July 14, 2005

1. What is the Center for HIV/AIDS Vaccine Immunology (CHAVI)?
   
   CHAVI is a new consortium of highly dedicated researchers who will undertake fundamental research directed at tackling major scientific obstacles that hinder HIV vaccine design and development. CHAVI’s goals were established by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), in response to recommendations by the Global HIV Vaccine Enterprise. CHAVI investigators will collaborate, develop and share novel research resources; engage non-CHAVI researchers; and contribute in a direct and meaningful fashion to the successful development of an efficacious and globally applicable HIV vaccine.
   
   
2. What is the Global HIV Vaccine Enterprise?
   
   The Global HIV Vaccine Enterprise, proposed in 2003 by prominent HIV/AIDS researchers, public health officials and advocates, was endorsed by the leaders of the G-8 nations in June 2004.
   
   The Enterprise is a virtual consortium of independent organizations committed to accelerating the development of a safe and effective preventive vaccine for HIV/AIDS through the creation and implementation of a shared strategic scientific plan, mobilization of resources and greater coordination and collaboration among HIV vaccine researchers worldwide.
   
   In addition to encouraging the development of global HIV vaccine centers/consortia such as CHAVI, the Enterprise will seek to
   • Stimulate the development of increased HIV vaccine manufacturing capacity
   • Establish standardized preclinical and clinical laboratory assessments for candidate HIV vaccines
   • Close the gap between global capacity and future requirements for conducting clinical trials of HIV vaccines
   • Promote greater engagement by scientists from developing countries in the HIV vaccine research effort
      
3.  What are the goals of CHAVI?
    
   CHAVI’s goals are linked to those of the Enterprise. CHAVI seeks to address major obstacles in HIV vaccine discovery through an immunological focus; to translate basic research information into new HIV vaccine designs; and to conduct small-scale clinical trials.
   
   Specifically, the newly created CHAVI will  

   • Elucidate early viral and immunological events and host genetic factors associated with HIV transmission, establishment of HIV infection and containment of virus replication in humans
   • Determine the correlates of immune protection in non-human primates
   • Design, develop and test novel immunogens and adjuvants that elicit persistent mucosal and/or systemic immune responses to HIV in humans and SIV in primates
   • Evaluate HIV-1 vaccine candidates in early phases of clinical trials
      
4. Doesn’t NIAID have a Vaccine Research Center on campus?  Why is another HIV vaccine research center necessary?
    
   NIAID has an exceptional team of investigators at the Vaccine Research Center (VRC) who are working in a concerted way to rationally design and test promising HIV vaccines. CHAVI will be charged with addressing areas of research, as outlined in the Global HIV/AIDS Vaccine Enterprise Scientific Strategic Plan, that are not currently being addressed by the VRC or other investigators. Unlike the VRC, which is housed in a building located on the NIH campus, CHAVI will not be situated in any specific building or institution but will consist of a collaborative group of scientists at multiple sites—research centers, universities and companies—around the world. In future years, CHAVI may also solicit and support high-priority new ideas and discovery efforts from the extramural research community. Requests will go through a CHAVI-specific peer review process to determine the scientific merit of proposals based on their potential to fill a scientific gap, add value or synergize with existing CHAVI proposals; as well as on the research record of the principal investigator and the availability of funds.
   
   
5. What will CHAVI address that current individual researcher-directed programs are not able to?
   
   CHAVI is an exciting opportunity to address critical gaps in scientific knowledge through carefully designed, focused and coordinated studies that cannot be done with the limited resources of individual researchers. One example of a CHAVI project is the plan to evaluate immune correlates of protection in non-human primates in a rigorous manner using the most sophisticated immune assays available in a sufficient number of animals to attain statistical significance.
   
   
6. How will CHAVI collaborate with existing research programs?
   
   CHAVI will conduct a comprehensive program of research with scientists in academic, clinical and industrial laboratories through a program of national and international collaborations. CHAVI will actively partner with industrial partners for product development and with the NIAID-sponsored HIV Vaccine Trials Network in the area of clinical trials. CHAVI also will develop new methodologies and offer training opportunities that benefit HIV vaccine researchers.
   
