Clinical trials: Humoral Immunodeficiency
Primary Immune Deficiency
Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency
The purpose of this study is to evaluate the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects with Primary Humoral Immunodeficiency (PHID).
- Trial name
- NCT04565015
- Testing
- GC5107
- Where
- 8 sites in United States, Bosnia and Herzegovina and 1 more
- Volunteers
- 24 people
- Sponsor
- GC Biopharma Corp
HIV Infections
Study of the HIV gp120/NefTat/AS02A Vaccine to Treat Individuals With Chronic HIV-1 Infection on Highly Active Antiretroviral Therapy (HAART)
This study will test the safety and immunogenicity of the gp120/NefTat/AS02A vaccine candidate in individuals with chronic HIV-1 infection successfully treated with HAART.
- Trial name
- NCT00117429
- Testing
- HIV gp120/NefTat/AS02A Vaccine
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Marcus Altfeld, M.D., Ph.D.
HIV
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
There is evidence that early and aggressive treatment with antiretroviral drugs can prevent the loss of immune cell function that accompanies HIV infection.
- Trial name
- NCT00039689
- Where
- United States
- Volunteers
- 750 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Immunologic Deficiency Syndromes, Neoplasms
Studies of the Immune Response in Normal Subjects and Patients With Disorders of the Immune System
The goal of the protocol is to define the normal humoral and cellular immune responses to antigens in volunteers and to define abnormalities of these immune responses in patients with immunodeficiency diseases or cancer.
- Trial name
- NCT00001158
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Cancer Institute (NCI)
Primary Immune Deficiency Disorder
Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)
This is a Phase III, multicenter, open-label study of RI-002 administered as an intravenous infusion of RI-002 (IGIV) every 21 or 28 days in approximately 60 subjects with Primary Immunodeficiency Diseases (PIDD).
- Trial name
- NCT01814800
- Testing
- RI-002
- Where
- 9 sites in United States
- Volunteers
- 59 people
- Sponsor
- ADMA Biologics, Inc.
Humoral Immunodeficiency, Hematopoietic Stem Cell Transplantation
Safety and Feasibility of FMT for Immune Recovery After HSCT
Patients who undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) often experience slow and incomplete recovery of their immune system, particularly the part responsible for producing antibodies (humoral…
- Trial name
- NCT07755319
- Testing
- Fecal microbiota transplantation (FMT)
- Where
- China
- Volunteers
- 86 people
- Sponsor
- The First Affiliated Hospital of Soochow University
Secondary Immune Deficiency
The Effect of Subcutaneous Immunoglobulin Gammanorm on the Distribution of IgG Subclasses and on Immunity of Patients With Secondary Immunodeficiency
Patients with Myeloma or CLL with severe secondary hypogammaglobinemia and recurrent infections will be included in this study; for whom an IgSC treatment was prescribed.
- Trial name
- NCT03369301
- Testing
- Gammanorm, Other Subcutaneous Immunoglobulins
- Where
- 6 sites in France
- Volunteers
- 102 people
- Sponsor
- Octapharma
Influenza, HIV
Effect of HIV and/or Active Tuberculosis on the Immune Responses to Trivalent Influenza Vaccine (TIV) in Adults
Prospective, open-labelled study which will enrol 360 participants in four groups of 80 participants including: HIV-uninfected adults without evidence of TB; HIV-infected adults without any evidence of TB; HIV-uninfected adults…
- Conditions
- Influenza, HIV, Tuberculosis
- Trial name
- TIV_HIV_TB (NCT01811823)
- Testing
- Trivalent Inactivated Influenza Vaccine
- Where
- South Africa
- Volunteers
- 301 people
- Sponsor
- University of Witwatersrand, South Africa
Immune Deficiency
Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency
This study is trying to find out if an undetectable serum immunoglobulin E (IgE) is a biomarker, or early sign of, the development of immune deficiency.
- Trial name
- NCT03968211
- Testing
- Salmonella typhi polysaccharide vaccine
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Immunologic Deficiency Syndromes
Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency
The purpose of this study is to evaluate the safety, efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in subjects with Primary Humoral Immunodeficiency (PHID).
- Trial name
- NCT02783482
- Testing
- GC5107
- Where
- 20 sites in United States, Canada
- Volunteers
- 49 people
- Sponsor
- Green Cross Corporation
Secondary Immune Deficiency
Humoral Immunodeficiency With Rituximab and Therapy With Subcutaneous Ig
To study the use of subcutaneous (injected under the skin) immunoglobulin replacement therapy (replacement of antibodies, which are infection-fighting proteins) in patients with a type of blood cancer called lymphoma, who have…
- Trial name
- NCT03211065
- Testing
- 20% subcutaneous immunoglobulin
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Rochester General Hospital
Healthy
Analysis of the Mechanisms of Protective Humoral Immunity in Response to the Pneumococcal Vaccine
The lack of clear guidelines and studies addressing the proper response to the pneumococcal vaccine (Pneumovax ®) has hampered our ability to diagnosis and care for our immunodeficiency patients.
