NIAID Council Minutes June 3, 2024

The 207^th meeting of the National Advisory Allergy and Infectious Diseases Council (NAAIDC) convened virtually at 10:30 a.m. on Monday, June 3, 2024. Dr. Jeanne Marrazzo, 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 4:10 p.m. The meeting was closed to the public from 8:30 a.m. to 10:30 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

Table of Contents

I. Review of Grant Applications
II. Remarks of the Director, NIAID— Jeanne Marrazzo, M.D., M.P.H.
III. Guest Speaker—Steven M. Holland, M.D., Director, Division of Intramural Research, NIAID
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 4,964 research and training applications with primary assignment to NIAID for a requested amount of $1,715,643,488 in first-year direct costs and recommended approval of 2,586 applications with $983,656,632 in first-year direct costs.

II. Remarks of the Director, NIAID— Jeanne Marrazzo, M.D., M.P.H.

Dr. Marrazzo opened the Council session by welcoming everyone to the meeting and noting that this was her first in-person Council meeting. She introduced four new Council members: Seema Shah, Associate Professor of Pediatrics at Northwestern Medical School and the Founder’s Board Professor of Medical Ethics at Lurie Children’s Hospital; Dr. Grace Aldrovandi, physician-scientist and Chief of the Division of Infectious Diseases at UCLA Mattel Children’s Hospital; Dr. Stokes Peebles, Professor of Medicine in the Division of Allergy, Pulmonary, and Critical Care Medicine at Vanderbilt University Medical Center; and Dr. Virginia Pascual, Director of the Drukier Institute for Children’s Health and Ronay Menschel Professor of Pediatrics at Weill Cornell Medical College.

Dr. Marrazzo then thanked two ad hoc Council members for participating in the meeting: Dr. Bali Pulendran, Violetta L. Horton Professor and Professor of Microbiology and Immunology at Stanford University School of Medicine, and Dr. Aaron Esser-Kahn, Professor of Molecular Engineering, Pritzker School of Molecular Engineering at the University of Chicago.

Consideration of Minutes of Previous Meeting

Council considered the minutes of the January 30, 2024 meeting and concepts that had been presented and approved them as written.

Staff and Organizational Changes

Dr. Marrazzo announced appointments and transitions that have taken place at NIAID since the last Council meeting.

In the Office of Science Management and Operations, Dr. Michael Nealy was named Director of the Office of Biodefense Research and Surety, and Kim Law was selected as Chief of the Biodefense Budget and Financial Management Branch.

In the Office of Acquisitions in the Division of Extramural Activities (DEA), Shamay Knox is now Associate Director and Laura Grey is Chief of the Acquisition Management and Operations Branch.

In DEA’s Grants Management Program, Shaun Gratton was appointed Chief of the Policy and Training Branch, and Robert Kirker was named Chief of Branch G.

Dr. Jason Gall was named Chief of the Vaccine Production Program in the Vaccine Research Center.

In the Division of Clinical Research (DCR), Dr. Lori Dodd is now Chief of the Clinical Trials Research Statistics Branch, and Dr. Libby Higgs was named Senior Scientific Officer, serving as the Global Health Science Advisor to the DCR Director.

Dr. Jason Brenchley was selected as Chief of the Laboratory of Viral Diseases in the Division of Intramural Research (DIR).

Tributes and Awards

Dr. Marrazzo announced that Dr. June Kwon-Chung, Chief of the Molecular Microbiology Section in the Laboratory of Clinical Immunology and Microbiology, DIR, was elected to the National Academy of Sciences.

Meetings and Events

On March 18, 2024, Dr. Marrazzo, NIH Director Dr. Monica Bertagnolli, and Office of Research on Women’s Health Director Dr. Janine Clayton attended the signing ceremony for President Biden’s executive order to invest $12 billion in new funding for women’s health research.

Budget Update

Dr. Marrazzo began by comparing NIAID’s fiscal year (FY) 2023 enacted budget to the FY 2024 enacted budget. NIAID’s FY 2024 enacted budget remained flat at $6.5 billion, as did the budgets for most other institutes and centers (ICs).

She then summarized NIAID’s FY 2024 financial management plan. Our R01 payline is set at the 10 percentile for established principal investigators (PIs) and the 14 percentile for new PIs. NIAID will fund noncompeting grants at 100 percent and competing grants will be funded at 90 percent of approved funding. Fellowship (F), training (T), career development (K), and small business (SBIR/STTR) awards will not be adjusted. Competing research initiatives have been cut up to 20 percent. Overall estimated success rates are 16 to 20 percent.

Dr. Marrazzo mentioned earmarks that were included in the FY 2024 budget and noted how earmarks limit flexibility to allocate additional funds to other NIAID priorities.

On March 11, President Biden released his FY 2025 budget request, which includes an overall increase of 5.6 percent for NIH, or $2.76 billion above the FY 2024 enacted level. NIAID and most other IC budgets remain flat.

Legislative Update

On May 23, Dr. Marrazzo accompanied NIH Director Dr. Monica Bertagnolli and directors of several other ICs at a hearing before the Senate L-HHS Appropriations Subcommittee to discuss the NIH FY 2025 budget.

Other Information Items

Dr. Marrazzo reviewed the timeline for preparing and releasing the NIAID Strategic Plan and provided an update on the status. Responses to the request for information were due on May 27, and NIAID staff are in the process of analyzing results and summarizing feedback. NIAID received 63 total responses: 23 from societies and advocacy organizations, 31 from individual researchers, 6 from federal staff, and 3 from patients and healthcare community representatives. NIAID plans to publish the detailed Strategic Plan in early FY 2025.

The Division of AIDS (DAIDS) released an updated NIAID HIV Language Guide. Many community, advisory, and working groups, as well as other NIH ICs, provided feedback for the update. The guide outlines best practices for using empowering rather than stigmatizing language.

Dr. Marrazzo provided an update on the transplantation of a gene-edited pig kidney to a human recipient, and results from clinical trials on the subcutaneous administration of a monoclonal antibody to prevent malaria and efficacy of a dengue vaccine candidate at a 2-year follow up.

She shared information on NIAID workshops that are being organized with other NIH institutes—Envisioning the Future of HIV/STI Prevention and Contraception; Exploring the Impact of Dietary Exposures on the Development of Mucosal Immunity and Immune-Mediated Digestive Diseases; and Genomic Medicine Meeting XVI: Apply Immunogenomics Knowledge to Treat Disease.

