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  1. yinx 3 november 2006 15:05
    Published: 15:00 03.11.2006 GMT+1 /HUGIN /Source: Crucell N.V. /AEX: CRXL /ISIN: NL0000358562

    The Netherlands Invest €18.4 Million to Develop Better Vaccines to Fight Raging TB Pandemic

    Aeras to Partner with Crucell, KNCV Tuberculosis Foundation and other Top Dutch Scientific Organisations

    (The Netherlands, Nov. 3, 2006) As extreme forms of drug resistant tuberculosis threaten to make the TB pandemic even worse, Dutch funding and scientific expertise are playing a critical role in the development of new, more effective TB vaccines.



    The Dutch Ministry of Foreign Affairs (DGIS) made an €18.4 million, four-year investment in Aeras Global TB Vaccine Foundation, a Product Development Partnership (PDP) that is collaborating with Crucell N.V., KNCV Tuberculosis Foundation, Netherlands Cancer Institute (NKI-AVI) and other Dutch organizations to develop new TB vaccines.



    "Vaccines have wiped out smallpox and nearly eliminated polio. A vaccine for TB could reverse the tide of the TB pandemic and save millions of lives," said Dr. Jerald Sadoff, President and CEO of Aeras Global TB Vaccine Foundation. "The Netherlands has shown great global leadership to develop new solutions to global health problems that burden developing countries. DGIS' strong financial support for Aeras' work and the Netherlands' first-rate scientific expertise will both speed development of a new vaccine and help mobilize commitments from other donor countries."

    TB kills nearly 2 million people a year, TB/HIV co-infection is worsening the pandemic, and recently-discovered extremely drug resistant TB (XDR-B), is on the rise, particularly in Eastern Europe and countries on the Baltic Sea. Today's TB vaccine is more than 85 years old, provides only marginal protection for infants and provides very little, if any, protection beyond childhood. Aeras' goal is to develop new, safe and effective vaccine regimens that prevent TB in children, adolescents and adults, targeted for licensure in 7-10 years.



    The Netherlands is taking a leading role in the battle against TB, both in terms of investment and in the knowledge and expertise in TB control. DGIS is also investing €12 million to develop new TB drugs and diagnostics, the current versions of which are also insufficient to combat the growing TB pandemic. Together, DGIS' €30.4 million investment is the single largest contribution ever by any country for the development of new tools against the global TB pandemic. It is also the single largest grant Aeras has received from any country government.



    "This initiative is a crucial step forwards in the continued development of our vaccine that is currently in Phase I clinical trials," commented Dr. Jaap Goudsmit, CSO of Crucell. "It is wonderful that the Netherlands is taking the lead in this battle against this truly devastating disease."



    "These investments show that the Dutch government not only talks about stopping TB, it is doing something about it," said Dr. Martien Borgdorff, Executive Director of KNCV Tuberculosis Foundation.



    "Working with the Aeras, NKI-AVL will provide a full characterization of Aeras' recombinant BCG, which escapes from the "endosome," thus providing a considerable support to the ultimate success of this new TB vaccine candidate," said Peter Peters, Professor of Structural Biology at NKI-AVL.



    Aeras is pursuing a "prime-boost" strategy in which an improved TB vaccine (BCG), the prime, will be given initially, and another type of vaccine, the boost, will be given at a specified period of time after the prime vaccination. Aeras' Dutch partners include:



    · Crucell N.V., a leading biotechnology and vaccine developer, which, in partnership with Aeras, is developing Aeras 402/Crucell Adenovirus35 TB vaccine. Last week, this vaccine went into clinical trials, marking the first time the world's most advanced adenovector technology has been used in humans.

    · KNCV Tuberculosis Foundation, one of the world's most influential TB research, training, and policy organizations, which will continue to provide epidemiological support at Aeras' South Africa trial site and help establish new TB vaccine clinical trial sites in other countries.

    · Netherlands Cancer Institute (NKI), a leading cancer research organization, which has discovered a promising new method of identifying the location of TB and BCG organisms inside the cell that could significantly impact development of crucial TB vaccine candidates.

    DGIS made the investment as part of a program to support "Public-Private Partnerships for research into and the development of medicines, vaccines and diagnostic aids in the domain of AIDS, tuberculosis and malaria."



    About the Netherlands Ministry of Foreign Affairs

    The Ministry of Foreign Affairs is the channel through which the Dutch Government communicates with foreign governments and international organisations. It coordinates and carries out Dutch foreign policy. Through its Directorate General for International Development Cooperation (DGIS) it channels and coordinates development aid.

    The Ministry has two halves: its headquarters in The Hague and its missions abroad (embassies, consulates, and permanent representations). The five key objectives of Dutch foreign policy are:

    · to promote the international order;

    · to promote international peace, security and stability;

    · to promote European integration;

    · to promote sustainable poverty reduction;

    · to maintain and promote bilateral relations.



