Crucell Terug naar discussie overzicht

draadje tuberculose

1. flosz 15 maart 2008 16:11

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   AERAS-402-Crucell inside!
   
   TB clinical trial US (C-001-402): status Open label phase I study
   Start: Oct. 2006 (PRA, Clinical Pharmacology Center, Lenexa, US)
   
   Follow up completed: safe at all doses tested
   Tuberculosis specific T cell responses following two doses in the higher dose groups
   Data to be presented at the conference ‘TB Vaccines for the world’ (9-11 April, 2008, Atlanta, US)
   
   The Third International Conference on TB Vaccines for the World
   9-11 April 2008, Centers for Disease Control and Prevention, 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. The TBV 2008 Scientific Advisory Panel invite the submission of late abstracts for consideration for inclusion in the TBV 2008 poster program.
   
   Thursday 10th April 2008
   SESSION 7:
   SAFETY & IMMUNOGENICITY
   
   Safety and immunogenicity of AERAS-402 in healthy adults’
   J. Bruce McClain et al.
   (AERAS Global TB Vaccine Foundation, Rockville, Maryland, USA)
   
   www.meetingsmanagement.com/pdf/TBV_20...
2. [verwijderd] 17 maart 2008 21:27

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   New TB Vaccines Urgently Needed to Fight TB
   Multi-Drug Resistance and HIV, Obstacles to Progress in Fight Against TB
   ROCKVILLE, MD, March 17, 2008 – Global efforts to slow the rate of new infections and death
   from tuberculosis are stalling, according to a new report published today by the World Health
   Organization in the lead up to World TB Day on March 24. New approaches to the tuberculosis
   epidemic are urgently needed, including new diagnostics, drugs and, ultimately, vaccines.
   “There are many factors contributing to the growth of the TB epidemic. Tuberculosis infections
   that are resistant to currently available treatments are increasing and HIV is fueling the epidemic,”
   said Jerald C. Sadoff, MD, the President and CEO of the Aeras Global TB Vaccine Foundation.
   “A new TB vaccine that is effective in all ages against all forms of TB could have an enormous
   global public health impact by arresting the continued expansion of this terrible disease.”
   According to the WHO 2008 Global TB Control Report, an estimated 1.7 million people died from
   TB in 2006, including 200,000 people who were also infected with HIV. Detection of TB disease
   continues to be stymied. Efforts to increase the detection of TB have slowed pace, and
   worldwide only an estimated 61% of TB cases were diagnosed. Lack of accurate diagnosis
   leaves many untreated and able to spread TB, including multi-drug resistant TB.
   The Aeras Global TB Vaccine Foundation is working with global scientific partners to test six new
   TB vaccines candidates. Three promising candidates are currently in early stage clinical trials
   and three more are due to enter clinical trials this year. With sufficient support and resources to
   advance research, a new more effective vaccine could be available by 2015.
   “Support to expand these efforts and other new tools to treat and diagnose TB are urgently
   needed,” said Dr. Sadoff. “I am encouraged by recent efforts to expand US government funding
   of new approaches and urge Congress to vote to authorize funding for TB vaccine research and
   development in the PEPFAR reauthorization bill.”
   The Aeras Global TB Vaccine Foundation is a non-profit product development partnership
   founded in 2003 to develop new tuberculosis vaccines and ensure their availability to all who
   need them. Aeras collaborates with academia, industry, foundations and governments to develop
   new TB vaccine candidates and delivery systems, manufacture vaccines at low cost and
   establish intellectual property rights to assure their future availability and affordability.
   
   www.aeras.org/news/documents/WTBD2008...
3. [verwijderd] 17 maart 2008 21:46

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   Motten ze nog ff 7 jaar wachtuh op het Crucell-vaccin.
   
   Dirk
4. flosz 7 april 2008 13:08

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   African trials aim for effective TB vaccine against 2 million yearly deaths
   
