NIAID Council Minutes: September 11, 2017

The 187th meeting of the National Advisory Allergy and Infectious Diseases Council (NAAIDC) convened at 10:30 a.m. on Monday, September 11, 2017, 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 11:45 a.m. and from 1:00 p.m. to 3:56 p.m. The meeting was closed to the public from 8:30 a.m. to 10:45 a.m. and from 11:45 a.m. to 12:00 noon for review and consideration of individual grant applications. Notice of the meeting was published in the Federal Register.

Meeting Attendees

Council Members Present:

Dr. Raul Andino
Dr. Aftab Ansari
Dr. Amanda Castel
Dr. Anita Chong
Dr. John Guatelli
Dr. Gurjit Khurana Hershey
Dr. Karen Nelson
Dr. Larry Schlesinger
Dr. Arlene Sharpe
Dr. Cara Wilson
Dr. Christopher Wilson

Ex Officio Members Present:

Dr. Victoria Davey
Dr. Anthony Fauci

Ad Hoc Members Present:

Dr. Mark Feinberg
Dr. Judith James
Dr. Ignacio Sanz 

Council Members Absent:

Dr. Wendy Book
Dr. Stephen Galli
Dr. Sally Hodder

Ex Officio Members Absent:

Dr. Rima Khabbaz

NIAID Senior Staff Present:

Dr. Hugh Auchincloss
Dr. Carl Dieffenbach
Dr. Emily Erbelding
Dr. Matthew Fenton
Dr. Cliff Lane
Dr. John McGowan
Dr. Daniel Rotrosen

Table of Contents

I. Review of Grant Applications
II. Remarks of the Director, NIAID—Anthony S. Fauci, M.D.
III. Guest Speaker
IV. Report of the Allergy, Immunology, and Transplantation Subcommittee—Daniel Rotrosen, M.D., director, DAIT
V. Report of the Microbiology and Infectious Diseases Subcommittee–Emily Erbelding, M.D., M.P.H., director, DMID
VI. Joint Meeting of the AIDS Subcommittee and AIDS Research Advisory Committee (ARAC)–Carl Dieffenbach, Ph.D., director, DAIDS
VII. Adjournment

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 4,564 research and training applications with primary assignment to NIAID for a requested amount of $1,505,632,525 in first-year direct costs and recommended approval of 2,005 applications with $580,682,180 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. He introduced three ad hoc Council members, Dr. Mark Feinberg, president and CEO of the International AIDS Vaccine Initiative; Dr. Ignacio Sanz, chief of the Division of Rheumatology at Emory University School of Medicine; and Dr. Judith James, vice president of clinical affairs at the Oklahoma Medical Research Foundation.

Council members Drs. Wendy Book, Steve Galli, and Sally Hodder were unable to attend the meeting.

Dr. Fauci acknowledged the contributions of four retiring Council members—Drs. Anita Chong, Larry Schlesinger, Arlene Sharpe, and Chris Wilson—and presented them with plaques and certificates of appreciation for their service.

Consideration of Minutes of Previous Meeting

Council considered the minutes of the June 5, 2017 meeting and approved them as written.

Appointments and Transitions

On June 10, the White House announced the appointment of Dr. Norman “Ned” Sharpless as the director of the National Cancer Institute. Dr. Sharpless replaces Dr. Doug Lowy, who has served as the acting director of NCI since 2015.

On June 7, Dr. Brenda Fitzgerald was named director of the Centers for Disease Control and Prevention. Dr. Fitzgerald replaces Dr. Anne Schuchat, who has been serving as acting director of CDC since Dr. Tom Frieden stepped down in January 2017.

Dr. Rima Khabbaz is the new director of the National Center for Emerging Zoonotic Infectious Diseases at CDC. Dr. Khabbaz is an ex officio member of NIAID’s Council.

On September 5, Dr. Jerome Adams was sworn in as the 20th Surgeon General of the United States.

On August 2, Dr. Robert Kadlec was confirmed as the new HHS assistant secretary for preparedness and response.

Staff and Organizational Changes

Dr. Fauci presented a substantial number of changes in the Intramural Research Program.

Dr. Josh Milner has been appointed chief of the Laboratory of Allergic Diseases. He replaces Dr. Dean Metcalfe, who has led the Laboratory since its formation in 1995. Dr. Metcalfe will remain as a section chief.

Dr. Luigi Notarangelo was named chief of the Laboratory of Clinical Immunology and Microbiology. The Laboratory of Clinical and Infectious Diseases and Laboratory of Host Defenses merged to form the new Laboratory.

Dr. Ron Germain has been named chief of the Laboratory of Immune System Biology, following the recent merger of the Laboratory of Immunology and Laboratory of Systems Biology.

Dr. Ted Pierson was named co-chief of the Laboratory of Viral Diseases. Dr. Bernie Moss will serve as co-chief until the start of next year, when he will step down from this position and remain a section chief in the Laboratory.

Dr. Tom Nutman is the new chief of the Laboratory of Parasitic Diseases. He replaces Dr. Alan Sher, who will remain as deputy chief of the Laboratory and chief of the Immunobiology Section.

Tributes and Awards

Dr. Fauci recognized Dr. Sher who received the 2017 International Cytokine and Interferon Society-Biolegend William E. Paul Award for Excellence.

He also congratulated Dr. Steve Holland, director of the Division of Intramural Research (DIR), NIAID, who was recently named a Fellow of the Infectious Diseases Society of America.

Meetings and Events

On June 2, Bill Gates visited NIH to participate in the fourth NIH Global Health Workshop with the Bill and Melinda Gates Foundation.

From August 10 to 24, the Discovery Channel aired a three-part documentary “First in Human.” The series featured research conducted at the Clinical Center on the NIH campus and explored the lives of physicians, researchers, and patients who collaborated to test experimental therapies.

On June 13, Dr. Fauci participated in the Atlantic PULSE, which was a health summit in Boston that featured discussions on health policy, public health, future technology, and doctors and patients.

Later in June at the 2017 Aspen Ideas Festival, Dr. Fauci presented at a session “Deep Dive: Preventing Pandemics” and participated in a forum “A World Without AIDS.”

On July 17, Mr. Joe Grogan, associate director of health programs at the Office of Management and Budget (OMB), toured the Clinical Center and met with Dr. Francis Collins and several institute directors. During his visit, Dr. Fauci briefed him on NIAID and our mission and activities.

On August 10, former HHS Secretary Tom Price visited and toured the Vaccine Research Center (VRC). After he met with Dr. Collins, Dr. Fauci provided an overview of NIAID and the Institute’s role in the discovery of new vaccines for emerging and re-emerging diseases.

Over the summer, Dr. Fauci and NIAID staff met with foreign delegations from Guinea, Kazakhstan, and Indonesia.

