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Draadje vogelgriep - Deel 2

1. flosz 22 februari 2008 12:34

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   Vervolg.
   Phages, of volluit bacteriophages, zijn virussen die bacterieen infecteren. In het wild zijn er zeeeer veel variaties, en phages spelen een belangrijke rol bij de evolutie van bacterieen, door transport van DNA van één bacteriesoort naar een ander.
   Sinds de jaren tachtig is de phage display techniek ontwikkeld en uitgebreid. De eerste stap is het creeren van een library. Hierbij worden een grote variatie aan eiwitten, of in het specifieke geval van Crucell, menselijke antilichamen, biotechnologisch gekoppeld aan een de buitenkant van een bepaalde phage. Deze variatie aan antilichamen komt vaak van een donor, d.w.z., alle in het bloed aanwezige antilichamen van de donor worden verzameld. Dit kunnen er vele verschillende zijn (miljoenen). (Ik neem aan dat als er antilichamen tegen H5N1 worden gezocht, er gestart wordt met bloed van een donor die geinfecteerd is/was met H5N1, maar weet dit niet zeker).
   Al deze antilichamen worden dus eerst gekoppeld aan de buitenkant van de phages, waardoor er miljoenen verschillende phages ontstaan, met verschillende menselijke antilichamen aanwezig ("ge-displayed") aan de buitenkant.
   
   Deze "phage library" bevindt zich in een waterige oplossing. Slechts enkele van de miljoenen verschillende ge-displayde antichamen zijn potentieel actief tegen H5N1 (of een andere ziekte). De kunst is nu om juist die er uit te vissen. Dat gebeurt nu door op een vast oppervlak een laagje met (in dit geval) H5N1 virus (of een onderdeel daarvan) te plakken. De phage library vloeistof wordt hierop aangebracht. Na enige tijd wachten wordt deze vloeistof weggewassen, inclusief de meeste phages. ALLEEN de phages met antilichamen die actief zijn tegen H5N1 zijn blijven plakken op dit H5N1 laagje, omdat deze antilichamen zich binden aan het H5N1 virus. Deze phages worden van het laagje afgehaald, vermenigvuldigd, en de hele procedure wordt nog een paar keer herhaald. Zo blijven alleen de phages/antilichamen over met de allersterkste werking tegen H5N1. Deze antilichamen worden uiteindelijk geisoleerd, waarna ze gekarakeriseerd kunnen worden, en vermeningvuldigd met behulp van Per.C6.
   www.iex.nl/forum/topic.asp?forum=228&...
   
   Presentation CSO Jaap Goudsmit at the 5th Bird Flu Summit in Las Vegas, Nevada
   Thursday, September 27 at 23.00 PM (CET)
   hugin.info/132631/R/1156548/223246.pdf
   
   IV, by sunshine:
   Vaccine vs Mono/Polyclonal Antibodies
   Antibodies to treat infectious disease is a completely new therapy not previously used or explored to treat infectious disease with one exception rabies where no other treatment existed for post exposure treatment and came from pooled human blood (not ideal for many reasons).
   Until Perc.6 the cost for production and for research and development was to high to consider antibodies as a therapeutic option. Until now antiboides have been used in severe disease processes only such as cancer. Crucell has changed this with an efficient and highly productive platform for production. President Brus has said that Crucell can produce the antibodies for rabies for about $10 (now in clinical trial) where it has cost $1000 or more in the past for a pooled human antibody product. The cost of production is low enough that it can and I beleive will be an important therapeutic arm for infections.
   Vaccines will always be the first defense against viral infection from a cost position alone but vaccines have to be given at least several weeks prior to exposure to allow the body to produce the necessary antibodies to provide protection. When a vaccine can not be produced in time or is not available an antibody product may be a great alternative. In addition the vaccine for may of these infections is only partially effective and serious disease can occur in those immunized, This is especially true for influenzae where the vaccines have been only marginally helpful expecially in the elderly. There are only a few vaccines available for bacterial infections and only marginally effective.
   We are increasingly having problems with multiple durg resistent organisms from staph to TB and antibodies may help fill the gap.
   It is very exciting to see this new field of medical therapeutics in developmenta dn Crucell at the forefront
   
   crucell.yourbb.nl/viewtopic.php?f=20&...
   