Dr. Marrazzo concluded by summarizing H5N1 information that has been collected over the last several months, including the number of human infections in dairy farmers and detection of noninfectious virus in milk. She noted NIAID’s extensive efforts within the Centers of Excellence for Influenza Research and Response, such as active shorebird surveillance that helps to monitor any genetic or immunologic changes in circulating viruses and helps better understand influenza’s natural history, influenza viruses circulating in bird populations, and how migratory patterns impact transmission.

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

Dr. Holland began by explaining that NIAID’s intramural programs are in Bethesda and at the Rocky Mountain Laboratories (RML) in Montana, along with sites around the world. DIR evaluates its research—the Board of Scientific Counselors reviews every lab, every PI—at least every 4 years. Reviews are done in June and December. He shared a snapshot of the number of PIs in DIR broken down by tenured and tenure-track PIs.

Dr. Holland gave an overview of DIR’s activities since the beginning of the fiscal year, which included 537 publications, 14 NIAID press releases/blog posts, and 212 ongoing clinical studies. COVID funding led to about 60 percent of DIR PIs being involved in COVID activities and over 400 publications. DIR has four current H5N1 projects with 12 different PIs involved, and 13 new projects are planned or funded.

He then outlined DIR staff changes that have occurred since the beginning of the fiscal year, including retirements and planned retirements, staff departures, a newly tenured investigator, new senior investigators, leadership changes, and a new tenure-track investigator. Searches are underway for a new deputy director, several lab chiefs, and tenure and tenure-track positions.

Dr. Holland noted the importance of improving diversity, equity, inclusion, and accessibility in DIR’s work and listed examples of steps being taken to accomplish this.

He acknowledged the significance of establishing the SARS-CoV-2 Virology Core, which continues to support COVID-19 bench and animal work by any NIH intramural investigators. The program has been successful as a paradigm for pandemic preparedness.

Next, Dr. Holland presented information about a few noteworthy NIAID resources, including integrated data sciences in the Research Technologies Branch and the Centralized Sequencing Program. He also mentioned that the Rocky Mountain Laboratory Animal Facility is now open, and the NIH Clinical Center’s E Wing renovation is complete.

Dr. Holland gave brief updates on some of DIR’s scientific research highlights related to subcutaneous administration of a monoclonal antibody to prevent malaria, how leishmania is regulated by IgM, mpox virus infection, systemic fungal infection, and immunity and immune function.

He concluded by summarizing DIR’s future directions, which include recruiting talented diverse investigators; continuing to support outstanding basic science; fostering bench-to-bedside approaches; making Clinical Center resources available to all labs; promoting pathophysiology, innovative strategies, vaccine targets, diagnostics, and therapeutics; and encouraging extramural and 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 207^th meeting of the National Advisory Allergy and Infectious Diseases Subcommittee meeting.

Dr. Rotrosen presented the following scientific and Division activities:

Staff and Organizational Changes

Hariharan Subramanian, Ph.D., Dr. Subramanian joined the Allergy, Asthma, and Airway Biology Branch in February 2024 as a Program Officer. He completed graduate training in Immunology at the University of Wisconsin and postdoctoral training in Allergy and Immunology at the University of Pennsylvania. He joined the academic faculty of Michigan State University in 2015, where his NIH-funded research focused on delineating the role of mast cells and their receptors in IgE-independent pseudoallergic reactions.

Kelly Hudspeth, Ph.D., Dr. Hudspeth joined the Autoimmunity and Mucosal Immunology Branch in March 2024 as a Program Officer. Prior to joining DAIT, Dr. Hudspeth was a Scientific Review Officer in the Scientific Review Program at NIAID. Dr. Hudspeth received his Ph.D. in 2013 from the University of Milan in Milan, Italy. He completed his postdoctoral training at NIAMS, studying autoimmune disease, molecular genomics, and innate immunity.

Selected Funding Opportunities

NIAID

RFA-AI-24-003: Novel Approaches for Radiation Biodosimetry Assays and Devices Development (U01, Clinical Trial Not Allowed). The purpose of this notice of funding opportunity (NOFO) is to support identification of biomarkers of injury and development of assays or devices for the purpose of triage, including assessing absorbed dose or predicting health outcomes of acute or delayed injuries resulting from radiation exposure during a public health emergency. This NOFO will support all stages of development of these approaches, with the goal of future regulatory approval.

NIAID-NIH-RFP-75N93023R0002: RNCP Portfolio-Wide Dosimetry Verification Services. The purpose of this request for proposals (RFP) is to support a program-led strategy to provide services, facilities, expertise, and capabilities to maintain and advance the centralized dosimetry harmonization effort, originally established in 2020, across the Radiation and Nuclear Countermeasures Program (RNCP)-funded radiation research portfolio.

RFA-AI-24-002: Research Initiative for Vaccine and Antibiotic Allergy (UG3/UH3, Clinical Trial Not Allowed). The purpose of this NOFO is to support research that enhances understanding of the mechanisms and management of vaccine and antibiotic drug allergy (research on allergic responses to anti-viral, anti-fungal, and anti-parasitic drugs will also be considered). A secondary objective is to expand the number of investigators working in the field of vaccine and antibiotic drug allergy.

Division Activities

Radiation and Nuclear Countermeasures Program

2024 Annual Update Meeting for the Centers for Medical Countermeasures against Radiation Consortium (CMCRC). On January 16 and 17, 2024, the CMCRC annual meeting was held in-person/hybrid in Baltimore, Maryland, marking the 4^th year of the current consortium, with awardees from the University of Maryland School of Medicine, Columbia University, and Duke University. Each center provided an overview of the research they will pursue during this funding period. The meeting offered an opportunity to showcase the portfolio to other key stakeholders from partner federal government agencies (NCI, BARDA, NASA, DoD, and FDA). In addition, the meeting fostered dialog and collaboration among the CMCRC investigators and program staff regarding future research and development directions. Also present were members of the External Advisory Board, who provided their insight and advice about the research discussed.

