Two Research Areas Comprise NIAID’s 2026 Omnibus Contract Solicitation

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NIAID’s Division of Microbiology and Infectious Diseases (DMID) is soliciting proposals as part of the 2026 NIAID Omnibus Broad Agency Announcement (BAA). DMID will use this BAA to advance the research and development of promising candidate therapeutics, vaccines, and diagnostics for biodefense and emerging infectious diseases. 

The 2026 BAA covers two distinct Research Areas: 001 and 002. Applicants may respond to either one or both Research Areas. See descriptions of each below. For each research area and topic, if applicable, make sure to submit separate technical and business proposals designed to meet the objectives described. 

For both research areas:

Performance Period: Not to exceed 5 years (base plus options).

Proposal Submission: Online through the electronic Contract Proposal Submission (eCPS) website.

Research Area 001 – Development of Candidate Therapeutics, Vaccines, and In Vitro Diagnostics for Antimicrobial-Resistant (AMR) Bacterial or Fungal Pathogens

Description: For Research Area 001, there are three separate topics. Offerors may submit a proposal in response to Topics A, B, and/or C:

Topic A: Therapeutics for AMR Bacterial or Fungal Pathogens

The objective of Topic A is to develop new therapeutic products against severe infections and/or drug-resistant strains of the following bacterial and fungal pathogens:

a.        Pseudomonas aeruginosa, and/or Acinetobacter baumannii; OR

b.       Candida auris, Cryptococcus spp., Aspergillus fumigatus, and/or Mucorales

Topic B: Vaccines for AMR Bacterial Pathogens 

The objective of Topic B is to protect human health and well-being by advancing vaccine candidates for the following ESKAPE bacterial pathogens: Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter species.

Topic C: In Vitro Diagnostics for AMR Fungal Pathogens

The objective of Topic C is to develop innovative platform technologies to speed the identification of infection from among a broad panel of fungi and to profile the phenotypic antifungal susceptibility. This emphasis aligns with NIAID’s goal of addressing persistent challenges in adequate clinical management associated with mycological infections and alleviating the burden of antifungal resistance.

Research Area 002 – Development of Direct Acting Antivirals (DAA) for Viral Families of Pandemic Potential

Description: This Research Area aims to develop safe and effective antivirals to combat viruses of pandemic potential, as well as to build sustainable platforms for targeted drug discovery and the development of a robust pipeline of candidates. Proposals submitted as part of this research area must focus on antivirals that:      

  • Directly modify viral target function (not through the modulation of the host responses); AND
  • Act by reducing viral burden in early stages of disease; AND
  • Act against viruses of pandemic potential (i.e., Bunyaviridae, Coronaviridae, Filoviridae, Flaviviridae, Orthopoxviridae, Paramyxoviridae, Picornaviridae, and Togaviridae); AND
  • Are new chemical entities limited to small molecules (e.g., natural products, nucleosides, or peptides of </= 40 amino acids) and nanobody conjugates/fusion products that are directly acting on viral targets and functions (not through the modulation of the host responses); AND
  • Have safety profiles and suitable routes of administration for broad outpatient use.

Number of Awards, Total Cost: NIAID estimates that one or two awards may be issued for Research Area 001 for a total cost of up to $8.5 million for the non-severable base period across all contracts (direct and indirect costs combined). Three to four awards may be issued for Research Area 002 for a total cost of up to $20 million for the non-severable base period across all contracts (direct and indirect costs combined).

Due Dates: for Research Area 001, February 21, 2025, by 3 p.m. Eastern Time; for Research Area 002, January 21, 2025, by 3 p.m. Eastern Time.

Find complete details in the solicitation itself as well as any amendments issued since this article was published. Direct inquiries to Swee L. Teo, Contracting Officer, at teosl@niaid.nih.gov or 240-669-5173. 

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Animal Models Standard Operating Procedures (SOPs) for Fungal Pathogens

Standard operating procedures for small animal models for fungal pathogens that are intended to help researchers establish and use these models and ensure uniform testing.

