National Institute of Allergy and Infectious Diseases (NIAID)s

National Institute of Allergy and Infectious Diseases (NIAID)

184 Protocols (126 Active Accrual of new subjects, 58 Follow-up of previously enrolled subjects)


Active Accrual, Protocols Recruiting New Patients 
* 002486-I:
A Study to Assess Safety and Tolerability, and Explore Efficacy of Leniolisib for Immune Dysregulation in Common Variable Immunodeficiency

* 002480-I:
A Phase 2 Randomized Stepped Wedge Study of Emapalumab in APECED Enteritis

* 002425-I:
VRC 329: A Phase I Open-Label, Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Quadrivalent Influenza HA Stem Vaccine VRC-FLUMOS0122-00-VP (STEMos1) with and without ALFQ Adjuvant in Healthy Adults

* 002385-I:
Base Editing Hematopoietic Stem Cell and BE T Cell Gene Therapy for CD40L-HyperIgM Syndrome-Single Patient Study

* 002313-I:
Use of the Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans with Dysphagia in Mali and the United States

* 002305-I:
An Intermediate Patient Population Expanded Access Protocol for MBP091 for Patients with Marburg Virus Disease (MVD)

* 002302-I:
A Pilot Prospective Study of the Esophageal String Test (EST) for the Diagnosis of Helicobacter Pylori

* 002295-I:
A Study to Evaluate Immunologic and Virologic Parameters During Analytical Treatment Interruption Following Combination bNAb Therapy During Suppressive ART

* 002293-I:
VRC 328: A Phase I Open-Label Clinical Trial to Evaluate the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) with and without ALFQ Adjuvant in Healthy Adults

* 002288-I:
Phase 1 Study of the Safety of an Epstein-Barr Virus (EBV) gH/gL/gp42-Ferritin Nanoparticle Vaccine With or Without gp350-Ferritin in Healthy Adults With or Without EBV Infection

* 002273-I:
Phase 1/2 Base-Edited Hematopoietic Stem/Progenitor Cell X-Linked Severe Combined Immunodeficiency Gene Therapy

* 002223-I:
An Open-Label, Single-Arm Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Leniolisib for Immune Dysregulation in Primary Immunodeficiency Disorders

* 002211-I:
Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People with HIV Receiving Antiretroviral Therapy

* 002206-I:
Intermediate Expanded Access Program for NT-I7 (efineptakin alfa) in Patients With Autosomal Recessive Genetic Deficiency of Interleukin-7

* 002176-I:
A Pilot Study to Evaluate the Safety and Tolerability of Baricitinib in Patients with Job s Syndrome with Lupus-like Disease and/or Atopic Dermatitis

* 002062-I:
Modeling Host-Pathogen Interaction Using Lymphoid Organoids

* 001979-I:
A Pilot Phase 2 Study of the Safety and Efficacy of Dupilumab as Add-on Therapy for Hypereosinophilic Syndrome with Partial Clinical Response to Eosinophil-Depleting Biologic Agents

* 001976-I:
A Study to Assess Safety and Tolerability, and Explore Efficacy of Leniolisib for Immune Dysregulation in Primary Immunodeficiency Disorders

* 001970-I:
Phase 1 Study of 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

* 001957-I:
Intermediate Patient Population Expanded Access Protocol for MBP134 for Patients with Sudan Virus Disease (SVD)

* 001928-I:
A Biorepository of Multiple Allergic Diseases (MADREP) With Longitudinal Follow-up

* 001899-I:
Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study

* 001867-I:
A Phase 1 Study of Repeat PET/CT Imaging in People with CAPS and Anakinra-Induced Amyloidosis Using Amyloid-Reactive Peptide 124I-AT-01 (124I-p5+14, Iodine-124I-Evuzamitide) to Measure Changes in Organ-Specific Amyloid Load

* 001854-I:
An Open-Label Study of Zemaira (Alpha 1-Trypsin Inhibitor) in Subjects with Eosinophilic Esophagitis

* 001824-I:
A Phase 2a Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients

* 001716-I:
Analysis of Autoinflammation in Chronic Granulomatous Disease Patients Undergoing Hematopoietic Cell Transplant or Gene Therapy RDCRN - PIDTC 6908

* 001706-I:
A Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naive Adults

* 001677-I:
A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Trial of Cardamom and Topical Roseomonas in Atopic Dermatitis

* 001658-I:
Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts

* 001580-I:
Phase 1/2 Trial of Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-linked Chronic Granulomatous Disease