Budget Update

In May, OMB Director Mick Mulvaney presented the President’s Budget for Fiscal Year 2018 to Congress, which would reduce the budget of most NIH institutes and centers (ICs) by more than 20 percent.

However, the FY 2018 House Appropriations Bill included an increase to the NIH budget of $1.1 billion or 3.1 percent over the FY 2017 level. The Senate’s FY 2018 budget was more generous, providing an increase of $2.1 billion or 6 percent over the FY 2017 budget.

NIH will start FY 2018 operating under a continuing resolution, which goes through December 8, 2017.

NIAID will begin FY 2018 with a conservative funding approach. Our interim R01 payline will be the 9th percentile for non-new investigators and the 13th percentile for new investigators. NIAID does not plan to make programmatic cuts to noncompeting and competing grants. Competing research initiatives will be cut up to 20 percent from their planned budget level. Our estimated success rates for research project grants will be between 18 and 20 percent.

Dr. Fauci gave a brief overview of the Next Generation Researchers Initiative, which will focus on funding a larger number of early-stage investigators than in previous years.

Legislative Update

Members of the Senate Appropriations Labor-HHS Subcommittee visited NIAID and the VRC on June 5. Dr. Fauci briefed them on the important and unique role of the Institute and our research efforts to use structure-based vaccine design to develop universal influenza vaccines and a vaccine for respiratory syncytial virus.

On June 12, Dr. Fauci joined Dr. Collins and other NIH leaders to welcome members of the New Democratic Coalition to NIH. The members received a briefing on the ongoing importance of NIAID research on global infectious disease threats.

On June 14, Dr. Fauci spoke at the Capitol Hill conference hosted by amFAR “Making AIDS History: A Roadmap for Ending the Epidemic.” He gave an update on the HIV/AIDS pandemic and NIAID’s research advances in HIV treatment and prevention.

On June 22, Dr. Collins, accompanied by Dr. Fauci and several other institute directors, testified before the Senate Appropriations Labor-HHS Subcommittee on NIH’s budget for FY 2018.

Senator Chris Coons of Delaware visited the VRC on July 5. Dr. Fauci briefed him on the role of NIAID in responding to emerging infectious diseases, including Zika and H7N9 influenza.

On August 16, majority staff of the House Budget Committee visited NIH. Dr. Fauci provided an overview of NIAID’s role in countermeasures against emerging infections.

On August 29, Dr. Fauci briefed staff of Senator Ben Cardin and minority staff of the Senate Foreign Relations Committee on the role of NIAID research in addressing challenges in global health.

Other Information Items

Dr. Fauci began with an update on HIV/AIDS, noting that there are 19.5 million people on lifesaving treatments, and AIDS-related deaths have halved since 2005. However, since there are 36.7 million people living with HIV, that means 17.2 million people have not received therapy.

He mentioned UNAIDS’ 90-90-90 target for 2020. Globally—if you get 90 percent of the people who are infected with HIV diagnosed, and take 90 percent of those people and put them on treatment, and get 90 percent of those and virally suppress them—we could turn around the trajectory of the epidemic. We aren’t quite there yet, but a few countries have reached that target.

The 9th International AIDS Conference was held in Paris, France, from July 23 to 26. Dr. Fauci summarized two of his talks, “An HIV Vaccine: Can We End the HIV Pandemic Without One and, If Not, How Do We Get One?” and “Sustained ART-Free HIV Remission: Opportunities and Obstacles."

He continued with a Zika update, presenting statistics on reported cases and summarizing results from a few significant studies.

Dr. Fauci concluded by giving brief updates on tick-borne diseases, seasonal and pandemic influenza, and tuberculosis. 

III. Guest Speaker—Steven Holland, M.D., director, Division of Intramural Research, NIAID

Dr. Holland began by presenting DIR’s priorities, which are:

  • Transformative medicine and biomedical research
  • Bench-to-bedside research taking advantage of NIH’s Clinical Center, as well as domestic and international clinical sites
  • Responding to public health threats, including drug-resistant microbes and emerging viruses
  • Partnering to advance vaccines, therapeutics, and diagnostics for infectious and immunologic diseases

He mentioned leadership and organizational changes that Dr. Fauci had presented and a new Clinical Genomics Program, with the goal being that every patient coming into NIAID will have a whole exome study done and reported back to the investigator and patient.

Dr. Holland gave an update on DIR personnel changes, including recent departures, new hires, recently tenured investigators, and new tenure-track investigators.

He highlighted some of DIR’s scientific research in the areas of HIV, Ebola, Zika, immunology, and immunodeficiency.

Dr. Holland concluded by summarizing DIR’s future directions.

  • Recruiting talented and diverse young investigators
  • Continuing to support outstanding basic science
  • Promoting bench to bedside approaches
  • Maintaining productivity in vaccine targets, innovative strategies, diagnostics, and therapeutics
  • Fostering collaborations with extramural investigators
  • Preserving and enhancing international collaborations

IV. Report of the Allergy, Immunology, and Transplantation Subcommittee—Daniel Rotrosen, M.D., director, DAIT

Dr. Rotrosen welcomed the subcommittee members to the 187th meeting of the National Advisory Allergy and Infectious Diseases Subcommittee meeting.

Dr. Rotrosen presented the following scientific and Division activities:

Staff and Organizational Changes

None.

Division Activities

Allergy, Asthma, and Airway Biology Branch

Sex Differences in Asthma Workshop. On June 1, 2017, NIAID organized a workshop in Rockville, Maryland, to examine the differences in asthma progression and severity as related to sex. Experts presented on endocrinology of puberty, the role of hormones in immune response, and asthma and airway inflammation. Participants discussed the gaps in current understanding and proposed approaches to investigate the role of the immune system in the shift in asthma prevalence from male to female as children grow into adults.

Unmet Needs in Eosinophilic Research. On July 19 and 20, 2017, NIAID and the Office of Rare Diseases co-sponsored a workshop in Goteborg, Sweden, to present on rare eosinophilic disorders, including hypereosinophilic syndrome (HES); Eosinophilic Granulomatosis with Polyangiitis (EGPA; Churg-Strauss vasculitis); and eosinophil-associated gastrointestinal disorders (EGID), a heterogeneous group of disorders that are characterized by marked eosinophilia in the peripheral blood and/or tissues without a secondary cause. The goals of the workshop were to: 1) bring together a multidisciplinary group of clinician-scientists with expertise in rare eosinophilic disorders to discuss issues related to improved patient care and clinical trial design and 2) continue to foster collaborative relationships between multidisciplinary clinical and basic science researchers interested in eosinophilic disorders that will lead to improved diagnosis and treatment of eosinophilic disorders. It is anticipated that the findings from this workshop will lead to an updated publication on unmet research needs.

