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COVID-19 Vaccine Responses in PIDD Subjects

NCT05321407
Conditions
X-linked Agammaglobulinemia, XLA, Primary Immune Deficiency, CVID, Common Variable Immunodeficiency, Primary Antibody Deficiencies, Secondary Hypogammaglobulinemia
Interventions
Not listed
Lead sponsor
Duke University
Other
Eligibility
6 Months and older
Enrollment
100 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2026
U.S. locations
3
States / cities
St. Petersburg, Florida • Chapel Hill, North Carolina • Durham, North Carolina
Conditions
HIV Infections
Interventions
Trimer 4571 vaccine 100mcg with 500mcg alum adjuvant, Placebo control for Trimer 4571 vaccine 100mcg with 500mcg alum adjuvant, Trimer 4571 vaccine 500mcg with 500mcg alum adjuvant, Placebo control for Trimer 4571 vaccine 500mcg with 500mcg alum adjuvant
Biological
Lead sponsor
Madhu Chhanda Choudhary
Other
Eligibility
18 Years and older
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
2
States / cities
Columbus, Ohio • Pittsburgh, Pennsylvania
Conditions
Fanconi Anemia, Severe Aplastic Anemia
Interventions
CAMPATH-1H, Anti-CD45, Fludarabine, Stem cell infusion
Biological · Drug · Procedure
Lead sponsor
Baylor College of Medicine
Other
Eligibility
Not listed
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2009
U.S. locations
2
States / cities
Houston, Texas
Conditions
Colorectal Tumors, Colorectal Neoplasms, Colorectal Carcinoma, Colorectal Adenocarcinoma, Colorectal Cancer
Interventions
Avelumab, Ad-CEA vaccine, Bevacizumab, 5-Fluorouracil (FU), Leucovorin, Oxaliplatin, Capecitabine
Drug · Biological
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2021
U.S. locations
2
States / cities
Washington D.C., District of Columbia • Bethesda, Maryland
Conditions
Bronchogenic Carcinoma, Chronic Granulomatous Disease, Job's Syndrome, Mycobacterium Infection, Wegener's Granulomatosis
Interventions
virtual bronchoscopy
Device
Lead sponsor
National Institutes of Health Clinical Center (CC)
NIH
Eligibility
Not listed
Enrollment
120 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1995 – 2001
U.S. locations
1
States / cities
Bethesda, Maryland
Conditions
Accelerated Phase Chronic Myelogenous Leukemia, Acute Undifferentiated Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Grade III Lymphomatoid Granulomatosis, Adult Nasal Type Extranodal NK/T-cell Lymphoma, Aggressive NK-cell Leukemia, AIDS-related Diffuse Large Cell Lymphoma, AIDS-related Diffuse Mixed Cell Lymphoma, AIDS-related Diffuse Small Cleaved Cell Lymphoma, AIDS-related Immunoblastic Large Cell Lymphoma, AIDS-related Lymphoblastic Lymphoma, AIDS-related Peripheral/Systemic Lymphoma, AIDS-related Primary CNS Lymphoma, AIDS-related Small Noncleaved Cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Blastic Phase Chronic Myelogenous Leukemia, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Burkitt Lymphoma, Childhood Chronic Myelogenous Leukemia, Childhood Diffuse Large Cell Lymphoma, Childhood Grade III Lymphomatoid Granulomatosis, Childhood Immunoblastic Large Cell Lymphoma, Childhood Myelodysplastic Syndromes, Childhood Nasal Type Extranodal NK/T-cell Lymphoma, Chronic Eosinophilic Leukemia, Chronic Myelomonocytic Leukemia, Chronic Neutrophilic Leukemia, Chronic Phase Chronic Myelogenous Leukemia, Contiguous Stage II Adult Burkitt Lymphoma, Contiguous Stage II Adult Diffuse Large Cell Lymphoma, Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma, Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma, Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma, Contiguous Stage II Adult Lymphoblastic Lymphoma, Contiguous Stage II Grade 1 Follicular Lymphoma, Contiguous Stage II Grade 2 Follicular Lymphoma, Contiguous Stage II Grade 3 Follicular Lymphoma, Contiguous Stage II Mantle Cell Lymphoma, Contiguous Stage II Marginal Zone Lymphoma, Contiguous Stage II Small