construct generated high levels of antigen-specific binding antibodies and exhibited a four-fold or greater rise in geometric mean titers and HAI titers ranging from 1:20 to 1:80 against six different H5N1 virus strains. A four-fold rise in HAI titers, compared to pre-vaccination, is considered an important indicator of immune activation. Our plan with this product is to access the pandemic stockpiling market, which is dominated by government buyers.
Second, we aim to develop a universal seasonal vaccine to protect us from future H1N1, H3N2, and the Type B influenza strains, the subtypes comprising today's TIV. In addition to the ongoing animal and human studies for H1N1, the Company is completing tests in animal models of its vaccine constructs for A/H3N2 and Type B influenza. Our goal is to develop vaccines that can also generate HAI titers exceeding 1:40 against unmatched strains within the H3N2 and Type B subtypes.
More specifically, our goal is to develop a more effective flu vaccine for those over 65 years of age, who currently account for about 90% of seasonal flu-related deaths. Inovio recently launched a third influenza study, called FLUPRIME, using its H1N1 construct alone and in combination with the 2012 seasonal influenza vaccine (TIV) to evaluate the results of these regimens in this population. We expect immunogenicity data in 2013.
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