Understudied Populations in Radiation Research: Needs, Challenges, and Mitigation Strategies. On April 10 and 11, 2024, an NIAID-sponsored workshop, planned with input from NCI, NICHD, and NIA, was held in Rockville, Maryland. Goals of the workshop were to identify specific challenges and needs of understudied populations (pediatric; pregnant/lactating and fetal; and geriatric) after exposure to radiation during a public health emergency; examine the state of science for radiation medical countermeasures and biodosimetry in these specialized populations; and discuss policies that influence the inclusion of these populations in the development of therapeutics and diagnostics. There were ~50 in-person attendees and 122 online participants involved in the meeting, which had 25 speakers from 25 institutions.

Allergy, Asthma, and Airway Biology Branch

National Institute of Allergy and Infectious Diseases (NIAID): Respiratory Syncytial Virus (RSV) and Asthma: Associations, Mechanisms, and the Potential Impact of Vaccines. On February 25, 2024, as part of the annual meeting of the American Academy of Allergy, Asthma, and Immunology (AAAAI) in Washington, DC, NIAID organized a symposium entitled “National Institute of Allergy and Infectious Diseases (NIAID): Respiratory Syncytial Virus (RSV) and Asthma: Associations, Mechanisms and the Potential Impact of Vaccines.” Three experts presented lectures on topics including the link between RSV infection and asthma, mechanisms underlying the RSV-asthma connection, and the current status and future potential role of RSV vaccines in preventing asthma.

Lessons Learned from the Asthma and Allergic Diseases Cooperative Research Centers (AADCRC): Advances in Genetic Medicine. On February 23, 2024, as part of the annual meeting of the AAAAI in Washington, DC, the NIAID-funded AADCRC organized a seminar entitled “Lessons Learned from the Asthma and Allergic Diseases Cooperative Research Centers (AADCRC): Advances in Genetic Medicine.” Three experts presented lectures on the genomic characterization and therapeutic utilization of IL-13-responsive genetic sequences in asthma, multi-omic approaches to post-GWAS gene discovery in asthma, and application of GWAS to childhood atopic dermatitis outcomes.

Lessons Learned from the Asthma and Allergic Diseases Cooperative Research Centers (AADCRC): Metabolism and the Epithelium. As part of the annual AAAAI meeting in Washington, DC, the NIAID-funded AADCRC organized a seminar entitled “Lessons Learned from the Asthma and Allergic Diseases Cooperative Research Centers (AADCRC): Metabolism and the Epithelium” as a pre-recorded session. Three experts presented lectures on the role of metabolic dysregulation in asthma development, androgen signaling restriction of immunometabolism driving sex-specific responses in airway inflammation, and the role of type-2 inflammation driving airway basal stem cell program through insulin receptor substrate signaling.

Airway Disease Endotyping Using Omics. On May 19, 2024, as part of the annual meeting of the American Thoracic Society (ATS) in San Diego, California, NIAID organized a symposium entitled “Airway Disease Endotyping Using Omics.” The session highlighted NIAID-funded programs utilizing airway omics to endotype viral respiratory infection (rhinovirus and SARS-CoV-2), omics studies in exacerbation prone asthma, and the relationship between type-2 inflammation and antimicrobial genes in children with allergic rhinitis and asthma.

Basic Immunology Branch

B Cell Epitope and Mechanisms of Antibody Protection, Large-Scale T cell Immune Epitope Discovery, and Immune Epitope Database and Analysis Resource (IEDB) Contract Annual Meeting. On March 4 and 5, 2024, a hybrid annual meeting was held in Rockville, Maryland, to bring together contractors for the two epitope discovery programs, the IEDB, and NIAID staff involved or interested in these programs. The purpose of these programs is to support highly interactive, multidisciplinary teams whose research efforts are focused on large-scale discovery of immune epitopes and antibodies associated with infectious or autoimmune diseases and validate these epitopes regarding their role in immune protection or immune-mediated pathogenesis in humans. This was a fourth-year progress meeting and allowed investigators to provide extensive and exciting updates on project progress and discuss next steps. Contractors who expanded their contract work to include T and B cell epitope discovery and evaluation of antibody protection for SARS-CoV-2 also incorporated these results in their presentations.

Human Immunology Project Consortium (HIPC). On March 19 and 20, 2024, NIAID held the HIPC annual meeting in Rockville, Maryland. This trans-NIAID program, led by DAIT, consists of a coordinating center and eight multi-project cooperative agreements (U19s), which are collecting detailed clinical data and conducting immune profiling on diverse human cohorts at steady state and in response to pathogenic infections or vaccines. The HIPC Coordinating Center leads collaborative activities across HIPC, including managing an infrastructure and opportunity fund, further developing and implementing clinical and immunologic data standards, and maintaining and expanding the human immunology knowledgebase and analysis portal, ImmuneSpace (https://immunespace.org/).

NIAID Focus Group at IMMUNOLOGY 2024. On May 4, 2024, DAIT hosted a focus group meeting in Chicago, Illinois, with select NIAID grant recipients at the annual American Association of Immunologists conference, IMMUNOLOGY 2024. Over 20 recipients from different career stages attended the meeting, during which Dr. Daniel Rotrosen, Director of DAIT, provided an update on current NIAID/NIH policies, the FY 2024 NIAID and NIH budgets, and projections for FY 2025. The participants provided feedback on how NIAID/NIH can improve its service to the immunology research community.

Utilizing Big Data and Data Science to Advance Human Immunology. On May 5, 2024, DAIT hosted a symposium at IMMUNOLOGY 2024 in Chicago, Illinois, entitled “Utilizing Big Data and Data Science to Advance Human Immunology.” This symposium was chaired by Dr. Alison Augustine (Chief, Basic Immunology Branch, DAIT), and Dr. Atul Butte (Priscilla Chan and Mark Zuckerberg Distinguished Professor, UCSF School of Medicine), and began with an overview of ImmPort (https://www.immport.org/home), the largest immunology-centric public data repository, in honor of its 20 year anniversary and its role in facilitating immunology data science. The symposium continued with four scientific presentations from leading scientists that highlighted the use of innovative data science and computational biology methods to expand our understanding of human immunity. The speakers and titles were:

• Dr. Anupama Gururaj, NIAID, “ImmPort at 20: Home for Immunology Research Data”
• Dr. F. Eun-Hyung Lee, Emory University, “Developing a Human Plasma Cell Atlas by Single Cell”
• Dr. Lindsay Cowell, UTSW, “Leveraging the Adaptive Immune Receptor Repertoire Knowledge Commons for Immunologic Insights”
• Dr. John Tsang, Yale University, “Measuring and Predicting Human Immune Health”
• Dr. Shai Shen-Orr, Israel Institute of Technology, “Charting the Immune Landscape”