2. [verwijderd] 22 februari 2008 12:37

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   Voor de volledigheid:
   
   meer over de anti-lichamen in dit draadje:
   
   www.iex.nl/forum/topic.asp?forum=228&...
3. flosz 22 februari 2008 12:54

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   quote:

   Gert50 schreef:

   Voor de volledigheid:
   
   

   Staat erbij...lol
   www.iex.nl/forum/topic.asp?forum=228&...
4. flosz 1 maart 2008 16:38

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   Tables on the Clinical trials of pandemic influenza prototype vaccines:
   www.who.int/vaccine_research/diseases...
   
5. flosz 12 maart 2008 13:51

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   Slides presentatie Jaap Goudsmit erbij...
   
   www.crucell.com/page/downloads/4_Jaap...
   
   human mAb CR6261 deals with uncertainty of strains
   human mAb CR6261 prevents death and blunts disease from H5N1
   prevents death and blunts disease even after four days
   human mAb CR6261 prevents death by H1N1 before and after infection
   
   Damn Good!
6. yinx 12 maart 2008 14:31

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   Wat ik mij afvraag, of deze mAbs m.b.v. PerC6 geproduceerd mogen worden vanwege het exclusieve contract met Sanofi m.b.t. influenza. Jammer dat niemand deze vraag stelde tijdens de q&a sessie.
   
   Zo niet, dan is Sanofi de enige mogelijke partner voor dit programma als ze op Per C6 willen produceren, of een deal om te delen in de eventuele opbrengsten. Dat gekluns met eieren lijkt me bij een pandemie een te langdurig proces.
   
   YinX
7. [verwijderd] 2 april 2008 21:20

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   China authorizes commercial production of human bird flu vaccine
   
   
   www.chinaview.cn 2008-04-02
   
   BEIJING, April 2 (Xinhua) -- China's food and drug regulators on Wednesday authorized a domestic pharmaceutical firm to begin commercial production of a human bird flu vaccine, following more than two years of clinical trials.
   
   The firm, Beijing-based Sinovac Biotech Co., Ltd. will produce vaccines to defend humans against the H5N1 virus and its epidemic variety.
   
   According to Yin Weidong, general manager of the firm, Sinovac has the ability to produce new vaccines even if the virus mutates in humans.
   
   China started clinical research and experiments as part of the process of making a vaccine in November 2005, after a domestic epidemic that caused huge losses for poultry breeders.
   
   Since 2005, there have been 29 human cases reported, according to the Chinese Center for Disease Control and Prevention.
   
   news.xinhuanet.com/english/2008-04/02...
8. flosz 9 april 2008 14:42

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   U.S. Department of Health and Human Services
   Pandemic Planning Update V
   A Report from Secretary Michael O. Leavitt
   March 17, 2008
   
   Since the HHS Pandemic Influenza Plan went into effect in November 2005, the Department has advanced the nation’s pandemic preparedness in a broad range of activities. HHS has worked to expand and diversify domestic vaccine production and surge capacity, enlarge H5N1 pre-pandemic vaccine and antiviral drug stockpiles, support advanced development of cell culture and antigen-sparing influenza vaccines and new antiviral drugs, support advanced development of point-of-care clinical diagnostics, and stockpile medical supplies, ventilators, and personal protective equipment such as facemasks and respirators. HHS is also building a robust and comprehensive portfolio leading to a broad array of medical countermeasures — vaccines, antivirals, and diagnostic tools.
   
   Vaccines and Vaccine Production Capacity
   A flu pandemic poses unique public health challenges. A novel influenza virus means that everyone in the world is susceptible, and the entire population should be vaccinated for optimal protection. Our investments in science and vaccine research will help bring about a new generation of influenza vaccines that could take the threat of a pandemic off the table. But our current approach requires that production of a pandemic vaccine can only start once that virus appears — after the flu pandemic begins — and we will be challenged to allocate a limited supply of vaccine early in a pandemic. We are taking steps now to address these challenges.
   