   Mar 23, 2008
   WORCESTER, South Africa — Janine September extends her slender arm toward a nurse's syringe, hoping that the hundreds of vials of blood extracted in the past six months will help conquer a 4,000-year-old curse: tuberculosis, which kills an estimated two million every year.
   Worcester, a small town among the fruit farms and vineyards outside Cape Town, has staggeringly high TB rates. It is at the fore of international field trials of a new TB vaccine, with three candidates being tested on hundreds of volunteers like the 23-year-old September.
   The aim is to develop an alternative to Bacille Calmette Guerin, or BCG, a vaccine in use since the 1920s that offers little protection against adult pulmonary TB, which accounts for the majority of cases.
   "This is the centre of TB vaccine research in the world, right here," says Jerry Sadoff, president and chief executive officer of Aeras Global TB Vaccine Foundation, the non-profit group financing the South African trials with grants from the Bill & Melinda Gates Foundation and the Dutch and Danish governments.
   TB research has languished in recent years while attention has been focused on fighting AIDS. But there is an upsurge of interest from drug companies, driven by evidence that TB and AIDS feed off each other. Researchers hope their new TB vaccine will be ready by 2015.
   "If we are able to shorten treatment and introduce one or two powerful new vaccines, then maybe the days of TB are numbered," said Marcos Espinal, head of Stop TB, a partnership spearheaded by the World Health Organization between the public and private sector.
   More than 4,000 years ago, TB killed an Egyptian, according to mummified remains. Hippocrates called it "consumption" in 460 BC.
   "We've been dealing with this for 4,000 years. It's a disgrace," said Espinal. "The current vaccine was introduced in 1922 and we have nine million new cases per year, which tells you there is a problem."
   Without new tools, he said, it will be impossible to tame TB.
   It is estimated that someone is infected every second with TB, which spreads easily through the air. China, India and Russia are among the hardest hit. But it is in sub-Saharan Africa that TB has combined with AIDS with devastating consequences, striking at the weakened immune system of its victims.
   Nearly 60 per cent of South African TB patients have the AIDS virus. The emergence of drug-resistant TB strains has worsened their chances of survival. There were 2,901 cases of multi-drug resistant TB in South Africa last year, and 561 cases of extensively drug-resistant TB, which is virtually incurable. Authorities have begun to quarantine patients in isolation wards surrounded by barbed wire.
   Worcester has one of the highest TB rates - if not the highest - in the world. A recent study by the South African TB Vaccine Initiative found that three per cent of infants had TB, or an incidence rate of 3,000 per 100,000. Among all age groups, there are 1,400 cases per 100,000 - double the national average in a country which is already one of the worst affected. Rates in most developed countries are well under 20 per 100,000, according to WHO.
   Beneath the veneer of small-town prosperity, the spanking-new casino and the manicured grounds of the wine estates lurks chronic and deep-seated poverty and overcrowding in desolate informal settlements that are invisible to the casual visitor.
   Many who toil on the farms and factories here are badly paid seasonal workers who migrate from inner-city areas, bringing their health problems with them. There is no reliable public transport system to take people in far-flung rural areas to health facilities - "the tyranny of distance," says Gregory Hussey, director of the South African TB Vaccine Initiative.
   Added to that is excessively high alcohol consumption. The areas around Worcester have the world's highest rates of fetal alcohol syndrome, the legacy of farmers in the apartheid era paying their workers in wine. Children are born small and weak and so are ready prey to TB, Hussey said.
   Many of the children on the ward at Brewelskloof hospital bear the telltale symptoms of alcoholic mothers, he says. At first sight, the kids tucking into minced meat and rice and squabbling over toys seem bright enough. But the jaunty girl with tight plaits who looks six is in fact 11 years old. She has multidrug-resistant TB and has been at the hospital for a year, with no early release in sight.
   About 10 people a day are currently being screened in small consulting rooms at the hospital to see if they are eligible to take part in the trials. They need to be healthy, HIV negative and with no history of TB.
   Volunteers are reimbursed for travelling costs and the time spent on the trials - a considerable amount of money in a community ravaged by 50 per cent unemployment.
   Clinical manager Michele Tameris says close links with local township clinics and factories has spread news of the trials through word of mouth and dispelled any suspicion. Many people volunteer because they get HIV and TB tests, with none of the stigma associated with going to a normal government clinic.
   "TB is rife here and it makes it easier for us to work. Most people know someone who has had TB," says Tameris. "If you ask someone if they have had TB, they will say 'not yet,' so they are assuming they will get infected."
   Results are promising from safety and immunology tests being conducted on three vaccines, including one developed by scientists at Britain's Oxford University. It is hoped that there will be large-scale trials by 2010 to determine if the vaccine works and a licensed vaccine by 2015, says Sadoff from Aeras. Much can go wrong in between, as other trials into promising HIV vaccines have shown, but Hussey and his colleagues are upbeat.
   Paul Fine, professor of communicable disease epidemiology at the London School of Hygiene and Tropical Medicine, finds the targets are optimistic given that TB is much more immunologically complex than, say, measles.
   "It's certainly not going to happen in the next few years," he says.
   Volunteer September wants her small part to pay off.
   "I hope it will help the community," she said.
   canadianpress.google.com/article/ALeq...
5. flosz 7 april 2008 13:15

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   AERAS-402-Crucell inside!
   
   TB clinical trial US (C-001-402): status Open label phase I study
   Start: Oct. 2006 (PRA, Clinical Pharmacology Center, Lenexa, US)
   
   Follow up completed: safe at all doses tested
   Tuberculosis specific T cell responses following two doses in the higher dose groups
   Data to be presented at the conference ‘TB Vaccines for the world’ (9-11 April, 2008, Atlanta, US)
   
   The Third International Conference on TB Vaccines for the World
   9-11 April 2008, Centers for Disease Control and Prevention, 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. The TBV 2008 Scientific Advisory Panel invite the submission of late abstracts for consideration for inclusion in the TBV 2008 poster program.
   
   Thursday 10th April 2008
   SESSION 7:
   SAFETY & IMMUNOGENICITY
   
   Safety and immunogenicity of AERAS-402 in healthy adults’
   J. Bruce McClain et al.
   (AERAS Global TB Vaccine Foundation, Rockville, Maryland, USA)
   
   www.meetingsmanagement.com/pdf/TBV_20...
   

   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)
   ********************
   Crucell is developing a recombinant tuberculosis vaccine based on our AdVac® and PER.C6® technology.
   The development of this vaccine is being carried out in collaboration with the Aeras Global TB Vaccine Foundation.
   Studies in mice conducted in 2005 resulted in high immune responses towards the adenovector vaccine candidate.
   A US Phase I trial (in BCG naïve individuals) has been completed. The results of the trial, which will be presented by Aeras in April 2008 at a TB vaccines conference in Atlanta.
   In Q2 2007 a second clinical trial was initiated in South Africa. This Phase I trial is a placebo controlled study in adults who were vaccinated at birth with the BCG vaccine. Enrolment has been completed and follow up is ongoing. The study shows the vaccine to be well tolerated.
   A new Phase I BCG-Ad35 prime boost clinical trial of the unique AdVac®-based tuberculosis vaccine was initiated in December 2007.
   
   Uit dec. 2007:
   Crucell and Aeras also announced the launch of a new Phase I BCG-Ad35 prime boost clinical trial of the unique AdVac®-based tuberculosis vaccine, weeks sooner than expected. The trial will be conducted in St. Louis, Missouri, USA under the direction of Dr. Daniel F. Hoft at the Saint Louis University Center for Vaccine Development.
   
   "We are very proud that Crucell's technologies are playing a key role in the search and development of a much-needed TB vaccine," said Dr. Jaap Goudsmit, Chief Scientific Officer at Crucell. "We also feel honored to collaborate with Aeras on this important mission."
   