Vaccine Candidate Active Against Candida and Staphylococcus aureus: NDV-3

Fighting Fungal Pathogens Through Discovery of Novel Therapeutics

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Help NIAID fight invasive fungal infections that remain a clinical challenge by applying to the Discovery and Development of Novel Therapeutics for Select Fungal Pathogens (R21/R33, Clinical Trial Not Allowed) notice of funding opportunity (NOFO). This NOFO seeks milestone-driven, early-stage translational research focused on drug discovery and development of novel therapeutics against select fungal pathogens including Candida species, specifically Candida auris; Aspergillus fumigatus; Coccidioides; and Mucorales. 

Phased Innovation Awards 

Due to the high-risk, high-impact nature of the research, this NOFO will use the R21/R33 Exploratory/Developmental Phased Award activity code. In this biphasic award mechanism, specific milestones during the R21 phase must be successfully completed in order to transition to the R33 phase. 

During the R21 phase, funding will support up to 2 years of milestone-driven research that enables proof-of-concept for novel therapeutic targets and/or candidate therapeutics specific to select fungal pathogens and describes how the therapeutic concept/candidate will be further developed in the R33 phase. During the R33 phase, funding will support an additional 3 years to engage in additional activities as appropriate, such as expanded development of the candidate therapeutics developed during the R21 phase. We expect that candidate therapeutics will be at the preclinical development stage by the end of the R33 phase. Proposed transition milestones will be reviewed and negotiated prior to award.  

Before the end of the R21 phase, recipients will submit the R33 transition package, which includes a detailed progress report describing advancement toward the transition milestones and a description of how the completed work justifies continuation with the originally proposed R33 studies. NIH program staff will evaluate these materials. Awards selected for continued funding will transition to an R33 award without the need to submit a new application. Transition to the R33 is neither automatic nor guaranteed. R33 funding decisions will be based on the original R21/R33 peer review recommendations, successful completion of transition milestones, program priorities, and availability of funds. We expect approximately 50 percent of awards funded in the R21 phase to transition to the R33 phase. For more information, refer to the Phased Award SOP. 

Scope of Research  

This initiative will support research projects focused on discovery and development of novel therapeutics against select fungal pathogens of clinical concern. Examples of potential approaches to be supported include, but are not limited to: 

  • Discovery and validation of novel fungal pathogen-specific or host-specific therapeutic targets using synthetic disease models or animal models. Exploitation of targets common to yeasts, dimorphic fungi, and molds is strongly encouraged. 
  • Identification and/or development of novel compounds that circumvent resistance mechanisms. 
  • Identification and/or development of novel compounds with broad-spectrum activity against select fungal pathogens. 
  • Characterization/down-selection of novel compounds and/or preclinical development of lead candidates. 

Refer to the NOFO for information about review criteria. 

Applications proposing the following will be considered nonresponsive and will not be reviewed:  

  • Projects not targeting at least one of the following priority fungal pathogens: Candida species, specifically Candida auris; Aspergillus fumigatus; Coccidioides; and Mucorales. 
  • Projects proposing to develop vaccine agents or adjuvants. 
  • Projects proposing to conduct investigational new drug-enabling studies. 
  • Projects proposing to conduct Good Manufacturing Practices manufacturing. 
  • Applications without a section with proposed transition milestones. 
  • Projects that propose clinical trials. However, clinical development strategies may be included within an overall project. 

Be sure to review the Specific Aims and Research Strategy sections of the NOFO to appropriately describe the planned research approach, address strategies, and provide proposed milestones. 

Application Budgets 

Application budgets are limited to $275,000 in direct costs over the 2-year R21 project period, with a maximum of $200,000 in direct costs allowed in any single year. For the R33 award phase, application budgets are not expected to exceed $300,000 in direct costs per year and should reflect the actual needs of the project. The maximum project period for an application submitted in response to this NOFO cannot exceed 5 years total. 

Submission Information 

Applications are due by January 28, 2025, at 5 p.m. local time of the applicant organization. Take note, this due date means you will need to use FORMS-I for your application. Likewise, that receipt date means reviewers will use NIH’s new Simplified Peer Review Framework to review your application. 