   
   Vaccine Production
   One of HHS’ highest priorities, in concert with an array of leading pharmaceutical companies, is to enhance and expand U.S.-based production capacity to the point that it can generate 600 million doses of a pandemic influenza vaccine (two doses for every American) within six months of the time that a reference strain of the actual pandemic virus is developed. When this initiative began just over two years ago, the U.S. had only a small fraction of this target capacity. Only two domestic manufacturers of approved influenza vaccine existed, and only one of those had a product that was licensed for use in all appropriate age groups.
   Today, with HHS funding, six companies are in various stages of implementing commercial-scale production cell culture methods and/or expanding their capacity for conventional manufacturing using chicken eggs. The target date for achieving the 600 million dose target is 2011. The work is on schedule.
   The driving motivation to build this target production capacity within the U.S. is to ensure that we can provide pandemic influenza vaccine for every American without having to purchase and import it from foreign-based manufacturing facilities. A condition of HHS’ funding for the participating companies is that their manufacturing facilities be located within the United States.
   
   No one can say with certainty when new technologies such as recombinant DNA vaccines will take center stage for influenza vaccine manufacturing. But HHS is committed to accelerating the maturation of DNA vaccines and other emerging technologies, funding important research on DNA vaccines against influenza viruses and soliciting contract proposals for advanced development of a DNA vaccine. This latter initiative is a critical milestone on the path from the laboratory bench to the manufacturing floor.
   
   www.pandemicflu.gov/plan/pdf/panflure...
   
9. [verwijderd] 12 april 2008 17:42

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   Bird Flu Transmission Evolution Scare
   
   BBC announced that there was a scare yesterday that a case of bird flu was transferred from one human to another, when a 52 year old father assumed he had caught bird flu from his son. Genetic analysis by the Lancet falsifies these claims but the potential for the virus to mutate and allow for human to human transmission strongly exists. Interestingly enough, after the 52 year old man was treated with anti-virals and a plasma cell transfer from a person who had previously vaccinated against the virus - he surrived!
10. [verwijderd] 15 april 2008 11:42

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    De concurrentie zit niet stil.
    
    Scientists Create First Successful Libraries of Avian Flu Virus Antibodies
    
    News source: Business Wire
    
    An international group of American and Turkish research scientists, led by Sea Lane Biotechnologies, has created the first comprehensive monoclonal antibody libraries against avian influenza (H5N1) using samples from survivors of the 2005/2006 "bird flu" outbreak in Turkey. These antibody libraries hold the promise for developing a therapy that could stop a pandemic in its tracks and provide treatment to those infected, as well as potentially pointing the way towards the development of a universal flu vaccine.
    
    The expanded treatment and containment options offered by Sea Lane's antibody libraries could help provide healthcare officials, researchers, and governments with unprecedented resources to combat this serious global health threat.
    
    "Three global influenza pandemics have occurred within the past 100 years, each with devastating consequences," said Richard A. Lerner, the Lita Annenberg Hazen Professor of Immunochemistry at, and President of, the Scripps Research Institute (La Jolla, CA) who collaborated with Sea Lane on the study. "Our study holds out the hope that a new outbreak could potentially be stopped at an early stage, and that effective treatment could be available to those infected."
    
    The study is being published in this week's Early Edition of the journal Proceedings of the National Academy of Sciences.
    
    Libraries Have Yielded More Than 300 Antibodies Active Against Avian Influenza
    
    So far, the new antibody libraries reported in the study have yielded more than 300 unique monoclonal antibodies that are active against H5N1 antigens--foreign substances that produce an immune system response. From this group, the authors identified several broadly neutralizing antibodies that were effective against a number of contemporary subtypes of H5 (avian) flu.
    
    Moving Towards A Universal Influenza Vaccine
    
    The new research reported here suggests that the antibodies recovered from the avian flu survivors may point to an exploitable weak spot in the virus, offering the tantalizing possibility that a "universal" vaccine against all strains might be made.
    
    Remarkably, three of the more than 300 antibodies catalogued have been found to neutralize both the H1 (common seasonal flu) and H5 (avian) subtypes.
    