Atopic Dermatitis and the Atopic March: Mechanisms and Interventions. On September 6 and 7, 2017, NIAID organized a workshop in Rockville, Maryland, on the association between atopic dermatitis (AD) and an increased risk of progression towards food allergies, allergic rhinitis, and asthma (the atopic march). Invited experts addressed abnormalities in the skin tissue and skin microbiome, which could promote sensitization to allergens, mechanisms by which allergen sensitization and/or changes in the microbiome promotes loss of tolerance and an allergic response at sites including the GI tract and airway, and potential clinical interventions and strategies to prevent the atopic march.

Basic Immunology Branch

Infant Immunity Program Annual Meeting. On June 12 and 13, 2017, the fifth meeting of the Infant Immunity Program was held in Rockville, Maryland, where investigators and staff from the 15 groups awarded under this program presented their final updates and achievements in understanding aspects of innate and adaptive infant immune development, regulation, mucosal immunity, and immunoregulatory mechanisms in the infant lung. The meeting provided a venue for investigators to exchange ideas and establish collaborations to foster advances in the program.

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Symposium at the 2017 Annual Federation of Clinical Immunology Societies (FOCIS). On June 14, 2017, NIAID sponsored a symposium held in Chicago, Illinois, titled “Insights in the Immunology of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, which provided a forum for experts in the immunology of ME/CFS to present the state of the science to key clinical immunology stakeholders. The intent of the meeting was to stimulate new approaches to decipher the mechanistic and immunological underpinnings of ME/CFS. The symposium featured five invited speakers and covered areas such as involvement of T cells in ME/CFS, the host genetics of response to ME/CFS, and the pathobiology of the disease.

Mechanisms of Fc-Dependent, Antibody-Mediated Killing. On June 23, 2017, NIAID held a workshop in Rockville, Maryland, to examine mechanisms of antibody Fc-dependent killing, including antibody-dependent cellular cytotoxicity, antibody-dependent phagocytosis, and complement-mediated cytotoxicity. Experts in antibody engineering, basic Fc/FcR function, and effector cell biology assembled to assist NIAID in prioritization of research needs to better understand how antibodies function in vivo, and to inform design of antibodies with specific killing profiles for therapeutic indications.

Toll-Like Receptor (TLR) Signaling in Adjuvants Workshop. On June 29, 2017, NIAID held a workshop in Rockville, Maryland, to discuss how to best apply basic knowledge of TLR and other innate signaling pathways to develop adjuvants that induce long-term protective immune responses. Participants included experts in the fields of innate immune signaling, molecular mechanisms of adjuvant action, and the induction of innate and adaptive memory responses.

Molecular Mechanisms of Combination Adjuvants (MMCA) Annual Meeting. On June 30, 2017, NIAID held the annual meeting of the MMCA Program in Rockville, Maryland. Investigators provided research updates and plans for collaborative projects that will maximize utilization of resources and complementary expertise. Seven U01 cooperative agreements were awarded in FY 2016 with the goal of determining the mechanisms by which targeting multiple immune pathways can improve the duration, quality, and magnitude of immune responses enhanced by adjuvants.

Radiation and Nuclear Countermeasures Program (RNCP)

Cellular Therapies for Treatment of Radiation Injuries RFA-AI-17-001. On February 8, 2017, the RNCP released a new funding opportunity supporting studies that evaluate candidate cellular therapies to treat radiation-induced injuries in appropriate in vivo models, when the therapy is administered 24 hours or later post-irradiation. The intent of the funding is to support research aimed toward the eventual approval of candidate cellular therapies under the United States Food and Drug Administration (FDA) Animal Rule licensure pathway.

Mesoscale Diagnostics Kick-Off Meeting for Contract HHSN272201700013C. On April 21, 2017, the RNCP held a kick-off meeting in Rockville, Maryland, to initiate the funding of a new contract with Mesoscale Diagnostics, in response to the Program Broad Agency Agreement “Development of Radiation/Nuclear Medical Countermeasures or Biodosimetry Devices.” The purpose of the award is to develop a high-throughput, biomarker based, biodosimetry device that will permit the distinction between irradiated and non-irradiated populations in the event of a large-scale, nuclear disaster. Further, this contract intends to determine the effect of qualities of radiation on biomarker signatures.

Trans-NIH Chronic Inflammation Biomarkers in Disease Development and Prevention. On May 31 to June 1, 2017, NIAID served on the planning committee and participated in a trans-NIH workshop on chronic inflammation biomarkers in disease development and prevention in Rockville, Maryland. The workshop brought together experts from multiple research disciplines who investigate chronic inflammation and its role in disease development and treatment. The goal of this workshop was to engage broader scientific dialogues and identify challenges in developing clinically-feasible strategies in monitoring chronic inflammation, to report the outcomes and recommendations to catalyze cross-cutting scientific collaborations, and to direct and encourage multi-disciplinary research approaches.

Regulatory/Scientific Challenges and Benefits of Repurposing Licensed Products for a Radiation Indication. On August 29, 2017, the RNCP, together with other HHS partners, hosted a meeting in Rockville, Maryland, to address licensure considerations for repurposing of existing, FDA-approved drugs in a radiation mass casualty incident. The meeting brought together medical countermeasures stakeholders, including researchers and companies, as well as funding and regulatory agencies Participants shared important regulatory experiences and highlighted ways to address potential hurdles to drug repurposing. A meeting report is being prepared for publication.

Concepts Presented for Clearance

FY 2019 Research Concept Clearances

Cooperative Centers on Human Immunology: The objectives of this program are to discover new principles of human immunology and advance hypothesis-driven research on the human immune system, leading to discovery of novel pathways of immune response and regulation relevant to the prevention and treatment of infectious and immune-mediated diseases.

The subcommittee endorsed and unanimously approved this initiative.

Maintaining Immunity After Immunization: This initiative will focus on determining the immune mechanisms that lead to sustained immunity, and identification of common versus distinct immune mechanisms for different vaccines and infections.

The subcommittee endorsed and unanimously approved this initiative.

Vaccine Adjuvant Discovery Program: The objective of the program is the discovery, optimization, and early-stage development of novel vaccine adjuvant candidates, using high-throughput screening of compound libraries, structure-activity-studies with the goal of improving lead compounds through medicinal chemistry, mechanism-of-action studies with the ultimate goal of gaining insights into immune mechanisms of adjuvanticity, and in vivo efficacy studies using well-defined animal models of infectious diseases.

The subcommittee endorsed and unanimously approved this initiative.