   Aeras and Crucell began jointly developing this vaccine candidate, called AERAS-402, in 2004 using Crucell's AdVac® vaccine technology and PER.C6® manufacturing technology. A Phase I clinical trial launched in October 2006 in the United States, indicates that the vaccine candidate is safe in healthy adults in the US. A second study in progress in healthy adults in South Africa appears to be showing safety, tolerability and immunogenicity of AERAS-402.
   
   The main parameters under examination in the St. Louis study will be the immunogenicity and safety of BCG prime followed by two AERAS-402 boost doses administered at three to six month intervals after BCG in healthy adults.
   
6. flosz 9 april 2008 12:30

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   AERAS-402
   Type of product
   Replication-deficient adenovirus 35 vector expressing M. tuberculosis antigens Ag85A, Ag85B, and TB10.4.
   Sponsors
   AERAS-402 is being developed by Crucell Holland B.V. and the Aeras Global TB Vaccine Foundation, with funding from the Bill & Melinda Gates Foundation and the government of the Netherlands.
   Product description
   Adenovirus 35 is an advanced adenoviral vector system for the induction of antigen-specific CD4+ and CH8+ T-cell responses
   Stage of development
   AERAS-402 has successfully completed Phase I trials in the United States and is now in Phase I trials in South Africa
   Date of entry or expected date of entry into Phase I trials
   2006
   Expected date for completion of Phase III trials
   2015
   
   www.stoptb.org/retooling/assets/docum...
   
7. flosz 9 april 2008 14:05

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   Aeras, Crucell and SATVI Announce Encouraging Preliminary Results of Tuberculosis Vaccine Clinical Trial in South Africa
   
   
   
   Atlanta, Georgia, USA / Leiden, The Netherlands, 9 April 2008 - Dutch biotechnology company Crucell N.V., the Aeras Global TB Vaccine Foundation and the South African Tuberculosis Vaccine Initiative (SATVI) present a progress update and immunology data from a Phase I Ad35 tuberculosis vaccine study at the biennial "Tuberculosis Vaccines for the World" conference (Atlanta, Georgia, April 9 to 11) today. The study, conducted in Worchester, South Africa and launched in May 2007, is the second phase I study in a current series of three and has revealed promising results.
   
   Highest CD8 immune responses ever in a TB vaccine study
   Preliminary data show both critical arms of the cellular immune system, CD4 and CD8 immune T-cells were induced and that in those participants who responded, CD8 immune responses are considerably higher than has ever previously been seen in a TB vaccine study.
   
   The trial of AERAS-402/Crucell Ad35, which began in May 2007, is being conducted as a double-blind, randomized, placebo-controlled dose escalation study in four groups of healthy adults vaccinated at birth with BCG (Bacille Calmette-Guérin) vaccine. A total of 40 healthy adult volunteers are enrolled.
   
   "While preliminary, these results are promising. We are pleased that Crucell's technologies are playing a key role in the search and development of a much-needed TB vaccine," said Dr. Jaap Goudsmit, Chief Scientific Officer at Crucell. "We highly value the collaboration with Aeras and SATVI on this important mission."
   
   Third key clinical phase I study in progress
   Aeras and Crucell began jointly developing this vaccine candidate in 2004 using Crucell's AdVac® vaccine technology and PER.C6® manufacturing technology. A first Phase I clinical trial launched in October 2006 in Kansas, USA indicated that the vaccine candidate is safe in healthy adults in the US. The results of a second study, launched in May 2007, are presented in Atlanta at the 'TB Vaccines for the World' conference. A third phase I study in healthy adults in St. Louis, Missouri, USA was launched in December 2007 and focuses on the immunogenicity and safety of two AERAS-402/Crucell Ad35 boost doses administered at three to six month intervals after BCG priming in healthy adults.
   
   "The world urgently needs a new TB vaccine, and although we are still in the early stages of clinical trials, the preliminary data of this second phase I study are promising," said Dr. Jerald C. Sadoff, President and CEO of Aeras. "Aeras is delighted to be working with the excellent researchers at Crucell and SATVI. We are grateful to the Bill and Melinda Gates Foundation, the Netherlands Ministry of Foreign Affairs, and our other donors for their financial support of this trial and our vaccine development efforts."
   
   This trial was conducted in the Boland-Overberg region of Western Cape Province in South Africa, which has one of the world's highest TB burdens.
   
   "SATVI is proud to be playing such an important role in the global effort to develop new vaccines to combat TB, which are needed in South Africa and worldwide," said Prof. Gregory Hussey, Director of SATVI and Principal Investigator for the trial. "By conducting this trial, we have advanced the development of a new TB vaccine, expanded scientific capacity, and built awareness of the need for new TB vaccines."
   
8. flosz 10 april 2008 16:16

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   Worcester TB vaccine trial 'promising'
   Staff Reporter
   April 10 2008 at 02:34PM
   
   Renowned for its agricultural viability, the sleepy town of Worcester in the Overberg district might soon gain international recognition as the birthplace of a new tuberculosis vaccine.
   
   On Wednesday, the South African Tuberculosis Vaccine Initiative (SATVI) will present an update on progress made on a vaccine for the deadly virus at an international TB conference in Atlanta, in the US.
   
   In November The Cape Argus reported that residents of Worcester from across the racial spectrum had offered themselves as "guinea pigs" in the hope that their selfless contribution will lead to a new, effective vaccine to halt the spiralling TB epidemic.
   Their selflessness might pay off as researchers report that the responses from patients in Worcester are considerably higher than those ever seen in a TB vaccine.
   
   Early data shows that the candidate (potential) vaccine, known as AERAS-402/Crucell Ad35, is thought to be central to the control of TB infection.
   
