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Draadje HIV/AIDS

1. flosz 24 juni 2009 09:00

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   This page includes information on the Step and Phambili trials of Merck's MRK-Ad5 vaccine candidate (immunizations were stopped in September 2007) as well as information on the NIH Vaccine Research Center's DNA prime/Ad5 boost vaccine strategy, initially planned to be tested in the proposed PAVE 100 vaccine trial. The strategy is now slated to be tested in a test-of-concept trial known as HVTN 505.
   
   The storyline for each of these trials is intertwined with the other, making it important for advocates to understand the "big picture" as it has been revealed over the past 18+ months. These trials and their attendant issues have been explored in AVAC Report 2009: Piecing Together the HIV Prevention Puzzle. In the Report, we address the communications efforts, community engagement and scientific discussions around these vaccine studies. To get a sense of the past and ongoing discussions, we invite you to download the following two pieces from the AVAC Report:
   
   ▪ A Trial by Any Other Name: HVTN 505 and the VRC candidate
   avac.org/pdf/reports/2009_Report/505_...
   ▪ PAVE 100 to HVTN 505: Key events and communications about testing the VRC strategy
   
   Heel de geschiedenis via:
   
   avac.org/vax_update.htm
   
   Zie ook AVAC Report 2009, link in post 23 jun 09, 19:51.
   
   The HVTN 505 Study
   www.hvtn.org/media/pr/HVTN505studyfly...
   
2. flosz 30 juni 2009 18:24

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   A Living History of AIDS Vaccine Research
   
   This is the first installment in a new IAVI Report series, A Living History of AIDS Vaccine Research. Its purpose is to provide perspective on historical moments in the quest for a vaccine, as well as insight into what lies ahead, as told by some of the leading researchers and policymakers in the field. Kicking off this series is Anthony Fauci, who has served as director of the National Institute of Allergy and Infectious Diseases (NIAID) for the past 25 years.
   
   www.youtube.com/watch?v=UlpUuGrauns
   www.youtube.com/watch?v=2s1WHECFEKA
   www.youtube.com/watch?v=Hkkk3PPniCo
   
3. flosz 18 juli 2009 12:07

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   Clin Exp Immunol. 2009 Aug
   Translational Mini-Review Series on Vaccines for HIV: T lymphocyte trafficking and vaccine-elicited mucosal immunity.
   Kaufman DR, Barouch DH.
   Division of Viral Pathogenesis, Beth Israel Deaconess Medical Center, Boston, MA 02115, USA. dkaufma1@bidmc.harvard.edu
   Many pathogens use mucosal surfaces to enter and propagate within the host, making particularly desirable vaccines that target immune responses specifically to mucosal compartments. The majority of mucosal vaccine design strategies to date have been empirical in nature. However, an emerging body of basic immunological knowledge is providing new insights into the regulation of tissue-specific lymphocyte trafficking and differentiation. These insights afford the opportunity for the rational design of vaccines that focus immune responses at mucosal surfaces. Mucosal cellular immunity may prove critical for protection in the context of HIV infection, and thus there has been considerable interest in developing vaccines that target HIV-specific cellular immune responses to the gastrointestinal and vaginal mucosa. However, the optimal strategies for eliciting mucosal cellular immune responses through vaccination remain to be determined. Here, we review both recent vaccine studies and emerging paradigms from the basic immunological literature that are relevant to the elicitation of potent and protective mucosal cellular immune memory. Increasing the synergy between these avenues of research may afford new opportunities for mucosal vaccine design.
   www.ncbi.nlm.nih.gov/pubmed/19604255
   
   Clin Exp Immunol. 2009 Aug
   Translational Mini-Review Series on Vaccines for HIV: Harnessing innate immunity for HIV vaccine development.
   Rhee EG, Barouch DH.
   Division of Viral Pathogenesis, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA.
   Innate immunity is critical for shaping vaccine-elicited adaptive immune responses. Several classes of immune sensors, including Toll-like receptors, retinoic acid-inducible gene-I-like receptors, nucleotide-binding oligomerization domain-like receptors and cytosolic DNA receptors mediate important innate immune pathways and provide potential targets for novel adjuvant development. Understanding how innate immunity modulates adaptive immune responses will probably be important for optimizing vaccine candidates. Here, we review recent advances in innate immunity, focusing upon their potential applications in developing adjuvants and vectors for HIV vaccines.
   www.ncbi.nlm.nih.gov/pubmed/19604256
   