Immune Mechanisms of Protection Against Mycobacterium tuberculosis Consortium (IMPAc-TB): The goal of this program is to accelerate an in-depth understanding of immune mechanisms that can be used to advance novel TB vaccine strategies while also increasing the predictive value of animal models.

The subcommittee endorsed and unanimously approved this initiative.

V. Report of the Microbiology and Infectious Diseases Subcommittee–Emily Erbelding, M.D., M.P.H., director, DMID

Director’s Report

Dr. Emily Erbelding, director of the Division of Microbiology and Infectious Diseases (DMID), chaired the NIAID Microbiology and Infectious Diseases Council Subcommittee meeting on September 11, 2017.

Dr. Erbelding provided several DMID research updates:

  • In follow up to Dr. Fauci’s Open Session presentation, Dr. Erbelding provided further information on NIAID’s recent universal influenza vaccine workshop, noting that DMID will play a large role in coordinating the extramural response required to achieve such a vaccine. She reported that the Institute is in the process of writing a strategic plan and that Council members would be kept apprised of this effort. She also noted that she anticipates presenting scientific concepts related to this effort to the Subcommittee in the future.
  • Noting that antimicrobial resistance in gonorrhea is a global threat, she reported on the outcome of a DMID-sponsored Phase 2 study testing Zoliflodicin as a therapy for gonorrhea. The recently formed Global Antibiotic Research and Development Partnership will conduct the next set of trials, which could lead to licensure of this agent in Europe for the treatment of uncomplicated gonorrhea.
  • She informed the Subcommittee that NIAID and FDA co-sponsored a public workshop entitled “Bacteriophage Therapy: Scientific and Regulatory Issues” in July, 2017. This workshop builds on a 2015 meeting, organized by NIAID, which explored bacteriophage therapy as an alternative strategy to combat drug resistance. Currently, NIAID is investing in research to understand the basic biology of and lay the foundation for the development of phage therapy and phage-derived products.
  • Following up on a previous report to the Subcommittee regarding NIAID’s collaboration with the Coalition for Epidemic Preparedness and Innovation (CEPI), she reported that the group had published a second call for proposals for innovative platform designs that could reduce the manufacturing time for vaccines. NIAID may provide in-kind support toward this effort, for example, support of assay development, animal model development, as well as helping with ancillary support of regulatory science studies, that are often required for these types of projects to be successful.
  • Dr. Erbelding described a new, multi-division NIAID concept that would fund a consortium of scientists working towards a TB vaccine (the concept was approved by the DAIT Subcommittee on September 11, 2017).

Program, Scientific, and Budget Updates

Extramural Research Response to Zika Virus–Cristina Cassetti, Ph.D., chief of DMID’s Virology Branch, described DMID’s efforts to rapidly develop and implement a research response to the 2015 Zika virus outbreak. She reported that DMID was able to leverage its existing flavivirus research portfolio to address early questions about Zika virus by supplementing ongoing grants. For example, DMID supported studies to elucidate Zika virus pathogenesis and improve diagnostic tools. DMID was also able to utilize its existing preclinical services programs to make reagents and genomics resources available to the research community, and develop assays to evaluate antivirals and vaccines. She also described ongoing efforts through the NIAID Vaccine and Treatment Evaluation Units, including a natural history study and the evaluation of a purified inactivated virus vaccine, a study DMID is conducting in collaboration with Walter Reed Army Institute of Research. She also acknowledged the Intramural Program’s robust efforts, which focus primarily on vaccine development and testing. She stated that NIAID would maintain the current research momentum despite the waning epidemic, and would use the lessons learned over the past two years to help inform future NIAID outbreak preparedness efforts.

Concepts Presented for Clearance

The following fiscal year 2019 concepts were presented to the Subcommittee:

Genomics Centers for Infectious Diseases–This concept would continue state-of-the-art, large scale Genomic Centers for Infectious Diseases (GCID) that will provide to the research community emerging genomic technologies and capacity for high-throughput sequencing, metagenomics and microbiome analysis, microbial and targeted human genotyping and computational platforms, software tools and data analysis. The DMID Subcommittee values the accomplishments of the GCID program, was supportive of the proposal to renew it, and recognized the importance of the scientific resources and technological advances that would continue to be generated by it. One Subcommittee member emphasized the need for coordination with other genomics efforts to ensure enhanced interactions and coordination with other centers within NIAID and NIH. Program staff noted that the current program interacts with a variety of centers and programs supported by NIAID and NIH through standing working groups and other collaborative efforts, and that these types of interactions would continue to be emphasized in the next iteration of the program.

One Subcommittee member underscored the importance of efforts to ensure the quality of data generated through the program, and was supportive of the continued development of robust methods for efficient transfer of quality-controlled data to public repositories. Another Subcommittee member stressed the importance of incorporating mechanisms to validate links from genotype to phenotype, both for basic and clinical research, which will continue to be part of the program. Program staff explained that the development of genomic tools and methodologies and computational analysis that incorporates validation experiments to support scientific research will continue to be a focus of the program. The concept was unanimously approved.

Bioinformatics Resource Centers for Infectious Diseases–This concept would continue a NIAID program to provide data-driven and web-based computational infrastructures and data-sharing platforms to support large-scale, system-level data integration and modeling, and enable predictive biology for pathogens and host-pathogen interactions for discovery research, clinical investigation, and therapeutic development for infectious diseases. The DMID Subcommittee acknowledged the accomplishments of the current NIAID program in providing bioinformatics resources to the infectious disease community and was supportive of the concept to renew the BRCs. The Subcommittee members recognized the BRC as a critical program able to address the need for high-quality data sets and inter-connected repositories, as well as its role in overcoming current barriers for data-sharing. Subcommittee members were pleased to learn that the program would continue to focus on further enhancing interoperability between data sets and other NIAID- and NIH-supported data repositories as well as continue the global, hands-on bioinformatics training efforts for the next generation of scientists working in big-data science.

The Subcommittee members inquired about how the various NIH institutes and centers (ICs) were working together to enhance awareness and (re-)usability of data and what were the drivers of the current concept objectives. Program staff reported that NIAID actively participates in NIH-wide working groups focused on data science. Dr. Maria Giovanni, director of the Office of Genomics and Advanced Technologies, noted the recent establishment of NIAID’s Office of Data Science, which will help enhance and promote trans-NIH efforts and will also help develop NIAID-wide data science guidelines and the reusability of assets. Program staff also reported that the changes proposed to the BRC in this renewal are driven by evolving bioinformatics needs as discerned through discussions with the community, and aim to leverage technological advances to accelerate data-intensive research and ensure continued alignment with other programs in data science at NIH as well as at other institutions. The concept was unanimously approved.