    "The antibodies we have isolated have the potential to be used directly as therapeutic agents against multiple influenza subtypes, permitting the resolution of infection upon administration to an infected individual," said Peter Palese, the Horace W. Goldsmith Professor & Chairman of Microbiology at The Mount Sinai School of Medicine (New York, NY), another collaborator on the project.
    
    "Perhaps most importantly, these antibodies may be used to identify cross-reactive epitopes on the hemagglutinin protein of an influenza virus. Identification of such epitopes may allow the rational design of vaccines with cross-subtype neutralizing activity.
    
    Such vaccines would constitute a major advance on current technology, and would be a first step towards the design of a universal influenza vaccine," noted Palese.
    
    Preventing The Worst-Case Scenario - Another Global Influenza Pandemic
    
    Human infection with the avian flu virus H5N1 was first reported in 1997. Since 2003, according to the World Health Organization, more than 370 confirmed cases of human infection have been reported in 14 countries.
    
    While overwhelmingly confined to bird populations in Asia and Europe, the H5N1 avian flu virus has shown its ability to infect humans and has killed more than 230 people around the world.
    
    Epidemiologists remain concerned that the virus will one day mutate and be able to spread more readily between people, sparking a global pandemic. The 1918-1920 Spanish flu, which shows evidence of originating in birds, killed somewhere between 40 and 100 million people.
    
    The antibodies recovered from these H5N1 survivor libraries, described in the report, provide opportunities for passive immunization with monoclonal antibodies that could help future individuals infected with H5N1 successfully overcome infection.
    
    Monoclonal antibody therapy is known as passive immunotherapy because patients are treated with antibodies that were made outside of their own immune systems instead of those actively made internally.
    
    The potential for passive immunization against influenza has been evident since the Spanish influenza pandemic nearly a century ago, where the benefits of transfused blood reduced the risk of mortality by more than 50 percent.
    
    Additionally, the benefits of treatment with convalescent plasma have begun to be reported in instances of H5N1, while passive immunization with human and mouse monoclonal antibodies have been shown to protect animals from death, even when given after H5N1 infection.
    
    Offers Additional Therapeutic Potential
    
    "The antibodies we recovered from Turkey have important and broad potential," said Michael Horowitz, Chief Operating Officer for Sea Lane.
    
    "They could lead the way to providing significant protection against a broad reach of influenza--perhaps as protection to first responders and those at immediate risk, and then as treatment for those infected."
    
    According to Ramesh Bhatt, Vice President for Research at Sea Lane, "The combination of the team's innovative antibody library techniques and tremendous scientific rigor enabled the recovery of this extensive collection of antibodies from the avian flu survivors.
    
    Because of the large number of antibodies obtained, we were able to perform a detailed immunochemical analysis of these survivors' antibody solutions against avian influenza virus during an actual outbreak."
    
    The resulting antibody libraries--collections of genetic antibody material--were not dependent on whether an important antibody was being produced by the body at the time of the sample collection. Instead, the scientists were able to obtain the entire immunologic history of an individual's response, which offered a clearer picture of the relationships between antibodies and their relative effectiveness. These insights may help scientists determine prescient strategies for therapies as the virus mutates in the future.
    
    "Our libraries create a roadmap for improving the efficacy and/or specificity of therapeutic influenza antibodies," Arun Kashyap, Director of Influenza and Antibody Libraries for Sea Lane said.
    
    "As a result, we might be able to engineer the best features of different antibodies into a single antibody that may not only treat contemporary strains of influenza, but also future influenza strains which normally would escape through simple mutations."
    
    - snip -
    
    Other authors of the study, Combinatorial Antibody Libraries from Survivors of the Turkish H5N1 Avian Influenza Outbreak Reveal Virus Neutralization Strategies, include Michael A. Dillon, Ryann E. Swale, Katherine M. Wall, Kimberly J. Perry, and Aleksandr Faynboym of Sea Lane Biotechnologies; John Steel of The Mount Sinai School of Medicine; and Mahmut Ilhan and Ahmet F. Oner of Yuzuncu Yil University.
    