   "While preliminary, these results are promising. We are pleased that Crucell's technologies are playing a key role in the search and development of a much-needed TB vaccine," said chief scientific officer at Crucell, Dr Jaap Goudsmit.
   
   Aeras, a non-profit developer of TB vaccines in the US, and Crucell, a Dutch biotechnology company, began jointly developing this TB vaccine candidate in 2004.
   
   The Worcester study is the second of three separate Phase 1 clinical trials.
   
   The first was launched in 2006 in the US.
   
   TB is highly endemic in the Overberg district. In 2004, TB accounted for 10 percent of total deaths there.
   www.iol.co.za/index.php?set_id=1&clic...
   
9. flosz 10 juli 2008 18:48

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   Friday 11th April 2008
   ‘Development of recombinant BCG:
   Adenovirus sertype-35 (rAd35-TB) prime-boost regimen
   vaccine against tuberculosis’
   Yasir Skeiky et al.
   
   

   Aeras Scientists Present Key Findings at TB Vaccine Meeting
   Atlanta, Georgia, USA
   Aeras scientists and researchers working in areas of vaccine discovery, vaccine assessment and clinical development presented key findings at the TB Vaccines for the World conference held from April 9 - 11, 2008 in Atlanta, Georgia.
   
   The third biennial meeting of TB vaccine researchers covered the latest findings and trends associated with the research and development of TB vaccines, including topics in science, policy, strategy, delivery and economics. The meeting was held at the Centers for Disease Control and Prevention.
   
   View Presentations:
   
   "Aeras Global TB Vaccine Foundation," Donata Sizemore, PhD
   
   "Development of New Vaccines to Address the TB Pandemic," Jerald C. Sadoff, MD
   
   "Development of Recombinant BCG: Recombinant Ad35 Prime-Boost Vaccine Regimen against Tuberculosis," Yasir Skeiky, PhD, and Charles Scanga, PhD
   
   "Progress with preparing sites for Phase III efficacy trials of new TB vaccines," Dr. Tony Hawkridge
   
   "rBCG Vaccines Designed to Elicit Immune Reponses to all Stages of Infection and Disease," John Fulkerson, PhD
   
   "Task Force on New Approaches to TB Vaccine Dev Report," Jerald C. Sadoff, MD
   
   View Posters:
   
   Aeras Posters:Assessment of Ag85B Specific TCells in PPD+ Individuals using Tetramer Technology, Gearhart, J. et al
   
   Bacterially Delivered dsRNA Vaccine Elicits Enhanced Immune Responses when Compared with Ad35 and rBCG Vaccines, Anantha, R., et al
   
   Building Staff Capacity for Clinical Research in Developing Countries, Page, J. et al
   
   Construction and Evaluation of a Stable Recombinant BCG AERAS-407 Using Antigens Identified by a Whole Genome Analysis, Velmurugan, K. et al
   
   Cryopreserved Whole Blood (WB) for use in Cell Mediated Immunity (CMI) Assays, Goldberg, S. et al
   
   Evaluating the persistence of a new rBCG vaccine candidate, AERAS-406, in the mouse model, Abdul-Majid, K. et al
   
   Immunogenicity and Protection of Prime-Boost Regimens Using TB Vaccine Candidates in Nonhuman Primates, Sizemore, D., et al
   
   Novel recombinant BCG vaccine with combined endosome escape and antigen over-expression properties; pre-clinical characterization, safety and protection against challenge with Mycobacterium tuberculosis, Skeiky, Y., et al
   
   Quantification (CFU determination) and Live/Dead Discrimination of BCG by Flow Cytometry, Mueller, S. et al
   www.aeras.org/newscenter/news-detail....
   
10. [verwijderd] 11 juli 2008 14:30

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    Biocon,
    
    Prettige feestdag vandaag.
    Nog steeds een stille believer blijkbaar.
    Pas op, uw mening is informatie voor mij.
    
    Veel dankbare groeten,
    
    Kite
12. flosz 9 oktober 2008 07:55

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    Stukje uit Aeras Quarterly e-News
    September 2008 | 9.10.2008
    
    Aeras Initiates Important Preclinical Studies in the Netherlands and the USA
    Prime-boost and Aerosol Delivery to be Tested
    
    Aeras has initiated two important preclinical studies of AERAS-402/Crucell Ad35, a candidate using an attenuated adenovirus vector delivery system. The first trial is being conducted with researchers at the Biomedical Primate Research Center in the Netherlands. It will determine if regimens of the currently used TB vaccine, Bacille Calmette-Guérin (BCG) boosted with AERAS-402/CrucellAd35 or recombinant BCG boosted with AERAS-402/CrucellAd35 protect better than the current regimen of BCG alone. This challenge trial is designed to show if rBCG boosted with AERAS-402/Crucell Ad35 will show greater levels of protection.
    
    A second important advancement is the start of a novel preclinical study to test aerosol delivery of AERAS-402/Crucell Ad35 scheduled to begin this month (September) at Tulane University in New Orleans. The study is designed to deliver 2-4 microns particles directly into the lungs of nonhuman primates to determine if aerosol delivery of AERAS-402/Crucell Ad35 protects when challenged with virulent TB.
    
    www.aeras.org/newscenter/newsletters/...
    
13. [verwijderd] 9 oktober 2008 11:38

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    quote:

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    Stukje uit Aeras Quarterly e-News
    September 2008 | 9.10.2008
    
    Aeras Initiates Important Preclinical Studies in the Netherlands and the USA
    Prime-boost and Aerosol Delivery to be Tested
    
    Aeras has initiated two important preclinical studies of AERAS-402/Crucell Ad35, a candidate using an attenuated adenovirus vector delivery system. The first trial is being conducted with researchers at the Biomedical Primate Research Center in the Netherlands. It will determine if regimens of the currently used TB vaccine, Bacille Calmette-Guérin (BCG) boosted with AERAS-402/CrucellAd35 or recombinant BCG boosted with AERAS-402/CrucellAd35 protect better than the current regimen of BCG alone. This challenge trial is designed to show if rBCG boosted with AERAS-402/Crucell Ad35 will show greater levels of protection.
    