* 001562-I:
A Phase I/II, Non-Randomized, Open-Label Study of pCCLCHIM-p47 (Lentiviral Vector Transduced CD34+ Cells) in Patients with p47 Autosomal Recessive Chronic Granulomatous Disease (AR-CGD)

* 001511-I:
Detection and Characterization of Neurologic Manifestations of Inborn and Acquired Errors of Immunity

* 001146-I:
A Repository to Study Host-Microbiome Interactions in Health and Disease

* 001043-I:
Evaluating the Genetics and Immunology of Periodic Fever, Aphthous Stomatitis, Pharyngitis, and Cervical Adenitis (PFAPA) Syndrome and Other Tonsil Disorders

* 001037-I:
A Randomized Placebo-controlled Study to Evaluate the Safety and Effects of Repeated Doses of 3BNC117-LS and 10-1074-LS on Persistent Viral Reservoirs in People Living with HIV and on Suppressive Antiretroviral Therapy

* 000977-I:
Phase I/II Study using Allogeneic Hematopoietic Stem Cell Transplantation for Chronic Granulomatous Disease with an Alemtuzumab, Busulfan and TBI-based Conditioning Regimen Combined with Cytokine (IL-6, +/- IFN-gamma) Antagonists

* 000906-I:
A Phase 2 Randomized Cross-Over Design Study of the Early Metabolic Effects of Dolutegravir or Tenofovir Alafenamide in Healthy Volunteers

* 000866-I:
Phase 1/2 Open-label Trial of Safety and Zoster Immunogenicity Evaluation for people with HIV with CD4 counts Under and Above 300 and Healthy Volunteers following Shingrix Vaccination (ZEUS)

* 000861-I:
A Phase 2 Open-Label Study to Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients with Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata

* 000821-I:
An Open-Label, Single-Arm, Phase 1/2 Dose-Escalation Trial of Long-Acting Recombinant Human IL-7 (NT-I7, Efineptakin-Alpha) for Idiopathic CD4 Lymphopenia

* 000809-I:
A Pilot Study of Fecal Microbiota Transplantation for Chronic Granulomatous Disease-Associated Colitis

* 000707-I:
Respiratory Virus Sampling and Repository

* 000688-I:
Longitudinal Observations of Vaccine Responses to SARS-CoV-2 and other Emerging Infectious Diseases

* 000392-I:
Metabolic Profiling of Immune Responses in Immune-Mediated Diseases

* 000331-I:
Investigating the Human Immune Response to Ixodes scapularis Tick Bites

* 000291-I:
Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

* 000281-I:
Pilot Assessment To Find Evidence of Gastric Motility Abnormalities in Eosinophilic Gastric Disorders

* 000256-I:
Natural History of Systemic and Nasal Mucosal Immunity to Influenza and SARS-CoV-2 in Adults after Vaccination

* 000226-I:
Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy

* 000201-I:
Pediatric SARS-CoV-2 and MIS-C Long-term Follow-up

* 000186-I:
Part B- Phase I/II, Non-Randomized, Single site study, Open-label Study of G1XCGD (Lentiviral Vector Transduced CD34+ Cells) in Patients with X-Linked Chronic Granulomatous Disease

* 000064-I:
A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of Tofacitinib for Chronic Granulomatous Disease with Inflammatory Complications

* 22-I-0001:
NADPH Oxidase Correction in mRNA transfected Granulocyte-enriched Cells in Chronic Granulomatous Disease (CGD)

* 21-I-0029:
Natural History, Epidemiology and Pathogenesis of Severe HPV-Related Diseases (Neptune)

* 19-I-0140:
A Phase 1 Evaluation of the Safety of Belimumab in People with Idiopathic CD4 Lymphopenia and Autoantibodies (Phoebe)

* 19-I-0133:
Paradoxical Tuberculosis Reactions in Patients without HIV Infection

* 19-I-0093:
Collection of Human Biospecimens for Basic and Clinical Research into Globin Variants

* 19-I-0069:
Phase I Open-Label Study of Safety and Immunogenicity of AD4-HIV Envelope Vaccine Vectors in Healthy Volunteers

* 19-I-0053:
Prospective Study to Identify Food-Specific and Component IgE Threshold Levels that Predict Food Allergy in Patients with Elevated Total Serum IgE Levels and Atopic Dermatitis

* 19-I-0022:
A Prospective, Multicenter Study to Compare and Validate Endoscopic, Histologic, Molecular, and Patient-Reported Outcomes in Pediatric and Adult Patients with Eosinophilic Esophagitis (EoE), Gastritis (EoG), Enteritis (EoN) and Colitis (EoC)

* 18-I-0128:
Send-In Sample Collection to Achieve Genetic and Immunologic Characterization of Primary Immunodeficiencies

* 18-I-0101:
Sample Collection From Healthy Volunteers for Assay Optimization

* 18-I-0041:
Investigating the Mechanistic Biology of Primary Immunodeficiency Disorders

* 17-I-0122:
NIAID Centralized Sequencing Protocol

* 17-I-0101:
An Open-Label, Proof of Concept Study of Vorinostat for the Treatment of Moderate-to-Severe Crohn's Disease and Maintenance Therapy with Ustekinumab

* 17-I-0083:
Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)

* 17-I-0016:
Studies of the Natural History, Pathogenesis, and Outcome of Autoinflammatory Diseases (NOMID/CAPS, DIRA, CANDLE, SAVI, NLRC4-MAS, Still's-like Diseases, and Other Undifferentiated Autoinflammatory Diseases)

* 16-I-0039:
Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge

* 15-I-0162:
Natural History and Genetics of Food Allergy and Related Conditions

* 15-I-0154:
Long-Term Observation of Hemagglutinin and Neuraminidase Inhibition Antibody Titers After Influenza Challenge

* 14-I-0206:
Novel Genetic Disorders of the Immune System

* 14-I-0146:
The Pathogenesis and Genetics of Disseminated or Refractory Coccidioidomycosis

* 14-I-0124:
PET Imaging and Lymph Node Assessment of IRIS in Persons With AIDS

* 14-I-0020:
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models

* 13-I-0157:
The Natural History of GATA2 Deficiency and Related Disorders

* 11-I-0187:
The Natural History and Pathogenesis of Human Fungal Infections

* 11-I-0183:
Screening for LID Clinical Studies Unit Healthy Volunteer Protocols

* 11-I-0164:
VRC 500: Screening Volunteers for Clinical Trials of Investigational Products and Licensed Products Evaluated for Research Purposes

* 11-I-0109:
Viral Infections in Healthy and Immunocompromised Hosts

* 11-I-0007:
Lentiviral Gene Transfer for Treatment of Children Older Than 2 Years of Age with X-Linked Severe Combined Immunodeficiency

* 10-I-0216:
Studies of Disorders with Increased Susceptibility to Fungal Infections

* 10-I-0197:
Admission and Management of Occupational or Other Exposures to Biodefense/Bioterrorism Agents or to Epidemic/Emerging Infectious Diseases

* 10-I-0195:
Natural History of Tuberculosis

* 10-I-0109:
VRC 900: Evaluation of Tissue-Specific Immune Responses in Adults 18 Years of Age and Older

* 10-I-0014:
The Natural History of Severe Viral Infections and Characterization of Immune Defects

* 09-I-0200:
A Phase I Study of MozobilTM in the Treatment of Patients with WHIMS

* 09-I-0133:
Establishing Fibroblast-derived Cell Lines from Skin/Tissue Biopsies of Patients with Immunodeficiency or Immunodysregulation Disorders

* 09-I-0102:
Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia

* 09-I-0032:
Comprehensive Multimodal Analysis of Patients with Neuroimmunological Diseases of the CNS

* 09-I-0030:
Clinical and Immunologic Monitoring of Patients with Known or Suspected HIV Infection

* 08-I-0221:
Analysis of HIV-1 Replication During Antiretroviral Therapy

* 07-I-0033:
Screening Protocol for Detection and Characterization of Infections and Infection Susceptibility

* 06-I-0015:
Screening Protocol for Genetic Diseases of Lymphocyte Homeostasis and Programmed Cell Death

* 05-I-0213:
Screening and Baseline Assessment of Patients with Abnormalities of Immune Function

* 04-I-0286:
A Longitudinal Study of Familial Hypereosinophilia (FE): Natural History and Markers of Disease Progression

* 04-I-0266:
Collection of Data and Samples from Healthy Donors for Use in Translational Research

* 03-I-0263:
VRC 200: A Multicenter Specimen Collection Protocol to Obtain Human Biological Samples for Research Studies

* 02-I-0286:
Efficacy of Tyrosine Kinase Inhibition in Reducing Eosinophilia in Patients with Myeloid and/or Steroid-Refractory Hypereosinophilic Syndrome

* 02-I-0277:
Regulation of the Proliferation and Survival of Normal and Neoplastic Human Mast Cells

* 02-I-0202:
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants

Next 84 Protocols

12/13/2025