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NIH National Advisory Allergy and Infectious Diseases Council

Minutes of Meeting: February 7, 2011

The 167th meeting of the National Advisory Allergy and Infectious Diseases Council (NAAIDC) convened at 10:30 a.m. on Monday, February 7, 2011, in Conference Rooms E1/E2, Building 45, National Institutes of Health. Dr. Anthony S. Fauci, director, National Institute of Allergy and Infectious Diseases (NIAID) presided as chair.

In accordance with the provisions of Public Law 92-463, the meeting was open to the public from 10:30 a.m. to 11:40 a.m. and from 12:45 p.m. to 5:30 p.m. The meeting was closed to the public from 8:30 a.m. to 10:00 a.m. and from 11:40 a.m. to 12:00 p.m. for review and consideration of individual grant applications. Notice of the meeting was published in the Federal Register.

Council Members Present:

  • Dr. Ann Arvin
  • Dr. Carol Carter
  • Dr. Connie Celum
  • Dr. Nelson Chao
  • Dr. Satya Dandekar
  • Dr. Sharon Kiely
  • Mr. William McLin
  • Dr. Louis Picker
  • Dr. Regina Rabinovich (p.m. by teleconference)
  • Dr. Samuel Stanley
  • Dr. Jenny Ting
  • Dr. Christel Uittenbogaart
  • Dr. Christopher Walker
  • Dr. Richard Whitley

Ex Officio Members Present:

  • Dr. Victoria Davey
  • Dr. Anthony Fauci
  • Dr. Bruce Gellin
  • Dr. Rima Khabbaz

Ex Officio Members Absent:

  • MG James Gilman
  • COL Kent Kester

Council Members Absent:

  • Dr. Robert Brooks
  • Dr. Marc Rothenberg
  • Dr. George Siber
  • Dr. David Wilkes

NIAID Senior Staff Present:

  • Dr. Hugh Auchincloss
  • Dr. Carl Dieffenbach
  • Dr. Carole Heilman
  • Dr. Marvin Kalt
  • Dr. Cliff Lane
  • Dr. John McGowan
  • Dr. Daniel Rotrosen

Table of Contents

I. Review of Grant Applications

The National Advisory Allergy and Infectious Diseases Council convened in closed session to consider applications in allergy and immunology, microbiology and infectious diseases, and AIDS.

Funding Actions: The Council reviewed 2,490 research and training applications with primary assignment to NIAID for a requested amount of $869,890,261 in first-year direct costs and recommended approval of 617 applications for $193,368,118 in first-year direct costs.

II. Remarks of the Director, NIAID—Anthony S. Fauci, M.D.

Dr. Fauci opened the Council session by welcoming visitors to the meeting. Four Council members, Drs. Brooks, Rothenberg, Siber, and Wilkes, were unable to attend the meeting. Ex officio members, Major General James Gilman and Colonel Kent Kester were unable to attend the meeting.

Consideration of Minutes of Previous Meeting

Council considered the minutes of the September 20, 2010, meeting and approved them as written.

Consideration of Operating Procedures

Council reviewed the 2011 Council operating procedures and adopted them as written.

Staff and Organizational Changes

Dr. Fauci announced several changes in leadership positions in DAIDS. At the end of 2010, Dr. Peggy Johnston retired as director of the DAIDS Vaccine Research Program. Dr. Alan Fix will serve as acting director while NIAID conducts a search to fill the position. Dr. Kevin Ryan was named deputy director of the DAIDS Vaccine Research Program.

Mr. Steve Smith, director, NIAID Office of Global Research (OGR), has been selected to serve as the HHS attaché in New Delhi, India. Dr. Karl Western will serve as acting director, OGR, until NIAID recruits a new director.

In NIAID’s Office of Technology Development, Dr. Mukul Ranjan was appointed chief of the Immunology and Emerging Infections Branch, and Dr. Vincent Feliccia was named chief of the Vaccine Design, Allergic, and Infectious Diseases Branch.

Tributes and Awards

Dr. Fauci paid tribute to Dr. Jeffrey Nadler, a pioneering HIV/AIDS researcher and clinician, who died in November.

In the January 1, 2011, issue of The Journal of Infectious Diseases, Drs. Albert Kapikian, David Morens, and Anthony Fauci, co-authored a piece honoring Dr. Robert M. Chanock, who died in July 2010.

Dr. Fauci announced that Dr. Thomas E. Wellems, chief of the Laboratory of Malaria and Vector Research, was elected to the Institute of Medicine. Also, Dr. Albert Kapikian, chief of the Epidemiology Section, Laboratory of Infectious Diseases, will receive the 2011 Maurice Hilleman/Merck Award in May at the 111th general meeting of the American Society for Microbiology.