    A second important advancement is the start of a novel preclinical study to test aerosol delivery of AERAS-402/Crucell Ad35 scheduled to begin this month (September) at Tulane University in New Orleans. The study is designed to deliver 2-4 microns particles directly into the lungs of nonhuman primates to determine if aerosol delivery of AERAS-402/Crucell Ad35 protects when challenged with virulent TB.
    
    www.aeras.org/newscenter/newsletters/...
    
    

    Worthy of a press release from Crucell? Or are waiting for PR on Phase I trials.
14. flosz 14 oktober 2008 13:19

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    Sanofi-aventis enters into Collaboration with TB Alliance to Fight Tuberculosis
    October 14, 2008
    en.sanofi-aventis.com/binaries/081014...
    www.iex.nl/forum/topic.asp?forum=228&...
    
15. flosz 14 oktober 2008 13:34

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    2008 Annual Report
    Innovate. Vaccinate. Eliminate | 10.17.2008
    
    Aerosol Delivery
    Aerosol delivery of a TB vaccine directly into the lungs is one
    of the leading scientific advancements Aeras has pursued this year.
    Pre-clinical studies with the National Institutes of
    Health have demonstrated the advantages of aerosol delivery
    of AERAS-402/Crucell Ad35, including a better immune
    response in the lung where infection occurs than can happen
    with an injection.
    Aeras scientists committed themselves to creating an aerosol
    delivery system, a vaccine powder optimized for inhalation,
    which would be effective and affordable for clinics in the
    developing world. Delivered with a single-use inhaler, a
    vaccine could be made available at low cost.
    In 2008, Aeras began conducting pre-clinical studies at
    Tulane University to assess aerosol delivery of AERAS-402/
    Crucell Ad35 in challenge studies, which will demonstrate
    the effectiveness of this route of delivery.
    
    AERAS-402/Crucell Ad35
    Jointly developed by Aeras and Crucell, a Dutch biotechnology
    company, AERAS-402/Crucell Ad35 is undergoing testing in
    Kenya, South Africa and the United States.
    l A completed Phase I clinical trial conducted in Kansas
    demonstrated that AERAS-402/Crucell Ad35 is safe in
    healthy adults in the USA.
    l A second ongoing Phase I study in South Africa in conjunction
    with SATVI has revealed encouraging immune
    responses in individuals who had previously received BCG.
    l A third two-arm Phase I study in healthy adults at the
    Center for Vaccine Development at St. Louis University
    is testing the immunogenicity and safety of BCG prime
    followed by AERAS-402/Crucell Ad35 boost doses
    administered at three- to six- month intervals.
    l A proof-of-concept study in people living with HIV is
    planned for 2009 in South Africa, pending regulatory
    approval to move forward.
    
    South Africa
    The clinical trial site run by the South African Tuberculosis
    Vaccine Initiative (SATVI) in Worcester, South Africa, has the
    capacity to host Phase I through Phase IV TB vaccine clinical
    trials and is the most advanced TB vaccine study site in the
    world. In addition, SATVI runs a world-class, cutting-edge
    immunology laboratory facility at the University of Cape
    Town, only one hour’s drive from Worcester.
    
    Aeras studies in South Africa:
    l Phase I trial of AERAS-402/Crucell Ad35 in adults
    l Phase II trial of AERAS-402/Crucell Ad35 in adults with a
    history of pulmonary TB
    l Phase I trial of SSI HyVac4 (AERAS-404) in adults
    l Phase II trial of GSK M72 in adults
    l Epidemiological studies of infants and adolescents to
    determine incidence of TB, 2005-2009
    www.aeras.org/newscenter/downloads/pu...
    

    Bijlage:
16. flosz 17 oktober 2008 08:08

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    Published: 07:45 17.10.2008 GMT+2 /HUGIN /Source: Crucell N.V. /AEX: CRXL /ISIN: NL0000358562
    
    Aeras and Crucell Announce TB Vaccine Clinical Trial in Kenya; Promising Vaccine Candidate Advances to Phase II Safety Study in South Africa
    
    Leiden, The Netherlands/Paris, France, 17 October 2008 - Dutch biopharma company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) and the Aeras Global TB Vaccine Foundation today announce the start of a Phase I clinical trial in Kenya of the jointly developed tuberculosis (TB) vaccine candidate, AERAS-402/Crucell Ad35. The announcement is made in the lead up to the 39th Union World Conference on Tuberculosis and Lung Disease in Paris, France (16-20 October, 2008).
    
    This first-ever study of the new TB vaccine candidate in Kenya will be conducted by the Walter Reed Project-Kenya (WRP) at Kombewa, near Kisumu, Western Kenya. The main parameters of the study will be to test the safety of the candidate in healthy adults, all of whom have been previously vaccinated with the Bacille Calmette-Guérin (BCG) vaccine and a subset of whom have evidence of having been exposed to TB.
    
    "I am glad that a high burden country like Kenya has been selected in these broader comprehensive efforts in advancing new tools that are urgently required in global TB control efforts, more so in an era where TB-HIV co-infection is a great challenge." said Lucy Chesire, a Kenyan TB Advocate.
    
    Crucell and Aeras also announce the start of the first Phase II study of AERAS-402/Crucell Ad35. The study is being conducted in Cape Town, South Africa by the University of Cape Town Lung Institute in conjunction with the South African Tuberculosis Vaccine Institute. Screening of volunteers has begun and immunization is scheduled to start in the next couple of weeks. The candidate will be tested in 82 adults who have had active TB.
    