    About Aeras Global TB Vaccine Foundation

    The Aeras Global TB Vaccine Foundation is a PDP leading an international effort to develop new and more effective tuberculosis (TB) vaccines for the world, and ensure their availability to all who need them as rapidly as possible. Aeras develops candidate vaccines in its own laboratory and actively pursues and helps fund joint development activities with other leading TB vaccine developers around the world. Aeras' goal is to develop, test, characterize, license, manufacture and distribute at least one new TB vaccine within 7-10 years. Aeras is supported by the Bill & Melinda Gates Foundation and has received funding from the US Centers for Disease Control and Prevention and the Government of Denmark, as well as the Netherlands. For more information please visit www.aeras.org



    About Crucell

    Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) is a biotechnology company focused on research, development and worldwide marketing of vaccines and antibodies that prevent and treat infectious diseases. Its vaccines are sold in public and private markets worldwide. Crucell's core portfolio includes a vaccine against hepatitis B, a fully-liquid vaccine against five important childhood diseases, and a virosome-adjuvanted vaccine against influenza. Crucell also markets travel vaccines, such as the only oral anti-typhoid vaccine and the only aluminum-free hepatitis A vaccine on the market. The Company has a broad development pipeline, with several Crucell products based on its unique PER.C6® production technology. The Company licenses this and other technologies to the biopharmaceutical industry. Important partners and licensees include DSM Biologics, sanofi aventis, GSK and Merck & Co. Crucell is headquartered in Lei
  2. [verwijderd] 5 november 2006 11:42
    quote:

    flosz schreef:

    Jerald Sadoff, M.D. over Aeras/Crucell's BCG and Ad35 vector

    Interessant luistervoer............

    Video, start Jerald Sadoff 00: 25:00 u.

    Jerald Sadoff, M.D.
    USA
    President and Chief Executive Officer
    Aeras Global TB Vaccine Foundation
    www.kaisernetwork.org/health_cast/hca...
    ...op ong. 00:28:00 U.... 18 miljoen van de NL-regering voor Aeras!

    Slides:
    www.kaisernetwork.org/health_cast/upl...
    The global plan to Stop TB
    2006 - 2015

    www.stoptb.org/globalplan/GP2flashdet...

    www.stoptb.org/globalplan/assets/docu...

    The funding gap is the difference between total needs for full implementation of the Global Plan to Stop TB 2006-2015 and projections of the funding that will be available over the next 10 years.
    The total cost of the Global Plan is US$56.1 billion over ten years. This includes US$9 billion for new tools working groups and US$47 billion for implementation working groups.
    Today, only about 45% of the total cost or an estimated US$25.3 billion is likely to be available. The estimated funding gap is US$30.8 billion.
    Without additional financial support, we cannot stop TB and save millions of lives.
    The funding gap of US$30.8 billion is not purely a financial gap. It represents critical gaps in global TB control in the next decade:
    It is an equity gap between the haves and have-nots of TB treatment and cure.
    It is a technological gap between the status quo and innovation in TB control.
    It is a humanitarian gap between those who will be saved and those who will not.
    It is a commitment gap between the vision of a TB-free world and the reality.
    www.stoptb.org/globalplan/funding_p1m...
  3. [verwijderd] 6 november 2006 08:51
    quote:

    flosz schreef:

    Sarah Boseley, health editor
    Friday November 3, 2006
    The Guardian

    Tuberculosis, a disease of the 19th century in the western world, is an increasing threat to the 21st, experts said yesterday as fresh figures were published showing the biggest annual rise in cases in the UK since 1999.

    www.hpa.org.uk/infections/topics_az/t...
  4. yinx 20 november 2006 16:52
    Publicatiedatum: 20-11-2006 06:47

    Tbc uit Oost-Europa rukt op
    West-Europa wordt ernstig bedreigd door een gevaarlijke vorm van tuberculose afkomstig uit Oost-Europa. Het komende kabinet moet in EU-verband snel maatregelen treffen om een ramp te voorkomen.

    Dit stelt het KNCV Tuberculosefonds in een persbericht dat vandaag verschijnt. Het fonds spreekt van 'een angstaanjagende variant' van de infectieziekte tuberculose, die vanuit Oost-Europa en Centraal-Azië naar West-Europa komt. 'Het is één minuut voor twaalf', zegt algemeen directeur Martien Borgdorff van het Tuberculosefonds.

    Volgens het fonds moet de ziekte aan de bron worden bestreden. Als ze zich eenmaal heeft verspreid, is dat veel moeilijker en duurder. 'De kosten van preventie en indamming aan de bron zijn een fractie van de uitgaven die gemoeid zijn met de bestrijding van de ziekte in West-Europa zelf.

    De bestrijding van een kleine uitbraak in 1993 in New York kostte $ 4,2 mrd.' De WHO (Wereldgezondheidsorganisatie) heeft berekend dat een effectieve aanpak met goede bestrijdingsprogramma's tussen 2006 en 2015 een investering vergt van bijna $ 9 mrd.