Budget Update

NIAID is still operating under a continuing resolution that expires on March 4, 2011, and provides for funding at FY 2010 budget levels. Congress is discussing several possible budget scenarios for the remainder of the fiscal year. One scenario has the budget remaining flat for the rest of the fiscal year, and another scenario funds all non-security discretionary programs at the FY 2008 level.

Because of these uncertainties, NIAID is taking a conservative funding approach. We set our interim R01 payline at the 8 percentile. At this level, our overall projected success rate would be approximately 17 percent. NIAID will set final paylines when we receive a final FY 2011 spending bill.

Legislative Update

As a result of the 2010 elections, Dr. Fauci presented changes in leadership positions in the House of Representatives and Congressional committees relevant to NIAID.

On September 29, 2010, Dr. Fauci testified before the House Committee on Foreign Affairs at a hearing on the President’s Emergency Plan for AIDS Relief (PEPFAR). Ambassador Eric Goosby, the U.S. Global AIDS Coordinator, and Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention, also testified.

In December, Dr. Fauci briefed the House Committee on Energy and Commerce on the promising results from the Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex With Men (iPrEx) study.

In September, Dr. Carole Heilman briefed Delegate Donna Christensen (D-VI) and Resident Commissioner Pedro Pierluisi (D-PR) on the NIAID dengue research program.

When Rep. Rodney Frelinghuysen visited NIH to learn more about multiple sclerosis research, Dr. Ronald Germain gave him an overview of the intramural NIH Center for Human Immunology, Autoimmunity, and Inflammation.

In October, Dr. James McNamara briefed the staff of the Senate Finance Committee on diabetes research and provided an update on the progress of type 1 diabetes research that the Immune Tolerance Network is conducting.

Other Information Items

Each year the Lancet conducts voting for the Lancet paper of the year. For 2010, three of the six finalists had NIAID support. Dr. Fauci briefly discussed each of the three papers and its significant findings.

Dr. Fauci spoke about the importance of the National HIV/AIDS Strategy that came from the White House Office of AIDS Policy. He acknowledged Dr. Carl Dieffenbach, DAIDS staff, and Dr. Jack Whitescarver for working with the White House on this effort.

On October 26, 2010, NIAID held a town hall meeting to discuss the restructuring of the clinical trials networks. Participants discussed priorities for HIV/AIDS research, looked at tuberculosis and hepatitis as part of the HIV/AIDS research agenda, and proposed forming a new infectious diseases leadership group.

DMID will lead another town hall meeting on March 7, 2011, to discuss incorporating other non-HIV/AIDS infectious diseases into the clinical trials networks.

Dr. Fauci gave brief updates on the cholera outbreak in Haiti, NIAID’s cholera research agenda, malaria, vaccine collaboration efforts, and food allergy research and guidelines.

III. Guest Speakers—Dr. Carl Dieffenbach, Director, Division of AIDS, and Dr. Carole Heilman, Director, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases

This discussion concerned the possibility of restructuring the AIDS clinical trials networks to include research on non-HIV/AIDS infectious diseases, such as tuberculosis and hepatitis.

Dr. Dieffenbach explained the structure of the new networks, which features a series of leadership groups. Within each group will be a leadership and operations center that sets priorities, a statistics and data management center, and laboratories.

He told members that during the past 20 months, DAIDS has worked with the HIV/AIDS scientific communities affected by the restructuring to establish priorities. The four priority areas for HIV/AIDS and AIDS-related research are HIV vaccines, therapeutics, pediatrics and maternal and child health, and HIV prevention.

Dr. Dieffenbach noted that pediatric and maternal and child health activities will be co-supported by the National Institute of Child Health and Human Development.

Providing the infectious diseases perspective, Dr. Heilman gave background on the research DMID is supporting and the existing infrastructure. DMID doesn’t have enough infectious diseases resources to develop a special infrastructure that would allow the Division to implement a larger clinical research agenda. However, using the infrastructure that DAIDS has in place, DMID hopes to integrate efforts to expand the infectious diseases network.

The non-HIV/AIDS infectious diseases component will have one leadership group. To help define the agenda, NIAID plans to hold a town hall meeting on March 7, issue a request for information asking the infectious diseases community for priority areas, publish a notice in the Federal Register, and present the initiative to Council for input.