VI. Joint Meeting of the AIDS Subcommittee and AIDS Research Advisory Committee (ARAC)–Carl Dieffenbach, Ph.D., director, DAIDS

The AIDS Research Advisory Committee (ARAC) met on Monday, September 11, 2017, from 1:00 p.m. to 4:00 p.m.

Participating voting members: Cara Wilson (chair), Aftab Ansari, Paul Bieniasz, Amanda Castel, John Guatelli, Sharon Hillier, Elizabeth McFarland, William G. Powderly, and Chris Wilson. Voting members missing: Richard Chaisson, Scott Hammer, Sally Hodder, and Ernest Hopkins. Ex-Officio members: Victoria Davey, Maureen Goodenow, Henry Masur, and Eugene McCray. Ex-Officio member missing: Colonel Nelson Michael. DAIDS Representatives: Carl Dieffenbach, Diana Finzi, Mary Marovich, Sarah Read, Carol Worrell, Sheryl Zwerski, and Kimberly Barasch served as executive secretary. DAIDS Representative missing: Manizhe Payton. Others present: Roy Gulick (OARAC liaison) and court reporter.

Welcome and Approval of Minutes

Cara Wilson, M.D.

Dr. Wilson welcomed everyone and the ARAC members reviewed and approved the minutes of the June 5, 2017 meeting.

Director’s Report

Carl Dieffenbach, Ph.D.

Dr. Dieffenbach recognized three members who were rotating off the committee: Ernest Hopkins, William Powderly, and Chris Wilson, and together with the ARAC members, thanked them for their service.

Budget Update

The current administration released their budget details of FY 2018 on May 23, 2017, which included significant cuts to the NIH and division realignment changes. The House and Senate subsequently proposed their budgets which contained an increase in funding to NIAID and the NIH overall, but none of these bills have been acted on. However, a continuing resolution (CR) has been received that runs until the end of December 8, 2017 and keeps NIH/NIAID operating at level funding. This CR resulted in an interim Financial Management Plan for NIAID FY 2018 where all grants will be paid to the 9th percentile and new PIs to the 13th percentile. There will be no reductions for competing or noncompeting grants. The interim Financial Management Plan will be revisited and adjusted accordingly after December 8th.

Next Generation Research Initiative

In August 2017, NIH announced the Next Generation Researchers Initiative (NGRI) that requires ICs to prioritize awards that will fund early stage investigators (ESIs) and early established investigators (EEIs). The NGRI replaces the now abandoned Research Commitment Index/Grant Support Index/mandated percentiles that were originally presented at the June ARAC meeting. As an Institute, NIAID, has decided to focus on ESIs and to keep a success rate for ESIs equivalent to what standard grantees have. For EEIs, NIAID will focus on those at risk and will act appropriately to stabilize them on an individual basis through bridge awards, select pays, and enhanced paylines. The goal is to achieve equal success rates across the different categories.

Update on Refining the Science-Driven HIV Research Enterprise

Every seven years DAIDS competitively renews the clinical trials networks which provides the opportunity to think about research priorities, adjust the research priorities, and seek to establish a forward-looking agenda that will refine and focus the HIV clinical trials networks through 2027. The goals for 2027 are to have long-acting and durable prevention and treatment strategies effective for at least six months, HIV vaccines with an efficacy greater than 60 percent, a functional cure in large percentages of people of all ages living with HIV, normalized life expectancy for people living with HIV, and reduced burden of infectious and non-infectious co-morbidities, including TB co-infection. Since January 2017, DAIDS has held a series of meetings and posted several blog posts to keep people informed and provide them an opportunity to give feedback. As a result of current feedback, there will be three key areas of research emphasis that will cover all target populations: prevention, vaccines, and therapeutics. These three areas of research emphasis will make up a triad of clinical trials networks, one in prevention, one in vaccines, and one in therapeutics. For prevention, the scientific foci will be on novel biomedical methods of HIV prevention that are safe, acceptable, desirable, and highly effective in preventing HIV acquisition, behavioral and social science partnerships, and protection of populations that are most at risk, including adolescents, young adults, and U.S. minorities. The vaccine scientific foci are to establish efficacy and define correlates of protection where the ultimate goal is vaccination strategies targeting youth to establish protection prior to sexual debut. With therapeutics, there are four critical areas that will be the focus: durable and novel therapy, cure, tuberculosis, and complications and co-infections. The importance of research collaborations and partnerships was stressed as these are needed to effectively impact public health. Current partnerships will be maintained, and new collaborations will be fostered. In terms of administrative refinement, the clinical trial unit (CTU) and clinical research site (CRS) model will be retained but they will be consolidated to work within multiple networks. The goal is to achieve between 30 to 35 CTUs with sites associated from 2020 and beyond, but this depends on the number of CRSs that are associated with specific CTUs. To this end, a number of stakeholder engagements have been held for discussions, with more planned. Feedback on the refinement process started in January and will continue until November 30, 2017. The formal presentation of the refined network and unit structure will be given at the January 29, 2018 ARAC meeting for approval. The writing of the FOAs will take place in 2018 with the FOAs issued and peer reviewed in 2019; awards for FY 2021 will be made in 2020.

Comment: T3 and T4 research domestically in HIV has been underfunded, and leaving everything to the National Institute of Mental Health (NIMH) is unwise. More can be done to ensure people in the U.S. benefit from developed ARV drugs compared with those from other countries and better approaches to deliver drugs to U.S. citizens are required. Such implementation will still be a problem despite investing in innovation. Partnerships are important but very few partners outside of NIH partners actually pay for research. This is a critical need, domestically, to improve HIV suppression levels in the U.S. to the levels seen in Europe.

Q1: Happy to see incorporation of concepts and scientific priorities that cross over the age continuum. How will you make sure that the pediatric priorities, which are getting split up, still get addressed when they are being integrated into the new three network system which have an adult focus and an existing scientific prioritization system?

A1: This is an important question that should be looked at from the perspective of each network. For prevention, the current proposed HIV trials that are being performed cover the 18 to 24-year-old population, which will include some adolescents. However, we would like the current networks to start putting more emphasis on adolescents. When a safety signal is received, everything is quickly done to move trials into younger adolescents. What MTN has done to move the ring and other products into younger women is a good model and an example of what the leadership groups can achieve. For vaccine, there had not yet been a good vaccine to move into younger people until we started this new round of efficacy trials, which are underway. More of these types of issues and interactions between the leadership of IMPAACT and HVTN will be discussed at tomorrow’s AIDS Vaccine Research Subcommittee (AVRS) meeting. For therapeutics: there are some key areas of getting drugs worked up for pharmacology and licensure, working toward a cure. In these cases, it can be written into a funding opportunity announcement (FOA) that these will be areas of emphasis with specific goals and leadership groups will have to write how they will achieve success in addressing those needs.