   J Infect Dis. 2009 Aug 15
   Power to Detect the Effects of HIV Vaccination in Repeated Low-Dose Challenge Experiments.
   Hudgens MG, Gilbert PB, Mascola JR, Wu CD, Barouch DH, Self SG.
   Department of Biostatistics, University of North Carolina, Chapel Hill; 2Fred Hutchinson Cancer Research Center and Department of Biostatistics, University of Washington, Seattle; 3Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; 4Division of Vaccine Research, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
   Simulation studies were conducted to estimate the statistical power of repeated low-dose challenge experiments performed in nonhuman primates to detect the effect of a candidate human immunodeficiency virus vaccine. The effect of various design parameters on power was explored. Results of simulation studies indicate that repeated low-dose challenge studies with a total sample of size 50 (25 animals/arm) typically provide adequate power to detect a 50% reduction in the per-exposure probability of infection resulting from vaccination. Power generally increases with the maximum number of allowable challenges per animal, the per-exposure risk of infection in control animals, and the proportion of animals susceptible to infection.
   www.ncbi.nlm.nih.gov/pubmed/19591571
4. flosz 21 juli 2009 08:07

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   Insights Into Failed HIV-1 Vaccine Trial
   
   ScienceDaily (July 20, 2009) — Following the disbandment of the STEP trial to test the efficacy of the Merck HIV-1 vaccine candidate in 2007, the leading explanation for why the vaccine was ineffective – and may have even increased susceptibility to acquiring the virus – centered on the hypothesis that high levels of baseline Ad5-specific neutralizing antibodies may have increased HIV-1 acquisition among the study subjects who received the vaccine by increasing Ad5-specific CD4+ T-cells that were susceptible to HIV-1 infection.
   
   Now, a study by Dan Barouch, MD, PhD, and a scientific team at Beth Israel Deaconess Medical Center (BIDMC), reported in the July 20 Advance Online issue of Nature Medicine, shows this was likely not the case.
   "Our findings demonstrate that there is no correlation between Ad5 neutralizing antibodies and T-cell immune responses," explains Barouch, who is Chief of the Division of Vaccine Research at BIDMC and Associate Professor of Medicine at Harvard Medical School. "Moreover, subjects with baseline Ad5-specific neutralizing antibodies did not develop higher levels of Ad5-specific T-cell responses as compared with subjects without baseline Ad5-specific neutralizing antibodies."
   The Ad5 virus is a weakened form of adenovirus, which is responsible for the common cold and is extremely widespread in the general population. In the Merck vaccine candidate, Ad5 was used as a vector to transport three HIV-1 genes, a strategy that helps to overcome limitations posed by the HIV-1 virus.
   "Because HIV-1 does not appear to respond to conventional vaccine strategies, which work by triggering the body's immune system to manufacture antibodies against an infectious organism, the STEP trial was testing a vaccine that would, instead, stimulate the immune system's killer T-cells to root out and disable the virus," explains Barouch. While this method does not eradicate HIV-1, the thinking is that it helps the immune system launch a more aggressive response in the event a person is exposed to HIV-1.
   However, prior exposure to the Ad5 cold virus leaves a large number of individuals with baseline neutralizing antibodies against Ad5. "This raised the possibility that these antibodies were triggering production of Ad5-specific T-cells [CD4+] that were susceptible to HIV-1 infection, thereby leaving study subjects at greater risk of acquiring the virus itself," explains Barouch. "But our findings challenge this hypothesis. It does not appear that the potential enhancement of the HIV-1 infection in the STEP study was the result of these secondary, vector-specific CD4+ T-cell responses."
   Going forward, Barouch suggests another alternative.
   "Safety considerations, including the possibility that vector-specific cellular immunity may impact HIV-1 susceptibility, have become major concerns for the HIV-1 vaccine field," notes Barouch. "Our findings suggest a path forward for HIV-1 vaccine development by using rare serotype vectors [not typically found in the general population] that are not suppressed by high levels of baseline vector-specific neutralizing antibodies." Barouch and colleagues are currently conducting Phase 1 clinical trials to test two such novel HIV-1 vaccines.
   In addition to Barouch, coauthors include BIDMC investigators Kara O'Brien, Jinyan Liu, Sharon King, Ying-Hua Sun, Joern Schmitz, and Michelle Lifton; Natalie Hutnick and Michael Betts of the University of Pennsylvania School of Medicine; Sheri Dubey, John Shiver, Michael Robertson and Danilo Casimiro of Merck Research Laboratories, West Point, PA; and Jaap Goudsmit of Crucell Holland BV, Leiden, The Netherlands.
   This study was supported by the Bill & Melinda Gates Foundation Collaboration for AIDS Vaccine Discovery and the National Institutes of Health.
   www.sciencedaily.com/releases/2009/07...
   