- Trial name
- NCT00589394
- Testing
- pneumococcal vaccination (Pneumovax)
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
COPD Exacerbation Acute
Prevalence of Humoral Dysfunction in Pts With Frequent Exacerbations of COPD, and the Effect of SCIgR for Prevention
To examine the prevalence of humoral immunodeficiency in patients with Chronic Obstructive Pulmonary disease (COPD) by evaluating both immunoglobulin levels and vaccine responses.
- Trial name
- NCT05764993
- Testing
- CUVITRU - Ig subcutaneous human 20%, Standard Medical Therapy
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Rochester General Hospital
Spinal Cord Trauma
Autoimmunity And Immune Deficiency After Spinal Cord Injury: Association With Rehabilitation Outcomes
The SCIentinel-prolong study systematically analyzes humoral autoantibody responses and thier interaction with post-spinal cord injury (SCI) immune-deficiency and infections as well as their association with the clinical course…
- Trial name
- NCT04211636
- Volunteers
- 81 people
- Sponsor
- Marcel Kopp, MD
Primary Immunodeficiency, Common Variable Immunodeficiency
Bronchiectasis Prevalence in Patients With Primary Humoral Immunodefiency in Champagne-Ardenne Region, France
Primary humoral immunodeficiency (PHID), such as common variable immunodefiency, are the most common symptomatic primary immunodeficiency in adults, in France.
- Conditions
- Primary Immunodeficiency, Common Variable Immunodeficiency, Igg Subclass Deficiency, Selective IgM Deficiency
- Trial name
- PREDDICHA (NCT06355323)
- Testing
- Blood test, chest CT scan
- Where
- France
- Volunteers
- 46 people
- Sponsor
- CHU de Reims
Humoral Primary Immunodeficiencies (PIDs), Secondary Form of Humoral Immunodeficiencies
Study of Populations at Risk of Developing Chronic Hepatitis Linked to Chronic Enteric Virus Infection in Patients With Primary Immunodeficiency and Secondary Humoral Deficiency
Dysimmune and specially hepatic immuno-pathological processes are frequent in patients with PIDs (primary immune deficiencies), particularly but not exclusively in patients with humoral defects.
- Conditions
- Humoral Primary Immunodeficiencies (PIDs), Secondary Form of Humoral Immunodeficiencies, Combined Immunodeficiency (CID), Severe Combined Immunodeficiency (SCID)
- Trial name
- EVAH (NCT06659588)
- Testing
- Plasma, urine and stool collection
- Where
- 3 sites in France
- Volunteers
- 200 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
HIV Infections
A Study of Thymic Humoral Factor (THF Gamma 2) in HIV-Infected Patients
To investigate the safety of thymic humoral factor (THF gamma 2), its effect on HIV load based on at least a 75 percent decrease in HIV quantitative PCR RNA copies/ml, and its persistence when administered in combination with an…
- Trial name
- NCT00002435
- Testing
- Thymic Humoral Factor, Zidovudine
- Where
- 10 sites in United States
- Sponsor
- Pharmacia
Primary Immunodeficiency
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency
The purpose of this study is to demonstrate bioequivalence of IVIG-PEG with Gamunex-C (IVIG-C) at steady-state as determined by comparing total Immunoglobulin G (IgG) area under the concentration-time curve during the defined…
- Trial name
- NCT04561115
- Testing
- Gamunex-C, IVIG-PEG
- Where
- 10 sites in United States
- Volunteers
- 33 people
- Sponsor
- Grifols Therapeutics LLC
Primary Immune Deficiency Disorders (PIDD)
Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)
The purpose of this study is to determine if NABI-IGIV (10%) [Immune Globulin Intravenous (Human), 10%] is safe and effective in preventing serious bacterial infections (SBIs) in the treatment of patients with primary immune…
- Trial name
- NCT00538915
- Testing
- Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%]
- Where
- 17 sites in United States
- Volunteers
- 63 people
- Sponsor
- ADMA Biologics, Inc.
Covid19, Humoral Acquired Immunodeficiency
Antibody Detection of Vaccine-Induced Secretory Effects
The purpose of this research study is to conduct a prospective longitudinal surveillance research study, enrolling approximately 60 lactating mothers who receive the SARS-CoV-2 vaccine, and then following their clinical and…
- Conditions
- Covid19, Humoral Acquired Immunodeficiency, Coronavirus, SARS-CoV Infection
- Trial name
- ADVISE (NCT04895475)
- Testing
- SARS-CoV-2 vaccine
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati