National Institute of Allergy and Infectious Diseases (NIAID)s

National Institute of Allergy and Infectious Diseases (NIAID)

176 Protocols (127 Active Accrual of new subjects, 49 Follow-up of previously enrolled subjects)


Active Accrual, Protocols Recruiting New Patients 
* 001899-I:
Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study

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

* 001631-I:
An Exploratory Study of The Effect of Bismuth Subsalicylate on The Gut Microbiome and Host Response in Healthy Adults

* 001614-I:
VRC 326 (001614): A Phase I Open-Label Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Mosaic Hexavalent Influenza Vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) in Healthy Adults

* 001573-I:
An Open-Label, Single Arm Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Leniolisib in Pediatric Patients (Aged 4 to 11 Years) With APDS (Activated Phosphoinositide 3-Kinase Delta Syndrome) Followed by an Open-Label Long-Term Ex

* 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

* 001509-I:
A Multicenter, Adaptive, Randomized, Controlled Trial Platform To Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections

* 001501-I:
Phase 1 Dose Escalation Study of The Plasmodium Vivax Transmission-Blocking Vaccine Pvs230D1-EPA/Matrix-M to Assess Safety, Immunogenicity, and Transmission-Blocking Activity in Healthy Malaria-Naive Adults

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

* 001124-I:
Expanded Access IND Protocol: Use of Tecovirimat (TPOXX (R)) for Treatment of Human Non-Variola Orthopoxvirus Infections in Adults and Children

* 001102-I:
A Phase 2 Randomized, Open-Label, Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox

* 001078-I:
Phase 1 Trial to Model Primary, Secondary, and Tertiary Dengue Using a Monovalent Vaccine

* 001048-I:
A Phase 1/2 Randomized, Double-Blinded, Placebo-Controlled Trial Evaluating the Immunogenicity and Safety of an Adjuvanted Epstein-Barr Virus (EBV) Glycoprotein 350 Vaccine in EBV-Seronegative Persons

* 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

* 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 following Shingrix Vaccination and Healthy Volunteers (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

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

* 000781-I:
A Phase III, Adjudicator-Blinded, Randomised Study to Evaluate the Efficacy and Safety of Treatment with Olorofim Versus Treatment with AmBisome(R) Followed by Standard of Care (SOC) in Patients with Invasive Fungal Disease (IFD) Caused by Aspergillus Sp

* 000707-I:
Respiratory Virus Sampling and Repository

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

* 000609-I:
Pilot Study to Assess the Use of JSP191 in Matched Unrelated Donor Transplantation for Chronic Granulomatous Disease (CGD)

* 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

* 000236-I:
A Phase 1 Study of Empagliflozin as Treatment for Severe Congenital Neutropenia Due to G6PC3 Deficiency

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

* 000186-I:
Part B- Phase I/II, Non-randomized, Multicenter, 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-0008:
A Single Arm Open Label Phase 2 Trial of Anti-CD4 Antibody UB-421 in Combination with Optimized Background Antiretroviral Therapy in Patients with Multi-Drug Resistant HIV-1 Infection

* 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)

* 21-I-0003:
A Phase 1/2 Study to Evaluate the Safety, Tolerability and Efficacy, of JSP191 for Hematopoietic Cell Transplantation Conditioning to Achieve Engraftment and Immune Reconstitution in Subjects with SCID

* 20-I-0160:
Dose-Escalation Study of a Low Pathogenicity Avian H10N7 Influenza Virus in a Healthy Human Challenge Model

* 20-I-0132:
A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 24-week Phase 3 Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients with Hypereosinophilic Syndrome (HES)

* 20-I-0123:
A Longitudinal Study of COVID-19 Sequelae and Immunity

* 20-I-0111:
COVID-19-associated Lymphopenia Pathogenesis Study in Blood

* 20-I-0084:
Sample Collection for Systems Evaluation of Patients with Unknown or Incompletely Characterized Immune Defects

* 20-I-0037:
Matched Related and Unrelated Donor Stem Cell Transplantation for Severe Combined Immune Deficiency (SCID): Busulfan-based Conditioning with h-ATG, Radiation, and Sirolimus

* 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-0108:
Elemental Diet for Treatment of Inflammatory Bowel Disease in Patients with Chronic Granulomatous Disease

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

* 19-I-0080:
Haploidentical Transplant for Patients with Chronic Granulomatous Disease (CGD) using Alemtuzumab, Busulfan and TBI with Post-Transplant Cyclophosphamide

* 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-0092:
A Phase 2, Open-Label Study to Assess the Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in Patients with Idiopathic CD4 T cell Lymphocytopenia

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

* 18-I-0022:
Use of Ustekinumab (Anti-IL-12/23p40 Monoclonal Antibody) in Patients with Leukocyte Adhesion Deficiency Type 1 (LAD1) who have Inflammatory Pathology

* 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-0078:
Microbial, Immune, and Metabolic Perturbations by Antibiotics (MIME study)

* 16-I-0065:
Screening for Alpha Globin Deletions

* 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

* 15-I-0056:
Collection of Plasma from Subjects that Recovered From or Were Vaccinated To Emerging Infectious Diseases

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

* 14-I-0194:
Screening of Volunteers for Clinical Trials of Investigational or Licensed Vaccines or Antiviral Products

* 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-0232:
FLU 003 Plus: An International Observational Study to Characterize Adults Who Are Hospitalized with Influenza or Other Targeted Respiratory Viruses

* 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

* 09-I-0013:
Biomarkers of Inflammation, Coagulation, and Endothelial Function in HIV-Infected Adults

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

* 08-I-0184:
Studies in the Pathogenesis of Anaphylaxis

* 07-I-0183:
The Collection of Research Samples and/or Data for Repository from Related or Unrelated Hematopoietic Stem Cell Transplantation Recipients for the National Marrow Donor Program

* 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

Next 76 Protocols

03/29/2024