Q2: There is excitement about using the networks to study other infectious diseases. This was included in the previous re-competition but was not successful. How will it be done this time?

A2: First, NIAID needs to be as interoperable as possible among the different divisions. Appropriate sites could then be offered globally, as is needed, for different studies. This will not be written into the request for applications but will be in the Terms of Award. This approach will be standardized and consistent between the divisions.

Q3: What recent feedback and concerns have been raised in regard to the recompetition?

A3: All questions, written and oral, and the responses will be posted on the website. There were two types of feedback received: 1) maintain what you have at the moment and 2) not enough is being done to streamline. So, there is an interesting balance going forward and it will be important to work internally at NIH to get to a point where NIH and the collaborating institutes in the Office of AIDS Research are comfortable with what is presented to the committee in January.

Concepts Presented for Clearance

Vaccine Research Program

Consortia for HIV/AIDS Vaccine Development (CHAVD)

Stuart Shapiro, M.D., Ph.D.

Dr. Shapiro presented the new CHAVD concept review that had an objective for a coordinated, multidisciplinary effort focusing on preclinical HIV vaccine discovery, translational vaccine design and development, and ultimately clinical vaccine manufacture. This initiative is a cooperative agreement using the UM1 complex project mechanism with a duration of seven years. It is proposed now as the current CHAVI-IDs will end in 2019 and this new initiative will be able to follow-on and continue the support of such coordinated, multidisciplinary efforts which cannot be supported by smaller grants. Big, and urgent, challenges with HIV vaccine development were stated and included identifying immunogens that induce durable, highly protective, broadly neutralizing antibody (bNAb) responses and identifying immunogens and adjuvants that induce functional Ab responses that significantly improve upon the protection seen in the RV144 trial. This proposal focuses on Ab mediated responses because, apart from Louis Picker’s CMV adenovirus vaccine approach, these are the most advanced in terms of proof of concept and have established clear target immunogenicities that can be measured in Phase 1 clinical trials. The proposed scope of the research or resource include exploration of different isolates/constructs/inserts/modifications/fragments/or combinations of the HIV-1 envelope to induce broad protective coverage, identification of qualities of antibody responses that can provide protective immunity, exploration of vectors/adjuvants/or delivery technologies that facilitate the induction of different qualities and specificities of potent, durable antibody responses, proof-of-concept active and passive protection studies in nonhuman primates and other animal models, and manufacture of vaccine immunogens for iterative phase I clinical testing. Research on the study of vaccine protection primarily mediated by CD8+ T-cell responses, expenditures for GMP manufacture and IND-enabling studies without prior approval of specific candidate vaccine products by DAIDS, and expenditures for clinical trial operations will not be allowed. The program structure, special terms of the award, and components of the application were listed. Reviewers’ comments were addressed, including a suggestion to change the name of the initiative to reflect its Ab-based nature, and members voted.

Q: Can you discuss integration of nonhuman primate (NHP) and other animal models into the development pipeline?

A: There are investigators already present within the CHAVI-IDs that are testing immunogen constructs in NHPs and knock-in mouse models. This is expected to continue. It is cheaper to make multiple versions of the immunogens constructs and test them in NHP, than to do the GMP manufacturing construct by construct. So, we expect the use of the NHP model will be used as down-selection of products for GMP manufacture.

Ballot Voting Outcome:

9 Approval
0 Approval with modification(s)
0 Deferral for further information
0 Disapproval

HIV Vaccine Research and Design (HIVRAD)

James Bradac, Ph.D.

Dr. Bradac presented this FY 2019 initiative which had the objective to support multidisciplinary projects that address important scientific questions relevant to AIDS prophylactic vaccine discovery research. This is a renewal of a program that funds five-year program project grants. The active HIVRAD awards were listed to make the point of the breadth of research currently covered under the program, and they included improved vector design, env-based immunogens, improved animal models, research to prevent maternal/fetal transmission, and defining mucosal barriers to transmission. The objective of the HIVRAD program is to support research that has advanced past the exploratory stage, to address questions and hypotheses that are crucial to HIV vaccine design, or to further develop promising vaccine platforms. Areas of research that would be responsive for HIVRAD support include (but are not limited to) elicitation of bNAbs, induction and properties of protective non-neutralizing antibodies, development/improvements of vaccine vectors, structural studies related to HIV immunogen design, improved animal model systems for vaccine efficacy, vaccine designed to address HIV heterogeneity, vaccines that prevent and/or minimize the formation of “viral reservoirs,” and immune modulators that enhance AIDS vaccine efficacy. A few highlights from previous HIVRAD awards were listed such as the isolation, characterization, and development of clade A and C env proteins immunogens; development and optimization of the SOSIP env protein platform; the determination that CMV vectors violate CD8+ T-cell epitope recognition paradigms; development of a platform for designing replication competent SHIVs; and development of vaccines that have reached clinical production and testing, including a number of envelope proteins, conserved/mosaic gene inserts, VEE replicons, and recombinant AAV and chimp Ad vectors. Dr. Bradac concluded with a summary of reviewers’ comments that resulted from a pre-review of the initiative. Reviewers suggested that two research areas be added to the list of areas responsive for HIVRAD support; those dealing with “viral reservoirs” and “immune modulators.” In response to how Program should adjust the FY 2019 initiative based on what was learned from past, less successful projects, the answer was that reviewers of new applications should be left to decide what research is relevant at a particular time. Members were then asked to vote on the HIVRAD program.

Ballot Voting Outcome:

9 Approval
0 Approval with modification(s)
0 Deferral for further information
0 Disapproval

Therapeutics Research Program

Advancing mAbs to Clear Early HIV Infection or Achieve a Drug Free Sustained Virologic Remission (U01)

Randall Tressler, M.D.

Dr. Tressler presented this initiative that had a main objective to support the early clinical development of native and engineered monoclonal antibodies (mAbs) to prevent HIV-1 reservoir establishment in acute HIV infection, reduce or eliminate existing HIV-1 reservoirs, and/or result in a drug free sustained viral remission (SVR). This is a new grant with a duration of five-years. As the project background was summarized; numerous bNAbs have been identified and characterized; prior PARs support the engineering of bNAbs to enhance their effector function (to kill cells expressing HIV antigens); preclinical has demonstrated that a SVR is possible with a short course of α4β7 monoclonal antibody or combination bNAb therapy in the NHP model. However, monotherapy with bNAbs did not achieve SVR. Currently, numerous next generation and engineered mAbs are entering clinical trials. It is therefore important to efficiently advance the leading candidates through proof-of-concept studies (POC) to determine whether the findings in the NHP studies can be reproduces in humans. The current state of other awards and programs to advance mAb to clear HIV or achieve a SVR was summarized and showed how this initiative would fill a gap that the other programs do not cover. Expectations, including that a clinical trial will begin within nine months of award, and a sample clinical development of mAb were shown. The scope of this initiative supports two studies to be completed within five years. At least one of which is a POC study with a treatment interruption. Predefined go criteria must be met prior to initiating the follow-on study. Clinical studies with combination and multifunctional mAb studies are preferred, but a mAb monotherapy study is permitted to enable a combination POC study or if monotherapy has resulted in the desired effect on the reservoir or achieved a SVR in NHPs. The initiative does not support clinical development of mAbs for the prevention of HIV infection or as long-acting antiretroviral therapy. Reviewers’ comments were then addressed, and members were asked to vote.

