[转移贴]Baxter's Celvapan欧洲批准的第一个细胞生产的禽流感疫苗
原帖由论坛会员aivr145发表于 2009-2-26 20:50转载：
Clinical data from a Phase III and subsequent booster study demonstrate safety,
immune response and cross-protective memory
DEERFIELD, Ill.--(Business Wire)--
Baxter International Inc. (NYSE: BAX) today announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA)
has issued a positive opinion for the marketing authorization of CELVAPAN, the
first cell culture-based H5N1 (avian flu) pandemic vaccine, in the European
Union.
The positive opinion precedes the licensure of themock-upvaccine, which
allows CELVAPAN to be used if the World Health Organization (WHO) officially
declares a pandemic. The positive opinion was based on results from a
comprehensive clinical development program, including a Phase III clinical trial
that demonstrated vaccines for two different H5N1 virus strains were well
tolerated and generated a functional immune response.
We are very pleased to receive the EMEA s positive opinion for CELVAPAN,said
Hartmut Ehrlich, M.D., vice president, BioScience global research and
development.This is another step towards our goal of supplying a safe and
effective vaccine to protect the population against a possible influenza
pandemic.
Amock upvaccine is identical to the future pandemic vaccine in composition
and manufacturing; however, since the actual pandemic strain is not known, the
vaccine contains another influenza strain not yet exposed to the general
population. Once a pandemic is declared, this licensure allows for a fast track
approval of the vaccine containing the actual pandemic strain.
CELVAPAN is made using Baxter s proprietary Vero cell technology, which offers
advantages against conventional egg-based vaccine technology. Baxter s Vero cell
manufacturing process is more rapid due to its ability to use thenativevirus
that does not need to be modified in order to grow in chicken eggs. The shorter
time for vaccine production is critical in accelerating vaccine supply in
response to an influenza pandemic.
CELVAPAN is produced in Bohumil, Czech Republic, at one of the largest cell
culture vaccine production facilities in the world. Vero cell technology uses a
well-established continuous mammalian cell line to produce the pandemic vaccine.
Baxter s candidate avian flu vaccine is derived from the H5N1 strain
A/Vietnam/1203/2004. Its antigen composition and structure are identical to the
actual virus circulating in nature. This vaccine formulation alleviates the need
to enhance the immune response by including adjuvants (additives) that may cause
side effects. In the Phase III study, CELVAPAN induced an immune response that
is similar to the body s defense against a natural influenza virus infection.
Phase III Clinical Trial Results
The purpose of the randomized Phase III study was to evaluate safety and immune
responses to 7.5g of the Vietnam strain vaccine in two age groups (adults
18-59 and elderly, i.e., older than 60). The antibody persistence and immune
response to a booster with either the same or a different strain was also
measured. The study also investigated the ability of the vaccine to induce
cross-immunity against divergent H5N1 strains.
Overall, the vaccine was well tolerated after the first and second vaccination
as well as after the booster, with a safety profile similar to currently
licensed seasonal influenza vaccines. The most common side effects were
injection site pain and headache, fatigue or malaise.
A positive immune response was induced even after only one immunization as
determined by measurement of functional antibodies using a microneutralization
assay (50.7 percent in the adult group; 54.4 percent in the elderly group).
Following the second immunization, 73 percent of subjects in the adult and 74
percent in the elderly age group demonstrated seroneutralizing levels of
antibody, meaning the vaccine was found to be at least equally immunogenic in
the elderly as in the adult age group. A six-month booster vaccination with
either A/Vietnam/1203/2004 or A/Indonesia/05/2005 strain vaccines induced a
substantial booster response. A booster vaccination using a different strain
resulted in high levels of antibodies against the initial and the booster
strain, which is indicative of cross-protective immunological memory.
Last June, The New England Journal of Medicine published data demonstrating
CELVAPAN met Phase I/II trial endpoints for safety and immunogenicity
(generating a functional immune response). This was the first peer-reviewed
publication of study results for CELVAPAN, the first cell culture-derived avian
influenza vaccine to undergo clinical evaluation.
About Pandemic Flu
A pandemic is a global disease outbreak caused by an agent for which there is
little or no immunity in the human population and which can spread easily from
person-to-person worldwide causing serious illness and death. Most cases of
avian flu infection in humans have so far resulted from direct or close contact
with infected poultry (e.g., domesticated chicken, ducks, and turkeys) or
surfaces possibly contaminated from feces of infected birds. Avian influenza
infection follows an unusually aggressive clinical course, with rapid
deterioration and a high fatality rate.
About Baxter
Baxter International Inc. develops, manufactures and markets products that save
and sustain the lives of people with hemophilia, immune disorders, infectious
diseases, kidney disease, trauma, and other chronic and acute medical
conditions. As a global, diversified healthcare company, Baxter applies a unique
combination of expertise in medical devices, pharmaceuticals and biotechnology
to create products that advance patient care worldwide.
Rojjer发表于 2009-2-27 14:36
Abstract：
The vaccine contains another influenza strain not yet exposed to the general population。
CELVAPAN is made using Baxter s proprietary Vero cell technology。
Baxter s candidate avian flu vaccine is derived from the H5N1 strain A/Vietnam/1203/2004.
CELVAPAN induced an immune response that is similar to the body s defense against a natural influenza virus
infection。
Phase III clinical trial investigated the ability of the vaccine to induce cross-immunity against divergent H5N1
strains.
The most common side effects were injection site pain and headache, fatigue or malaise.
The vaccine was found to be at least equally immunogenic in the elderly as in the adult age group.