Lymphocytic Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, Essential Thrombocythemia, Extramedullary Plasmacytoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma, HIV Infection, HIV-associated Hodgkin Lymphoma, Intraocular Lymphoma, Isolated Plasmacytoma of Bone, Juvenile Myelomonocytic Leukemia, Mast Cell Leukemia, Meningeal Chronic Myelogenous Leukemia, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Myeloid/NK-cell Acute Leukemia, Nodal Marginal Zone B-cell Lymphoma, Noncontiguous Stage II Adult Burkitt Lymphoma, Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma, Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma, Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma, Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma, Noncontiguous Stage II Adult Lymphoblastic Lymphoma, Noncontiguous Stage II Grade 1 Follicular Lymphoma, Noncontiguous Stage II Grade 2 Follicular Lymphoma, Noncontiguous Stage II Grade 3 Follicular Lymphoma, Noncontiguous Stage II Mantle Cell Lymphoma, Noncontiguous Stage II Marginal Zone Lymphoma, Noncontiguous Stage II Small Lymphocytic Lymphoma, Noncutaneous Extranodal Lymphoma, Peripheral T-cell Lymphoma, Polycythemia Vera, Post-transplant Lymphoproliferative Disorder, Previously Treated Myelodysplastic Syndromes, Primary Central Nervous System Lymphoma, Primary Myelofibrosis, Primary Systemic Amyloidosis, Progressive Hairy Cell Leukemia, Initial Treatment, Prolymphocytic Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, Stage 0 Chronic Lymphocytic Leukemia, Stage I Adult Burkitt Lymphoma, Stage I Adult Diffuse Large Cell Lymphoma, Stage I Adult Diffuse Mixed Cell Lymphoma, Stage I Adult Diffuse Small Cleaved Cell Lymphoma, Stage I Adult Hodgkin Lymphoma, Stage I Adult Immunoblastic Large Cell Lymphoma, Stage I Adult Lymphoblastic Lymphoma, Stage I Adult T-cell Leukemia/Lymphoma, Stage I Childhood Anaplastic Large Cell Lymphoma, Stage I Childhood Hodgkin Lymphoma, Stage I Childhood Large Cell Lymphoma, Stage I Childhood Lymphoblastic Lymphoma, Stage I Childhood Small Noncleaved Cell Lymphoma, Stage I Chronic Lymphocytic Leukemia, Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, Stage I Grade 1 Follicular Lymphoma, Stage I Grade 2 Follicular Lymphoma, Stage I Grade 3 Follicular Lymphoma, Stage I Mantle Cell Lymphoma, Stage I Marginal Zone Lymphoma, Stage I Multiple Myeloma, Stage I Small Lymphocytic Lymphoma, Stage IA Mycosis Fungoides/Sezary Syndrome, Stage IB Mycosis Fungoides/Sezary Syndrome, Stage II Adult Hodgkin Lymphoma, Stage II Adult T-cell Leukemia/Lymphoma, Stage II Childhood Anaplastic Large Cell Lymphoma, Stage II Childhood Hodgkin Lymphoma, Stage II Childhood Large Cell Lymphoma, Stage II Childhood Lymphoblastic Lymphoma, Stage II Childhood Small Noncleaved Cell Lymphoma, Stage II Chronic Lymphocytic Leukemia, Stage II Cutaneous T-cell Non-Hodgkin Lymphoma, Stage II Multiple Myeloma, Stage IIA Mycosis Fungoides/Sezary Syndrome, Stage IIB Mycosis Fungoides/Sezary Syndrome, Stage III Adult Burkitt Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage III Adult Diffuse Mixed Cell Lymphoma, Stage III Adult Diffuse Small Cleaved Cell Lymphoma, Stage III Adult Hodgkin Lymphoma, Stage III Adult Immunoblastic Large Cell Lymphoma, Stage III Adult Lymphoblastic Lymphoma, Stage III Adult T-cell Leukemia/Lymphoma, Stage III Childhood Anaplastic Large Cell Lymphoma, Stage III Childhood Hodgkin Lymphoma, Stage III Childhood Large Cell Lymphoma, Stage III Childhood Lymphoblastic Lymphoma, Stage III Childhood Small Noncleaved Cell Lymphoma, Stage III Chronic Lymphocytic Leukemia, Stage III Cutaneous T-cell Non-Hodgkin Lymphoma, Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Grade 3 Follicular Lymphoma, Stage III Mantle Cell Lymphoma, Stage III Marginal Zone Lymphoma, Stage III Multiple Myeloma, Stage III Small Lymphocytic Lymphoma, Stage IIIA Mycosis Fungoides/Sezary