    The study was supported by Sea Lane Biotechnologies, LLC. Partial support to Peter Palese was also provided by NIH grants.
    
    www.genengnews.com/news/bnitem.aspx?n...
11. flosz 15 april 2008 12:28

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    quote:

    Gert50 schreef:

    De concurrentie zit niet stil.
    
    Scientists Create First Successful Libraries of Avian Flu Virus Antibodies
    
    News source: Business Wire
    
    An international group of American and Turkish research scientists, led by Sea Lane Biotechnologies, has created the first comprehensive monoclonal antibody libraries against avian influenza (H5N1) using samples from survivors of the 2005/2006 "bird flu" outbreak in Turkey. These antibody libraries hold the promise for developing a therapy that could stop a pandemic in its tracks and provide treatment to those infected, as well as potentially pointing the way towards the development of a universal flu vaccine.
    
    - snip -
    
    

    - snap -
    
    Crucell has discovered the first human monoclonal antibodies for the prevention and treatment of avian flu. The antibodies provide immediate protection and neutralize the broadest range of H5N1 strains in pre-clinical models.
    
    Leiden, The Netherlands, September 27, 2007 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL, Swiss Exchange: CRX) today announced the discovery of a set of human monoclonal antibodies against H5N1. These results, demonstrating the potential of human monoclonal antibodies for pandemic preparedness, were presented today at the 5th International Bird Flu Summit held in Las Vegas, Nevada.
    
    A total of twenty one human monoclonal antibodies were discovered. These were found to be able to neutralize the H5N1 virus of avian influenza, which currently presents a global threat. The most potent of the antibodies was shown to neutralize the broadest range of H5N1 strains that have emerged between 1997 and 2004. This antibody may therefore provide a powerful tool in pandemic preparedness. In addition, this antibody prevents flu, in pre-clinical models, when given twenty four hours before a challenge with a lethal dose of highly pathogenic H5N1 virus. When given three days after infection, it also was shown to prevent death and cure the disease.
    
    "Our discovery of potent human monoclonal antibodies against a number of different H5N1 pandemic flu types, provide proof of concept that antibodies are a serious alternative to vaccination or antiviral treatment", said Dr. Jaap Goudsmit, Chief Scientific Officer of Crucell. "What is most encouraging is the fact that these antibodies are not only able to prevent infection, but also open the possibility to treat infected individuals. Treatment with this antibody provides an instantaneous antiviral response, which is an advantage over the delayed immune response after (prepandemic) vaccination."
    
    The set of monoclonal antibodies, which was produced by Crucell researchers using phage display and Crucell PER.C6® technology, showed the potential to neutralize distinct H5N1 viruses, A/Vietnam/11994/04, A/Hong Kong/213/03 and A/Hong Kong/156/97. The antibodies apparently recognize a part of the viral membrane protein that is present among all H5N1 viruses tested. The most potent neutralizing antibody was tested in pre-clinical models for the ability to protect against infection with the highly pathogenic A/Hong Kong/97 H5N1 virus and was also tested for its ability to stop the development of the disease caused by this virus. When the monoclonal antibody was given in a pre-clinical model, one day prior to infection with the H5N1 virus, it resulted in full protection against infection. Treatment with the antibody up to three days after infection, resulted in 100% survival and cure of the disease.
    
    123video.nl/playvideos.asp?MovieID=14...
    
12. [verwijderd] 28 april 2008 09:45

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    AFX UK Focus) 2008-04-28 07:39
    
    Sanofi-Aventis wins new $192.5 mln order for avian flu vaccine from U.S. govt
    
    PARIS (Thomson Financial) - Sanofi Pasteur, the vaccines division of Sanofi-Aventis, said it has received an order worth $192.5 million from the U.S. government for vaccines against a new strain of avian influenza.
    
    Sanofi Pasteur said it will receive from the U.S. Department of Health and Human Services (HHS) a payment of $192.5 million, to be booked in the second quarter of 2008, for supplying H5N1 bulk vaccine antigen that will produce approximately 38.5 million doses of vaccine.
    