IV. Report of the Division of Allergy, Immunology, and Transplantation Council Subcommittee—Daniel Rotrosen, M.D., Director

Dr. Rotrosen opened the subcommittee Council meeting by welcoming all returning members of the National Advisory Allergy and Infectious Diseases Council Subcommittee. After welcoming the subcommittee members, Dr. Rotrosen informed the members of new staff members to the division: Dr. Maria-Concetta Veri, Regulatory Affairs Officer in the Office of Regulatory Affairs; Dr. Kasia Bourcier, Program Officer, the Clinical Immunology Branch; Dr. Halonna Kelly, Scientific Program Analyst, the Basic Immunology Branch; and Dr. Erika Lamb, Health Scientist - AAAS Science Policy Fellow in the Office of Product Development.

Dr. Rotrosen informed the subcommittee there has been a tremendous amount of activity related to food allergy research, clinical trials in food allergy, and the release of the food allergy guidelines. As such, it was our pleasure to have Dr. Hugh A. Sampson, Director, Jaffee Food Allergy Institute, Mount Sinai School of Medicine present on the “The Consortium of Food Allergy Research (CoFAR) – Past, Present and Future.” He noted, that before we hear Dr. Sampson’s presentation, Dr. Marshall Plaut, Asthma, Allergy, and Inflammation branch would give an overview of “The NIAID Food Allergy Research Portfolio” within the Division.

Dr. Rotrosen concluded his remarks by letting the subcommittee members know that members of the division’s branches and offices had participated in a number of workshops, symposiums and meetings. In addition, the division had released several scientific initiatives.

Dr. Rotrosen informed the Council members there were 2 concepts for review and approval.

The following concepts were presented for the Subcommittee’s consideration:

Nonhuman Primate Islet/Kidney Transplantation Tolerance: This research initiative will recompete and renew the islet and kidney transplantation portion of the Nonhuman Primate Transplantation Tolerance Cooperative Study Group, a multi-institution research program of U01/U19 grants established in FY 1999. Renewal of the NHPCSG will allow the continuation of the development of promising therapeutic strategies and novel studies of tolerance induction, maintenance, and/or loss in kidney and islet transplantation. The Subcommittee unanimously approved the initiative.

Predictive Biodosimetry: Discovery and Development of Biomarkers for Acute and Delayed Radiation Injuries: This initiative will support basic, applied, or translational research projects on identifying and validating biomarkers of acute and delayed radiation injury to different physiological systems for prompt medical intervention, including developing easy-to-use assays, techniques, and/or devices for use in all segments of the civilian population. Dynamic considerations will be incorporated into these studies, as well as assessment of variance with individual radiation sensitivity, age, gender, ethnicity, and underlying health conditions. The Subcommittee unanimously approved the initiative.

V. Report of the Division of Microbiology and Infectious Diseases—Carole Heilman, Ph.D., Director

Dr. Carole Heilman, Director of the Division of Microbiology and Infectious Diseases (DMID), chaired the NIAID Microbiology and Infectious Diseases Council Subcommittee meeting on February 7, 2011. After welcoming the Subcommittee, Dr. Heilman referred to the Branch Chiefs in attendance to introduce their respective new hires.

Following welcoming remarks and introductions, Dr. Heilman referred to program staff to present the following concepts for the Subcommittee’s consideration and approval:

Vaccine and Treatment Evaluation Units (VTEUs) – the goal of this program is to support a clinical trial infrastructure for evaluating vaccines, biologics, therapeutics, diagnostics, biomarkers, and devices for infectious diseases. Dr. Richard Gorman summarized recent accomplishments of the VTEUs, and outlined proposed changes to the program. One Subcommittee member asked how concepts were selected and prioritized, and how program staff interfaced with industry. Dr. Gorman stated that the public health impact quotient is a critical element in considering concept prioritization. He also described the variety of ways DMID program staff interact with industry, and noted that those interactions have been and continue to be productive and positive.

One committee member remarked that the VTEUs were coming up on their 50th Anniversary and were a “national treasure;” DMID was encouraged to ensure that the program did not stray or vary too much from the character and composition that has made it so successful at responding to public health priorities to date. Another member asked how the VTEUs will compare to the new Leadership Group concept (see below). Dr. Heilman said that the VTEUs are supported through a contract mechanism, which provides DMID with the flexibility to address all infectious diseases and any public health priority as it arises, whereas the Leadership Group will be supported by a cooperative agreement and will focus on a specific research agenda proposed by the applicant and then peer reviewed. Subcommittee members unanimously supported this concept for clearance.

Leadership Group for a Clinical Research Network for Infectious Diseases Other than HIV – the goal of this concept is to establish a leadership group to address non-HIV clinical research priorities, with related research conducted in already established NIAID clinical trial units and sites, including those historically designated for HIV research.

