National Institute of Allergy and Infectious Diseases (NIAID)s

National Institute of Allergy and Infectious Diseases (NIAID)

179 Protocols (130 Active Accrual of new subjects, 49 Follow-up of previously enrolled subjects)


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

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

* 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

* 001965-I:
VRC 617: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate Safety and Pharmacokinetics of a Human Bispecific Antibody, VRC-HIVMAB0121-00-AB (CAP256J3LS) Administered Intravenously or Subcutaneously to Healthy Adults

* 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

* 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

* 001722-I:
An Open-label, Single Arm Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Leniolisib in Pediatric Patients (Aged 1 to 6 Years) with APDS (Activated Phosphoinositide 3-Kinase Delta Syndrome) Followed by an Open-label Long-term Ext

* 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

* 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

* 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

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

* 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

* 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

* 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

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

* 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-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

Next 79 Protocols

12/21/2024