    In 2007, Sanofi Pasteur received $126.9 million for its bulk pandemic vaccine as part of a multi-year contract with HHS under the department's pandemic program.
    
    The company said the antigen in the latest order will protect against a clade 2.2 strain of H5N1 virus (A/Barheaded goose/Qinghai Lake/01/2005) that is the first to be identified in an outbreak of migratory birds, which have the potential to spread the virus across continents.
    
    Sanofi Pasteur last year received a U.S. licence for its H5N1 vaccine, the first avian influenza vaccine for humans.
    
    www.iii.co.uk/news/?type=afxnews&arti...
13. [verwijderd] 28 april 2008 10:02

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    Helaas nog gewoon op eitjes gefabriceerd.
    
    Dirk
14. flosz 8 mei 2008 16:03

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    Bill Gates to explore bird flu vaccine development in Indonesia
    
    Jakarta (ANTARA News) - Owner and founder of the giant company Microsoft Corporation, Bill Gates, will discuss the development of bird flu vaccine with the Indonesian government during his visit here on May 8 and 9, 2008.
    
    "The Indonesian government and Bill Gates will talk about cooperation in developing bird flu vaccine," Coordinating Minister for People`s Welfare Aburizal Bakrie said here on Tuesday.
    
    Indonesia, Bakrie said, had advance talks on the development of bird flu vaccine with Gates but no conclusion had been reached.(*)
    www.antara.co.id/en/arc/2008/5/6/bill...
    ***********************************
    Feb.2007:
    Public health experts have warned that an H5N1 vaccine deal Indonesia has struck with a pharmaceutical company may jeopardize the world's access to a pandemic vaccine, if the country becomes the epicenter of a global outbreak.
    Indonesia on Wednesday signed a memorandum of understanding with U.S. drug manufacturer Baxter Healthcare Corp. to develop a human bird flu vaccine.
    Under the agreement, Indonesia will provide H5N1 virus samples in exchange for Baxter's expertise in vaccine production. Other organizations would have access to Indonesian samples provided they agree not to use the viruses for "commercial" purposes, said Siti Fadilah Supari, Indonesia's health minister.
    www.foxnews.com/story/0,2933,250909,00.html
    
15. diederique 8 mei 2008 18:56

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    WHO warns of rising bird flu pandemic risk
    
    The headlines may have died down in recent months, but bird flu experts say that the threat of a global pandemic has actually been growing. The World Health Organization outlined the spread of the bird flu virus around the world to 150 experts drawn together to discuss protective measures.
    
    "We can't delude ourselves. The threat of a pandemic influenza has not diminished," said WHO's Keiji Fukuda, coordinator for the Global Influenza Program.
    
    According to the group, the bird flu virus is now endemic in Asia, Africa and parts of Europe as the disease continues to spread in bird populations. There's great concern that at some point the virus will mutate into a new version that is easily spread among humans. Even in its current strains bird flu has infected 382 people and killed 241 of them--an astonishingly high rate of death for a virus. Indonesia has been the hardest hit, counting 108 deaths from the virus.
    
    In response, WHO has been tracking the progress of 16 companies that have been developing new bird flu vaccines and plans to create a stockpile of 150 million doses.
    
    email4.orange.nl/webmail/nl_NL/read.h...
16. [verwijderd] 19 mei 2008 08:54

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    Glaxo to market bird flu vaccine
    
    UK drugs firm GlaxoSmithKline has won European Union approval for its vaccine designed to protect people against the H5N1 strain of bird flu.
    
    The ruling makes Prepandrix the first vaccine to receive a licence for use in the 27-member region.
    
    Other governments, including the US and Switzerland, have already started stockpiling the vaccine.
    
    It is feared that the H5N1 virus could mutate into a form that could be spread between humans, killing millions.
    
    Since 2003, the virus has been circulating in a number of distinct forms in Asia, Europe and Africa.
    
    GSK has said that its Prepandrix vaccine has worked effectively against these different variants.
    
    Other drug firms, including the French drug company Sanofi Aventis and Swiss Novartis, have also been working on bird flu vaccines, which analysts say could be worth $1bn in revenue for the firms.
    