5. flosz 21 juli 2009 08:11

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   Brief Communication abstract
   ________________________________________
   Nature Medicine
   Published online: 20 July 2009 | doi:10.1038/nm.1991
   Adenovirus-specific immunity after immunization with an Ad5 HIV-1 vaccine candidate in humans
   Kara L O'Brien1, Jinyan Liu1, Sharon L King1, Ying-Hua Sun1, Joern E Schmitz2, Michelle A Lifton2, Natalie A Hutnick3, Michael R Betts3, Sheri A Dubey4, Jaap Goudsmit5, John W Shiver4, Michael N Robertson4, Danilo R Casimiro4 & Dan H Barouch1,6
   Top of page
   The immunologic basis for the potential enhanced HIV-1 acquisition in adenovirus serotype 5 (Ad5)-seropositive individuals who received the Merck recombinant Ad5 HIV-1 vaccine in the STEP study remains unclear. Here we show that baseline Ad5-specific neutralizing antibodies are not correlated with Ad5-specific T lymphocyte responses and that Ad5-seropositive subjects do not develop higher vector-specific cellular immune responses as compared with Ad5-seronegative subjects after vaccination. These findings challenge the hypothesis that activated Ad5-specific T lymphocytes were the cause of the potential enhanced HIV-1 susceptibility in the STEP study.
   Top of page
   ________________________________________
   1. Division of Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
   2. Division of Viral Pathogenesis, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
   3. Department of Microbiology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.
   4. Merck Research Laboratories, West Point, Pennsylvania, USA.
   5. Crucell Holland BV, Leiden, The Netherlands.
   6. Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, Massachusetts, USA.
   Correspondence to: Dan H Barouch1,6 e-mail: dbarouch@bidmc.harvard.edu
   www.nature.com/nm/journal/vaop/ncurre...
   
6. flosz 21 juli 2009 08:12

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   Published online 20 July 2009 | Nature | doi:10.1038/news.2009.707
   News
   Mystery of HIV vaccine failure deepens
   Heightened immune response to cold virus may not be to blame.
   Erika Check Hayden
   Two groups of scientists have cast doubt on a leading explanation for the failure of a key HIV vaccine.
   In September 2007, researchers halted a trial of the vaccine made by Merck & Co. of Whitehouse Station, New Jersey, because it seemed to increase the risk of HIV infection. The failure of the trial — known as STEP — was a serious setback for AIDS researchers, who were at a loss to explain its disappointing results.
   One theory was that some people responded more strongly than others to a component of the vaccine tested in the STEP trial, making them more vulnerable to HIV, which attacks immune cells that are actively responding to a pathogenic threat. Research teams led by immunologists Dan Barouch at the Beth Israel Deaconess Medical Center in Boston, Massachusetts, and Michael Betts of the University of Pennsylvania School of Medicine in Philadelphia, decided to test this idea in independent studies1,2, both published in Nature Medicine today.
   The two teams examined immune cells from volunteers who received the vaccine used in the STEP trial. The vaccine was built on a backbone made from a modified cold virus — adenovirus 5. In the STEP trial, people who had been infected with adenovirus 5 before receiving the experimental vaccine were more likely to become infected with HIV than people who had not. So the researchers asked whether people whose immune systems had 'seen' adenovirus 5 before the trial responded more strongly to the vaccine than the other volunteers.
   The researchers examined particular immune-system cells, called T cells, from the blood of those who had received the vaccine. They found that people with previous exposure to adenovirus 5 did not have more T cells that recognized adenovirus 5. They did not make more T cells after vaccination, and did not make more 'activated' T cells — those specifically targeted by HIV — than those who had no previous exposure to the cold virus.
   "The bottom line is that, immunologically, there do not appear to be any substantial differences" between those who were and were not exposed to adenovirus 5, "so this would not explain the differences in HIV susceptibility seen in the STEP trial", Betts said.
   Positive messages
   Larry Corey, principal investigator of the HIV Vaccine Trials Network, which conducted the STEP trial, said that researchers within the network had seen similar results. But he cautioned that these latest studies do not examine T cells from specific tissues where HIV enters the body, such as the rectum and the penis foreskin, and so do not rule out the possibility that previous adenoviral immunity made tissues at those sites more vulnerable. "The hypothesis doesn't go away totally," he said.
   However, Corey also notes that continuing analyses suggest that previous adenoviral exposure is not as important as was thought at the time the STEP trial was stopped. Investigators continue to follow volunteers both from STEP and from a sister trial, and to reanalyse their original data. These analyses have highlighted the role of circumcision and of infections with genital herpes in susceptibility to HIV in these trials. In particular, uncircumcised men who received the vaccine were at least three times more likely than circumcised men to become infected with HIV. As time goes on, Corey adds, differences in HIV-infection rates between the vaccine and placebo groups are narrowing.
   "The role that [adenovirus 5] immunity plays has taken a back seat to the role that lack of circumcision has played, and also, to some extent, to the role that genital herpes plays," Corey said. "The issues are getting increasingly more complex as time goes on."
   Although there is still no answer as to what caused the increased HIV-infection rates in the STEP trial, Barouch says the new data are a positive development for the field, meaning that other vaccines built on backbones made from viruses may not necessarily be harmful. Many scientists, including Barouch, are developing such vaccines.
   "We hope that these papers will be positive messages for the field, which has been quite depressed over the past year and a half, and will provide a path for testing of future HIV vaccine candidates," Barouch says.
   www.nature.com/news/2009/090720/full/...
   
