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Home  /  Forum  /  Crucell  /  Crucell and Harvard Join Forces with IAVI

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Crucell and Harvard Join Forces with IAVI

69 Posts
Pagina: «« 1 2 3 4 | Laatste | Omlaag ↓
  6. [verwijderd] 13 augustus 2010 16:14
    Heb ik die op 15.45 dan van jou gekocht?

    Voor de gok op goede cijfers, trouwens dat interesseert me verder geen bal, als de koers maar omhoog gaat, zodat ze liefst met forse winst weer weg kunnen, voor bezoek aan de Aldi, Lidl en niet te vergeten , ter financiering van mijn komende vakantie.
    Zijn jullie weer even van me af,

    dus CruSELL , hup Crucell hup, up me du gijt, upupup. (:->D)
  7. [verwijderd] 13 augustus 2010 18:18
    1. The Ad26.ENVA.01 vaccine candidate used in this study is manufactured by Crucell, while the Ad35-ENV vaccine is developed by International AIDS Vaccine Initiative (IAVI).
    Both vaccines candidates are based on Crucell's proprietary AdVac® technology.

    A.Wat mij hierbij opvalt dat bovengenoemde vaccines beiden gebaseerd zijn op de AdVac® technologie van Crucell. International AIDS Vaccine Initiative (IAVI) , vanaf Sep. 2004, voor AdVac® tegen HIV.

    2.The clinical trial, which will be led by the International AIDS Vaccine Initiative (IAVI), represents a collaboration between 1e IAVI, 2e Crucell, 3e the Ragon Institute, 4e and Beth Israel Deaconess Medical Center (BIDMC), a major teaching hospital of Harvard Medical School.

    B. Wat mij hierbij opvalt dat er 4 partijen bij betrokken zijn.

    3.Crucell today (11-8-2010) announces its intention to participate in an international Phase I clinical trial in the United States and Africa of a combination of two AdVac®-based AIDS vaccine candidates, Ad26.ENVA.01 and Ad35-ENV, in healthy adults who are not infected with HIV.

    C. Wat mij hierbij opvalt is dat de clinical trial zowel plaats gaat vinden in de Verenigde Staten als in Afrika.

  8. flosz 13 augustus 2010 19:38
    @JAR51: ter aanvulling.

    Fast Facts
    Crucell and the International AIDS Vaccine Initiative (IAVI) jointly announced an agreement in November 2004, in which Crucell agreed to develop AdVac® vectors for use in IAVI's AIDS vaccine development program.
    In August 2005, Crucell and Harvard Medical School were jointly awarded a US$19.2 million (€15.9 million) grant by the US National Institutes of Health (NIH) to develop new adenovirus vector-based vaccines against HIV/AIDS.
    The Investigational New Drug Application (IND) for Phase I of the trial with Harvard Medical School (supported by the NIH) was approved by the FDA in January 2008.
    In April 2008, Crucell announced the start of a Phase I clinical study of the novel recombinant HIV vaccine (using adenovirus serotype 26 (rAd26) as the vector) that we are jointly developing with the Beth Israel Deaconess Medical Center.
    In October 2009, preliminary results of the Phase I study were presented at La Conférence AIDS Vaccine 2009 in Paris, France. They showed that a 3 dose regimen with this HIV candidate vaccine is safe and immunogenic.
    Phase I clinical studies are being conducted at the Brigham and Women's Hospital in Boston, USA and are focused on assessing the safety and immunogenicity of the vaccine in several trials including single and multi-dose regimens.
    www.crucell.com/R_and_D-Clinical_Deve...

    Vaccines based on the AdVac® technology belong to the second generation of vaccines, comprising Ad11-, Ad35-, and Ad49-based vectors and derivatives thereof. Since pre-existing immunity against these vectors is very limited, they allow effective delivery of small fragments of otherwise deadly pathogens to the immune system using a replication incompetent adenovirus vehicle.

    AdVac® vaccination vectors can be manufactured to high titers on a PER.C6® cell substrate. AdVac® vectors combine all the advantages of the commonly used adenovirus vector for vaccination, such as high production yields, strong immunogenicity and an excellent safety profile, together with accurate dose control of the vector-based vaccine. Thus, Crucell’s AdVac®-based vaccines are expected to deliver consistent results in clinical studies.
    AdVac® technology for highly immunogenic vaccines
    AdVac®-based vaccines for malaria, AIDS, hepatitis C, hemorraghic fevers, and tuberculosis have been successfully constructed and have been tested in pre-clinical vaccine models. Strong CD4 and CD8 T-cell responses were elicited by the AdVac®-based vaccines as well as potent and neutralizing antibody responses. In all instances, the high immune response elicited upon vaccination against the pathogenic antigens resulted in completed protection of the vaccinated animals upon high dose challenge demonstrating the strengths of AdVac® vectors.
    AdVac® vector-based products from bench to clinic
    Crucell has fully operational BSL-II laboratories with integrated upstream and downstream capacities up to a 10L scale. These units are used to develop purification methods closely resembling an end-stage manufacturing process. With this facility, Crucell has the ability to manufacture Ad11 or Ad35 vaccine vectors for comprehensive pre-clinical programs. Crucell has a fully operational GMP facility that has been designed as a multi-purpose production plant, which allows for the production of clinical-grade vaccines based on live vectors such as recombinant adenovirus. These products can be manufactured using PER.C6® technology under serum-free conditions in formats ranging from roller bottles to bioreactors. Crucell is expanding the GMP production capacity to 100L working volumes.
    __