    Up until now, H5N1 has remained primarily a virus affecting birds, but scientists fear it is the most likely next global pandemic in humans.
    
    news.bbc.co.uk/1/hi/business/7407714.stm
17. flosz 23 mei 2008 10:03

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    Twee jonge doden door griepvirus
    Publicatie: Nr. 21 - 23 mei 2008
    Rubriek: NieuwsReflex
    Bron(nen): 886
    
    Zowel in Utrecht als in Rotterdam is een patiënt overleden aan griep, door resistentie tegen oseltamivir (Tamiflu). De slachtoffers waren jonge patiënten met een sterk verzwakt immuunsysteem.
    
    De Rotterdamse hoogleraar virologie Charles Boucher maakte melding van slachtoffers van het resistente griepvirus op het congres ‘100 jaar farmacologie’ op 16 mei in Utrecht. ‘Jaarlijks overlijden duizend mensen aan de griep, maar dat zijn ouderen. Het was zwaar deze jonge patiënten te verliezen aan griep’, licht Boucher toe
    
    ‘Tot voor kort dachten we dat er geen resistente griepvirussen waren tegen oseltamivir. Dat blijkt onjuist. Voor de klinische praktijk is het belangrijk dat rekening wordt gehouden met deze mogelijkheid van resistentie.’
    
    Op 31 januari 2008 meldde het tijdschrift Eurosurveillance voor het eerst resistentie van het griepvirus H1N1 tegen oseltamivir. Deze virussen waren nog wel gevoelig voor zanamivir (Relenza) en amantadine of rimantadine. In Nederland was 6 procent van de gemeten H1N1-virussen resistent.
    
    Oseltamivir heeft een duidelijke plaats bij de preventie van griep bij immuungecompromitteerde patiënten, bijvoorbeeld na een transplantatie. Een ‘normaal’ griepvirus kan voor deze patiënten dodelijk zijn. In het algemeen is in Nederland veel te weinig aandacht gegeven aan griep, volgens viroloog Boucher.
    medischcontact.artsennet.nl/content/d...
    
18. [verwijderd] 11 juni 2008 23:38

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    The New England Journal of Medicine Publishes Study Investigating the Safety and Efficacy of Baxter's Cell-Based Pandemic, Avian Flu Vaccine
    
    
    First scientific, peer-reviewed publication showing the candidate vaccine
    induced neutralizing antibodies against widely divergent H5N1 virus
    
    DEERFIELD, Ill., June 11 /PRNewswire-FirstCall/ -- Baxter International
    Inc. (NYSE: BAX) announced publication in the June 12, 2008 issue of The
    New England Journal of Medicine (NEJM) of data demonstrating Baxter's
    candidate avian influenza (H5N1) vaccine, CELVAPAN, met Phase I/II trial
    endpoints for safety and immunogenicity (generating a functional immune
    response). This is the first peer-reviewed publication of study results for
    CELVAPAN, the first cell culture-derived avian influenza vaccine to undergo
    clinical evaluation. The primary authors of the manuscript are Hartmut J.
    Ehrlich, MD, vice president of global research and development for Baxter's
    BioScience business, and Noel Barrett, vice president of Baxter's vaccines
    research.
    
    "Cell culture technology could represent the future of influenza
    vaccine production," said John Oxford, professor of Virology, The Queen
    Mary School of Medicine, London, United Kingdom. "Baxter has demonstrated
    the ability to rapidly make large quantities of the vaccine that may
    protect people against divergent H5N1 viruses."
    
    Based on manufacturing processes, Vero cell technology may offer
    several advantages versus conventional egg-based vaccine technology.
    Baxter's Vero cell manufacturing process is more rapid due to its ability
    to use a "native" virus that does not need to be modified to allow growth
    in chicken eggs, therefore accelerating vaccine production.
    
    "CELVAPAN combines innovative science and breakthrough production
    technology with the aim of protecting people against an H5N1 pandemic flu
    infection," said Hartmut J. Ehrlich, MD. "This is an immunogenic vaccine
    without the need for an adjuvant to boost the immune response."
    