   
7. How will CHAVI share its results?
    
   CHAVI investigators will share their results with the scientific community in the same way that the research community normally does: via workshops, publications, informal discussions, formal presentations at scientific meetings, as well as via other mechanisms that may be created to foster interchange among Enterprise-related consortia.
   
   
8. How many CHAVI grants will be awarded in 2005, and at what level of funding?
    
   One seven-year grant from NIAID, which was just announced, will be awarded in fiscal year 2005. NIAID has committed more than $15 million in first-year funding for this award. The cooperative agreement award mechanism will allow an unprecedented synergy between NIAID, CHAVI and other extramural investigators, while at the same time permitting the CHAVI director to retain responsibility for planning, directing and executing the proposed project.
   
   
9. Will CHAVI funding be expanded in subsequent years?  
    
   NIAID anticipates committing up to $49 million per year to support the full implementation of the CHAVI research program to this awardee in years two through seven. Continued support will depend on the acceptability of the CHAVI expansion plan and scientific progress, and the availability of funds. The current plan is to recompete CHAVI at the end of the seven-year award.
   
   
10. How does CHAVI fit into NIAID’s overall plans for vaccine research?  Does funding for CHAVI reduce the availability of funds for other HIV/AIDS vaccine research?
     
    CHAVI enables NIAID to expand support of HIV vaccine research, and it has not changed funding for other HIV vaccine research activities. CHAVI also has not affected funding for unsolicited applications. NIAID is proceeding with its HIV vaccine research agenda, and plans are underway to award one new Integrated Preclinical/Clinical AIDS Vaccine Program award through the Cooperative Agreement (U19) mechanism. This multi-project program supports iterative product evaluation and vaccine optimization. In addition, NIAID expects to fund four HIV Vaccine Research and Design research awards that will target research essential for translating basic research concepts into prototype vaccine/prevention candidates, through the Program Project grant (P01) mechanism.
    
    The $15 million for CHAVI in fiscal year (FY) 2005 comes from the additional monies that the President and Congress provided NIAID in FY 2005 specifically for CHAVI. For FY 2006, the President has requested an additional $34 million for NIAID so NIAID can expand CHAVI, as he announced at last year's G-8 summit, without adversely affecting other HIV/AIDS research that NIAID supports.
    
    
11. What criteria were used to evaluate the CHAVI applications?
     
    All applications went through a peer review process. The overall score for each application was based on the scientific merit of the individual components and the overall synergy and integration of the components. These included
    • The scientific agenda/strategic plan
    • The management and operations group
    • The research and development plans of the CHAVI director and the CHAVI scientific leadership group, and the CHAVI director’s documented experience in directing large, complex, integrated and multifaceted research activities
    • The availability of shared scientific resources and facilities
    • In addition, the reviewers looked at the effectiveness and adequacy of plans for developing and managing CHAVI, the capability of the associated personnel, as well as the plans for expansion through the addition of new research activities and principal investigators after year one. Finally, the evaluation of the applications was based on the extent to which the proposed center would contribute to the AIDS vaccine research, development and evaluation effort.
      
      
12. Upon what does the success of CHAVI depend?
     
    The success of CHAVI will be based on the ability of its scientific leadership to
    • Engage the best researchers
    • Build teams to work collaboratively
    • Dedicate the majority of their effort to HIV vaccine research
    • Resolve intellectual property issues
    • Develop a highly functional organization focused on specific, well-defined questions
      
      
13. Who is the CHAVI director and what qualification does he bring to this job?
     
    Barton Haynes, M.D., of Duke University, is the CHAVI director. He is an internationally recognized leader with an outstanding research record in basic T- and B-cell immunology, retrovirus research and translational vaccine development. His experience includes leadership of large, complex research groups and milestone-driven developmental activities. For more information on Dr. Haynes, see The Duke Human Vaccine Institute Web site and his faculty Web page at Duke University.
    
    
14. Who are the members of the CHAVI scientific leadership group?
     
    Dr. Barton Haynes has chosen four superb leaders to the join the CHAVI scientific leadership group: Norman Letvin, M.D., and Joseph Sodroski, M.D. both of Harvard Medical School; George Shaw, M.D., Ph.D., of the University of Alabama at Birmingham School of Medicine; and Andrew McMichael, M.D., of Oxford University, Oxford, United Kingdom
    

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