7. [verwijderd] 21 juli 2009 12:59

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   96-Week MERIT ES Analysis Shows Efficacy Of Pfizer's HIV/AIDS Treatment Celsentri/Selzentry (Maraviroc) In Treatment-Naive HIV Patients; Results Consistent With 48-Week Analysis
   
   Last update: 7/21/2009 5:30:00 AM
   
   NEW YORK, Jul 21, 2009 (BUSINESS WIRE) -- At 96-week follow up, data from the MERIT ES analysis show that treatment-naive HIV patients taking Celsentri/Selzentry (maraviroc), in combination with Combivir(R) (zidovudine/lamivudine) experienced comparable virologic suppression to undetectable levels and significantly greater increases in CD4 T-cell count through 96-weeks, compared to patients taking efavirenz in combination with zidovudine/ lamivudine. The data also show the favorable tolerability of Celsentri/Selzentry, which was associated with fewer discontinuations due to adverse events.(1)
   
   The 96-week results from MERIT ES were presented today at the 5th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention in Cape Town, South Africa. MERIT ES is an analysis of the data from the MERIT (Maraviroc versus Efavirenz Regimens as Initial Therapy) study following retesting of screening samples using the enhanced sensitivity Trofile(TM) assay - therefore representing a subset of the MERIT primary analysis population. This enhanced sensitivity test was not available at the time of the MERIT study and is the only version of Trofile currently available.
   
   Results from the MERIT ES population show that, at 96 weeks, a similar number of patients taking Celsentri/Selzentry achieved undetectable viral load compared to those taking efavirenz (<50 copies/mL = 58.5 percent and 62.4 percent, respectively). Comparable results were seen based on a Time to Loss of Virologic Response* (TLOVR) analysis (<50 copies/mL = 60.5 percent on Celsentri/Selzentry versus 60.7 percent on efavirenz). Results also show that, at the end of almost two years, a similar number of patients taking Celsentri/Selzentry remained on therapy compared to those taking efavirenz (66.9 percent and 66.0 percent, respectively).
   
   "Durable HIV treatments are critical as they better ensure that patients remain on therapy, which can delay disease progression and help patients live considerably longer lives," said Dr. Michael Saag, professor of Medicine and director of the Center for AIDS Research at the University of Alabama at Birmingham, who presented the results. "These results further support maraviroc's durability and safety profile and, therefore, offer the potential to enhance currently available treatment options for treatment-naive HIV patients."
   
   For patients from the MERIT ES population with higher viral loads at screening (>100,000 copies/mL), a similar number of patients taking Celsentri/Selzentry maintained undetectable viral load compared to those taking efavirenz (56.0 percent and 56.7 percent, respectively, based on TLOVR analysis). Additionally, at Week 96 the increase in CD4 T-cell count was significantly greater with Celsentri/Selzentry than with efavirenz (median change from baseline was +212 cells/mm3 and +171 cells/mm3, respectively, a difference of 41 cells/mm3 [95 percent CI: 17, 65]).
   
   Safety results from the full MERIT population show that, among those patients who remained on therapy (total patient years of exposure of 506 years for Celsentri/Selzentry and 507.9 years for efavirenz), less than half the number of malignancies were observed in patients taking Celsentri/Selzentry compared to those taking efavirenz (1.1 percent and 2.8 percent, respectively). There were also fewer cases of tuberculosis with Celsentri/Selzentry compared to efavirenz (0.3 percent and 2.2 percent, respectively). At 96-weeks, similar to 48-weeks, the most common adverse events reported by patients taking Celsentri/Selzentry were nausea, headache, fatigue and dizziness.
   
   For patients taking efavirenz, nausea, headache, diarrhea, dizziness, vomiting and abnormal dreams were the most commonly reported adverse events. Among those patients taking Celsentri/Selzentry in MERIT at 96-weeks, 1.5 percent had elevated LDL-cholesterol levels that exceeded established thresholds to consider lipid-lowering drug initiation (defined by the NCEP guidelines)(2), compared to 9.9 percent for patients taking efavirenz.
   
   About MERIT and MERIT ES
   MERIT is an ongoing randomized, blinded, non-inferiority trial in treatment-naive patients with CCR5-tropic HIV-1. The Phase 3 trial compares the safety and efficacy of Celsentri/Selzentry 300 mg twice daily versus efavirenz 600 mg once daily, administered with the fixed-dose combination Combivir (a standard of care at the time of trial enrollment). Results of MERIT at 48-weeks were presented in July 2007 at the IAS Conference on HIV Pathogenesis, Treatment and Prevention in Sydney, Australia. Overall for the MERIT ES analysis, 106 patients (15 percent) originally classified as having CCR5-tropic virus were reclassified as having dual or mixed tropic virus.
   
   Results of MERIT ES at 48-weeks were presented in October 2008 at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC(R))/ 46th Annual Meeting of the Infectious Diseases Society of America (IDSA) in Washington D.C., USA. * A patient classified as a TLOVR non-responder required two consecutive viral load measurements of >50 copies/mL. A patient classified as a primary efficacy non-responder required one viral load measurement of >50 copies/mL.
   