    About CELVAPAN
    
    CELVAPAN is manufactured in a cell culture-based system in Bohumil,
    Czech Republic, at one of the largest cell culture vaccine production
    facilities in the world. Vero cell technology uses a well-established cell
    line originally derived from African green monkey kidneys in 1962. A
    continuous cell line has been derived from these cells so that an unlimited
    supply of cells is available without the requirement of generating
    additional cells from animals.
    
    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 without the need to enhance an
    immune response by including adjuvants, additives that may cause side
    effects. In this Phase I/II study, CELVAPAN induced an immune response that
    is similar to the body's defense against a natural virus infection. Earlier
    this year CELVAPAN was accepted for licensure review by the Committee for
    Medicinal Products for Human Use within the European Medicines Agency,
    making it the first cell culture-based pandemic influenza vaccine to be
    reviewed by the regulatory authority. The U.S. National Institute of
    Allergy and Infectious Diseases (NIAID), part of the National Institutes of
    Health, is also conducting a trial with Baxter's CELVAPAN in the United
    States.
    
    Phase I/II Clinical Trial Results
    
    The randomized Phase I/II study enrolled 284 subjects in Austria and
    Singapore (ages 18-45) and met its immunogenicity and safety endpoints. The
    study mainly investigated the ability of the vaccine to induce substantial
    levels of cross-immunity against divergent H5N1 strains.
    
    The trial tested four different antigen concentrations ranging from
    3.75 micrograms to 30 micrograms; 7.5 micrograms and 15 micrograms
    formulations were studied with and without adjuvant (additive).
    Statistically, the non- adjuvanted formulations induced the highest rates
    of subjects with a titer (antibody concentration in the blood) more than
    1:20 after the first (40.5 percent and 39.5 percent for 7.5 micrograms and
    15 micrograms) and second (76.2 percent and 70.7 percent for 7.5 micrograms
    and 15 micrograms) vaccinations, demonstrating this vaccine generates a
    robust immune response.
    
    Regarding seroconversion (development of antibodies) or the percent of
    subjects demonstrating a more than four-fold increase in titer after
    immunization, the highest responses were again seen with the 7.5 micrograms
    and 15 micrograms non-adjuvanted formulations, with 69.0 percent and 68.3
    percent seroconversion, respectively.
    
    High levels of cross-reactivity were demonstrated against the A/Hong
    Kong strain with the 7.5 micrograms and 15 micrograms non-adjuvanted
    formulations (76.2 percent and 78.0 percent, respectively, with
    neutralizing titer more than 1:20). The responses against the clade 2
    strain were somewhat lower (45.2 percent and 36.6 percent with NT titers
    greater than or equal to 1:20 for the 7.5 micrograms and 15 micrograms
    non-adjuvanted formulations, respectively). This demonstrates the ability
    of the vaccine to induce cross-reactive immune responses against divergent
    H5N1 strains.
    
    The most common side effects were injection site reactions, headaches
    and fatigue, and the most common local reaction was pain at the injection
    site.
    
    Baxter's Pre-Pandemic Planning Efforts
    
    Baxter works closely with governments worldwide on pandemic
    preparation. The company has delivered several million doses of CELVAPAN to
    various governments around the world. In 2006, Baxter entered into a
    pandemic preparedness contract with the Austrian Ministry of Health to
    supply 16 million doses of pandemic influenza vaccine in the event a
    pandemic is declared. The company also delivered a stockpile of two million
    doses of CELVAPAN to the U.K. Department of Health as part of an agreement
    announced in February 2006. To improve access to treatment in developing
    countries, Baxter also supports the World Health Organization's pandemic
    planning programs through participation in a planned international
    stockpile program.
    
    www.prnewswire.com/cgi-bin/stories.pl...
19. [verwijderd] 13 juni 2008 12:30

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    Ben geen expert, maar IMHO zijn de resultaten van de clinical trial van Baxter niet bepaald denderend.
    
    
20. flosz 16 juni 2008 19:06

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    Kijk oudje, even vloeken......lol.
    
    ir.vical.com/phoenix.zhtml?c=83618&p=...