Syndrome, Stage IIIB Mycosis Fungoides/Sezary Syndrome, Stage IV Adult Burkitt Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Stage IV Adult Diffuse Mixed Cell Lymphoma, Stage IV Adult Diffuse Small Cleaved Cell Lymphoma, Stage IV Adult Hodgkin Lymphoma, Stage IV Adult Immunoblastic Large Cell Lymphoma, Stage IV Adult Lymphoblastic Lymphoma, Stage IV Adult T-cell Leukemia/Lymphoma, Stage IV Childhood Anaplastic Large Cell Lymphoma, Stage IV Childhood Hodgkin Lymphoma, Stage IV Childhood Large Cell Lymphoma, Stage IV Childhood Lymphoblastic Lymphoma, Stage IV Childhood Small Noncleaved Cell Lymphoma, Stage IV Chronic Lymphocytic Leukemia, Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Grade 3 Follicular Lymphoma, Stage IV Mantle Cell Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Small Lymphocytic Lymphoma, Stage IVA Mycosis Fungoides/Sezary Syndrome, Stage IVB Mycosis Fungoides/Sezary Syndrome, T-cell Large Granular Lymphocyte Leukemia, Testicular Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific, Waldenström Macroglobulinemia
Interventions
fludarabine phosphate, total-body irradiation, peripheral blood stem cell transplantation, cyclosporine, mycophenolate mofetil, laboratory biomarker analysis
Drug · Radiation · Procedure + 1 more
Lead sponsor
Fred Hutchinson Cancer Center
Other
Eligibility
Up to 75 Years
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 1999
U.S. locations
1
States / cities
Seattle, Washington
Conditions
Autosomal-dominant Hyper-IgE Syndrome
Interventions
NDV-3A
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 55 Years
Enrollment
3 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016 – 2018
U.S. locations
1
States / cities
Bethesda, Maryland
Conditions
Immune Thrombocytopenic Purpura ( ITP ), HIV Infections
Interventions
CD4-IgG
Drug
Lead sponsor
Genentech, Inc.
Industry
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
U.S. locations
1
States / cities
San Francisco, California
Conditions
Cytomegalovirus Retinitis, HIV Infections
Interventions
Sevirumab, Foscarnet sodium, Ganciclovir
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
13 Years and older
Enrollment
167 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Ends 1998
U.S. locations
20
States / cities
Birmingham, Alabama • Los Angeles, California • San Jose, California + 13 more
Conditions
Colon Cancer
Interventions
Ad5-hGCC-PADRE vaccine
Biological
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Other
Eligibility
18 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Conditions
Secondary Immune Deficiency Disorder
Interventions
Hizentra
Drug
Lead sponsor
Rochester General Hospital
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
1
States / cities
Rochester, New York
Conditions
HIV Infections
Interventions
BMS-936559, Placebo for BMS-936559
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 70 Years
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
5
States / cities
Aurora, Colorado • St Louis, Missouri • Chapel Hill, North Carolina + 2 more
Conditions
Advanced Malignant Solid Neoplasm, Anal Carcinoma, HIV Infection, Kaposi Sarcoma, Lung Carcinoma, Metastatic Malignant Solid Neoplasm, Recurrent Classic Hodgkin Lymphoma, Refractory Classic Hodgkin Lymphoma, Unresectable Solid Neoplasm, HIV-associated Cancers
Interventions
Biospecimen Collection, Bone Marrow Biopsy, Computed Tomography, Ipilimumab, Nivolumab, Positron Emission Tomography
Procedure · Biological
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
79 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2024
U.S. locations
32
States / cities
La Jolla, California • Los Angeles, California • Sacramento, California + 19 more
Conditions
Primary Immune Deficiency
Interventions
Newnorm
Biological
Lead sponsor
Octapharma
Industry
Eligibility
2 Years to 75 Years
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
10
States / cities
