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  • We all know the numbers, but lets focus on one: 2.5 Million people were still infected with HIV last year Although prevalence and incidence have steadied in some regions since 2001, for every 2 people placed on treatment 3 more become infected You can’t treat your way out of an epidemic We need both short and long-term solutions to stop the global AIDS epidemic. A safe and effective HIV vaccine is the most promising long-term strategy for stopping the spread of HIV.
  • Vaccines will work and stop new infections.
  • Although we must focus on learning as much as possible about the human immune response, we cannot forget about NHPs. NHPs also have much to contribute to understanding and to vaccine development. But at the moment, they have not been as effectively developed or exploited as they might be.
  • Design clinical research of new immunogens as a means of developing new assays of upstream markers Viral load and clinical protection are downstream markers that do not provide much insight into what is going on after immunization with a new immunogen New, more upstream and mechanism based assays are urgently required to shed light on what is happening after immunzation
  • Recent advances, including systems biology, computational biology, transcriptional profiling, RNAi technologies, multiparameter cell phenotyping , have now made the human amenable to direct experimental analysis. These new advances have much to contribute to understanding the human system and its response to HIV.
  • The HIV vaccine field needs to renew itself. Many of the distinguished investigators in this field entered it in the 1980s when HIV/AIDS was first described. Now, 25 years later, we need to ensure that there is a new generation of equally talented, committed and supported scientists to continue the effort.
  • The average age for first R01 grant today is 43.
  • The Enterprise serves, in essence as the global convener for all those committed to eliminating HIV/AIDS
  • This new era in HIV vaccine research calls for changes in how we work. We need to develop strong relationships between bench scientists and their clinical colleagues. We need to forge seamless relationships between academia and industry. And graduate students need to be exposed early on to the human dimensions of AIDS.
  • Transcript

    • 1. An HIV Vaccine: Where Do We Go From Here? Dr. Alan Bernstein Monday August 4, 2008
    • 2. Why We Still Need an HIV Vaccine ©2008 Global HIV Vaccine Enterprise Source: UNAIDS , 2007 Estimated Number of Adults and Children Newly Infected with HIV, 2007
    • 3. Why We Need an HIV Vaccine ©2008 Global HIV Vaccine Enterprise
      • A safe and effective HIV vaccine is the most promising way to stop the spread of the AIDS pandemic
      • The world needs an integrated plan to defeat HIV/AIDS that includes short, medium, and long term strategies
        • Short-Term: Expand currently accepted treatment modalities
        • Medium-Term: Explore promising approaches (e.g. circumcision, microbicides)
        • Long-Term: A safe and effective preventative vaccine
    • 4. Impact of Vaccines in the United States
    • 5. Steps Towards an HIV Vaccine ©2008 Global HIV Vaccine Enterprise 1. Understand Human Immune Response to HIV
      • Design clinical trials to advance understanding of innate and adaptive immune response to HIV
      • Bring revolution in post-genomics research to HIV vaccine development
      • Expand research on long-term nonprogressors and host immune control of viral set point
      • Attract and retain next generation of vaccine researchers
    • 6.
      • Essential for elucidating correlates of immune protection
      • Validated models advance understanding of:
        • HIV disease progression
        • Natural Immune response
      • Further develop macaque models
        • SIV mac239
        • Novel models
      Pre-Clinical Research: Non-Human Primates 2. Better Exploit NHP Models to Inform and Refine Vaccine Development
    • 7. Rethinking Clinical Trials
      • 3. Shift Focus from Licensure to Research
      ©2008 Global HIV Vaccine Enterprise
      • Move away from “home run” mentality
        • Need for incremental increases in understanding of immune response
        • Require that future clinical research emphasize approaches that will yield insights into human immune response
      • Better connection between product development and fundamental research
        • More collaboration: industry and researchers
        • Consortium approach:
          • CHAVI (NIH); CAVD (Gates Foundation); Eurovac, Europrise (EU); UK HIV Vaccine Research Consortium (Wellcome Trust); Canadian HIV Clinical Trials Network (CIHR); IAVI Consortia
    • 8. Rethinking Clinical Trials
      • 4. Develop Upstream Markers to Understand and Monitor Human Immune Response To HIV
      ©2008 Global HIV Vaccine Enterprise
      • Viral load and clinical protection are downstream markers
        • Not immediately informative about mechanism or vaccine design
        • Downstream markers take time
        • These markers make iterative vaccine design difficult
      • Upstream, mechanism-based assays are required
    • 9. New Approaches: Vital to Progress
      • 5. Bring Post Genomics Revolution to HIV Vaccine Development
      ©2008 Global HIV Vaccine Enterprise
      • New technologies allow development of downstream markers and direct study of immune response in humans
        • Systems and computational biology
        • RNAi technologies
        • Transcriptional profiling
    • 10. New Minds, New Ideas: Engines of Discovery
        • Young researchers bring energy, creativity, and new approaches
        • Investigators from countries most affected by HIV offer new insights and perspectives
        • Researchers from other fields bring new technologies
      • 6. Attract Best Young Investigators
    • 11. New Minds, New Ideas ©2008 Global HIV Vaccine Enterprise Nobel Laureates 1901-2003 in Three Disciplines Stratified by Age at Time of Award-Winning Discovery Data From: Dietrich, Arne, and Narayanan Srinivasan. 2007. The optimum age to start a revolution. Journal of Creative Behavior 41: 54-74.
    • 12.
      • “ In Today’s World, Marshall Nirenberg would get his Nobel Prize before he got his first R01 grant”
      • – Elias Zerhouni
      • Director, US NIH
      ©2008 Global HIV Vaccine Enterprise
    • 13. Young Scientists: Struggling to Enter Research ©2008 Global HIV Vaccine Enterprise Source: Science , 2008, Vol. 319 p391 Researchers under 40 account for less than 40% of NIH Grants Trends in Distribution of Principal Investigators Receiving NIH Grants
    • 14. How Do We Attract New Researchers?
        • New Minds, New Ideas Satellite: Conclusions
        • Change perception of HIV vaccine field from product development to cutting-edge human immunological research
        • Encourage established researchers to expand mentorship of young scientists
        • Capitalize on growing global health programs at major universities to engage young researchers
        • Support “brick and mortar” investments in developing countries to build sustainable research infrastructure and reduce brain-drain
        • Reach out to other scientific fields to bring new skills, cutting-edge technologies (e.g. systems biology) and more collaborative, interdisciplinary approaches to HIV vaccine research
      ©2008 Global HIV Vaccine Enterprise
    • 15. The Global HIV Vaccine Enterprise ©2008 Global HIV Vaccine Enterprise A global partnership, put together by the world’s leading funders of HIV/AIDS research, to articulate the fastest way forward to a safe and effective HIV vaccine
      • Global Strategic Plan
      • Neutral Convener
      • Honest Broker
      • Catalyst
    • 16. Facilitating Collaboration Global Strategic Plan Researchers Funders Industry
    • 17. Convening Critical Meetings
      • Nossal Workshop, New York, April 2008
      • Satellite: New Minds, New Ideas, AIDS 2008, August 2008
      • First Council Meeting, New York, September 2008
      • Systems Biology Workshop, Princeton, October 2008
      • AIDS Vaccine 2008, Cape Town, October 2008
      • Science Board, Fall 2008
      • New Global Strategic Plan, 2009