Direct any scientific/research questions to Dr. Baoying Liu at baoying.liu@nih.gov or 301-627-3697. For questions about peer review, contact Dr. Annie Walker-Abbey at aabbey@niaid.nih.gov or 240-627-3390.

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How Do Fungal Infections Take Hold? Rare Disease Offers New Insights

By studying the rare disease APECED, NIAID researchers and colleagues uncovered an unexpected immune mechanism that promotes susceptibility to fungal infections of the mucous membranes. Their findings suggest potential therapies for people with APECED and pave the way for work to investigate these tissue-specific immune responses in other diseases.

Fungal Disease Awareness Week—Fighting Fungi at NIAID

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A round Coccidioides fungal spherule (colorized yellow) found in a tissue sample (colorized pink). It is round and contains many smaller round dots.

A Coccidioides fungal spherule found in a tissue sample. This organism causes coccidioidomycosis, also known as Valley Fever.

Credit: micrograph by CDC; colorization and visual effects by NIAID

The world of fungi includes a wide range of organisms, such as mushrooms, molds, and yeast, that are common outdoors in water, soil, and air; indoors on surfaces; and on our skin and inside our bodies. Although many fungi are helpful—or even delicious, like some mushrooms—there are many others which can cause disease. Some fungal infections are more common in people with weakened immune systems or hospitalized individuals, while other fungal infections can infect anyone, including otherwise healthy people. According to the Centers for Disease Control and Prevention (CDC), more than one billion people worldwide get a fungal infection each year. There are four main classes of antifungal drugs, and the rising rate of antimicrobial resistance is limiting and complicating existing treatment options. Currently, there are no approved vaccines to prevent fungal infections.

NIAID conducts and supports basic, translational, and clinical research to understand how fungal pathogens cause disease and how the immune system responds to infection. NIAID researchers are exploring how fungal susceptibility and infection impact the function of immune cells. The following are examples of ongoing clinical trials supported by NIAID through the investigator-initiated clinical trial funding mechanism investigating various aspects of fungal disease. 

Stewardship in AMR – Examining a shorter treatment course for children

Immunocompromised patients are at risk for the development of fungal infections. Hospitalized patients can get severe, often deadly, fungal diseases like candidemia, a bloodstream infection caused by the Candida fungus. According to the CDC, candidemia is one of the most common bloodstream infections in the U.S. with an estimated 25,000 cases each year. The current treatment guidelines for invasive candidemia recommend 14 days of antifungal therapy.  This guideline is based on expert opinion rather than comparative data and the optimal treatment duration remains unknown. NIAID-funded researchers Drs. William J. Steinbach and Brian T. Fisher are conducting a clinical trial (NCT05763251) to examine whether a shorter 7-day treatment strategy is just as safe and effective as current practice. This trial is only enrolling pediatric patients at the study-site hospitals with uncomplicated cases of candidemia. A shorter treatment would significantly reduce the burden of care on sick and recovering pediatric patients, allowing families to come home earlier from the hospital, and could help combat the rising rates of antimicrobial resistance. This is the first randomized control trial to explore the efficacy of a shorter course treatment for any invasive fungal disease. The trial is supported through NIAID grant funding R01 AI 170385. 

Cryptococcus neoformans contributing to HIV/AIDS-related mortality 

Cryptococcus neoformans is a fungal pathogen that can cause cryptococcal meningitis. Those most at risk are immunocompromised, such as people/persons living with HIV/AIDS. Although Antiretroviral therapy (ART) has significantly reduced the incidence of HIV/AIDS in the United States, regions of the world with limited access to ART are still seeing tens of thousands of cases. According to the CDC, each year an estimated 152,000 people living with HIV experience cases of cryptococcal meningitis, of which an estimated 112,000 deaths occur, most in sub-Saharan Africa. In the weeks prior to the onset of meningitis, the cryptococcal antigen (CrAg) is detectable in the blood and is a good predictor of meningitis and death. NIAID-funded researcher Dr. Radha Rajasingham is leading a clinical trial (NCT03002012) to examine whether the treatment combination of liposomal amphotericin (AmBisome) and fluconazole for those who receive a positive CrAg antigen test effectively prevents cryptococcal meningitis and death. Dr. Rajasingham’s lab at the University of Minnesota is dedicated to improving cryptococcal meningitis treatment strategies and outcomes for people/persons living with HIV/AIDS and is supported through NIAID grant funding U01 AI 174978 and R01 AI162181. 