Irvine, California • Centennial, Colorado • Port Saint Lucie, Florida + 7 more
Recruiting Phase 1 Interventional

IVIG vs SCIG in CIDP

NCT05584631
Conditions
CIDP, Immunoglobulin Deficiency, Chronic Inflammatory Demyelinating Polyneuropathy
Interventions
Intravenous immune globulin G, Subcutaneous immune globulin G
Drug
Lead sponsor
Rutgers, The State University of New Jersey
Other
Eligibility
18 Years to 65 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
1
States / cities
New Brunswick, New Jersey
Conditions
Acquired Hemophilia A
Interventions
OBI-1
Biological
Lead sponsor
Baxalta now part of Shire
Industry
Eligibility
18 Years and older
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2013
U.S. locations
8
States / cities
Indianapolis, Indiana • New Orleans, Louisiana • Bethesda, Maryland + 4 more
Conditions
Ebola Virus Disease, Marburg Virus Disease
Interventions
cAd3-Marburg, cAd3-EBO-S
Biological
Lead sponsor
Albert B. Sabin Vaccine Institute
Other
Eligibility
18 Years to 50 Years
Enrollment
32 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021
U.S. locations
1
States / cities
Oklahoma City, Oklahoma
Conditions
Cryptosporidiosis, HIV Infections
Interventions
Cryptosporidium Immune Whey Protein Concentrate (Bovine)
Drug
Lead sponsor
Stolle Milk Biologic International
Industry
Eligibility
12 Years and older
Healthy volunteers
Healthy volunteers not accepted
U.S. locations
1
States / cities
New York, New York
Conditions
Refractory MSI - H Solid Tumors Prior of PD-(L) 1 Therapy, MSI-H Tumors
Interventions
Nivolumab, Relatlimab
Drug
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Other
Eligibility
18 Years and older
Enrollment
38 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2026
U.S. locations
2
States / cities
Los Angeles, California • Baltimore, Maryland
Conditions
Primary Immune Deficiency Disorders (PIDD)
Interventions
Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%]
Biological
Lead sponsor
ADMA Biologics, Inc.
Industry
Eligibility
6 Years to 75 Years
Enrollment
63 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2009
U.S. locations
17
States / cities
Birmingham, Alabama • Phoenix, Arizona • Los Angeles, California + 13 more
Conditions
HIV Infections, Hepatitis B, Measles, Pneumococcal Infections, Pertussis
Interventions
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed, Measles-Mumps-Rubella Vaccine (Live), Pneumococcal Vaccine, Polyvalent (23-valent), Pneumococcal Conjugate Vaccine, Heptavalent, Hepatitis B Vaccine (Recombinant)
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
2 Years to 18 Years
Enrollment
300 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Ends 2004
U.S. locations
38
States / cities
Birmingham, Alabama • Long Beach, California • Los Angeles, California + 26 more
Conditions
Obesity, Immune Deficiency
Interventions
Institutional standard intravenous immune globulin treatment
Drug
Lead sponsor
Rutgers, The State University of New Jersey
Other
Eligibility
18 Years to 75 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
1
States / cities
Somerville, New Jersey
Conditions
HIV Infections
Interventions
TNX-355
Drug
Lead sponsor
Tanox
Industry
Eligibility
18 Years and older
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2004
U.S. locations
13
States / cities
Phoenix, Arizona • Los Angeles, California • Washington D.C., District of Columbia + 8 more
Conditions
Primary Immunodeficiency Diseases (PID)
Interventions
SC treatment with IGSC, 10% with rHuPH20 followed by SC/IGSC, 10% only (safety), SC treatment with IGSC, 10% with rHuPH20 followed by IV/IGSC, 10% only (safety), IV treatment with IGSC, 10%
Biological
Lead sponsor
Baxalta now part of Shire
Industry
Eligibility
2 Years and older
Enrollment
66 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2013
U.S. locations
11
States / cities
Cypress, California • Irvine, California • Los Angeles, California + 8 more