    "There are many potential uses of a new TB vaccine. Therefore, it is important to determine a candidate's safety and immune responses in those who have already been exposed or have had active TB disease," said Jerald C. Sadoff, MD, President and CEO of Aeras. "We are pleased to be working with two outstanding organizations in Kenya and South Africa - the Walter Reed Project-Kenya and the University of Cape Town - to move this promising candidate forward in development."
    
    "We are very pleased with our continued progress with this next generation TB vaccine," said Dr. Jaap Goudsmit, Crucell's Chief Scientific Officer. "The initiation of these two new studies through our fruitful collaboration with Aeras puts us another step closer to our ambition of reducing the global burden of this fatal disease."
    
    Aeras and Crucell began jointly developing this vaccine candidate in 2004 using Crucell's AdVac® vaccine technology and PER.C6® manufacturing technology. A first Phase I clinical trial launched in October 2006 in Kansas, USA indicated that the vaccine candidate is safe in healthy adults in the US. The preliminary results of a second study, launched in May 2007, were presented at the 'TB Vaccines for
    the World' conference in April 2008. Preliminary data showed both critical arms of the cellular immune system, CD4 and CD8 immune T-cells, were induced and that in those participants who responded, CD8 immune responses were considerably higher than had ever previously been seen in a TB vaccine study.
    
    A third phase I study in healthy adults in St. Louis, Missouri, USA was launched in December 2007 and focuses on the immunogenicity and safety of two AERAS-402/Crucell Ad35 boost doses administered at three to six month intervals after BCG priming in healthy adults.
    www.iex.nl/forum/topic.asp?forum=228&...
    
17. flosz 20 oktober 2008 08:27

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    Posted to the web on: 20 October 2008
    Scientists to test TB vaccine in Cape Town
    
    Tamar Kahn
    CAPE TOWN — Local scientists have started enrolling volunteers in a phase 2 clinical trial to test the safety of a potential tuberculosis (TB) vaccine developed by Dutch pharmaceutical company Crucell and the not-for-profit Aeras Global TB Vaccine Foundation.
    SA has battled with large numbers of TB patients for many years and the crisis has deepened in the past decade with the growing HIV/AIDS epidemic. HIV weakens an infected person’s immune system, making them more susceptible to TB.
    Vaccines are the most effective way to protect a population against a disease, but the only TB jab on the market at present works solely in childhood, and does not work against all forms of the illness. The Bacille-Calmette Guérin (BCG) vaccine is routinely given to young babies around the world. It contains a live, but weakened, form of Mycobacterium bovis, a strain of TB originally isolated from cows.
    It gives babies and young children protection against meningitis, and “disseminated” TB, which affects organs such as the stomach or bones, but the vaccine does not protect people against TB of the lungs, which is the most common form in adults.
    Scientists from the University of Cape Town’s Lung Institute and the South African Tuberculosis Vaccine Institute are planning to start immunising volunteers in the next few weeks. The Aeras-402/Crucell Ad35 candidate vaccine, which has already been shown to be safe in a smaller phase 1 trial in healthy adults in the US, will be given to 82 adults who have recently had TB, or are being treated for the disease.
    Aeras and Crucell have also launched a phase 1 clinical trial in Kenya to test the safety of the vaccine in healthy adults, all of whom had the BCG vaccine and some of whom have previously had TB.
    “There are many potential uses for a new TB vaccine. Therefore, it is important to determine a candidate’s safety and immune responses in those who have already been exposed or have had active TB disease," said Aeras president and CEO Jerald Sadoff.
    Cape Town had been chosen as a trial site because it had a high TB burden and good research infrastructure, said Aeras clinical project physician Sean Bennett.
    TB is the world’s second-deadliest infectious disease, and is the leading cause of death for people infected with HIV. More than 9-million new cases were diagnosed in 2006, and 1,7-million people died from the disease. More than 337000 new cases were diagnosed in SA in 2005, the most recent year for which figures are available, an 8% increase on the previous year.
    The recent global surge in TB has led to fresh efforts to find new vaccines, tests and drugs. Last week, the Global Alliance for TB Drug Development and pharmaceutical firm Sanofi-Aventis announced that they had entered into a collaborative agreement to speed up TB drug development. Sanofi-Aventis developed rifampicin, the backbone of TB treatment in the early 1960s, and markets several other TB drugs.
    www.businessday.co.za/articles/topsto...
    
18. flosz 21 oktober 2008 07:47

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    New TB vaccine trials set for Kenya
    Written by Steve Mbogo
    
    October 21, 2008: Trials for a new tuberculosis vaccine are to start in Kenya, raising hopes of stopping a disease that requires at least half a year to treat.
    
    It is estimated that 200,000 Kenyans have TB, but only half the number are aware of their status. The cost of treating TB is now taken care of by the Government. The new trials will be conducted in Kisumu by the Walter Reed Project-Kenya.
    
    The project is part of the United States Department of Defence’s HIV programme in Kenya, in association with the Kenya Medical Research Institute (KEMRI) in Nairobi.
    The vaccine has been developed by Dutch biopharma company Crucell and the Aeras Global TB Vaccine Foundation.
    
    The main parameters of the study will be to test the safety of the vaccine in healthy adults, all of whom have been previously vaccinated with the existing TB vaccine and a subset of whom have evidence of having been exposed to TB.
    
    Ms Lucy Chesire, an international TB-HIV activist, said Kenya would gain enormously from the programme because of the health challenges presented by TB, especially to those infected with HIV.
    
    The Kenyan trials follow testing of the same vaccine in October, 2006 in Kansas, US, which indicated that the vaccine candidate is safe in healthy adults.
    
    Screening of volunteers has begun and immunisation is scheduled to start in the next couple of weeks.
    
    The candidate will be tested in 82 adults who have had active TB.
    