Though these conditions can be severe, they are not the only fungal diseases of concern for NIAID. From aspergillosis to Valley Fever, NIAID is committed to researching new treatments, diagnostics, and preventative measures for a wide array of fungal diseases, especially in the face of rising antifungal resistance.

Contact Information

Contact the NIAID Media Team.

301-402-1663
niaidnews@niaid.nih.gov

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Lucas Dos Santos Dias, Ph.D.

Section or Unit Name
Fungal Pathogenesis Section
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NIH Main Campus, Bethesda, MD
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Lucas Dos Santos Dias, Ph.D.
Parent Lab/Program
Laboratory of Clinical Immunology and Microbiology
Program Description

In the Fungal Pathogenesis Section, we use an integrated bench-to-bedside multidisciplinary approach encompassing immunology, mycology, and genetics to investigate protection against and susceptibility to pathogenic fungi. We evaluate large cohorts of patients with inherited or acquired susceptibility to fungal disease and study antifungal immune responses in vitro and in vivo in a variety of clinically relevant mouse models of fungal disease. Thus, we employ various immunological, biological, and imaging approaches to measure biological determinants of disease outcomes in humans and mice. Our research directly informs clinically actionable interventions, including developing targeted preventive and therapeutic interventions in at-risk patients.

Selected Publications

Woodring T, Dewey CN, Santos Dias LD, He X, Dobson HE, Wüthrich M, Klein B. Distinctive populations of CD4+T cells associated with vaccine efficacy. iScience. 2022 Aug 13;25(9):104934.

Kohn EM, Taira C, Dobson H, Dias LDS, Okaa U, Wiesner DL, Wüthrich M, Klein BS. Variation in Host Resistance to Blastomyces dermatitidis: Potential Use of Genetic Reference Panels and Advances in Immunophenotyping of Diverse Mouse Strains. mBio. 2022 Feb 22;13(1):e0340021.

Dos Santos Dias L, Dobson HE, Bakke BK, Kujoth GC, Huang J, Kohn EM, Taira CL, Wang H, Supekar NT, Fites JS, Gates D, Gomez CL, Specht CA, Levitz SM, Azadi P, Li L, Suresh M, Klein BS, Wüthrich M. Structural basis of Blastomyces Endoglucanase-2 adjuvancy in anti-fungal and -viral immunity. PLoS Pathog. 2021 Mar 18;17(3):e1009324.

Dobson HE, Dias LDS, Kohn EM, Fites S, Wiesner DL, Dileepan T, Kujoth GC, Abraham A, Ostroff GR, Klein BS, Wüthrich M. Antigen discovery unveils resident memory and migratory cell roles in antifungal resistance. Mucosal Immunol. 2020 May;13(3):518-529.

Rocke TE, Kingstad-Bakke B, Wüthrich M, Stading B, Abbott RC, Isidoro-Ayza M, Dobson HE, Dos Santos Dias L, Galles K, Lankton JS, Falendysz EA, Lorch JM, Fites JS, Lopera-Madrid J, White JP, Klein B, Osorio JE. Virally-vectored vaccine candidates against white-nose syndrome induce anti-fungal immune response in little brown bats (Myotis lucifugus). Sci Rep. 2019 May 1;9(1):6788.

Holanda RA, Muñoz JE, Dias LS, Silva LBR, Santos JRA, Pagliari S, Vieira ÉLM, Paixão TA, Taborda CP, Santos DA, Bruña-Romero O. Recombinant vaccines of a CD4+ T-cell epitope promote efficient control of Paracoccidioides brasiliensis burden by restraining primary organ infection. PLoS Negl Trop Dis. 2017 Sep 22;11(9):e0005927.