    M ultiresistent

    De woordvoerder noemt het groeiende aandeel van de multiresistente vormen van tbc 'schrikbarend'. Wanneer behandeling niet consequent wordt uitgevoerd, kan zich extensieve resistentie ontwikkelen en wordt de patiënt, en degenen die hij besmet, mogelijk onbehandelbaar. Vooral de extensieve XDR-variant boezemt angst in.

    Oost-Europa is met 14% tot 19% van de nieuwe gevallen een belangrijke bron van deze tbc-vorm. Volgens experts manifesteert zich bij deze longziekte resistentie tegen alle relevante medicijnen. In Letland lijdt 21% van de patiënten aan XDR-tbc. In de voormalige Sovjet-landen, met hun verouderde bestrijdingsstrategieën en verbrokkelde gezondheidssystemen, is het probleem vermoedelijk groter. Arme gebieden en overvolle gevangenissen zijn brandhaarden.

    Immigranten

    Het ministerie van Sociale Zaken en Werkgelegenheid verwacht dit jaar een toestroom van 53.000 tot 63.000 arbeidsmigranten uit Midden- en Oost-Europa. Ook is er een golf van 33.000 tot 45.000 illegale seizoensarbeiders uit deze landen.

    Toch is de toename van de infectieziekte in Europa volgens het Tuberculosefonds een zaak van oost en west. 'In steden als Londen, Parijs en Madrid, waar armoede onder gemarginaliseerde groepen stijgt, stagneert de terugdringing van het aantal tuberculosegevallen. Daarnaast is sprake van grotere infectierisico's onder migranten.'

    In 2004 waren er in Europa circa 450.000 nieuwe gevallen van tuberculose. Jaarlijks overlijden 70.000 mensen als gevolg van de besmettelijke ziekte. Daarmee is tuberculose de dodelijkste infectieziekte.

    Copyright (c) 2006 Het Financieele Dagblad

  5. [verwijderd] 15 december 2006 12:59
    European Medicines Agency
    Pre-authorisation Evaluation of Medicines for Human Use
    7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
    Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47
    E-mail: mail@emea.eu.int www.emea.eu.int
    29 November 2006
    EMEA/71122/2006
    Public Statement on Positive Opinion for Tuberculosis Vaccine
    On 9 September 2005 the COMP adopted a positive Opinion recommending orphan designation of
    recombinant modified vaccinia virus Ankara expressing tuberculosis antigen 85A (MVA TB vaccine),
    a booster vaccine for prevention of tuberculosis disease. The opinion was given on the grounds that
    marketing of the medicinal product would be unlikely to generate sufficient return to justify the
    necessary investment.
    The medicinal product that is the subject of this positive Opinion has a wide public health interest.
    Tuberculosis (TB) is one of the most serious and devastating problems threatening public health
    worldwide. As more than 30 years have passed since the introduction of a new medicinal product to
    prevent or treat TB, the need for new medicinal products cannot be overstated.
    After the publication of the information on this opinion, several potential sponsors of vaccines for
    prevention of tuberculosis disease have expressed their concerns on the impact that the designation
    could have both on the development of other products for prevention and on the application of the
    incentives for Orphan Designated Products, and particularly on the market exclusivity.
    One of the objectives of the orphan drugs Regulation 141/2000 is to stimulate research and
    development in the field of orphan and rare diseases. Therefore, in the EMEA’s view the designation
    of a vaccine will trigger development for other vaccine candidates in the same field, and will also
    increase the interest from other potential sponsors to apply for Orphan Designation. Consequently, it
    will give them the opportunity to benefit from the incentives offered for these products, for instance
    free protocol assistance, which is given before marketing authorisation independently of the existence
    of similar designated products.
    The EMEA would like to clarify that market exclusivity is applicable only after a product has reached
    the market, which means the medicinal product has received a positive opinion from the EMEA
    Committee for Medicinal Products for Human Use (CHMP) and has been granted marketing
    authorisation by the European Commission. As orphan designation does not confer any protection
    during the development of the drug it does not preclude developing a competitor product. Nothing
    prevents the designation for the same or similar products as orphan medicinal products. In addition,
    market exclusivity applies only to the same or similar products for the same therapeutic indication
    after autorisation of a first orphan product, as stated in Article 8(1) of Regulation 141/2000.
    Further information on the definition of similarity and the elements to be considered for its evaluation
    are available in the European Commission guideline on aspects of the application of Article 8 of
    Regulation (EC) No. 141/2000, available from the European Commission website
    (http://pharmacos.eudra.org/F2/pharmacos/archives.htm#2004).
    www.emea.eu.int/pdfs/human/press/pus/...
  6. [verwijderd] 27 december 2006 11:20
    "This agreement will make it possible to speed up the delivery of our malaria and TB vaccines to the people in need, and makes it realistic to do so on the mass scale required," said Jaap Goudsmit, Chief Scientific Officer at Crucell. "It also opens the way for Crucell to speed up the Ebola program with the VRC, which has recently entered a phase I clinical trial. But most importantly, it brings the reality of vaccines such as these significantly closer."