Ballot Voting Outcome:

9 Approval
0 Approval with modification(s)
0 Deferral for further information
0 Disapproval

Advancing HIV Therapeutic Vaccine Science

Stephen Smiley, Ph.D.

Dr. Smiley presented this concept which had a main objective of identifying and optimizing immune responses that can be induced by vaccines to sustainably suppress virus in HIV infected individuals. This is a U01 mechanism for five-year awards. The estimated number of awards is two or three. The need for a therapeutic vaccine was made that highlighted some limitations of current life-long ART that lead to problems with adherence. The challenges for therapy development are that HIV readily mutates and establishes latency, natural immune responses are ineffective, and immune dysregulation persists with ART. The current status of clinical trials has been disappointing, generally only showing a transient 0.5 to 1 log difference in viral copy number when compared to placebo, and a more systemic approach is needed to dissect the many variables in vaccine regimes, identify immune correlates of virologic control, replicate key observations, and optimize promising regimens. In the few cases of partial success, it is unclear which variables of the regimen affected the immune and virologic responses. Despite this, there are reasons for optimism, including data related to CD8 T cells, CD4 T cells, HLA-E-specific T cells, and broadly neutralizing antibodies. The approach for this initiative is to propose a desired immune response and vaccination strategy, run a small, multi-arm, clinical trial that enroll with an optional interruption of treatment to evaluate suppression, and then run a second, follow-on trial to replicate key observations, optimize, and improve. Such an approach is thought to fill a gap in the DAIDS portfolio by supporting small iterative trials focused on optimizing vaccine-inducible antiviral responses. This initiative is administratively referred to as a new initiative, but is actually a reissue of an FY 2017 initiative. The FY 2017 initiative funded three applications that focus on T-cells and aim to determine whether vaccines can safely prime and/or boost responses to conserved elements of HIV. The goals for the FY 2019 reissue are to fund novel approaches and technologies that include antigen delivery methods, latency-reversing agents, and antibody-based approaches. Reviewers’ comments were then addressed, and members were asked to vote.

Q1: Explain what you are looking for in terms of preclinical evidence that suggests more funding is needed considering that other projects have previously been funded?

A1: The field is hampered by lack of robust preclinical models for therapeutic vaccine research. You would have to infect with a SHIV then treat for a long time with ART if you want to mimic humans, then vaccinate and then take them off treatment. These are extremely expensive studies so people sometimes bypasses this and just do safety studies and preclinical toxicology, and then move onto human studies. 

Q2: The HIVRAD presentation earlier indicated that there are better and more diverse SHIVs. Has the paradigm shifted such that more can be done using SHIVs? GMP grade manufacture of vaccines (multiple iterations) for safety studies then immunogenicity studies would also be expensive. What is the risk benefit ratio?

A2: We are not funding the GMP manufacture of vaccines. These applications require that products are ready for trials to begin within 12 months.

Q3: The number of candidates are small, but what indicates these are the best ones?

A3: Partly because someone put in the effort into making these materials to GMP standards.

Comment: The fundamental problem we are trying to solve is, what is the scientific underpinning for the therapeutic vaccine in the science? The three vaccines currently available are a good start but are there more out there that meet those same levels of the performance or criteria that could be added to the existing series of vaccines that are being evaluated. If we run this and there is nothing there, we do not have to fund it and that money can be put to better uses. To my mind this is an opportunity of seeing what else is out there.

Q4: Got the impression that keeping vaccines in the pipeline is important for later use potentially as part of a cure therapy. That is part of the effort behind this as well, correct?

A4: Yes, there has been a lot of discussion about kick-and-kill type strategies, but there is not a strong candidate currently for the kill.

Q5: I was concerned about the absence of a structured treatment interruption. Focusing only on immunogenicity and then not doing the treatment interruption is avoiding the key question. You can induce all the immune responses you want, but if they do nothing when you remove treatment, then how have you moved forward?

A5: To date it has been difficult to induce strong immune responses in HIV positive individuals. We have not yet had a chance to examine what happens after you get a strong new immune response in those individuals. Until we get strong immunogenicity it is difficult to assess if the vaccine has worked.

Comment: No one would support doing a structured treatment interruption in the absence of a decent immune response, but this must be part of a test for a therapeutic vaccine.

Comment: Should consider “When?” for treatment interruption when putting this together.

Ballot Voting Outcome:

7 Approval
0 Approval with modification(s)
0 Deferral for further information
2 Disapproval

Prevention Sciences Program (PSP)

Sustained Release Innovation (SRI) for HIV and

Next Generation Multipurpose (NGM) Prevention Strategies

Jim Turpin, Ph.D.

Dr. Turpin presented these initiatives “back-to-back” because of their relative similarities and to prevent any repetitions.

The initial focus highlighted the non-vaccine biomedical prevention preclinical scientific objectives and future directions that would cover both concepts. This included developing a sustainable pipeline of products, drug delivery systems (DDS) and technologies to support advancement of non-vaccine biomedical prevention (nBP) single and combination strategies to clinical testing; supporting innovative and proof-of-concept studies in priority preclinical areas including sustained/extended duration prevention strategies and Multipurpose Prevention Technologies (MPTs); integrating Preferred User Characteristics (PUC) into the earliest stages of product development; and continually evolving and updating programs to reflect new knowledge and trends in the HIV prevention field. Program definitions for sustained/extended release and MPT were given. Following data obtained from the ASPIRE clinical trials in 2016, a question was asked of what would the preclinical pipeline look like in 2025. This essentially raised challenges and other critical questions: 1) what areas of product development can have the greatest impact on HIV prevention in the era of PrEP and Dapivirine IVR and 2) how to mitigate the negative role of adherence in achieving effective HIV prevention for at risk-individuals during product development? Addressing these questions required reconceptualizing the drug development pipeline to include behavioral science. Potential solutions for this were presented that used biophysical approach (sustained extended release), combined approach (MPTs), or behavioral approach (PUC) to drug development. The way these concepts could fit into the established pipeline program was overviewed. Concept harmonization was identified as the best way, operationally, to use available resources to create new sustained/extended release and MPT products. Critical points for harmonization include the need to reduce drug development risk while promoting advancement of products, to do pharmacology, to choose durations of action that are technologically feasible, and to focus on impact. The R61/R33 phased innovation grant mechanism was chosen for both initiatives. Pre-award, the applicant will identify milestones that will be reviewed by peer review and Program and a final set of milestones that will go into the award are negotiated. After the first three years of the reward, Program will look at the achievement of milestones, if the science has remained a program priority, and if there are available funds. If all milestones are met, the awards will transition to the R33 for two years with a required milestone for FDA communication in year four. The impact of PK tail and forgiveness on product development needs to incorporate not only medical and virological concerns but must also meet user expectation for redosing convenience. The inclusion of preferred user characteristics into early DDS design is important and will be supported.