Visit PubMed for a complete publication list.

Major Areas of Research
  • AIRE-dependent mechanisms of antifungal immunity and protection from autoimmunity in mouse models of AIRE deficiency and in APECED patients 
  • Novel mechanism-based strategies to treat fungal disease and autoimmunity in APECED and STAT1 gain-of-function patients
  • Experimental models (mice) for the study of the mechanism of vaccine-induced immunity to Blastomyces and other fungal pathogens (Coccidioides, Candida, Histoplasma)
  • Cellular immunology
  • Fungal immunology

Juan C. Gea-Banacloche, M.D.

Section or Unit Name
Infectious Diseases Consult Service
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Juan C Gea-Banacloche, M.D.
Program Description

Provide direct clinical care to patients requiring management of infectious diseases in the Clinical Center as an attending on the general ID and transplant ID consult service.

Work closely with the transplant ID service to strengthen teaching and develop the educational experience of ID fellows rotating on the service and the transplant ID fellow.

Work closely with the transplant ID service to develop the new NIH transplant ID fellowship.

Provide infectious disease expertise in the management of pre- and post-transplant clinical care.

Provides ID consultation/support to DCR special projects as requested.

Selected Publications

Gea-Banacloche JC. Infectious complications of chimeric antigen receptor (CAR) T-cell therapies. Semin Hematol. 2023 Jan;60(1):52-58.

Gea-Banacloche J, Komanduri KV, Carpenter P, Paczesny S, Sarantopoulos S, Young JA, El Kassar N, Le RQ, Schultz KR, Griffith LM, Savani BN, Wingard JR. National Institutes of Health Hematopoietic Cell Transplantation Late Effects Initiative: The Immune Dysregulation and Pathobiology Working Group Report. Biol Blood Marrow Transplant. 2017 Jun;23(6):870-881.

Gea-Banacloche JC. Rituximab-associated infections. Semin Hematol. 2010 Apr;47(2):187-98.

Gea-Banacloche J, Masur H, Arns da Cunha C, Chiller T, Kirchhoff LV, Shaw P, Tomblyn M, Cordonnier C; Center for International Blood and Marrow Transplant Research; National Marrow Donor Program; European Blood and Marrow Transplant Group; American Society of Blood and Marrow Transplantation; Canadian Blood and Marrow Transplant Group; Infectious Disease Society of America; Society for Healthcare Epidemiology of America; Association of Medical Microbiology and Infectious Diseases Canada; Centers for Disease Control and Prevention. Regionally limited or rare infections: prevention after hematopoietic cell transplantation. Bone Marrow Transplant. 2009 Oct;44(8):489-94.

Dellinger RP, Carlet JM, Masur H, Gerlach H, Calandra T, Cohen J, Gea-Banacloche J, Keh D, Marshall JC, Parker MM, Ramsay G, Zimmerman JL, Vincent JL, Levy MM; Surviving Sepsis Campaign Management Guidelines Committee. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Crit Care Med. 2004 Mar;32(3):858-73.

Gea-Banacloche JC, Clifford Lane H. Immune reconstitution in HIV infection. AIDS. 1999;13 Suppl A:S25-38.

Visit PubMed for a complete publication listing

Major Areas of Research
  • Immune reconstitution after allogeneic Hematopoietic Stem Cell Transplantation
  • Infections in transplant recipients

Seher H. Anjum, M.D.

Section or Unit Name
Translational Mycology Section
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Seher H. Anjum, M.D.
Parent Lab/Program
Laboratory of Clinical Immunology and Microbiology
Program Description

Associate Investigator for Protocol 93-I-0106: Cryptococcosis in Previously Healthy Adults

Background: 

Cryptococcus is a fungus that causes infections most commonly in immunocompromised patients, such as those with AIDS and solid organ transplant recipients and is currently responsible for an estimated 15% of all AIDS-related deaths globally. Within the U.S., approximately 15-20% have no identifiable immune defect and cryptococcal infection in these hosts has a mortality rate of 30-50% despite optimal antifungal therapy.  