A booster vaccination using a different strain resulted in high levels of antibodies against the initial and the
booster strain, which is indicative of cross-protective immunological memory
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获欧盟药品管理局(EMEA)的正面评价
第三阶段临床试验证实产品的安全性、免疫反应以及交叉保护记忆。
2008年12月18日DEERFIELD, III.消息-美商百特(Baxter International Inc. (NYSE: BAX))今天公佈欧盟药品管理局人体用医药产品委员会（Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA)）针对CELVAPAN禽流感疫苗的正面评价，此为欧盟区第一个採细胞培养对抗H5N1(禽流感病毒株)的新流感疫苗。
该份正面评价是在「新型流感模拟疫苗」(mock-up Vaccine)执照核发之前发表，即表示，若世界卫生组织正式宣告流感大流行时，CELVAPAN禽流感疫苗可立即被使用以保护民众。欧盟的正面评价系依据大量的临床数据，其中包含了第三阶段临床试验使用两种不同H5N1病毒株的研究，其结果显示，该疫苗具有良好的耐受性并可以诱发人体免疫反应。
百特医疗公司生物科技产品全球研究与发展部副总裁哈特穆‧艾理（Hartmut J. Ehrlich）医学博士表示，「我们相当高兴获得欧盟药品管理局对CELVAPAN禽流感疫苗的正面评价。」「我们迈入了另一个相当重要的里程碑，提供安全且有效的疫苗保护人群，对抗可能爆发的流感大流行。」
所谓「新型流感模拟疫苗」在组成成分和製程皆与未来大流行疫苗的相同；然而，实际的大流行病毒株目前并无法得知，因故该模拟疫苗採用尚未感染人群的流感病毒株。一旦发生全球性流感大流行，此核淮执照可加速审查核淮，以实际的大流行病毒株製成疫苗（即新型流感疫苗），达即时上市之目的。
CELVAPAN新型流感疫苗系运用百特医疗Vero细胞培养之专利技术，以众多优势取代传统鸡胚培养。百特的Vero细胞製造过程更为迅速，原因在于运用原生病毒（"native" virus）进行细胞培养，无须借助鸡胚製成。当流感肆虐时，可争取时间加速疫苗生产，而其为防疫工作致胜的关键点。
CELVAPAN禽流感疫苗在捷克Bohumil进行研发生产，该处为全世界最大的细胞培养疫苗生产基地之一。Vero细胞技术採用连续性哺乳动物细胞株来生产新型流感疫苗。
百特的禽流感候选疫苗来自H5N1病毒株A/Vietnam/1203/2004，其抗原的组成和结构本质与在自然界中循环的实际病毒相同。又因无须加入佐剂以强化免疫反应，避免了添加佐剂可能产生的副作用。第三期临床试验结果证实，CELVAPAN禽流感疫苗可诱发人体对自然流感病毒感染的防御能力。
第三期临床试验结果
此试验的主要目的为评估两组不同年龄族群(18-59岁成人组及60岁以上的年长组)对7.5μg越南病毒株的安全与免疫反应。而抗体的持续性与使用相同或不同病毒株疫苗追加接种之后的免疫反应，也列入评估。这次的试验还探讨了疫苗是否对不同的H5N1病毒株具有诱发交叉免疫反应的能力。
整体研究结果显示，人体对第一剂与第二剂注射的疫苗耐受性，与后来再追加注射的耐受性一样好，且其安全性与目前核淮的季节性流感疫苗相似。而一般常见的副作用包括注射部位酸痛、头痛与产生疲倦感等。
使用中和试验侦测有效的抗体可得知，即使只有一次疫苗接种也能诱发阳性免疫反应(成人组50.7%；年长组54.4%)，第二次疫苗接种后，73%成人组与74%年长组的人有阳性免疫反应。该试验结果意谓著年长族群与成人族群对疫苗至少具有相同的免疫反应。不论6个月后追加接种越南病毒株(A/Vietnam/1203/1204)或印尼病毒株(A/Indonesia/05/2005)的疫苗，都可以诱发更强的反应。而使用不同病毒株追加接种的结果显示，人体对于第一种与后来的病毒株皆产生高抗体反应，这也表示该疫苗可以引发交叉保护的免疫记忆。
今年六月，新英格兰医学杂志刊登百特研发的禽流感疫苗CELVAPAN通过了第一、二期人体试验的安全性和免疫力报告。这也是第一次针对禽流感疫苗CELVAPAN研究计画的刊登文献，为全球第一个进入临床评估阶段的细胞培养新禽流感疫苗。
何谓流感大流行
大流行是一种流行全球的疾病．经由人类甚少或全无抵抗力的病原造成的，且极易经由人传人而蔓延全世界，进而造成严重的疾病与死亡。目前最受关注的是对人类健康具有严重威胁的禽流感，其传播途径为直接或间接接触已感染的家禽类诸如鸡、鸭、火鸡或是鸟类。禽流感已被证实具有高致病率，病毒亦不断变异、进化导致高死亡率，已引起全球高度关注。
关于百特
百特医疗产品股份有限公司(Baxter International Inc.) 以提高客户生活品质为主要宗旨来製造和生产医疗产品，服务范围涵括血友病、免疫疾病、传染病、肾脏病、外伤，和其他慢性和急性病等疾病。身为世界顶尖医疗产品的製造销售商，百特公司致力于提供独特且多元化医疗产品线，如肾脏医疗产品、药物输注系统以及生物製剂产品等。
http://www.baxter.com.tw/about_baxter/news/2008/sub/0612.html
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