   About Celsentri/Selzentry
   Celsentri/Selzentry is an oral medicine that blocks viral entry to human cells. Rather than fighting HIV inside white blood cells, Celsentri/Selzentry prevents the virus from entering uninfected cells by blocking its predominant entry route, the CCR5 co-receptor. Celsentri/Selzentry has been approved for use in several markets around the world including the United States, Canada and European Union in combination with other antiretroviral medicinal products, for the treatment of experienced adult patients with only CCR5-tropic HIV-1 detectable. In South Africa, maraviroc is not available commercially and is currently under review by the Medicine Control Council. Maraviroc is marketed under the trade name Selzentry(R) in the United States and Celsentri(R) in all other countries in which it is approved.
   
   Dirk
8. flosz 22 juli 2009 20:47

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   Wild chimpanzees get AIDS-like illness
   www.nature.com/news/2009/090722/full/...
   
   wo 22 jul 2009, 20:19
   Chimpansees sterven aan aidsachtig virus
   LONDEN - Chimpansees die met de apenvariant van hiv(SIV) zijn geïnfecteerd, kunnen wel degelijk doodgaan aan de gevolgen van de ziekte. Dat blijkt uit onderzoek waarvan de resultaten haaks staan op eerdere aannames, berichtte het Britse wetenschappelijke tijdschrift Nature woensdag.
   
   Tot nu toe werd gedacht dat chimpansees immuun waren voor het zogeheten siv-virus, dat het immuunsysteem van apen afbreekt, net als hiv doet bij mensen. Onder wetenschappers was alleen bekend dat de rhesusaap eraan kon bezwijken.
   Veel wetenschappers zien siv als voorloper van hiv, het virus dat de dodelijke ziekte aids tot gevolg heeft bij mensen. Ongeveer een eeuw geleden zou siv zijn overgedragen op de mens.
   Wetenschappers onderzochten 94 chimpansees in Tanzania gedurende negen jaar. De onderzoeksresultaten vergroten de zorgen om de al onder druk staande apenpopulatie. De chimpansee is een bedreigde diersoort waarvan het voortbestaan wordt bedreigd door erosie van zijn leefomgeving en de jacht.
   www.telegraaf.nl/buitenland/4458467/_...,2
   
9. leo s 22 juli 2009 21:25

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   Uit fierce biotech
   
   3. Glaxo reports dramatic success with AIDS drug
   By John Carroll Comment | Forward
   
   GlaxoSmithKline's experimental AIDS drug produced dramatic results in a small human study. Researchers say that S/GSK1349572 reduced the virus level 500-fold, according to Bloomberg, and none of the 35 patients involved demonstrated any resistance to the drug.
   
   Virus levels were reduced to undetectable levels in 70 percent of patients and none exhibited the genetic mutations linked with standard therapies now in use.
   
   Michael Saag, director of the Center for AIDS Research at the University of Alabama in Birmingham, described the data as "spectacular." Saag was not involved with the study. "In 10 days to go to undetectable is pretty strong. This thing's working."
   
   - read the story from Bloomberg
10. flosz 22 juli 2009 21:32

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    quote:

    leo s schreef:

    Glaxo reports dramatic success with AIDS drug
    Virus levels were reduced to undetectable levels in 70 percent of patients and none exhibited the genetic mutations linked with standard therapies now in use.
    
    - read the story from Bloomberg
    

    Wow!
    www.ias2009.org/pag/Abstracts.aspx?AI...
    
    www.bloomberg.com/apps/news?pid=newsa...
    
11. flosz 24 juli 2009 15:23

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    20 Jul 2009
    IAVI Congratulates SAAVI on the Start of a Trial
    Using the First African-Developed AIDS Vaccine Candidate
    
    Trial to be jointly conducted by the South African AIDS Vaccine Initiative, the HIV Vaccine Trials Network and the U.S. National Institute of Allergy and Infectious Diseases
    Cape Town and New York, July 20, 2009 –The International AIDS Vaccine Initiative (IAVI) congratulates the South African AIDS Vaccine Initiative (SAAVI) on the launch of the SAAVI 102/HVTN 073 vaccine clinical trial. The trial, which will test the first African-developed HIV vaccine candidate, marks a step forward for science in South Africa and Africa.
    “As an African working on the continent, it gives me great pleasure to see immensely skilled homegrown scientists working towards solutions that will serve not only Africa, but possibly the rest of the world,” said Maaza Seyoum, Program Director for IAVI’s Southern Africa office.
    “South Africa was one of the first governments in the world to understand the importance of new AIDS prevention technologies, establishing the South African AIDS Vaccine Initiative to coordinate the research and testing of HIV candidates in 1999. Today, ten years later, we celebrate the fruits of this sustained commitment to AIDS vaccine research and development,” said Seth Berkley, President and CEO of IAVI.
    “It could take a number of years before efforts to develop an effective AIDS vaccine lead to success. But the fact that work is being done in Africa, where the burden of the pandemic is greatest, has already begun to pay dividends. This trial of the South African vaccine candidate will add to scientific knowledge and help advance the field of AIDS vaccine R&D,” added Berkley.
    As the scientific and technological leader of the region, South Africa has much to contribute to the global effort to develop an AIDS vaccine. It also has much to gain from the success of that effort. HIV prevalence within South Africa’s borders is thought to be about 18%, which places South Africa among the countries with the highest percentage of HIV-infected individuals worldwide. An AIDS vaccine, even a partially-effective one, would have dramatic impact on the trajectory of the epidemic in the country.
    www.iavi.org/news-center/Pages/PressR...
    