    Crucell's malaria vaccine program is supported by the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health (NIH). The TB vaccine program is a collaboration with the Aeras Global TB Vaccine Foundation. Both programs are based on Crucell's adenovirus vector technology, AdVac®, and are currently in Phase 1 clinical trials.

    www.iex.nl/forum/topic.asp?forum=228&...
  7. [verwijderd] 3 januari 2007 14:50
    quote:

    yinx schreef:

    Publicatiedatum: 20-11-2006 06:47

    Tbc uit Oost-Europa rukt op
    West-Europa wordt ernstig bedreigd door een gevaarlijke vorm van tuberculose afkomstig uit Oost-Europa. Het komende kabinet moet in EU-verband snel maatregelen treffen om een ramp te voorkomen.
    Riskante tbc-vorm bedreigt Nederland
    Nederland en andere West-Europese landen riskeren blootstelling aan een zeer resistente vorm van tuberculose uit Oost-Europa en Centraal-Azië. Volgens de Wereldgezondheidsorganisatie WHO kost effectieve bestrijding ervan euro 9 mrd.
    'Gevangenissen in de voormalige Sovjet-Unie zijn brandhaarden van multiresistente vormen van tbc', zegt epidemioloog Frank Cobelens van het Academisch Medisch Centrum Amsterdam. 'Vooral arbeidsmigranten kunnen de gevaarlijke tbc-variant verspreiden door West-Europa'
    Dit kan volgens hem snel uit de hand lopen. Illegale arbeidsmigranten en asielzoekers van buiten de Europese Unie worden niet gescreend op tbc. De longziekte waart ook rond in Roemenië. Nu de Roemenen zijn toegetreden tot de EU, worden ze niet langer onderzocht op tbc.
    Noodklok
    Het KNCV Tuberculosefonds luidt de noodklok en wijst op het belang van een regionale benadering. 'Medicijnresistentie van tbc is "man made" en ontstaat door het vroegtijdig afbreken van de behandeling al dan niet in combinatie met slechte medicijnen', aldus een woordvoerder.
    Goede bestrijdingsprogramma's zijn de enige manier om medicijnresistentie te voorkomen en terug te dringen. Demissionair minister Hans Hoogervorst van Volksgezondheid erkent het probleem en dringt in een brief aan de Tweede Kamer aan op een 'slagvaardige benadering'.
    Zowel uit Brussel als uit Den Haag gaan jaarlijks enkele tientallen miljoenen naar bestrijding van tbc. Bij de euro 9 mrd die de WHO tot 2015 nodig acht, lijken dat druppels op een gloeiende plaat. Volgens experts moet dit geld er snel komen: preventie en indamming aan de bron is veel goedkoper dan bestrijding in West-Europa.
    In Nederland lijden jaarlijks gemiddeld tien personen aan een multiresistente vorm van tbc (MDR). In 20% van de gevallen is deze niet goed behandelbaar. De behandelkosten per patiënt bedragen euro 100.000 oplopend tot euro 150.000 voor de zeer resistente variant (XDR).
    De laatste variant rukt op in de EU. Bij 21% van de Letten is XDR geconstateerd. Volgens Cobelens is dat 'balanceren op de rand van het doodvonnis'. XDR is in driekwart van de gevallen niet behandelbaar.
    De grootste problemen doen zich voor in overvolle gevangenissen in de oude Sovjet-Unie. Consultant Agnes Gebhard van het KNCV Tuberculosefonds is sinds 2004 betrokken bij een bestrijdingsprogramma in Kazachstan dat in 1997 is opgezet in de provincie Pavlodar en verspreid in andere provincies.
    'Met mijn snoetje op probeer ik alles na te lopen', zegt zij. 'Dat betekent opsporen, de diagnose stellen, behandelen en intensief begeleiden. Maar bij een amnestie belanden tienduizenden gevangenen op straat. Het percentage tbc-patiënten dat zich opnieuw meldt, is in drie jaar tijd gelukkig gestegen van 30% tot 80%.'
    De gevangenispopulatie in Kazachstan is sinds 1997 teruggelopen met 50% tot 61.000, onder meer door kortere straffen en boetes in plaats van hechtenis. Maar bevolkingsgroepen met een verminderde weerstand als hiv-patiënten, armen en ouderen blijven kwetsbaar.
    De Global Alliance for TB Drug Development in New York kan een belangrijke bijdrage leveren aan de bestrijding van resistente vormen van tbc. Aangesloten zijn overheden, wetenschappelijke instituten en bedrijven zoals Bayer en GlaxoSmithKline .
    Er is vooral vraag naar medicijnen die betaalbaar zijn en beschikbaar op afgelegen locaties. Daarnaast is volgens Gebhard behoefte aan nieuwe medicijnen voor lastiger vormen van tbc en voor kortere behandeltijden. Maar volgens analisten is de kans dat dit vóór 2010 al lukt, heel gering.
    Bert Koopman
    Copyright (c) 2007 Het Financieele Dagblad
    Publicatiedatum: 3-1-2007 09:22
    www.fd.nl/ShowRedactieNieuws.asp?Cont...