Transplantation Branch

None

Autoimmunity and Mucosal Immunology Branch

Primary Immune Deficiency Treatment Consortium (PIDTC), Tenth Annual Scientific Workshop and Education Day. From April 8 to 11, 2024, the PIDTC convened in a face-to-face scientific workshop in Atlanta, Georgia. Over 200 attendees from more than 40 participating centers discussed progress and administration of their natural history studies of treatment outcomes after hematopoietic stem cell transplantation or gene therapy for inborn errors of immunity that include severe combined immunodeficiency (SCID) (NCT01186913 and NCT01346150), chronic granulomatous disease (NCT02082353), Wiskott-Aldrich syndrome (NCT02064933), and primary immune regulatory disorders. In addition, over 20 cases submitted by young investigators mentored by PIDTC senior staff were selected for oral presentations during Education Day. PIDTC is now in its fifteenth and final year of continuous funding permitted as a member of the Rare Diseases Clinical Research Network (RDCRN). The U54 award under RFA-TR-020 is sponsored by NIAID and co-funded by NCATS.

Mucosal Immunology Studies Team (MIST), Annual Meeting. On May 21, 2024, MIST investigators met in Rockville, Maryland, to present their research progress as they enter the final year of the current 5-year program, with most research focused on immunology of gut mucosal tissues. The goal of the program is to understand immune processes at mucosal sites and how they impact both protective immunity from infectious diseases and immune-mediated, inflammatory processes both in the gut and at distal sites. Major accomplishments of the program include the first demonstration that goblet cells serve as conduits for antigen delivery from the gut lumen to dendritic cells; definition of critical roles of ILCs as effector and regulatory cells at mucosal barrier surfaces; identification of roles of commensal-specific Th17 cells in shaping gut immune responses; definition of a novel role of M cells in pulmonary immune responses; and novel findings on the impact of neuronal pathways on mucosal immunity.

FY 2025 Research Concept Clearances Presented to Division Advisory Council

The subcommittee endorsed and unanimously approved the following three Research Concept Clearances:

Development of Alternative Human Models of Radiation-Induced Injuries (Extracorporeal Systems) (U01, Clinical Trial Not Allowed). This initiative will support the research and development of alternative human models of acute and delayed radiation-induced injuries. It is anticipated that microphysiological systems (tissue chips), 3-dimensional culture systems, and organ tissue ex vivo models will be explored in applications submitted in response to this initiative.

Development of Radiation/Nuclear Medical Countermeasures (MCMs) and Biodosimetry Devices. This broad agency announcement serves as the RNCP’s only mechanism to solicit investigator-initiated mid- to advanced-stage research directed to FDA investigational new drug application (IND)-enabling efforts to develop medical countermeasures (MCMs) to treat acute radiation syndrome (ARS), and/or the delayed effects of acute radiation exposure (DEARE), and to advance biodosimetry approaches toward an FDA investigational device exemption (IDE) application.

Immune Epitope Database and Analysis Resource (IEDB). The goal of this initiative is to continue support of the IEDB, which provides the research community with an easy, accurate, and up-to-date resource for searching experimental data characterizing human, non-human primate, and other animal antibody and T cell epitopes involved in infectious disease, allergy, autoimmunity, and transplantation.

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 June 3, 2024. She provided a DMID personnel update, recognizing new staff appointments made in the Division since the last Council meeting, including: Cynda Hall and Jeremy Warner, Office of Clinical Research Resources; Tom DiMaggio, Lisa Cazares and Ricky Soong, Office of Biodefense, Research Resources and Translational Research; Lauren Byrd-Leotis and Ankita Garg, Respiratory Diseases Branch; Catherine Luke, Office of Regulatory Affairs; Maurice Edwards, Parasitology and International Programs Branch; and Patricia Strickler-Dinglasan, Aleks Clark and Amanda Coleman, Office of Scientific Coordination and Program Operations. She also announced the appointment of Erik Stemmy as the Deputy Branch Chief of the Respiratory Diseases Branch.

Following staff introductions, Dr. Erbelding provided a report on recent activities of note:

• Highly Pathogenic Avian Influenza: Several DMID staff members, together with multiple government agencies, have been actively investigating the current H5N1 influenza outbreak in dairy cattle.
• Meningococcal Pentavalent Vaccine: Interim results of the ongoing DMID Infectious Diseases Clinical Research Consortium study comparing the pentavalent Meningococcal Serogroup ACYWX Conjugate Vaccine with MenACWY-TT Conjugate Vaccine showed that in the study’s 9-month infant group, the pentavalent conjugate vaccine is safe and highly immunogenic at 28 days post-vaccination. Based on these results, WHO’s SAGE recommended that all countries in the African meningitis belt introduce the novel pentavalent meningococcal conjugate vaccine (targeting serogroups A, C, Y, W and X) into their routine immunization programs in a single-dose schedule at 9 to 18 months of age. Nigeria has become the first country in the world to roll out a vaccination campaign with the pentavalent meningococcal conjugate vaccine.
• NIAID’s Multisite Observational Maternal and Infant COVID-19 Vaccine (MOMI-Vax): This study found that when pregnant women receive a COVID-19 vaccine or booster, their infants receive protection against the virus for at least 6 months after birth.
• NIAID’s TB Strategic Plan: The updated plan was recently published and posted on the NIAID website (https://www.niaid.nih.gov/sites/default/files/tb-strategic-plan-2024.pdf).
• Preclinical studies on a more broadly protective influenza vaccine: Researchers supported by the Collaborative Influenza Vaccine Innovation Centers (CIVICs) program conducted preclinical studies on a new vaccine designed to encourage the immune system to target the influenza HA stalk, a portion of the virus surface that is less variable. Studies in mice and ferrets found that the experimental vaccine caused the immune system to respond more strongly than traditional flu vaccines.

Finally, Dr. Erbelding presented one additional topic for inclusion in the 2025 Small Business Innovation Research (SBIR) Contract Solicitation for the Subcommittee’s consideration (three topics were presented and approved at the January 2024 meeting): “Discovery and Development of Oral Small-molecule Direct-acting Antivirals Targeting Viruses of Pandemic Potential.” The topic was approved by the Subcommittee.

