SPONSOR

National Institute of Allergy and Infectious Diseases (NIAID)

Total Trials

Recruiting

Phases

Phase 1, Phase 2, Phase 1, Phase 2

Conditions studied: HIV Healthy Volunteers EBV HSV VZV HPV CMV XLA CVID Yao Syndrome

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.

National Institute of Allergy and Infectious Diseases (NIAID)

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

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

A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adult Participants Without HIV-1

Sample Collection From Healthy Volunteers for Assay Optimization

The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise

Immune Regulation in Patients With Common Variable Immunodeficiency and Related Inborn Errors of Immunity (IEI)

Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Challenge Agent and Evaluate Transmission in Mosquito Feeding Assays

Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation

Dasatinib for HIV-1 Reservoir Reduction

Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia

Study of Factors Regulating Mast Cell Proliferation

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

Viral Load in Blood and Lymph Tissues in People Living With HIV

Quadrivalent Influenza HA Stem Vaccine VRC-FLUMOS0122-00-VP (SteMos1) With and Without ALFQ Adjuvant in Healthy Adults

A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults

Natural History of Treated Neurocysticercosis and Long-Term Outcomes

Fecal Microbiota Transplantation for Chronic Granulomatous Disease-Associated Colitis

PET Imaging and Lymph Node Assessment of IRIS in People With AIDS

Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers

Advancing Transplantation Outcomes in Children

Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)

Activation and Function of Eosinophils in Conditions With Blood or Tissue Eosinophilia

NADPH Oxidase Correction in mRNA-transfected Granulocyte-enriched Cells in Chronic Granulomatous Disease (CGD)