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National Institute of Allergy and Infectious Diseases (NIAID)

Total Trials
13
Recruiting
13
Phases
Phase 2, Phase 1, Phase 2, Phase 1

The National Institute of Allergy and Infectious Diseases (NIAID) is a component of the US National Institutes of Health dedicated to understanding, treating, and preventing infectious, immunologic, and allergic diseases. With an annual budget exceeding $6 billion, NIAID supports the largest network of publicly funded infectious disease clinical trials in the world, spanning HIV, tuberculosis, malaria, emerging viral pathogens, influenza, respiratory viruses, immune-mediated diseases, and now long COVID.

NIAID's clinical trial infrastructure includes the HIV/AIDS Clinical Trials Networks (ACTG, HVTN, IMPAACT, MTN), the Collaborative Antiviral Study Group (CASG), the Asthma and Allergic Diseases Cooperative Research Centers, the Precision Vaccines Program, and the COVID-19 Prevention Network (CoVPN). During the COVID-19 pandemic, NIAID-managed the ACTIV consortium — Accelerating COVID-19 Therapeutic Interventions and Vaccines — that rapidly initiated and coordinated master protocols across dozens of candidate therapeutics and vaccines including remdesivir, baricitinib, and molnupiravir.

Beyond infectious disease, NIAID funds trials in primary immune deficiency disorders, autoimmune conditions including type 1 diabetes, lupus, and IBD, and severe allergic conditions including food allergy (including landmark peanut allergy desensitization trials), eosinophilic esophagitis, and mastocytosis. NIAID-sponsored trials often incorporate biospecimen banking and deep immune phenotyping to advance mechanistic understanding alongside clinical endpoints.

Frequently Asked Questions — National Institute of Allergy and Infectious Diseases (NIAID)

What HIV clinical trials does NIAID sponsor?
NIAID is the world's largest public funder of HIV clinical research. Through the AIDS Clinical Trials Group (ACTG), NIAID supports trials on HIV treatment optimization (simplification regimens, long-acting injectables including cabotegravir and rilpivirine), HIV cure strategies (broadly neutralizing antibodies, latency reversal agents, gene editing approaches), and HIV-associated comorbidities (cardiovascular disease, neurocognitive impairment, kidney disease). The HIV Vaccine Trials Network (HVTN) runs preventive vaccine trials globally. IMPAACT (International Maternal Pediatric Adolescent AIDS Clinical Trials Network) focuses on pregnant women and children with or at risk of HIV. Enrollment sites span the US, sub-Saharan Africa, Latin America, and Asia.
Does NIAID fund trials on allergic diseases and immune conditions?
Yes. NIAID's allergy and immunology program is substantial. The Consortium for Food Allergy Research (CoFAR) has conducted foundational trials on peanut, egg, and milk oral immunotherapy and helped establish the evidence base for FDA-approved peanut allergy treatment (AR101/Palforzia). NIAID also funds trials on atopic dermatitis, eosinophilic gastrointestinal disorders, asthma phenotyping, and primary immune deficiency disorders. The Immune Tolerance Network (ITN) focuses on therapeutic tolerance induction in transplantation, autoimmunity, and allergy — with active trials in type 1 diabetes, lupus nephritis, and multiple sclerosis.
Is NIAID involved in COVID-19 and long COVID research?
NIAID played a central role in COVID-19 clinical trial coordination through the ACTIV consortium, which operated master protocols testing antivirals, immunomodulators, and convalescent plasma across hundreds of sites simultaneously. NIAID funded the ACTT (Adaptive COVID-19 Treatment Trial) series — ACTT-1 through ACTT-4 — which generated pivotal data on remdesivir, baricitinib, and abatacept. For long COVID (post-acute sequelae of SARS-CoV-2, PASC), NIAID manages the RECOVER Initiative with $1.15 billion in funding, supporting a national cohort study and multiple Phase 2 platform trials testing antivirals, anti-inflammatory agents, and pacing protocols for fatigue and cognitive symptoms.

Clinical Trials by National Institute of Allergy and Infectious Diseases (NIAID)

NCT04794829
Recruiting

Natural History of Systemic and Nasal Mucosal Immunity to Influenza and SARS-CoV-2 in Adults After Vaccination

Influenza
NCT06476132 Phase 2
Recruiting

Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients

Lung Transplant
NCT05463133 Phase 1, Phase 2
Recruiting

Allogeneic Hematopoietic Stem Cell Transplantation for Chronic Granulomatous Disease (CGD) With an Alemtuzumab, Busulfan and TBI-based Conditioning Regimen Combined With Cytokine (IL-6, +/- IFN-gamma) Antagonists

Chronic Granulomatous Disease
NCT01222741
Recruiting

Studies of Disorders With Increased Susceptibility to Fungal Infections

Fungal Infections
NCT03949855 Phase 2
Recruiting

Belimumab With Rituximab for Primary Membranous Nephropathy

Membranous Nephropathy
NCT00246857
Recruiting

Screening Protocol for Genetic Diseases of Lymphocyte Homeostasis and Programmed Cell Death

Primary Immune Deficiency
NCT00001184
Recruiting

Immune Regulation in Ulcerative Colitis or Crohn s Disease

Inflammatory Bowel Disease
NCT00001467
Recruiting

Genetic Analysis of Immune Disorders

DOK 8
NCT06096857 Phase 2
Recruiting

Cardamom and Topical Roseomonas in Atopic Dermatitis

Atopic Dermatitis
NCT01375530
Recruiting

Screening Volunteers for Clinical Trials

Screening
NCT01905826
Recruiting

Natural History Study of GATA2 Deficiency and Related Disorders

GATA2 Deficiency
NCT06075745 Phase 2
Recruiting

Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates

Liver Transplant
NCT06796686 Phase 1
Recruiting

Clinical Trial to Evaluate the Safety and Immunogenicity of a Priming Regimen of 426c.Mod.Core-C4b Followed by HxB2.WT.Core-C4b Boosts, Both Adjuvanted With 3M-052 AF + Alum, in Adult Participants Without HIV and in Overall Good Health

HIV
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