Subcommittee members expressed concern that since infectious diseases encompass many different pathogens, clinical presentations and clinical questions, the implementation of this broad concept might prove problematic. In addition, there were several questions regarding the practical implementation of this grant program, e.g., how it would interface with programs supported by the Division of AIDS, specifically the Clinical Trial Units and Clinical Research Sites. Though supportive of the concept in general, they urged further discussion of the details since the non-HIV infectious diseases community is not familiar with the Leadership Group approach to conducting clinical research.

Note: on February 16, NIAID leadership issued a statement to report that the primary focus of this leadership group will be to develop and implement a comprehensive clinical research agenda to address bacterial antimicrobial resistance; see: http://blog.aids.gov/2011/02/toward-defining-the-non-hiv-infectious-diseases-leadership-group.html.

Development of Technologies that Accelerate the Immune Response to Biodefense Vaccines – this concept would support the development of new technologies for Category A and B priority pathogen vaccine candidates that will enhance the immune response of these products. The Subcommittee members enthusiastically and unanimously supported this initiative, emphasizing the importance of studying new technologies to improve a wide variety of vaccines spanning biodefense and emerging diseases. To develop this concept, companies with technologies will likely need to partner with vaccine development counterparts. State of the art technologies from this fast moving field will help optimize existing vaccines by improving aspects such as needle free injection and other delivery devices, and cold chain elimination. Members also indicated that this concept addressed some questions raised by the Institute of Medicine and the World Health Organization concerning vaccines of the future and optimization of current vaccines.

VI. Joint Meeting of the AIDS Subcommittee, National Advisory Allergy and Infectious Diseases Council and AIDS Research Advisory Committee (ARAC)—Carl Dieffenbach, Ph.D., Director, DAIDS

Dr. Uittenbogaart welcomed the ARAC members, DAIDS representatives, and guests. She presented the minutes of the September 20, 2010, ARAC meeting, and the members approved them, with no changes, by a hand vote.

Director's Report

Carl W. Dieffenbach, Ph.D., Director, DAIDS

Dr. Dieffenbach welcomed the attendees and, introduced the following new members - Myron (Mike) Cohen, M.D, Francine E. McCutchan, Ph.D., and Judith N. Wasserheit, M.D., M.P.H.

Dr. Dieffenbach reported that Peggy Johnston, Ph.D., retired at the end of 2010. Dr. Johnston had been serving as director, Vaccine Research Program and as Assistant Director for HIV/AIDS at NIAID. Her retirement was the culmination of a long and distinguished career at NIAID. Alan Fix, M.D., has agreed to serve as acting director of the Vaccine Research Program during the search for a permanent replacement for Dr. Johnston. He is chief of the Vaccine Clinical Research Branch. Kevin Ryan, Ph.D., has returned to DAIDS and will serve as deputy director of the Vaccine Research Program. He recently served as program officer/deputy chief of the Pediatric, Adolescent, and Maternal AIDS Branch, Center for Research for Mothers and Children, National Institute of Child Health and Human Development (NICHD).

Dr. Dieffenbach reported that Jeff Nadler, M.D., passed away in the fall of 2010. Dr. Nadler had retired from DAIDS in July 2010 and previously served as deputy director and acting director of the Therapeutics Research Program. He was recognized internationally for his expertise in HIV/AIDS clinical care.

Budget

Dr. Dieffenbach reviewed aspects of the past, present, and future NIAID budget, noting that the payline has remained fairly constant for the past four years. The success rates for research project grants (RPGs) and R01s have held steady for the past five years, while the success rates for program project grants (P01s) have varied somewhat. The number of applications and awards for R21s increased significantly in 2010. A comparison of NIAID success rates (RPGs and R01s) with other institutes and the NIH overall reveals that the NIAID’s rates are slightly above average. The AIDS-research-related 2010 success rates for P01, R01, and R21 mechanisms were, respectively, 28 percent, 23 percent, and 26 percent.

The FY2011 budget has not yet been passed, and NIAID will continue to work under a continuing resolution (2010 levels) until March 4. There is great uncertainty about the FY2011 budget levels. Congress is considering options including a full-year continuing resolution at FY2010 levels or a roll-back to FY2008 levels. In response to the uncertainty, NIAID is taking a conservative approach, setting the interim R01 payline at the 8th percentile, with a projected overall success rate of 17 percent. If roll-back to an earlier level occurs, the NIAID will reset the base for all programs and will institute cuts in FY2011 committed funding levels for intramural and noncompeting grants and contracts.

Scientific Highlights

The NIAID-supported iPrEx study found that the use of preexposure chemoprophylaxis (PrEP) was safe and effective in reducing HIV infection (44 percent reduction in incidence). An even higher reduction in incidence (73 percent) was found among participants who more closely adhered to the regimen. The study involved HIV-seronegative men and transgender women who have sex with men in Brazil, Ecuador, Peru, South Africa, Thailand, and the United States. Study participants received emtricitabine and tenofovir disoproxil fumarate (Truvada) or placebo. A follow-on study of long-term effectiveness, safety, and behaviors is being developed.