    HIV study vaccines are designed to lower the chance of someone becoming HIV- infected if that person is exposed to
    HIV. We do not know if the study vaccines tested in this trial will decrease, increase, or not change a trial participant’s
    chance of becoming infected if he or she is exposed to HIV.
    
    There is a chance that these study vaccines could increase a trial participant’s risk of becoming infected if he or she is exposed to HIV.
    
    A previous study called the STEP Study, which was conducted in the USA, tested an HIV study vaccine that contained
    a weakened common cold virus called adenovirus type 5 (Ad5). In a subset of participants from this study who were
    previously infected with Ad5 and who were uncircumcised, there was a higher number of HIV infections in those who
    received the vaccine than those who received the placebo. Th e people who became infected with HIV in the STEP Study
    did not get HIV from the study vaccine. Th ey became infected with HIV from another infected person.
    Th ere was also a South African trial of the Ad5 study vaccine called the Phambili study. It was stopped following the
    above results from the STEP study. Th e group of trial participants from Phambili who had been infected with Ad5 before
    entering the study and who received the study vaccine did not have more HIV infections than the group who had been
    infected with Ad5 before entering the study and who got the placebo. One reason could be that fewer trial participants
    were vaccinated in the Phambili trial compared to those who were vaccinated in the STEP Study.
    Researchers are still looking at the STEP study results to try to learn more and to understand the relationship between
    vaccination, circumcision and prior infection to Ad5.
    Th e study vaccines used in this trial are not like the vaccine used in the STEP study as they have a completely diff erent
    design.
    It is very important that participants avoid exposure to HIV during the study. Th e trial site staff will give trial participants
    comprehensive risk reduction counselling to help them learn how to reduce behaviour that puts them at risk of getting
    HIV.
    www.saavi.org.za/qavaccine.pdf
    
    
12. flosz 3 augustus 2009 10:06

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    Scientists find new strain of HIV
    
    Gorillas have been found, for the first time, to be a source of HIV.
    
    Previous research had shown the HIV-1 strain, the main source of human infections, with 33m cases worldwide, originated from a virus in chimpanzees.
    But researchers have now discovered an HIV infection in a Cameroonian woman which is clearly linked to a gorilla strain, Nature Medicine reports.
    A researcher told the BBC that, though it was a new type of HIV, current drugs might still help combat its effects.
    HIV originated from a similar virus in chimpanzees called Simian Immunodeficiency Virus (SIV).
    
    Although HIV/Aids was first recognised by scientists in the 1980s, it is thought to have first entered the human population early in the 20th Century in the region of the Democratic Republic of Congo.
    The virus probably originally jumped into humans after people came into contact with infected bush meat.
    SIV viruses have been reported in other primates, including gorillas.
    
    Unusual case
    French doctors treating the 62-year-old Cameroonian woman who was living in Paris said they initially spotted some discrepancies in routine viral load tests.
    
    Further analysis of the HIV strain she was infected with showed it was more closely related to SIV from gorillas than HIV from humans.
    She is the only person known to be infected with the new strain, but the researchers expect to find other cases.
    Before moving to Paris, she had lived in a semi-urban area of Cameroon and had no contact with gorillas or bush meat, suggesting she caught the virus from someone else who was carrying the gorilla strain.
    Analysis of the virus in the laboratory has confirmed that it can replicate in human cells.
    Co-author Dr David Robertson, from the University of Manchester, said it was the first definitive transfer of HIV seen from a source other than a chimpanzee, and highlighted the need to monitor for the emergence of new strains.
    "This demonstrates that HIV evolution is an ongoing process.
    "The virus can jump from species to species, from primate to primate, and that includes us; pathogens have been with us for millions of years and routinely switch host species."
    The fact the patient had been diagnosed in France showed how human mobility can rapidly transfer a virus from one area of the world to another, he said.
    