    Met dank aan Dirk:
    www.iex.nl/forum/topic.asp?forum=228&...

    ....en Babs
    zie: www.artsenzondergrenzen.nl/news/artic...
    www.iex.nl/forum/topic.asp?forum=228&...

    *******************
    Parool:
    www.parool.nl/nieuws/2007/JAN/03/eco2...
  8. [verwijderd] 23 januari 2007 18:49
    The dilemma of a deadly disease: patients may be forcibly detained
    Doctors fear TB strain could cause a global pandemic if it is not controlled

    Chris McGreal in Johannesburg and Sarah Boseley, health editor
    Tuesday January 23, 2007
    The Guardian

    South Africa is considering forcibly detaining people who carry a deadly strain of tuberculosis that has already claimed hundreds of lives. The strain threatens to cause a global pandemic, but the planned move pits public protection against human rights.
    The country's health department says it has discussed with the World Health Organisation and South Africa's leading medical organisations the possibility of placing carriers of extreme drug resistant TB or XDR-TB under guard in isolation wards until they die, but has yet to reach a decision.
    Article continues



    Pressure to take action has been growing since a woman diagnosed with the disease discharged herself from a hospital last September and probably spread the infection before she was finally coaxed back when she was threatened with a court order.
    More than 300 cases of the highly infectious disease, which is spread by airborne droplets and kills 98% of those infected within about two weeks, have been identified in South Africa.
    But doctors believe there have been hundreds, possibly thousands, more and the numbers are growing among the millions of people with HIV, who are particularly vulnerable to the disease. Their fear is that patients with XDR-TB, told that there is little that can be done for them, will leave the isolation wards and go home to die. But while they are still walking around they risk spreading the infection.
    Now a group of doctors has warned in a medical journal that if enforced isolation is not introduced XDR-TB could swamp South Africa and spread far beyond its borders. Regular TB is already the single largest killer of people with Aids in South Africa.
    Pandemic
    Jerome Amir Singh of the Centre for Aids Programme of Research in South Africa and two colleagues wrote in the peer-reviewed journal Public Library of Science Medicine that the government must overcome its understandable qualms over human rights in the interests of the majority. Without exceptional control measures, including enforced isolation, XDR-TB "could become a lethal global pandemic", they say.
    "The containment of infectious patients with XDR-TB may arguably take precedence over any other patients not infected with highly infectious and deadly airborne diseases, including those with full-blown Aids. This is an issue requiring urgent attention from the global community," they wrote.
    "The South African government's initial lethargic response to the crisis and uncertainty amongst South African health professionals concerning the ethical, social and human rights implications of effectively tackling this outbreak highlight the urgent need to address these issues lest doubt and inaction spawn a full-blown XDR-TB epidemic in South Africa and beyond."
    Mary Edginton of the Witwatersrand university's medical school endorses enforced quarantining.
    "You can look at it from two points of view. From the patient's point of view, you are expected to stay in some awful place, you can't work and you can't see your family. You will probably die there. From the community's point of view such a person is infectious. If they go to the shops or wander around their friends they can spread it, potentially to a large group of people," she said.
    Karin Weyer of the Medical Research Council has called for enforced hospitalisation of high-risk TB patients on the grounds that the risks to society outweigh individual rights. But she opposes forcible treatment because of the dangers associated with the drugs.
    Professor Edginton said that medical authorities in the US and other countries can obtain a court order to detain a person with infectious TB or someone who is non-infectious but has failed to adhere to treatment. "The Americans are much better at enforcing their laws on this," she said.
    South African law also permits enforced isolation but some lawyers say it comes into conflict with the constitutional guarantees on individual rights. However, the constitution also guarantees communal rights, including protection from infection and the right to a safe environment.
    South Africa's health department yesterday said it has discussed the possibility of enforced isolation with the country's Medical Research Council and the World Health Organisation but has not reached a conclusion.
    Poor housing
    Ronnie Green-Thompson, a special adviser to the health department, said the issue at stake is the human rights of the individual weighed against the rights of the wider public. "The issue of holding the patient against their will is not ideal but may have to be considered in the interest of the public. Legal opinion and comment as well as sourcing the opinion of human rights groups is important," he said.
    "Also of importance is preventing those factors that lead to infectious TB and these are poverty, poor housing, overcrowding and poor nutrition and any other factors that weakens patients' resistance to acquiring infections."
    Umesh Lalloo, of Durban's Nelson Mandela School of Medicine and head of the research team into the first XDR-TB outbreak, said he is not persuaded that detention is necessary.
    "It's a very difficult call. Given our recent past with human rights violations we need to be careful. I'm not dismissing such a move but it's a very radical step. What we should be pushing for is a reinforcement of the TB control programme which would contain the spread," he said. Professor Lalloo said one consideration is that almost all infections appear to have spread to patients in hospital.
    The doctors and co-authors said that it is essential that patients were detained in "humane and decent living conditions" and they urged the government to change the rules so that those in hospital with TB continue to receive welfare payments which are cut off if they are treated at the state's expense.
    Although cases of XDR-TB were discovered in South Africa a decade ago, the disease started claiming dozens of lives at the small Tugela Ferry hospital in rural KwaZulu-Natal two years ago. XDR-TB's origins are uncertain but the WHO says the misuse of anti-tuberculosis drugs is the most likely cause.
    www.guardian.co.uk/frontpage/story/0,,1996612,00.html
  9. [verwijderd] 6 juni 2007 13:39
    Infect Immun. 2007 May 25; [Epub ahead of print]