The published report of this study and two other NIAID-supported publications are finalists in the Lancet’s “paper of the year” contest.

The Strategic Timing of Antiretroviral Treatment (START) study expanded enrollment after achieving a number of pre-set milestones. The study, which is being conducted through the INSIGHT network, seeks to provide evidence for the optimal timing of the use of antiretroviral therapies.

Strategic Working Group Update

Carl W. Dieffenbach, Ph.D., Director, DAIDS

Dr. Dieffenbach reported that the Strategic Working Group met on October 13 to 14, 2010, and addressed the following topics:

  • The future NIAID clinical research networks structure.
  • Community partners.
  • Activities of the Office of HIV/AIDS Network Coordination (HANC).
  • The tuberculosis agenda of the AIDS Clinical Trials Group (ACTG).
  • The national HIV/AIDS strategy.

The working group members expressed support for NIAID’s goal of establishing a multi-disease research capacity using the HIV/AIDS infrastructure. They applauded the efforts of HANC and encouraged the ACTG to continue to strengthen its TB agenda.

Update: Office of AIDS Research Advisory Council

Christel H. Uittenbogaart, M.D., Chair, ARAC

Dr. Uittenbogaart reviewed the meeting agenda of the Office of AIDS Research Advisory Council (OARAC), which took place on November 9, 2010. The meeting focused on HIV research in adolescents and the inclusion of adolescents in research. The meeting also included:

  • An update on the OARAC working groups for treatment and prevention guidelines.
  • A summary of a workshop on the inclusion of adolescents in HIV biomedical prevention clinical trials.
  • Presentations on development in HIV-infected adolescents.
  • Presentations on behavioral risks and prevention for adolescents.
  • Presentations on treatment and clinical research for adolescents.
  • Presentations on adolescents engaged in HIV research.

Key points that were raised for discussion included the following:

  • The occurrence of MSM and intravenous drug use depends on the country and, within a country, on region and race.
  • Poor growth is related to high viral load.
  • Antiretroviral therapy is related to lipodystrophy, hypercholesteremia, glucose abnormalities, and decreased bone mineral density.
  • Technology that is part of the adolescent’s daily life (e.g., cell phones) can be used in prevention outreach.
  • Treatment and care for adolescents differ from care for children and adults.

During the ARAC discussion, it was noted that the OARAC council meeting’s conclusions about the need for and opportunities for research on adolescents ought to be considered as NIAID proceeds with its restructuring of the HIV/AIDS clinical research networks. A request was made to have the meeting summary forwarded to all ARAC members. A suggestion was also made to have a summary of that meeting sent to Ambassador Goosby because of the opportunities for adolescent research within PEPFAR. When PEPFAR started many of the children put on ART were under ten years old, and that was eight years ago. There are now about 200,000 adolescents on ART and no one knows what to do with them.

Update: AIDS Vaccine Research Subcommittee

James A. Bradac, Ph.D., Preclinical Research and Development Branch, DAIDS

Dr. James Bradac reviewed activities of the AIDS Vaccine Research Subcommittee (AVRS), which held meetings in May 2010 and September 2010. Among the many topics covered at those meetings, he highlighted the discussions on macaque models for AIDS vaccine research at the May meeting and the discussion in September on correlates analysis associated with the RV144 Thailand vaccine trial.

The May meeting discussion focused on macaque challenge models and research that is being carried out to make these models more relevant to the human situation. In the past virus challenge was done exclusively via intravenous inoculation with high titer virus. More recently investigators have developed mucosal exposure models to the point that the number of transmitted viruses closely mimics what is seen in human infection. Utilizing these improved models, a number of experimental vaccines have been shown to protect from virus acquisition. It remains to be seen if these models will predict protection of vaccines in human clinical testing.

Dr. Bradac presented the strategy being followed to attempt to decipher the correlates of protection observed in the RV144 vaccine efficacy trial. A team of investigators have been designing and testing assays that measure various immune responses, and have assayed samples derived from the RV144 trial. Assays have been chosen based on a number of criteria including the ability to differentiate vaccines from placebo controls. The next step will be to utilize the prioritized assays in the case-controlled study, testing samples derived from vaccines who ultimately became infected versus vaccines who remain uninfected. The next meeting will be held the two days following ARAC, February 8 and 9, where the topics of discussion include the Gates Foundation’s vaccine strategy and activities planned for 2011-2016, and the vaccine trials that are being planned to build on the success of RV144.