Update: NIAID Centers of Excellence for Influenza Research and Response (CEIRR) H5N1 Research Update - Lauren Byrd-Leotis, PhD, CEIRR Program Officer.

Dr. Byrd-Leotis provided an update on CEIRR activities initiated in response to the recent highly pathogenic H5N1 avian influenza outbreak in dairy cattle. As background, Dr. Byrd-Leotis reported that the CEIRR program was established by NIAID nearly 20 years ago with the goal of leveraging the expertise of extramural influenza investigators to understand the impact of epidemic influenza and reduce the threat of pandemic influenza. She provided information on the seven active Centers and described programmatic requirements regarding risk assessment activities. In response to the current situation, DMID was able to rapidly redirect the efforts of CEIRR scientists to investigate the outbreak.

Dr. Byrd-Leotis presented historical information about H5N1, noting that the first human case of this highly pathogenic strain was reported in 1997 in a person who had contact with an infected bird, but that to date there has been no direct, sustained human-to-human transmission. She noted the arrival of clade 2.3.4.4b influenza viruses in 2020, which spread extensively across Africa, Asia, and Europe. In the following 2 years they crossed to North America and South America. Infections from these viruses resulted in an unprecedented number of deaths of wild birds and outbreaks in domestic poultry. Additionally, there have been more spillover events to mammals.  Dr. Byrd-Leotis provided several slides outlining the timeline of the current outbreak and how it has progressed, reporting that the week prior to Council the CDC reported a third human case following exposure to dairy cattle and that this individual had respiratory symptoms in addition to conjunctivitis, which has raised concerns. All infected persons have recovered.

Dr. Byrd-Leotis then presented several slides describing ongoing CEIRR activities, which include sample collection from cattle to determine the extent of infection in the herds; viral characterization and risk assessment studies, including those that track mammalian adaptation of viruses isolated from milk samples from infected cows; studies to assess sensitivity to existing antivirals; and reagent development, among other activities. Dr. Byrd-Leotis highlighted several of the studies in further detail, including those that determined the enhanced stability of the virus in milk on surfaces across a range of temperatures and humidity conditions, as well as the extensive testing of retail milk samples to detect viral fragments and confirm that live virus could not be isolated following processing and pasteurization. Additionally, work from CEIRR investigators, published in the New England Journal of Medicine, was discussed which examines pasteurization conditions as well as the effects of raw milk consumption in mice. Dr. Byrd-Leotis reported that the CEIRR investigators are posting information on all of these activities and more on the CEIRR website (https://www.ceirr-network.org/) in a timely manner.

FY 2025 DMID Concepts Presented for Clearance

The following concepts were presented to the Subcommittee:

Centers for Accelerating Phage (Bacteriophage) Therapy to Combat ESKAPE Pathogens (CAPT-CEP) – This concept proposes to establish highly collaborative, multidisciplinary research centers focused on developing preclinical assays and tools for phage therapy to treat bacterial infections. The DMID Subcommittee recognized the importance of addressing the scientific needs of this proposed program, which are to develop standardized assays and tools, to generate appropriate in vitro and in vivo models for phage therapy, to conduct systems pharmacological studies, and to evaluate optimal delivery systems and dosages for different phages. They also noted that meeting these needs is essential for developing robust phage therapy and that it will ultimately pave the way for large clinical trials needed to bring phages to market. One Subcommittee member suggested exploring phage’s valency to improve broader host ranges and stability, which is crucial for efficacious phage cocktails. Program staff acknowledged the suggestion and discussed how it may be included moving forward. The Subcommittee members also recommended that this program fosters collaborative interactions among different supported centers and avoids overlap with other ongoing programs. They also recommended ensuring that the review panel includes the necessary phage expertise to adequately review applications on this topic. Program staff noted the suggestions and emphasized that this program aims to develop necessary assays/tools/models for phage therapy. The Subcommittee approved the concept with a unanimous vote.

CARBIRU Combating Antibiotic-Resistant Bacteria (CARB) Interdisciplinary Research Units (CARBIRU) – This concept proposes to continue support for multidisciplinary research centers focused on fundamental, collaborative research to improve our understanding of bacterial and host factors important for antibiotic resistance and infection and to inform new ways to prevent, diagnose, and treat antibiotic-resistant infections. One Subcommittee member noted that the scope of the program is broad and that it will be important to ensure that the CARBIRUs remain multidisciplinary and synergistic. Another Subcommittee member recommended that the program description be revised to clarify which aspects of the host response are included in these centers. Program staff responded by noting the previously successful efforts to promote synergy among the diverse teams of investigators covering a wide range of topics and the plans to continue these efforts. In addition, Program staff acknowledged the suggestion to add more specificity regarding the areas of the host response that would be suitable for the CARBIRUs. The Subcommittee was enthusiastic about the CARBIRU program addressing knowledge gaps in antibiotic resistance and bringing together multidisciplinary teams of investigators to address these questions. The Subcommittee approved the concept with a unanimous vote.

New Therapeutic Strategies for Genital Herpes – This concept proposes to advance the discovery of new candidates and/or identify new targets for the treatment of genital herpes to include, but not be limited to new antiviral therapeutics; therapeutic vaccines; monoclonal antibodies; and gene editing technologies. This concept seeks to capitalize on the robust HSV basic research field and encourage more researchers to advance products into the development pipeline. The DMID Subcommittee recognized the importance of the development of new therapeutics to treat genital herpes, as outbreaks still occur with current treatments. There was a lot of enthusiasm expressed for new therapeutics that could reduce asymptomatic shedding and transmission, which one Subcommittee member noted was a major concern of patients in her own medical practice.

The Subcommittee members were also very supportive of the wide variety of approaches that would be captured in this proposed initiative and thought the biphasic R21/R33 funding mechanism was appropriate for supporting any efficacy studies or development that might not be captured under an R21 mechanism alone. One Subcommittee member questioned the expected duration of virus suppression with monoclonal antibody therapy and the feasibility of implementing this type of treatment. Program staff responded that there are currently several long-acting formulations of monoclonal antibodies in use or under development for COVID-19 (6 months), HIV (3 – 6 months), and Zika (9 months) that demonstrate the potential feasibility of a similar product for HSV. One Subcommittee member inquired as to the direct budget caps for each portion of the biphasic award, to which Program staff responded that the R21 could receive up to $275,000 over 2 years and then those that transition to the R33 phase (about 50 percent) would be eligible for up to $300,000 annually for 3 years. Transition to the R33 phase would be based on the original R21/R33 peer review recommendations, successful completion of R21 milestones, program priorities, and availability of funds. The Subcommittee approved the concept with a unanimous vote.