    Protective immune responses to an rAd35 TB vaccine in two mouse strains (H-2d vs. H-2b): CD4 and CD8 T-cell epitope mapping and role of IFN{gamma}

    Radosevic K, Wieland CW, Rodriguez A, Weverling GJ, Mintardjo R, Gillissen G, Vogels R, Skeiky YA, Hone DM, Sadoff J, van der Poll T, Havenga M, Goudsmit J.

    Crucell Holland BV, PO Box 2048, 2301 CA Leiden, the Netherlands; Center of Infection and Immunity, Amsterdam Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands; Aeras Global TB Vaccine Foundation, 1405 Research Blvd., Rockville, MD 20850 USA.

    There is an urgent need for an efficacious vaccine against tuberculosis (TB). Cellular immune responses are key to an effective protective response against TB. Recombinant adenoviral (rAd) vectors are especially suited for the induction of strong T-cell immunity and thus represent promising vaccine vehicles for prevention of TB. We have previously reported on an rAd vector serotype 35, the serotype of choice due to low pre-existing immunity worldwide, which expresses a unique fusion protein of Mycobacterium tuberculosis (Mtb) antigens Ag85A, Ag85B and TB10.4 (Ad35-TBS). Here we demonstrate that Ad35-TBS confers protection against Mtb when administered to mice through either an intranasal or an intramuscular route. Histological evaluation of lung tissue corroborated the protection, and, in addition, demonstrated difference between two mouse strains, with diffuse inflammation in BALB/c mice and distinct granuloma formation in C57BL/6 mice. Epitope mapping analysis in these mouse strains showed that the major T-cell epitopes are conserved in the artificial fusion protein, while three novel CD8 peptides were discovered. We reveal, using a defined set of T-cell epitopes, differences between the two mouse strains in the type of protective immune response, demonstrating that different antigen-specific IFNgamma-producing T-cells can provide protection against Mtb challenge. While in BALB/c (H-2(d)) dominant CD8 T-cell response was detected, in C57BL/6 (H-2(b)) more balanced CD4/CD8 T-cell responses were observed, with more pronounced CD4 response in the lungs. These results unify conflicting reports on relative importance of CD4 vs. CD8 T-cell responses in protection and emphasize the key role of IFNgamma.
    PMID: 17526747 [PubMed - as supplied by publisher]
    crucell.yourbb.nl/viewtopic.php?t=135
  10. jecebe 6 juni 2007 13:54
    Geweldig weer Flosz, bedankt.

    Ga nu eerst voor de buis zitten genieten van Ned. Thailand.
  11. [verwijderd] 22 juni 2007 17:28
    New plan to contain drug-resistant TB
    WHO, Stop TB Partnership release two-year response plan
    22 JUNE 2007 | GENEVA -- Hundreds of thousands of cases of drug-resistant tuberculosis (TB) can be prevented and as many as 134 000 lives saved through the implementation of a two-year response plan, published/launched today by the World Health Organization (WHO) and the Stop TB Partnership.
    www.who.int/mediacentre/news/releases...

    Launch of US$2.15 billion dollar plan to contain drug-resistant tuberculosis
    www.who.int/tb/features_archive/globa...

    The Global MDR-TB & XDR-TB Response Plan 2007-2008
    www.stoptb.org/resource_center/assets...

    Fact sheet on the Global Response Plan
    www.stoptb.org/resource_center/assets...
    ************************************************

    NEW TUBERCULOSIS VACCINES IN DEVELOPMENT
    COULD PROTECT AGAINST DEADLY DRUG RESISTANT STRAINS
    Dr. Jerald C. Sadoff, President of Aeras Global TB Vaccine Foundation,
    Says New Vaccine Candidates in Trials This Year
    May 30, 2007