Restructuring the HIV/AIDS Clinical Trials Networks

Carl W. Dieffenbach, Ph.D., Director, DAIDS

Dr. Dieffenbach discussed the ongoing effort to restructure the HIV/AIDS clinical trials networks, noting that the current leadership groups will expire in 2013. The goals of the new structure will include the development of a multi-disease research capacity, a focus on targeted scientific priorities, continuation of an international scope and community involvement, the maintenance of research infrastructure, the presence of a transparent mechanism for supporting meritorious ideas, the linkage of site capacity to trials, and efforts to increase efficiency and timeliness for trials in other countries.

Following a large number of meetings and consultations with experts and stakeholders, the NIAID decided to create a network structure that features a Leadership and Operations Center (LOC) within each network that provides scientific and administrative leadership, central operations, and communications, a Laboratory Center (LC), and a Statistical and Data Management Center (SDMC). The clinical trials units and clinical research sites (CTU/CRS) will be funded separately (the concept for that RFA will be discussed and reviewed at the May ARAC meeting). The network structure will address four main priority areas: HIV vaccines, therapeutics, prevention, and pediatric and maternal health, and will result in five RFAs. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is co-sponsoring the pediatric and maternal health HIV RFA. None of the other NIH Institutes have made a commitment to co-fund any of the networks to the extent of wanting to support an RFA. Often the other Institutes fund on a study by study basis. Therefore, what is being presented represents NIAID funds for the networks. However, given the lack of a clear budget for this fiscal year and next, two scenarios were developed. The worst case scenario is the possibility of a rollback to 2008 levels, followed by no growth for five years. The slightly rosier scenario is freezing the budget at 2010 levels, and then very limited growth for a five year period.

All of the prevention-related networks will be required meet on an annual basis to ensure coordination among vaccine, microbicide, and integrated prevention research, which will be important as NIAID moves forward with large studies. The Office of HIV/AIDS Network Coordination (HANC) will continue to be funded to support the coordination of a wide range of network activities.

NIAID will be using a new grant mechanism—the UM1 mechanism—to support the leadership groups. It is a multi-component research project cooperative agreement and will be for seven years. The RFA for the new structure will be developed during 2011 and will be released in early 2012.

There were several questions and suggestions during the discussion.

  • Given limited budgets, the need for coordination among all government agencies with related HIV/AIDS research was emphasized to ensure that there is no duplication of effort.
  • With regard to budget, it was noted that the current assumptions extend from a high-end estimate of about 5-percent growth to a low-end estimate of a significant reduction. Specific decisions about increases or decreases in budgets will be made at a later time. Budgeting flexibility for research portfolios will be considered by the division’s strategic working group.
  • It was suggested that ACTG representatives be included in the annual meetings of the prevention leadership groups.
  • There was concern that broadening the scope of work to other infectious diseases could make it difficult to plan up-front for the RFAs 7-year period. It was however, also noted that the leadership groups will be engaged in decision-making regarding agendas as the science proceeds.
  • In discussing changes in the international agenda, there will be shifts in emphasis and NIAID will work with the Office of AIDS Research (OAR) and other NIH institutes to plan appropriately. The development of treatment and prevention guidelines will continue to be under the auspices of OAR and will remain an extremely important activity.

Concept Review

Leadership Group for a Clinical Research Network on Vaccines to Prevent HIV Infection

Alan Fix, M.D., Vaccine Research Program, DAIDS

The objective of this concept is to establish a Network Leadership Group comprising an LOC, LC, and SDMC to lead a comprehensive clinical research program for discovering and developing an efficacious prophylactic HIV vaccine. There is also a new objective of contributing to a scientific agenda and providing capacity for trials that support the development of vaccines against other infectious diseases that affect HIV populations. This is a renewal with restructuring, supported by the UM1 cooperative agreement mechanism. The award is for seven years, with one award each for the LOC, the LC, and the SDMC.

Dr. Fix listed potential scientific priorities and partners for the program and capacities that the grantee will need. Reviewers (Celum, Michael, Warren) asked for clarification about the framework for the relationship between clinical studies and nonhuman primate studies, the balance between the HIV focus and the focus on other diseases (e.g., TB and HCV), the role of the LOC in choosing new sites, and the balance between behavioral/social science research and clinical trials. It was noted that behavioral/social science research will not drive projects, but will be incorporated into research where appropriate. It was suggested that the final RFA be clear regarding collaborations and interactions, particularly as in terms of multiple prevention modalities; it should ensure that diversifying to include other diseases does not dilute the primary HIV focus, and emphasize the need for accurate protocol budgets, accountability, and transparency throughout the network.