    Jerald Sadoff, the chief executive officer of Aeras said it is important to determine a candidate’s safety and immune responses in those who have already been exposed or have had active TB disease.
    
    According to the World Health Organization (WHO), an estimated 1.7 million people died from TB in 2006 over 9 million new cases diagnosed in the same year 2006.
    
    Current TB treatments takes 6-9 months. The current TB vaccine Bacille Calmette-Guerin (BCG), developed over 85 years ago, reduces the risk of severe forms of TB in early childhood but is not very effective in preventing pulmonary TB in adolescents and adults - the populations with the highest rates of TB disease.
    
    In Kenya, the challenge of TB is groeing fast because of evolvement of a strain that is resistance to the existing medicines, although the strain is yet to be detected in Kenya, according to Dr Joseph Sitienei, head of the National TB and Leprosy Programme in the Ministry of Public Health and Sanitation.
    
    Earlier, the government announced it is to hire 250 laboratory technologists in five years to help improve prompt diagnosis of TB and its management.
    
    Kenya’s TB case detection rate stands at 70 per cent and treatment success rate at 84.8 percent, the highest in sub-Saharan Africa.
    www.bdafrica.com/index.php?option=com...
    
19. aossa 27 oktober 2008 12:48

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    Vlaams wondermiddel krijgt tbc eindelijk klein
    
    Nieuwe remedie werkt vijf keer beter dan klassieke antibiotica
    
    Een nieuw medicijn tegen hardnekkige tbc, ontworpen door Vlaamse wetenschappers van het bedrijf Tibotec, blijkt ruim vijf keer beter te werken dan klassieke antibiotica. Dat wereldnieuws werd gisteren verkondigd in Washington.
    
    Tuberculose blijft een massamoordenaar. De bacterie wordt steeds moeilijker te bekampen, want ze wordt resistent tegen vrijwel alle bekende antibiotica. Er leven inmiddels wereldwijd zowat een half miljoen zieken met multiresistente tbc, vooral in de Derde Wereld maar ook steeds meer in de geïndustrialiseerde wereld. Er duikt zelfs extreem resistente tbc op die aan alle klassieke middelen weerstaat.
    
    Begrijpelijk dus dat er opschudding ontstond in het wereldje toen Tibotec-wetenschapper Koen Andries in 2004 in het vakblad Science aankondigde dat hij en zijn ploeg een compleet nieuw middel hadden ontwikkeld, TMC 207. Tibotec is een researchafdeling van de multinational Johnson & Johnson, gevestigd in Mechelen.
    
    In de zomer van vorig jaar begonnen klinische proeven met het middel op het terrein. De wetenschappers kozen voor Zuid-Afrika, dat én goede ziekenhuizen heeft én veel multiresistente tbc-lijders.
    
    Op het congres in Washington kon dr. Diacon van de Stellenbosch universiteit in Zuid-Afrika zondagmiddag de eerste resultaten toelichten. En die blijken ophefmakend. Een groep multiresistente tbc-lijders kreeg de klassieke cocktail van vijf antibiotica plus TMC 207, een even grote groep kreeg dezelfde cocktail plus een neutraal vervangmiddel. Na acht weken bleek dat het middel goed verdragen werd en in bijna de helft van de groep (47,5 procent) een beduidende daling van het ziektebeeld teweegbracht. In de nevengroep gaf de klassieke cocktail een daling bij amper 8,7 procent, of ruim vijf keer slechter.
    
    Wim Parys, hoofd van de cel klinisch onderzoek van Tibotec die de proeven in Zuid-Afrika begeleidde: 'Dit lijkt op een doorbraak, zowel inzake nevenwerkingen als inzake genezende werking.'
    
    De eerste klinische proeven werden veiligheidshalve uitgevoerd op een kleine groep van 47 patiënten. Nu wordt overgeschakeld op een ruimer staal van 150 patiënten die het nieuwe middel gedurende 24 weken krijgen toegediend. Dr. Parys: 'We willen de optimale behandelingstermijn vaststellen. Met de klassieke cocktail kan die uitlopen tot twee jaar, met ons middel denken we meer patiënten te kunnen genezen en de behandelingsduur sterk te kunnen inkorten.'
    
    Het vernieuwende aan het middel is dat het werkt volgens een compleet nieuw mechanisme: het legt de energievoorziening van bacteriën lam. Daar hebben zelfs (extreem) resistente bacteriën geen verweer tegen. 'We mikken vooral op tbc. Maar als we dit onderzoek met volledig succes afronden, beschikken we over alle middelen om het uit te breiden naar andere bacteriën. Eventueel kunnen we een volledig nieuwe klasse van antibiotica op de markt brengen.'
    
    Het zal nog minstens twee jaar vergen voor het product TMC 207 klaar is voor de markt.
    
    www.nieuwsblad.be/Article/Detail.aspx...
    
    
20. flosz 31 oktober 2008 08:42

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    10.24.2008
    New Hope for TB
    The commitment from the new minister of health will go a long way in the fight against the disease
    
    Hoosen Coovadia | MAIL & GUARDIAN
    
    Last week's jubilation over new Minister of Health Barbara Hogan's unequivocal call to arms against the Aids epidemic obscured an equally important point the minister made: the urgent need to tackle tuberculosis.
    HIV and TB are entwined in South Africa. The country urgently needs to tackle them as a combined problem and two separate epidemics.
    South Africa has the highest number of people living with HIV in the world and the fourth-highest number of people with TB.
    Nearly half of all TB patients in South Africa are also HIV-positive.
    One quarter of South Africa's health budget is spent on HIV and related diseases, with most of it spent on treating TB.
    Speaking at an international Aids conference the health minister said: "The TB vaccine was invented before the car. The diagnosis of TB has a similar profile and the medicines used to treat and cure TB are more than 40 years old.
    "We urge you to advocate for these technologies because without them the rights to health, life and dignity for millions of people globally cannot be realised."
    We need new, efficient diagnostic tools and new drugs to cure TB quicker. And these drugs must be designed to treat the growing proportion of drug-resistant diseases. But to stop TB we must focus on preventing it. We need a more effective TB vaccine and we must make it available and affordable.
    The current TB vaccine, Bacille-Calmette Guerin (BCG), offers some protection against severe forms of TB in children.
    It is given to all infants in South Africa. But BCG is ineffective against pulmonary TB in children and adults, the most common form of the disease.
    The bacterium that causes TB currently infects about one-third of the world's population, or two billion people. Yet a vaccine that is effective against all strains of the disease in children, adults and people living with HIV may be scientifically achievable within a decade - and South Africa is likely to be its birthplace.
    