Chemistry Center for Combating Antibiotic-Resistant Bacteria (CC4CARB) – This concept proposes to continue the innovative CC4CARB chemistry center which designs, synthesizes, and delivers compound libraries to the scientific community for use in antibacterial drug discovery. The DMID Subcommittee recognized the importance of continuing the work of the CC4CARB with a renewal concept. They agreed that the lack of appropriate chemical matter for new drug discovery efforts continues to be a limitation in the search for new agents effective against drug resistant bacteria. Two of the Subcommittee members noted that, besides direct killing of bacteria, there are other modalities CC4CARB could address, including drug potentiation by cell permeabilization or efflux inhibition. They were keenly interested in the intellectual property aspects of a chemistry center that collaborates with external researchers on drug design and they were reassured by the 18-month embargo period included in the concept. Finally, both thought Tier 1 in vitro testing data would enable future machine learning approaches that may be applied to the CC4CARB collection. While not an explicit goal of the concept, it is an additional value of in vitro testing that may be realized in the future. The subcommittee approved the concept with a unanimous vote.

Discovery/Development of Novel Therapeutics for Select Fungal Pathogens – This concept proposes to advance research focused on the discovery and development of novel therapeutics against select fungal pathogens of clinical concern. The concept focuses on novel therapeutics for the following priority fungal pathogens identified by the WHO and CDC: Candida species, specifically Candida auris; Aspergillus fumigatus; Coccidioides; and Mucorales. The DMID Subcommittee strongly supported the concept, recognizing the unmet medical need to address invasive fungal infections and the threat of emerging antifungal resistant fungi. Furthermore, they noted that there is an urgent need for the discovery and development of novel therapeutics for the fungal pathogens included in the concept. One Subcommittee member inquired as to whether the amount of funding is sufficient for R33 phase. Program responded that it is anticipated that about 50 percent of the R21s will be transitioned to the R33 phase and R33 funding decisions will be based on the original R21/R33 peer review recommendations, successful completion of R21 milestones, program priorities, and availability of funds.One Subcommittee member suggested that it be made clear to the research community that transition to the R33 phase will depend on successful completion of milestones from the R21 phase. The Subcommittee approved the concept with a unanimous vote.

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

Welcome and Approval of Minutes

Elaine Abrams, M.D. (ARAC Chairperson)

Dr. Abrams welcomed everyone to the hybrid meeting. Dr. Abrams called for the Committee vote on approval of the minutes of the January 30, 2024 ARAC meeting. The minutes were approved.

Director’s Report

Carl Dieffenbach, Ph.D.; Director, Division of AIDS (DAIDS)

Dr. Dieffenbach introduced new members on the ARAC: Grace Aldrovandi, Seema K. Shah, Kelly A. Gebo, Timothy J. Henrich, Raphael Landovitz, Lishomwa C. Ndhlovu. Linda Koenig attended as the alternate ex-officio from the CDC, representing Robyn Neblett Fanfair. A change in leadership at the White House Office of National AIDS Policy (ONAP) was announced on April 8. Mr. Francisco Ruiz is the new Director of ONAP.

Dr. Dieffenbach announced that the Division of AIDS released the updated NIAID HIV Language Guide in May based on feedback from many community groups, advisory and working groups, and across NIH ICs. Like the original guide, this edition outlines best practices for use of empowering rather than stigmatizing language. NIAID is making every effort to eliminate the use of stigmatizing terminology and advance the use of person-first, inclusive, and respectful language. It should be noted that the NIAID HIV Language Guide has relevance beyond HIV. It includes language related to other areas of research, diseases and conditions, gender and sexuality, general research terminology, and more.

Budget Update

The FY 2024 NIAID budget was flatlined as compared with the FY 2023 enacted budget.

NIAID FY 2024 Financial Management Plan

Key points:

• R01 Payline: Established PIs are at the 10^th percentile. New PIs are at the 14^th percentile.
• NIAID will fund noncompeting grants at 100 percent; Competing investigator-initiated awards will be funded at 90 percent of approved funding.
• No adjustments to fellowship (F), training (T), career development (K) and small business (SBIR/STTR) awards.
• Competing research initiatives could be cut up to 20 percent, with an estimated success rate between 16 and 20 percent for the entire Institute.

The President's budget for FY 2025 has been released. NIAID has a small increase proposed over FY 2024 of $19 million, or 0.3 percent.

Dr. Dieffenbach reviewed the timeline for the revised NIAID Strategic Plan and also shared the proposed organizational structure for the plan, starting with the vision, mission, priorities, objectives, and focus areas. A request for information (RFI) inviting comments and suggestions on NIAID’s Strategic Plan closed on May 27. The RFI feedback that we received is being summarized and results are being analyzed. We will provide an update at the September 9^th ARAC meeting.

This ties in very nicely with the beginning of the process of looking at the size, scope, and future direction of our HIV Clinical Trials Networks Enterprise. We plan to update you about progress of the renewal of the Clinical Trials Enterprise in September and then again in January. A timeline for renewal of the enterprise was shown:

• Spring 2024: Launch process with Network presentations to Strategic Working Group
• Summer 2024: Input from the stakeholders (investigators, community, etc.)
• Fall 2024: Preliminary discussion at ARAC and other advisory committees
• Jan 2025: Formal presentation to ARAC of the refined Networks and Clinical Trials Units (CTU) structure – RFAs presented for concept approval at ARAC
• 2025: Begin RFA authorship
• Jan 2026: Publish RFAs
• Fall 2026: RFA applications due
• Winter/Spring 2027: Peer Review of grant applications
• Sept 2027: Applications to Council
• Dec 2027 (FY 2028): Earliest start date of Network and CTU awards

NIH Office of AIDS Research Advisory Council (OARAC) Briefing

Anne M. Neilan, M.D., M.P.H.

Dr. Neilan presented a report-out of the OARAC virtual meeting held on February 22, 2024.