The objectives of this protocol can be broadly categorized as: 

  • Characterize the immunologic and genetic mechanisms predisposing to disease acquisition.
  • Understand the post-infectious inflammatory response and distinguish its consequences from those directly due to fungal growth.
  • Management of post-infectious neuro-inflammatory syndromes associated with cryptococcal meningitis 

This protocol recruits patients who have microbiological evidence of cryptococcal neurologic or non-CNS disease (typically pulmonary or bone). Cerebrospinal fluid (CSF) and blood samples collected during clinical care, are used to measure serum and intrathecal cellular and soluble cytokines as well as to perform in-situ immunohistochemistry. Observational data detailing audiological, ophthalmological and neurocognitive deficits in these patients is also recorded. 

We have recently described a post-infectious inflammatory syndrome (PIIRS) associated with cryptococcal meningoencephalitis (CM) which can be best described as a neuro-inflammatory state during which CM patients present with altered mental status (Montreal Cognitive Assessment Score <22/30), auditory deficits and/or vision loss despite having negative CSF fungal cultures after being treated with optimal antifungal therapy. Based on findings in CSF and brain tissue samples, the underlying mechanism behind this phenomenon is related to the intrathecal expansion of both the innate and adaptive immune system, including HLA-DR+ CD4+ and CD8+ lymphocytes and NK cells. In a cohort of 15 previously healthy CM patients, we have been able to demonstrate an improvement in clinical outcomes with pulse corticosteroid therapy for patients with PIIRS and are currently exploring alternative immunomodulatory agents as steroid-sparing therapy for this indication.

Clinical Studies
Selected Publications

Okeagu CU, Anjum SH, Vitale S, Wang J, Singh D, Rosen LB, Magone MT, Fitzgibbon EJ, Williamson PR. Ocular Findings of Cryptococcal Meningitis in Previously Health Adults. J Neuroophthalmol. 2022 Oct 18.

Anjum S, Dean O, Kosa P, Magone MT, King KA, Fitzgibbon E, Kim HJ, Zalewski C, Murphy E, Billioux BJ, Chisholm J, Brewer CC, Krieger C, Elsegeiny W, Scott TL, Wang J, Hunsberger S, Bennett JE, Nath A, Marr KA, Bielekova B, Wendler D, Hammoud DA, Williamson P. Outcomes in Previously Healthy Cryptococcal Meningoencephalitis Patients Treated With Pulse Taper Corticosteroids for Post-infectious Inflammatory Syndrome. Clin Infect Dis. 2021 Nov 2;73(9):e2789-e2798.

Yang DH, England MR, Salvator H, Anjum S, Park YD, Marr KA, Chu LA, Govender NP, Lockhart SR, Desnos-Ollivier M, Chen S, Halliday C, Kan A, Chen J, Wollenberg KR, Zelazny A, Perfect JR, Chang YC, Bennett JE, Holland SM, Meyer W, Williamson PR, Kwon-Chung KJ. Cryptococcus gattii Species Complex as an Opportunistic Pathogen: Underlying Medical Conditions Associated with the Infection. mBio. 2021 Oct 26;12(5):e0270821.

Anjum S, Williamson PR. Clinical Aspects of Immune Damage in Cryptococcosis. Curr Fungal Infect Rep. 2019 Sep;13(3):99-108.

Visit PubMed for a complete publication listing.

Additional Information

Research Networks

CINCH (Cryptococcus Infection Network in non-HIV Cohort)

Training Programs

NIH-Duke Clinical Research Training Program

 

Major Areas of Research
  • Cryptococcal meningitis in previously healthy hosts
  • Post-infectious neuro-inflammatory responses 
  • The use of steroid-sparing, immunomodulatory agents in neuro-inflammation 
     

Seher H. Anjum, M.D.

Specialty(s): Infectious Disease, Internal Medicine
Provides direct clinical care to patients at NIH Clinical Center

Education:

M.D., 2010, Kasturba Medical College, India

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