    Improving the Gene Delivery Technology for Vaccination
    Leiden, The Netherlands, June 1, 2001

    Crucell and Harvard Medical School Announce Promising Results for Novel Vaccine Technology (AdVac®)
    Vaccine vectors overcome pre-existing immunity to rAd5
    Leiden, The Netherlands, August 30, 2004

    Crucell Grants IAVI Exclusive License to use AdVac® Technology for AIDS Vaccine
    Leiden, The Netherlands, September 14, 2004

    Crucell Signs Agreement with IAVI to Develop AdVac® Vector for AIDS Vaccine Program
    Leiden, The Netherlands, November 12, 2004

    Harvard and Crucell Receive $19.2 million NIH Grant to Develop Next-Generation AdVac®-based Vaccines
    Leiden, The Netherlands, August 1, 2005

    Crucell Secures $16.2 million NIH Contract for HIV Vaccine Design and Development
    Leiden, The Netherlands, October 9, 2006

    Crucell Announces First in Man Study with New Adenovirus Vector
    Recombinant adenovirus 26 vector avoids pre-existing immunity and is used in new HIV vaccine
    Leiden, The Netherlands, 3 April 2008

    Crucell HIV Vaccine: Promising Preliminary Results Phase I Study Presented by Dr Dan Barouch at AIDS Vaccine 2009 in Paris
    Leiden, The Netherlands (October 21, 2009)
    www.crucell.com/News%20-%20Press%20Re...

    IAVI Grants Harvard Researchers License To Use AIDS Vaccine Production Technology
    16 Mar 2006
    New York / Boston, March 16, 2006 - The International AIDS Vaccine Initiative (IAVI) and Beth Israel Deaconess Medical Center (BIDMC) jointly announced an agreement whereby IAVI will provide BIDMC researchers with a non-exclusive, non-commercial research and development license to use AdVac® technology, an adenovirus-based vaccine production technology, for AIDS vaccine development.
    www.iavi.org/news-center/Pages/PressR...

    Ad35-GRIN/ENV A—An Ad35-based AIDS vaccine candidate (USA): This Phase I trial, launched in collaboration with the University of Rochester Medical Center, aims to evaluate the safety and immunogenicity of an AIDS vaccine candidate based on serotype 35 of the adenovirus (Ad35).
    www.iavi.org/research-development/tri...

    clinicaltrials.gov/ct2/show/NCT00851383

    Two Phase I Trials Launched
    …
    IAVI is also planning to begin enrolling volunteers in a Phase I trial of its adenovirus serotype 35 (Ad35)-based vaccine candidate. The trial will enroll 42 volunteers at the University of Rochester Medical Center who will be randomly selected to receive either two intramuscular injections of the Ad35-based vaccine candidate or placebo at three different doses. Clinicians will first administer the lowest dose and will review the safety data before proceeding to the next higher dose.
    Ad35 is a serotype or strain of the common cold virus that researchers are using as a vaccine vector in this candidate to shuttle non-harmful fragments of clade A HIV, which is the predominant strain circulating in East Africa. The prevalence of naturally circulating Ad35 is much lower worldwide than the prevalence of adenovirus serotype 5, which was the virus used as a vector in Merck's AIDS vaccine candidate that was tested in the STEP trial. By using Ad35, it may be possible to circumvent issues involving pre-existing immunity to the viral vector
    www.iavireport.org/vax/2009/Pages/IAV...

    Understanding Pre-existing Immunity www.iavireport.org/vax-primers/scienc...

  9. flosz 13 augustus 2010 19:39
    Adenovirus 35: Work on candidates based on alternative adenovirus vectors is exciting because it offers the possibility of a fast track to testing effectiveness in a Phase IIb trial. Adeno vectors are easily manufactured, immunogenic and have a good track record on side effects. IAVI and partners are testing an AIDS vaccine candidate based on adenovirus type 35 (Ad35) in a Phase I trial. Adenoviruses have been popular vectors for AIDS vaccine development, but because many people have been exposed to common adenoviruses and thus have immunity to them, IAVI and partners are pursuing a platform based on the rare type Ad35. In the current tests, two different Ad35 vaccine candidates have been created, each containing different genetic components of HIV. The goal is to assess safety and see whether one component prompts a stronger immune response than the other, and to understand a broader range of biological reactions to components of HIV in humans. Data from this trial will inform a possible progression to a new trial using adenovirus vectors in a prime-boost strategy, which has shown promising results in animal models.
    www.iavi.org/research-development/Doc...

    Draadje HIV: www.iex.nl/forum/topic.asp?forum=228&...
69 Posts
Pagina: «« 1 2 3 4 | Laatste |Omhoog ↑

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