NIH OAR leadership transitions were announced. Dr. Diana Finzi continues as the Acting OAR Director while a search committee recruits for a new Director. The OAR Deputy Director, RDML Timothy Holtz, retired on March 31. CAPT Mary Glenshaw is the Acting OAR Deputy Director as well as the Designated Federal Official of the OARAC.

The OARAC meeting Director’s Report delivered by Dr. Finzi included updates on OAR's plans for the next NIH strategic plan for HIV and HIV-related research which is going to cover 5 years - fiscal years 2026 through 2030. OAR is looking to OARAC and the broader community for input as it works to determine HIV research priorities, gaps, and areas of focus. OAR proposed a revised framework of strategic goals that reflects the HIV research continuum, and this framework is based on three research goals and a capacity goal that were highlighted.

Goal 1: Enhance discovery and advance HIV science through fundamental research. Goal 2: Advance the development and assessment of novel interventions for HIV prevention, treatment, and cure. Goal 3: Optimize public health impact of HIV discoveries through translation, dissemination, and implementation of research findings. Goal 4: (Capacity Goal) Build research workforce and infrastructure capacity to enhance sustainability of HIV scientific discovery.

The OARAC meeting also included briefings from NIH Advisory Council representatives and updates on the HIV clinical guidelines from the working groups of OARAC.

DAIDS FY 2026 Concepts Presented – ARAC Approval Requested

Seven proposed FY 2026 research grant and contract concepts were presented by DAIDS Program staff for ARAC approval. The concepts are briefly described below.

To begin, three companion concepts for the flagship Martin Delaney Collaboratories (MDC) Program were presented for approval. These will be awarded for a duration of 5 years:

• Martin Delaney Collaboratories for HIV Cure Research (Reissue)
• Martin Delaney Collaboratory for Pediatric HIV Cure Research (Reissue)
• Martin Delaney Collaboratories for HIV Cure Research Coordination Center (New)

Martin Delaney Collaboratories for HIV Cure Research

Diane Lawrence, Ph.D., DAIDS Basic Sciences Program

The MDC is a longstanding trans-NIH program on HIV cure since 2011. The objective of this UM1 flagship grant program is to address major obstacles to the eradication (cure) of HIV infection and long-term antiretroviral therapy (ART)-free control of viral rebound (remission) in people living with HIV. The goal is to extend our understanding of the basic biology and dynamics of persistent HIV reservoirs; to develop improved assays, methodology, and animal models to expedite research progress; and to design, develop, and test therapeutic strategies for achieving long-term HIV remission or eradication. This will require innovative and highly collaborative research, rapid response to evolving science and emerging technologies, emphasis on the basic biology and dynamics of persistent HIV reservoirs in diverse global populations, and development of improved assays, methodologies, and model systems. The dynamic structure of the Martin Delaney Collaboratory (MDC) program seeks to increase the pace of research, leverage common resources, facilitate collaborations, and engage and train future HIV cure researchers.This initiative will support highly collaborative research partnerships among academic institutions, industry, government, and community-based organizations. NIAID plans to partner with the following other NIH Institutes: NIMH, NIDA, NINDS, NIDDK, NHLBI, and NIA.

Martin Delaney Collaboratory for Pediatric HIV Cure Research

Tania Lombo, Ph.D., DAIDS Prevention Sciences Program

The objectives are to stimulate research to address major obstacles to the eradication (cure) of HIV infection or long-term antiretroviral therapy-free control of viral rebound (remission) in infected pediatric individuals. The goals are to extend our understanding of the basic biology and dynamics of persistent HIV reservoirs; to develop improved assays, methodology, and animal models to expedite research progress; and to design, develop, and test therapeutic strategies for achieving long-term HIV remission or eradication specifically in people living with HIV under 18 years of age. The collaborative and dynamic structure of the pediatric MDC program seeks to increase the pace of HIV cure research, leverage common resources, facilitate collaborations, and engage and train the next generation of pediatric HIV cure researchers. This UM1 grant concept proposes to support HIV cure research in pediatric populations through partnerships between academic institutions, industry, government, and community-based organizations. It is anticipated that one pediatric program will be supported. The award recipient will be encouraged to communicate and collaborate with the awards made under the companion Martin Delaney Collaboratory programs via annual meetings, trans-MDC working groups, and review by a Scientific Advisory Board. The pediatric MDC will work together with the Coordination Center and other MDCs to maximize collaboration and sharing of data, and resources to ensure coordination for common activities. There will be one pediatric MDC award. NIAID plans to partner with the following other NIH Institutes: NICHD, NIMH, and NIDA.

Martin Delaney Collaboratories for HIV Cure Research Coordination Center

Diane Lawrence, Ph.D., DAIDS Basic Sciences Program

This is a newly proposed U01 concept to establish a comprehensive Coordination Center for the MDCs that serves as a platform for a more integrated and strategic Collaboratory research program. The purpose is to facilitate communication, collaboration, and coordination among the individual MDCs and key stakeholders to strengthen their collective efforts. The Coordination Center will support effective collaborations, enhancing efficiency, facilitating consultations to support MDC research, engaging early-stage investigators, and organizing feedback on the overall program. Providing opportunities for synergy will add value for overcoming common scientific challenges. The Coordination Center will provide administrative, scientific, technical, and management support to enhance the collaborative and cooperative interdisciplinary environment of the MDC award recipients and stakeholders. The Coordination Center will establish harmonized policies and management practices across the MDCs. A centralized support infrastructure will unify the program and facilitate cross-MDC and cross-NIH activities working together to optimize cure strategies. Facilitating communication will help manage the complexity of the overall program. It is anticipated that the Coordination Center will manage a formal program to support next-generation HIV cure researchers. There will be one Coordination Center award. (See companion adult MDC and pediatric MDC concepts above.)