For the SRI concept, the objective is to support and expand sustained/extended release research for HIV prevention through a high-risk/innovation program that focuses on new products and DDS with the potential for increased impact through extended windows of protection and integration of product development with user informed design. It is estimated that there will be two or three awards made. For the Next Generation Multipurpose (NGM) Prevention Technologies concept, the objective is to support and expand the development of a separate MPT using licensed or unlicensed ARVs and licensed contraceptive hormones or devices using high-risk/innovation program that focuses on new products and DDS with the potential for increased impact through extended windows of protection and integration of product development with user informed design of the proposed products. An estimated two or three awards will be made. Use of a separate MPT was explained by comparing the adaptive-designed MPT (current) with the purpose-designed MPT (NGM concept) approaches. This latter approach makes the MPT product for the NGM approach more complementary to the single indication licensed contraceptive product. Reviewers’ comments were then addressed, and members voted on the two concepts presented.

Q1: Will PEPFAR pay for a multi-purpose therapy?

A1: Unknown, but a case can be made for this.

Q2: (1) What about an MPT for incentivizing MSM activities and therapies and (2) is the field considering other ideas other than the hypothesis that contraception will drive uptake and indirectly drive down the epidemic?

A2: (1) That ends up being HIV/HPV, HIV/syphilis and HIV/various other STIs. DMID has an R21/R33 program that will look at these issues for MSM. (2) In terms of incentives, lots of thing are being done. What is being given is the focus we have on what do we do given the current status out there, what is in development, what is in clinical trials, and of how we assure there is a next generation sitting there in 2025. There are incentives programs going on within PSP. There are programs to look at how you get prevention strategies into communities.

Ballot Voting Outcome Sustained Release Innovation (SRI) for HIV:

9 Approval
0 Approval with modification(s)
0 Deferral for further information
0 Disapproval

Ballot Voting Outcome Next Generation Multipurpose (NGM) Prevention Strategies:

9 Approval
0 Approval with modification(s)
0 Deferral for further information
0 Disapproval

Basic Sciences Program

Getting to Zero: Understanding HIV Viral Suppression and Transmission in the United States

Carolyn Williams, Ph.D.

Dr. Williams presented this concept which had an objective to improve measurement and understanding of viral suppression and HIV transmission in the United States using population-level epidemiology and novel tools from Big Data science and mobile and electronic health records. This research should focus on expanding the understanding of HIV viral suppression by bringing together different types of data to reveal new associations and causal factors. This new knowledge could be used to develop approaches for viral control that are more effective, more timely and tailored for specific contexts and populations. This is a new R01 that will last for five years. The number of awards is estimated to be three to five. Co-funding ICs include the National Institute of Mental Health (NIMH) and the National Institute of Child Health and Development (NICHD). This concept was developed because despite the successes in HIV treatment, HIV testing and timely initiation of treatment has been slow and not uniform across all HIV at-risk groups, allowing continued HIV transmission. Clinical studies have shown that stable viral load suppression prevents transmission. The National HIV/AIDS Strategy-Updated to 2020 reiterated the issue of continuing the drive to lower transmission rates with a goal for a 25 percent reduction in the United States. The need to link individuals to care more quickly and to increase their retention in care was emphasized. Data from the CDC regarding linkage to care was presented but this is currently incomplete for some areas in the United States. Viral suppression data is below the targeted 80 percent value (54.7 percent overall) and again was missing for certain states. The DAIDS portfolio was discussed in terms of approaches used to address the National Strategy. Big Data science was overviewed and highlighted as to how it can be used together with other data to further understand complicated, multifaceted risk behaviors for HIV infection and linkage to care. Research priorities of this initiative are to focus on the HIV diagnosis and engagement in care transitions necessary to achieve Viral Suppression, which include testing and speed of identification of HIV-infected persons, linkage to quality HIV care, patterns of ARV use, specific ARV treatment, HIV viral suppression, and prediction of temporal patterns of HIV viral suppression. Questions included in the research priorities include how to improve timeliness of data for optimal interventions, how to get accurate measurement of each transition point by categories (i.e., by gender, by race, by geographic region), and how to evaluate predictors and patterns of success and failure for each transition point. Reviewers’ comments were then addressed, and members voted.

Q1: Consider using international data to inform some of the domestic studies as some of their 90, 90, 90 numbers are better than the U.S. numbers.

A1: I do not think that the U.S. data informs the non-domestic epidemic. The U.S. medical care system may not be adequately serving patients with chronic diseases and barriers in the care delivery system are quite troublesome. Suppression rates in Europe are much better than in the United States. Understanding where the barriers are would be very helpful.

Q2: What are the barriers to getting data such as viral suppression? What are the policies for this?

A2: Local policies either allow or prohibit access to certain data. Progress is being made, for instance, in Florida which will finally have data by next year. But in some areas local barriers remain that are based in old thinking. With this funding opportunity, we hope that surveillance and prevention information will be integrated to improve the program. The other barrier is the issue of Personal Identification Information (PII) and whether agencies such as CDC should be involved in supporting projects that examine PII-linked data.

Ballot Voting Outcome:

9 Approval
0 Approval with modification(s)
0 Deferral for further information
0 Disapproval

Future Meetings:

  • September 12 to 13, 2017 (AVRS)
  • January 29, 2018 (ARAC)
  • June 4, 2018 (ARAC)
  • June 5 to 6, 2018 (AVRS)
  • September 17, 2018 (ARAC)
  • January 28, 2019 (ARAC)

Public Comment

None.

VII. Adjournment

The meeting of the Council adjourned at 3:56 p.m., on Monday, September 11, 2017.

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

11/21/2017

Date

 
-s-

Matthew J. Fenton, Ph.D.

Executive Secretary

National Advisory Allergy and Infectious Diseases Council

Director, Division of Extramural Activities

National Institute of Allergy and Infectious Diseases

11/14/2017

Date

 

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

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