    New problems 'unlikely'
    Speaking to the BBC's Wold Today programme, Dr Robertson said there was no reason to believe that existing drugs would not work on the new virus.
    "If some day we do manage to develop a vaccine, there's no reason to believe it wouldn't work," he said.
    "There's no reason to believe this virus will present any new problems, as it were, that we don't already face."
    Professor Paul Sharp, from the University of Edinburgh, said the virus probably initially transferred from chimpanzees to gorillas.
    He said the latest finding was interesting but perhaps not surprising.
    "The medical implication is that, because this virus is not very closely related to the other three HIV-1 groups, it is not detected by conventional tests.
    "So the virus could be cryptically spreading in the population."
    However, he said that he would guess it would not spread widely and become a major problem.
    "Although the patient with this virus was not ill, there is no reason to believe that it will not lead to Aids," he added.
    
    news.bbc.co.uk/2/hi/health/8175379.stm
    
13. voda 3 augustus 2009 16:15

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    Nieuwe hiv-variant bij mens ontdekt
    3 augustus 2009, 6:24 | ANP
    YAOUNDE (ANP) - Voor het eerst hebben wetenschappers een hiv-variant bij een mens ontdekt die afkomstig is van gorilla's. Franse virologen constateerden het nieuwe subtype bij een 62-jarige vrouw uit het West-Afrikaanse Kameroen, zo berichtte de BBC zondagavond.
    
    Tot nu toe zijn alle hiv-gevallen bij mensen gerelateerd aan het van chimpansees afkomstige siv, dat het immuunsysteem van apen afbreekt, net als hiv doet bij mensen.
    
    Artsen testten de Kameroense in 2004 positief op hiv, kort nadat ze naar Parijs was verhuisd. De vrouw is de enige bij wie de nieuwe variant is vastgesteld, maar wetenschappers verwachten meer gevallen te vinden.
    
    De vrouw woonde in een halfstedelijk gebied in Kameroen en had geen contact gehad met gorilla's of vlees uit de jungle. Dat duidt erop dat ze het virus heeft gekregen van iemand anders.
    
    
14. flosz 7 augustus 2009 14:52

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    www.outandaboutnewspaper.com/article/...
    www.vanderbilthealth.com/HIV-vaccine-...
    
    Estimating the Impact of an AIDS Vaccine in Developing Countries
    Published: August 2009
    This new Policy Brief from IAVI examines the potential impact that an AIDS vaccine could have on the HIV/AIDS pandemic in developing countries. The brief updates results of earlier studies to reflect newer and more accurate data on the pandemic’s characteristics.
    tinyurl.com/mhzccs
    
15. flosz 18 augustus 2009 00:09

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    Project Number: 5U19AI066305-05
    Sub-Project ID: 9001
    Principal Investigator (PI): GOUDSMIT, JAAP
    Title: CORE--VECTOR
    Organization: CRUCELL HOLLAND, BV
    Budget Start Date: 1-APR-2009
    Budget End Date: 31-MAR-2010
    Year 2009
    Funding IC NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
    FY Total Cost by IC $34
    
    The Vector Core Facility (Core B) will manufacture all the recombinant adenovirus (rAd) vaccines for the preclinical studies and the clinical trials described in this IPCAVD grant. Crucell Holland BV is a medium-sized biotechnology company that is dedicated to the development of vaccines for infectious diseases. In particular, Crucell has pioneered the development of rAd vector-based vaccines and has developed vaccine vectors from several Ad serotypes that have low seroprevalence in human populations. Crucell has also been a leader in the preclinical-to-clinical translational development of rAd vector-based vaccines. In particular, Crucell has developed robust production and purification methods to manufacture clinical-grade rAd vaccines that conform to all FDA and EC requirements, standardized and validated release assays, and developed several packaging cell lines that support pharmaceutical-scale manufacturing. Centralized production, purification, and quality control standards are critical to ensure the quality of the rAd vector-based vectors that will be used in the vaccine studies in this IPCAVD grant. This Core Facility will produce the research-grade rAd vaccines to support the preclinical studies described in Projects 1 and 2 and the clinical-grade rAd vaccines to support the clinical trials described in Project 2. We propose the following three Specific Aims for this Core Facility: 1. To manufacture, purify, and quality control research-grade rAd vaccines expressing HIV-1 and SIV antigens; 2. To manufacture, purify, quality control, and release clinical-grade rAd vaccines expressing HIV-1 antigens under Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) conditions; and 3. To coordinate preclinical toxicology studies under GLP conditions and prepare IND applications to support the initiation of phase I and phase II clinical trials.
    projectreporter.nih.gov/project_info_...
    Results projectreporter.nih.gov/project_info_...
    
    Project Number: 5U19AI078526-02
    Sub-Project ID: 0003
    Principal Investigator (PI): GOUDSMIT, JAAP
    Organization: CRUCELL HOLLAND, BV
    Title: MANUFACTURING OF NOVEL ADENOVIRUS PRIME-BOOST HIV-1 VACCINE
    
    Budget Start Date:1-AUG-2009
    Budget End Date:31-JUL-2010
    
    Year 2009
    Funding IC NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
    FY Total Cost by IC$11,476,040
    