Limited Competition: International epidemiology Databases to Evaluate AIDS (IeDEA)

Carolyn Williams, Ph.D., M.P.H., DAIDS Basic Sciences Program

This reissue U01 grant initiative seeks to continue the seven regional data center awards comprising the IeDEA program, which brings together clinical and research data within regions, and in collaboration globally, to monitor and guide the response to the HIV/AIDS epidemic. The objective of this limited competition concept is to continue this international epidemiology program focused on clinical effectiveness across the NIH Institutes/Centers/Offices (ICOs’) interests to understand the changing HIV epidemic globally. IeDEA answers key questions about the long term-term impact of HIV and its treatment, the epidemiology of common co-infections (hepatitis and tuberculosis) and respective health care utilization including medications, procedures, and vaccines. IeDEA uses cutting-edge data science techniques to validate and harmonize data within and across regions. It develops novel statistical methods to account for missing data, to understand and minimize bias, and utilizes other techniques to maximize the utility of observational data. The goal is to conduct analyses that produce comparable results across regions, combine data from multiple regions to answer compelling questions, and produce patient-level surveillance outcomes to monitor program implementation. Results will contribute to success in implementing the National HIV/AIDS Strategy, and monitoring outcomes and success of international HIV programs such as PEPFAR. The awards will continue funding for five U.S. institutions and two European universities to conduct research in seven global regions of the world. The regions are: North America; Caribbean; Central and South America; West, Central, Eastern, and Southern Africa; and Asia Pacific. The program supports epidemiologists, data management specialists, and statisticians to conduct research on collected clinical data and selected subcohorts of patients. Sources include cohort studies, clinical trials networks, public and private clinics and hospitals, and private care providers. The initiative will support work on the long-term impact of HIV and its treatment, the epidemiology of common co-infections (hepatitis and tuberculosis), and evaluations of the implementation of health care including medications, procedures, and vaccines; studies of comorbidities such as cancer; disruption of physiological and metabolic processes leading to end organ impairment; mental health; and alcohol and substance use. Research should include participants across the lifespan. While most data are collected through normal clinical care or other research protocols, IeDEA also supports a Sentinel Research Network, which samples participants from clinic populations in a more intensive prospective cohort.

Consortia for HIV/AIDS Vaccine Development & Immunology (CHAVDI)

Stuart Z. Shapiro, M.D., Ph.D., DAIDS Vaccine Research Program

The objective of this UM1 initiative is to support a coordinated multidisciplinary effort focused on preclinical HIV vaccine discovery, translational vaccine design and development, clinical vaccine manufacture, and ultimately achieve proof of concept of vaccine induction of broadly neutralizing antibodies (bNAbs) to at least three different bNAb targets, and inclusion of other, cooperative immune responses. The ultimate goal is to develop the underlying science so that pharma can take over the vaccine product development and DAIDS only needs to provide the clinical trials network.

This initiative will support multidisciplinary teams focused on critical questions such as: 1) immune responses that prevent and control HIV/SIV infection; 2) immunogens that induce broadly cross-protective antibodies to HIV-1; and 3) immunogens that otherwise prevent and/or control infection through, for example, enhancement of T cell-based mechanisms of early virus control.

The awards will be for a duration of 5 years. Use of the complex cooperative agreement award will facilitate “big science” approaches, i.e., research that requires close coordination of multiple investigators or groups of investigators. Examples of projects include iterative design and testing in nonhuman primates and GMP manufacture of product for testing in clinical trials of: 1) multi-stage immunogens designed to induce the affinity maturation necessary to make broadly neutralizing antibodies; 2) immunogens designed to induce T cell responses to conserved, immune-subdominant virus epitopes; and 3) vaccines that induce other immune responses that may synergize with neutralizing antibodies to induce protection against HIV transmission and/or control of infection.

Advancing Translation of Long-Acting Strategies for HIV and HIV-Associated Co-Infections (AT LASt)

Marina Protopopova, Ph.D., DAIDS Therapeutics Research Program
Kristen Porter, Ph.D., DAIDS Prevention Sciences Program

The purpose of this new biphasic grant concept is to support preclinical activities for the development of safe and effective long-acting/sustained release (LA/SR) technologies for prevention and treatment of HIV, HIV-associated tuberculosis (TB), hepatitis B and hepatitis C, and to ultimately enable submission of an investigational new drug (IND) application to the U.S. FDA – to facilitate the transition of innovative LA/SR technologies from R&D to IND. LA/SR technologies in the DAIDS portfolio have shown high promise in treatment and prevention of HIV and HIV-associated co-infections. This initiative will invite applicants engaged in the development of LA/SR strategies that have already demonstrated strong rationale, competitive advantage, and effectiveness in appropriate animal disease models at intermittent dosing from either a single administration (injection, topical, oral administration) or continuous dosing regimen (implant, transdermal patch, etc.).

The awards will be for a duration of 5 years. The first phase (2 years) of the milestone-driven award will support research that has demonstrated significant preliminary data but has not advanced to the level of clinical translation; to obtain critical research and preclinical data to further demonstrate the feasibility and competitive advantages of proposed technologies. The second phase (3 years) will support research that is in the final state of preclinical development with potential for IND submission. To facilitate clinical translation, a plan to submit a pre-IND to the FDA will be required.

NIAID Virology Quality Assurance (VQA) Program

Keith W. Crawford, R.Ph., Ph.D., DAIDS Therapeutics Research Program

The objective of the reissue of this longstanding contract, the NIAID VQA Program, is to provide a comprehensive quality assessment program for laboratories performing virologic assays for HIV (e.g., quantitative viral load, qualitative total nucleic acid testing, drug resistance testing) and other viral pathogens in support of NIAID-sponsored multisite clinical studies. Examples of NIAID-sponsored laboratories supported by the VQA Program include the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG), International Maternal Pediatric and Adolescent AIDS Clinical Trials Group (IMPAACT), and the HIV Vaccine Trials Network (HVTN).

The VQA Program contract will support the following key tasks and activities:

• Establish an external quality assurance program to assess the ability of laboratories performing virologic testing for NIAID-sponsored clinical trials to successfully perform the assays.
• Implement standards of performance for new and existing state-of-the-art virologic assays for HIV and HIV-related pathogens.
• Support DAIDS laboratories in validating virologic assays of relevance to DAIDS clinical trials.
• Conduct studies on the evaluation, standardization, and application of new and existing virologic and biostatistical methodologies for HIV and other viral co-infections.
• Prepare and distribute proficiency testing panels to laboratories participating in NIAID-sponsored clinical trials.

The contract award will be for 7 years beginning in September 2026.

Ballot Voting Outcome:
All seven of the concepts presented were unanimously approved by the voting members of the Committee.

Public Comments: None

VII. Adjournment

The meeting of the Council adjourned at 4:10 p.m., on Monday, June 3, 2024.

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

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