National Institute of Allergy and Infectious Diseases (NIAID)s

National Institute of Allergy and Infectious Diseases (NIAID)

178 Protocols (132 Active Accrual of new subjects, 46 Follow-up of previously enrolled subjects)

 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)

 001922-I:

Expanded Access Protocol: TFF-VE-001: Use of Voriconazole Inhalation Powder for the Treatment of Pulmonary Aspergillosis

 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

 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

 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

 001078-I:

Phase 1 Trial to Model Primary, Secondary, and Tertiary Dengue Using a Monovalent Vaccine

 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-0084:

Skin Immunity Sample Collection Involving Blisters and Biopsies

 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

 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

 08-I-0184:

Studies in the Pathogenesis of Anaphylaxis

 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

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