Technical issues related to developing the candidate vaccines for other diseases were raised and NIAID was encouraged to seek synergies and opportunities as it pursues multi-disease work.

The ARAC members expressed support for the concept and voted approval.

Leadership Group for a Clinical Research Network on Integrated Strategies to Prevent HIV Infection

Sheryl Zwerski, R.N., Prevention Sciences Program, DAIDS

The objective of this concept is to establish two leadership groups, each with a LOC, LC, and a SDMC. One of the leadership groups will evaluate integrated HIV prevention strategies [including pre-exposure prophylaxis (PrEP)], while the other will evaluate topical microbicides for HIV prevention. This is a renewal with restructuring, supported by the UM1 cooperative agreement mechanism. There will be two resulting FOAs and the awards would be seven years; there will be separate awards for the LOC, LC, and SDMC within each group.

Ms. Zwerski noted that priorities for the integrated prevention strategies leadership group include developing and testing integrated biomedical and behavioral prevention strategies to reduce incidence on a population level. This includes but is not limited to oral PrEP, behavioral interventions for both HIV negative and HIV positive people as well as HIV treatment as prevention, and other emerging biomedical products and/or strategies. Priorities for the microbicides leadership group include testing and bringing to licensure microbicides for vaginal and rectal use, including new agents, formulations and delivery systems. Ms. Zwerski listed potential partners for each of these efforts.

The ARAC reviewers (Warren, Birx, and Goodenow) had inquired about the budgets, the potential for redundancies (e.g. in the labs), linkages across the two programs, and the potential for site efficiencies. The need for a strong behavioral science component in the trial and data designs was also raised. In clarifying the roles of the two efforts, it was noted that pre-exposure prophylaxis and long-acting prevention strategies would fall under the purview of the integrated prevention leadership group. Concern about the potential for redundancies in the research, for example, related to the use of resources was discussed and NIAID was urged to ensure that the two programs develop a means of consolidating and sharing expertise and resources and coordinating research activities.

The ARAC members expressed support for the concept and voted approval.

Leadership Group for a Clinical Research Network on Therapeutics for HIV/AIDS and HIV- Associated Infections in Adults

Carla B. Pettinelli, M.D., Therapeutics Research Program, DAIDS

The objective of this concept is to establish a Leadership Group comprised of a LOC, LC, and SDMC to carry out the NIAID adult therapeutic HIV-related agenda domestically and internationally. This is a renewal with restructuring, supported by the UM1 cooperative agreement mechanism. The award is for 7 years, with one award each for the LOC, LC, and SDMC. The program will address four scientific areas:

  • Cure or functional cure for HIV.
  • Infectious hepatitis.
  • Tuberculosis.
  • Non-infectious co-morbidities and novel interventions.

Dr. Pettinelli listed research priorities for each of the four scientific areas above and the capacities that the applicant must demonstrate, such as an ability to respond to emerging high priority research needs, and an ability to collaborate with communities, other networks, and stakeholders.

The ARAC reviewers (Lieberman and Swindells) inquired about the possibility of separate leadership groups for topic areas, which was not pursued because of the need for efficiency and flexibility, the need to encourage investigator-initiated research ideas, and the possibility of expanding to include research on additional infectious co-morbidities. Applicants will need to demonstrate flexibility to respond to changing priorities, and to engage experts outside the network. It was also noted that international investigators will be involved in developing the network’s scientific agenda. ARAC members discussed the need for collaboration, and suggested that the related research supported by the National Institute for Diabetes and Digestive and Kidney Diseases on hepatitis B may provide an opportunity for collaboration. The ARAC members expressed support for the concept and voted approval.

Leadership Group for a Clinical Research Network on HIV/AIDS and HIV-Associated Infections in Pediatric and Maternal Populations

Ed Handelsman, M.D., International Maternal, Adolescent, and Pediatric Branch, DAIDS

The objective of this concept is to establish a Leadership Group comprising a LOC, LC, and SDMC to carry out the HIV-related pediatric and maternal scientific research agenda of NIAID and NICHD domestically and internationally. This is a renewal with restructuring, supported by the UM1 cooperative agreement mechanism. The award is for seven years, with one award each for the LOC, LC, and SDMC. The program will address five scientific areas:

  • Prevention of HIV acquisition.
  • Cure or functional cure.
  • Pharmacology, drug formulation, and novel interventions.
  • Co-infections, co-morbidities, and ART consequences.
  • Vaccines of high priority to the populations.

Dr. Handelsman listed research priorities for each of these five scientific areas and the capacities that an applicant must demonstrate, such as an ability to respond to emergency high-priority research needs and an ability to collaborate with communities, other networks, and stakeholders. The grantee will need to demonstrate expertise in pediatric, maternal, and adolescent populations and will need expertise in non-HIV infectious diseases and metabolic and behavioral issues as well as HIV.