    WASHINGTON, D.C. – New tuberculosis (TB) vaccines in development have the
    potential to provide protection against all strains of TB, including multidrug-resistant
    (MDR) and extensively drug-resistant (XDR) TB, Dr. Jerald C. Sadoff, president and
    CEO of the Aeras Global TB Vaccine Foundation, said here today at the International
    Conference on Global Health.
    Aeras, the only non-profit organization dedicated solely to creating new TB vaccines, is
    working to develop at least one new TB vaccine regimen for infants and one for
    adolescents within seven to nine years and to ensure they are available worldwide to all
    who need them.
    Aeras and its partners have the largest TB vaccine pipeline in the world with six vaccine
    candidates in or expected to be in Phase I-II trials in 2007.
    Dr. Sadoff cited the rise of the new, deadlier strains of TB – including MDR and XDR –
    which are spreading around the world, including to the United States. This week the
    U.S. Centers for Disease Control and Prevention (CDC) quarantined a patient in Atlanta
    who is infected with XDR, and who had been traveling on transatlantic flights. XDR TB
    is resistant to many of the first and second line drugs, severely limiting treatment options.
    At least 37 nations have reported cases of XDR.
    “TB is second only to HIV/AIDS as the world’s most deadly infectious disease and is the
    leading cause of death among individuals infected with HIV. TB takes a victim every 20
    seconds, which adds up to more than 1.5 million people every year,” Dr. Sadoff said.
    “The rise of MDR and XDR TB, which has a particularly high fatality rate in people with
    HIV, makes our mission even more critical. The vaccines under development by Aeras
    and its partners are intended to protect against all strains of TB and to be safe for use in
    people infected with HIV.”
    www.aeras.org/documents/53007GHCConfe...
  12. flosz 27 februari 2008 20:11
    • Today’s most commonly used TB diagnostic, sputum microscopy, is more than 100 years old. It can
    only detect half of all active cases of TB, and does not distinguish drug-sensitive from drug-resistant
    disease. As a consequence, many patients are given drugs that are destined not to work.
    • Today’s first-line TB drugs are more than 40 years old and must be taken for 6-9 months, while
    treating MDR-TB usually takes 18-24 months. Inconsistent treatment breeds drug-resistant strains
    that increasingly defy current medicines. Faster acting drugs are needed to shorten treatment
    duration, and new drugs that attack novel targets are needed to fight resistant strains of M.tb.
    • FIND is developing rapid, accurate and affordable TB tests and point-of-care diagnostics to more
    efficiently detect TB and drug-resistant forms of TB.
    • The TB Alliance is developing new affordable TB drugs that will dramatically shorten treatment time,
    work against drug-resistant TB, be compatible with HIV antiretrovirals and improve treatment of
    latent TB.
    • Today’s TB vaccine, which is more than 85 years old, provides some protection against severe
    forms of TB in children but is unreliable against pulmonary TB, which accounts for most of the
    worldwide disease burden.
    • Aeras is developing new, safe, effective and affordable vaccine regimens to protect against all forms
    of TB –MDR and XDR, to prevent TB in children, adolescents and adults, and to be safe for use in
    people infected with HIV.
    Why We Need New Tools to Fight Drug-Resistant TB
    Tuberculosis (TB) is a problem of global proportions, killing someone every twenty seconds, while it is
    estimated that its cause, Mycobacterium tuberculosis (M.tb), infects one-third of the world’s population.
    Mounting drug resistance, including multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB
    (XDR-TB), coupled with a growing number of people co-infected with TB and HIV, are making the pandemic
    more threatening and more deadly.
    New tools are desperately needed to save millions of lives needlessly lost to TB.
    We will never defeat TB, and especially drug-resistant TB, without new and more effective tools: simpler,
    faster drug regimens that treat all forms of TB; rapid, more accurate diagnostic tools to quickly detect TB and
    its drug-resistance patterns; and a vaccine that will be effective in preventing all forms of TB. New tools will
    play a crucial role along side the growing commitment to more aggressive TB control and broader treatment
    to end the needless burden of this infectious disease.
    Three public-private partnerships lead development of needed new tools.
    Research is currently under way to develop these critically needed new tools through innovative partnerships
    that maximize the likelihood of success and minimize costs. The Aeras Global TB Vaccine Foundation
    (Aeras), the Foundation for Innovative New Diagnostics (FIND) and the Global Alliance for TB Drug
    Development (TB Alliance) — three not-for-profit Product Development Partnerships (PDPs) — are leading
    the global effort to develop new TB tools.
    Harnessing the collective resources of government, industry, academics, and philanthropies, FIND, the TB
    Alliance and Aeras have created over the past five years the largest pipeline of new TB drugs, diagnostics and
    vaccines in history. Nevertheless, increased investments and support for this research are needed to speed
    development of better TB tools and ensure access for those who need them most.
    The WHO and Stop TB Partnership's Global MDR-TB & XDR-TB Response Plan 2007-2008 calls for an
    investment of US$314 million over two years for research and development of new vaccines, drugs and
    diagnostics to respond to drug resistance. This is in addition to the $9 billion funding gap for research and
    development of new tools that was identified by the Global Plan to Stop TB 2006-2015.

    WHO Drug Resistance Surveillance Report:
    www.aeras.org/documents/drs_report4_2...

    Stalking A Killer
    www.youtube.com/watch?v=FTX5kwr1mk0

    Zie ook post herculess:
    www.iex.nl/forum/topic.asp?forum=228&...