    Six potential vaccines are being developed for human clinical trials, under the aegis of the University of Cape Town's South African Tuberculosis Vaccine Initiative (Satvi). Working with the United States-based not-for-profit organization, Aeras Global TB Vaccine Foundation, Satvi is testing four vaccines in humans in Worcester.
    
    Three are in phase two trials to confirm their safety. Subject to Medicines Control Council approval, two of them could start additional trials next year to test their efficacy.
    
    One of these candidates will be tested in Johannesburg at the Aurum Institute for Health Research. The study will focus on people with HIV and TB to test whether their weakened immune systems affect the efficacy of the vaccine.
    
    By answering these questions, we ensure that a new TB vaccine will have a direct impact on TB-HIV HIV co-infection. An expensive vaccine is ineffective, no matter how potent it is.
    
    With this in mind, as the scientific work advances, Satvi, Aeras and their partners and donors must ensure that the new vaccine can be manufactured quickly and inexpensively and distributed to all who need it.
    
    Addressing TB has been on the back burner for too long. The disease will kill an estimated 1,7-million people this year - including 230 000 people living with HIV - and infect more than nine-million people.
    Hogan recognises that new tools are needed to bring TB and HIV under control. She pledged to support South African scientists and clinicians in the development of new technologies to tackle both diseases.
    We are heartened by such leadership and by Hogan's recognition of the new TB-HIV co-infection epidemic.
    The political support she offers, the financial backing by donors, the skills of scientists and the thousands of South African volunteers participating in these trials have increased the chances of ending one of humanity's oldest and deadliest scourges.
    Hoosen Coovadia MD is Victor Daitz chair in HIV/Aids research at the Doris Duke Medical Research Institute, Nelson R Mandela school of medicine, University of KwaZulu-Nata,; and a member of the board of directors of the Aeras Global TB Vaccine Foundation
    www.aeras.org/newscenter/presscoverag...
    _____________________________
    10.17.2008
    TB vaccine trials kick off amid funding woes
    IRIN PLUSNEWS
    JOHANNESBURG - Clinical trials of a new tuberculosis (TB) vaccine recently kicked off in Kenya, meanwhile international TB researchers and activists are worried by funding gaps that may worsen in the global financial crisis.
    In the first stage of human testing, known as Phase I trials, the new vaccine will be tested for safety on healthy adults with no previous history of TB in Kombewa, near Kisumu in western Kenya.
    Researchers hope the candidate vaccine, which has already undergone similar testing in the United States, will improve immunity in people who have already received the standard Bacille Calmette Guerin (BCG) vaccine, created in 1921 and used the world over.
    
    "Many people have been vaccinated with BCG but it is no longer as effective as it once was," said Oya Yavuz, director of corporate communications and investor relations for the Dutch vaccine company Crucell N.V., which has partnered the Aeras Global TB Vaccine Foundation in the testing process.
    
    In Africa, TB is the biggest killer of people living with HIV, who are 50 times more likely than HIV-negative people to develop TB, according to the World Health Organisation (WHO). Without proper treatment, 90 percent of those co-infected with HIV and TB usually die within months, according to the international health body.
    
    
21. flosz 31 oktober 2008 08:44

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    Vervolg.
    
    According to Yavuz, phase II clinical trials, in which larger samples sizes will be used, should begin in Cape Town, South Africa, in coming weeks. These trials will be conducted in adults with a history of active TB, in the hope that they will show an increased immunity to future episodes of the disease.
    
    Funding worries and silver linings
    
    The trials were announced just days after Francoise Barre-Sinousi, a co-discoverer of AIDS and recent Nobel Prize winner, told international journalists that the current global financial crisis could lead to further funding shortfalls in the fight against TB.
    
    The declining US dollar and the global financial uncertainty are expected to slow the pace of TB research said the Treatment Action Group, a US-based AIDS research and policy think-tank. The group released a report earlier this week analysing funding trends from 2005 to 2007, and noted that investment in research and development in the TB field was slowing, and said this was likely to be exacerbated by the devaluing dollar.
    
    Judith Mandelbaum-Schmid, spokeswoman for the Stop TB Partnership, said she could not comment on the impact of the crisis on the fight against TB, but said a funding shortage was apparent long before the current economic meltdown.
    
    The WHO's annual stock-taking report on the fight against TB, released in March, cited the stagnation of funding in all but five high-burden countries, creating a global funding gap of at least a $328 million, which was likely to widen.
    
    However, not all the news is bad. Hassan Mahomed, clinical director for the South African TB Vaccine Initiative at the University of Cape Town, agreed with Mandelbaum-Schmid that it might be too soon to tell how funding would be affected, but commented that so far there had actually been a slight benefit for foreign-funded researchers.
    
    "There has been a paradoxical beneficial effect because of the weakening of the [South African] rand against the dollar and [British] pound," said Mahomed, who has seen the dollars and pounds funding his research going farther as the rand weakened.
    www.aeras.org/newscenter/presscoverag...
    www.aeras.org/newscenter/presscoverag...
    
    www.aeras.org/newscenter/presscoverag...