The ARAC reviewers (Goodenow, Uittenbogaart) inquired about the types of vaccines to be considered and it was pointed out that this includes all vaccines that are part of the pediatric vaccine schedule and high priority vaccines in development, such as TB vaccine, hepatitis C vaccine and other newly developed vaccines that are of particular importance in this population. The reviewers encouraged the program to collaborate with the Adolescent Trials Network (ATN). There is already collaboration with the ATN at all levels with the current networks and it is anticipated that there will be amplified coordination in the future. It was also noted in discussion that vaccines would be tested in infants only after efficacy in adults is established.

The ARAC members expressed support for the concept and voted approval.

Pilot Collaborative US-China Program on HIV and Co-morbidities, Infectious Disease, Immunology, and Cancer

F. Gray Handley, M.S.P.H., International Research Affairs, NIAID

The objective of this concept is to allow investigators to foster or expand research collaboration with Chinese co-investigators. It is a new program and will use the R21 mechanism. The duration is 1-to-2 years with a first year cost of $1 million. In addition, the National Cancer Institute (NCI) and OAR will each contribute $1 million, and there will be complementary funding from the Chinese.

Mr. Handley described the benefits of working with China and the potential of the National Natural Science Foundation of China (NSFC), a Chinese scientific research institution, which is similar in some ways to the NIH (e.g., featuring a peer review system and targeted programs that focus on young investigators). The NSFC has a significant health research component. Mr. Handley described the history of the proposed program, including outreach by the NSFC to NIAID and NCI and the development of formal agreements. This pilot R21 project will foster or expand research collaborations and help U.S. investigators interested in collaboration with strong Chinese investigators of their choosing. An RFA will be developed in the first half of 2011, with input from NIAID, NCI, OAR, and NSFC.

The ARAC reviewers (Cohen, Celum, and McCutchan) welcomed this proposal and recommended the establishment of program assessment tools and metrics from the beginning. They suggested that the participants should agree on research priorities and productivity goals. Mr. Handley added that the identification of shared priorities and scientific goals could be elements of the application review criteria. ARAC members also encouraged the program designers to consult with the Fogarty Center (FIC) and to learn from similar recent experiences with India. Mr. Handley noted that FIC has been involved in the initial planning and continues to play a role in the advisory team. He also said the program is designed based on lessons learned in the Indo-US HIV/AIDS Collaborative Research Program. Eventually, additional institutes might also join the China program, depending on their interest and funding capability. The ARAC asked about the protection of intellectual property. Mr. Handley responded that the MOU and Implementing Arrangement (formal documents underpinning the program) clearly address intellectual property rights and protections for all participating parties. The sharing of research materials and data also has been discussed and is understood to be possible within the context of a jointly approved research plan or protocol. Mr. Handley indicated that there is also a possibility that some Chinese sites could eventually interact with the HIV/AIDS clinical research networks.

The ARAC members expressed support for the concept and voted approval.

Public Comment

Two attendees made public comments.

Daniel Kuritzkes, M.D., of the ACTG, while appreciative of the reasoning behind suggestions made for sharing laboratory resources, noted that if we want to engage a greater diversity of laboratory scientists, each network will require its own laboratory center in order to better and more fully integrate laboratory sciences into its research agenda.

Sten Vermund, M.D., Ph.D., of the HPTN, expressed concern that a large percentage of the new networks, when taken as a whole, will be devoted to some form HIV prevention research and hopes that greater flexibility for investments will be built into the new structure. He supported the emphasis on collaborations, and encouraged NIAID to consider logistical solutions to reduce the burden for international collaborators, such as holding overlapping meetings, joint meetings, or back-to-back meetings.

VII. Adjournment

The meeting of the Council was adjourned at 4:45 p.m., on Monday, February 7, 2011.

We do hereby certify that, to the best of our knowledge, the foregoing minutes are accurate and complete.

 

-s-

Anthony S. Fauci, M.D.

Chair, National Advisory Allergy and Infectious Diseases Council

Director, National Institute of Allergy and Infectious Diseases

3-28-2011
Date
-s-

Marvin R. Kalt, Ph.D.

Executive Secretary

National Advisory Allergy and Infectious Diseases Council

Director, Division of Extramural Activities

National Institute of Allergy and Infectious Diseases

3-25-2011
Date

These minutes will be formally considered by the Council at its next meeting; any corrections or notations will be incorporated in the minutes of that meeting.

Last Updated August 15, 2013

Last Reviewed August 15, 2013