    Meer TB:
    Aeras 402 (=Crucell Ad35 vectored TB vaccine!)
    In April 2007 a Phase 1 trial of a candidate vaccine, Aeras 402, was commenced. Aeras 402 presents tuberculosis antigens in the setting of a new, live replication deficient adenovirus vaccine that may increase T-cell immunity and thus, protection from tuberculosis. This study is a double-blind, randomized, placebo-controlled dose escalation study in four groups of healthy adult subjects previously vaccinated with BCG. Three dose levels will be investigated in this study with dose escalation between groups 1,2 and 3. Group 4 will receive a single dose at the highest dose level (or placebo) on Study Day 0 and a second dose at the highest dose level (or placebo) on Day 56. We have currently enrolled and vaccinated 20 participants, i.e. Groups 1 and 2, and are awaiting Day 28 safety data group 2 before proceeding with vaccination of group 3.
    www.satvi.uct.ac.za/research_aeras_40...

    TB Vaccines for the World
    April 9-11, 2008
    Atlanta, Georgia USA

    TBV 2008, the follow-up to the successful TBV 2003 and TBV 2006 meetings, will focus attention on ‘Vaccine Issues’
    in relation to TB worldwide. TB vaccines is a developing area of activity and TBV 2008 will once again allow
    researchers to come together to discuss the latest findings and trends associated with the research and development
    of TB vaccines – science, policy, strategy, delivery, economics.

    Friday 11th April 2008
    ‘Development of recombinant BCG:
    Adenovirus sertype-35 (rAd35-TB) prime-boost regimen
    vaccine against tuberculosis’
    Yasir Skeiky et al.
    (AERAS Global TB Vaccine Foundation, Rockville, Maryland, USA)
    www.meetingsmanagement.com/pdf/TBV_20...
    crucell.yourbb.nl/viewtopic.php?f=7&t...
  13. [verwijderd] 28 februari 2008 14:23
    By MARIA CHENG, AP Medical Writer
    Wed Feb 27, 5:59 PM ET


    LONDON - Drug-resistant tuberculosis is spreading even faster than medical experts had feared, the World Health Organization warned in report issued Tuesday. The rate of TB patients infected with the drug-resistant strain topped 20 percent in some countries, the highest ever recorded, the U.N. agency said.

    ADVERTISEMENT


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    "Ten years ago, it would have been unthinkable to see rates like this," said Dr. Mario Raviglione, director of WHO's "Stop TB" department. "This demonstrates what happens when you keep making mistakes in TB treatment."

    Though the report is the largest survey of drug-resistant TB, based on information collected between 2002 and 2006, there are still major gaps: Data were only available from about half of the world's countries.

    In Africa, where experts are particularly worried about a lethal collision between TB and AIDS, only six countries provided information.

    "We really don't know what the situation is in Africa," Raviglione said. "If multi-drug resistant TB has penetrated Africa and coincides with AIDS, there's bound to be a disaster."

    Raviglione said it was likely that patients — and even entire outbreaks of drug-resistant TB — were being missed.

    Experts also worry about the spread of XDR-TB, or extensively drug-resistant TB, a strain virtually untreatable in poor countries. When an XDR-TB outbreak was identified in AIDS patients in South Africa in 2006, it killed nearly every patient within weeks. WHO's report said XDR-TB has now been found in 45 countries.

    Globally, there are about 500,000 new cases of drug-resistant TB every year, about 5 percent of the 9 million new TB cases. In the United States, 1.2 percent of TB cases were multi-drug resistant. Of those, 1.9 percent were extensively drug-resistant.

    The highest rates of drug-resistant TB were in eastern Europe. Nearly a quarter of all TB cases in Baku, Azerbaijan, were drug-resistant, followed by about 20 percent in Moldova and 16 percent in Donetsk, Ukraine, WHO said.

    High rates of drug-resistant TB were also found in China and India, the world's two most populous nations that together are home to half the world's cases.

    Drug-resistant TB arises when primary TB treatment is poor. Countries with strong treatment programs, like the U.S. and other Western nations, should theoretically have very little drug-resistant TB.

    That is not the case in China, however, where the government says 94 percent of TB patients complete their first TB treatment.

    "There's a huge, gross discrepancy there if they are then reporting 25 percent of the world's multi-drug resistant TB cases," said Mark Harrington, executive director of Treatment Action Group, a public health think tank. "They are clearly nurturing a multi-drug resistant TB epidemic and failing to report XDR-TB at all."

    With growing numbers of drug-resistant TB patients, there is concern some national health systems will soon be overwhelmed.

    "We are totally off track right now," said Dr. Tido von Schoen-Angerer, executive director of Medecins Sans Frontiere's Campaign for Access to Essential Medicines. He said only 30,000 multi-drug TB resistant patients were treated last year.

    Experts said new drugs are needed if the outbreak is to be curbed, along with new diagnostic tests to identify drug-resistant TB strains faster — current tests take about a month for results.

    WHO said a new diagnostic test able to provide results within a day is being tried in South Africa and Lesotho. If successful, the test could be introduced across Africa in a few months, though new labs would be needed to run the tests.

    "Multi-drug resistant TB is a threat to every person on the planet," Harrington said. "It's not like HIV, where you are only infected through specific actions. TB is a threat to every person who takes a train or a plane."
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