    The goal of this project is for Crucell to manufacture clinical-grade master virus seed stocks and trivalent, clinical-grade rAd26 and rAd5HVR48 vaccine products for the clinical trials described in Project 2. Crucell Holland BV is a medium-sized biotechnology company that is dedicated to the development of vaccines for infectious diseases. In particular, Crucell has pioneered the development of rAd vector-based vaccines and has developed vectors from Ad serotypes that have low seroprevalence in human populations. Crucell has also been a leader in the preclinical-to-clinical translational development of rAd vector-based vaccines for a variety of pathogens. In particular, Crucell has developed robust production and purification methods to manufacture clinical-grade rAd vaccines. Crucell has also standardized and validated release assays and has developed several packaging cell lines that support pharmaceutical-scale manufacturing in full compliance with Good Manufacturing Practice (GMP) guidelines. Vaccine candidates based on several different Ad serotypes have been manufactured and released by Crucell and have recently entered clinical trials for Ebola, malaria, and tuberculosis in both the United States and South Africa. Crucell will guarantee uniform, high quality manufacturing of the rAd vaccines as well as strict adherence to Standard Operating Procedures (SOPs) and rigorous quality control / quality assurance (QC/QA) standards in full compliance with all pertinent regulatory authorities. Research-grade vaccines will be provided for the GLP preclinical toxicology studies in rabbits, and clinical-grade vaccines will be manufactured for the phase 1 and phase 2a clinical trials described in Project 2. In our current IPCAVD AI066305 program, we have developed rAd26 and rAd5HVR48 GMP manufacturing processes and release assays that have already been approved by the FDA. In Project 3, we propose to utilize and to improve these existing production processes and analytical assays to manufacture and release the multivalent rAd26 and rAd5HVR48 clinical vaccine products. To accomplish these goals, we propose the following three Specific Aims: 1. To manufacture and release clinical-grade master virus seed stocks for rAd26 and rAd5HVR48 vectors expressing the optimal HIV-1 Gag-Nef, Pol, and Env antigens under GMP conditions; 2. To improve our current manufacturing processes for rAd26 and rAd5HVR48 vectors by optimizing vector yields at harvest and downstream purification steps; and 3. To manufacture, purify, release, and monitor the stability of trivalent, clinical-grade rAd26 and rAd5HVR48 vaccines expressing the optimal HIV Gag-Nef, Pol, and Env antigens under GMP conditions.
    projectreporter.nih.gov/project_info_...
    
16. MeawandMoo1 18 augustus 2009 08:02

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    Goed gevonden en een ab-tje.
    
    

    quote:

    flosz schreef:

    Project Number: 5U19AI066305-05
    Sub-Project ID: 9001
    Principal Investigator (PI): GOUDSMIT, JAAP
    Title: CORE--VECTOR
    Organization: CRUCELL HOLLAND, BV
    Budget Start Date: 1-APR-2009
    Budget End Date: 31-MAR-2010
    Year 2009
    Funding IC NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
    FY Total Cost by IC $34
    [/quote]
    Bovenstaande lijkt budgetair gezien een type-fout. Zeker gezien het programma wat hier aan gekoppeld is.
    
    [quote=flosz]
    Project Number: 5U19AI078526-02
    Sub-Project ID: 0003
    Principal Investigator (PI): GOUDSMIT, JAAP
    Organization: CRUCELL HOLLAND, BV
    Title: MANUFACTURING OF NOVEL ADENOVIRUS PRIME-BOOST HIV-1 VACCINE
    
    Budget Start Date:1-AUG-2009
    Budget End Date:31-JUL-2010
    
    Year 2009
    Funding IC NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
    FY Total Cost by IC$11,476,040
    

    Met dit programma krijg ik een beetje een "aossa /pavlov-reactie". Destijds werd door aossa (Corrigeer me indien ik fout zit) eveneens een miljoenen sponsoring gevonden (Malburg /Ebola).
    Waarschijnlijk een verstandige zet om Crucell even te vragen? (Via een ander overzicht kan men opmaken dat de gelden inderdaad zijn gereserveerd.)
17. wilb52 18 augustus 2009 08:06

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    Voor dit "nachtwerk "
    en AB-tje
18. [verwijderd] 18 augustus 2009 09:00

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    Klasse werk Flosz! AB-tje!
    
    Trouwens ook bedankt voor de waarschuwende woorden in het kader van de "interpretatie" van de informatie.
19. aossa 18 augustus 2009 11:36

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    quote:

    MeawandMoo1 schreef:

    Met dit programma krijg ik een beetje een "aossa /pavlov-reactie". Destijds werd door aossa (Corrigeer me indien ik fout zit) eveneens een miljoenen sponsoring gevonden (Malburg /Ebola).
    

    Woef-woef...
20. MeawandMoo1 18 augustus 2009 11:48

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    quote:

    aossa schreef:

    [quote=MeawandMoo1]Met dit programma krijg ik een beetje een "aossa /pavlov-reactie". Destijds werd door aossa (Corrigeer me indien ik fout zit) eveneens een miljoenen sponsoring gevonden (Malburg /Ebola).
    [/quote]
    Woef-woef...
    

    Bij mij ging wel een belletje rinkelen. (Nog even en ik kan kwijlend naar de kantine; lol).
    
    Iemand toevallig bij Crucell geïnformeerd, of zij "toevallig" deze funding niet in het snotje hebben. (à lá Malburg / Ebola?)