Assessment of Immunogenicity of Zostavax® in Patients With Antibody Deficiency 60 Years of Age and...
Common Variable Immune DeficiencySpecific Antibody Deficiency1 moreRecommendations concerning the administration of Zostavax® in patients with antibody deficiency are unclear. The investigators plan to assess the immunogenicity and safety of Zostavax® in patients with antibody deficiency as compared with healthy volunteers.
Specific IgG Antibody in Patients With Primary Antibody Deficiencies Treated With Subcutaneous Immunoglobulin...
Common Variable ImmunodeficiencyAgammaglobulinemiaObjective: Measure serum IgG antibody to Streptococcus pneumoniae serotypes 1, 3, 5, 6B, 9V e 14, Haemophilus influenzae type b and tetanus toxoid in patients with primary antibody deficiencies who were treated with subcutaneous immunoglobulin infusions.
Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10...
Primary Immune Deficiency DisordersCommon Variable Immunodeficiency2 moreThe primary objective is to demonstrate the bioequivalence of Gammaplex® 10 intravenous immunoglobulin (IGIV) and Gammaplex® 5% IGIV with respect to area under the curve within a 28-day dosing interval (AUC0-28) in a cohort of adult subjects. The secondary objectives are to demonstrate the bioequivalence of Gammaplex® 10 IGIV and Gammaplex® 5% IGIV with respect to area under the curve within a 21-day dosing interval (AUC0-21) in adult subjects; to assess the pharmacokinetics of Gammaplex 10 IGIV and Gammaplex 5% IGIV including Immunoglobulin G (IgG) trough levels and to investigate the safety and tolerability of Gammaplex 10 IGIV and Gammaplex 5% IGIV in adults subjects; to assess the pharmacokinetics of Gammaplex 10 IGIV including IgG trough levels and to investigate the safety and tolerability of Gammaplex 10 IGIV in pediatric subjects.
Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies...
AgammaglobulinemiaIgG Deficiency1 moreThe purpose of this study is to demonstrate the effect of IVIG-F10 on the prevention of serious bacterial infections in patients with primary immunodeficiency. As secondary endpoints the rate of overall infections, the tolerability and safety of IVIG-F10 are studied.
Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies...
AgammaglobulinemiaIgG Deficiency1 moreThe purpose of this study is to demonstrate the effect of IgPro10 on the prevention of serious bacterial infections in patients with primary immunodeficiency. As secondary endpoints the rate of overall infections, the tolerability and safety of IgPro10 are studied. A part of the patients are participating in a pharmacokinetic substudy.
A Study to Find Out How Safe and Effective Gammaplex® is in Young People With Primary Immunodeficiency...
Primary Immune Deficiency DisordersCommon Variable Immunodeficiency3 moreThe main objective is to determine the efficacy of Gammaplex by measuring the number of serious acute bacterial infections during treatment with Gammaplex over a 12 month period. The secondary objectives are to assess the safety and tolerability of Gammaplex and to compare the data collected from adult subjects with PID from the GMX01 study
Intravenous Immunoglobulin (IVIG) in Lung Transplantation
HypogammaglobulinemiaLung TransplantationThe purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent bacterial infections in lung transplant patients with low serum levels of immunoglobulin.
Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases
Primary Immune Deficiency DisordersCommon Variable Immunodeficiency2 moreThe main objective of the study is to determine the pharmacokinetics profile of Subgam-VF. The secondary objectives are to assess the safety of Subgam-VF and refine the dose adjustment coefficient for Subgam-VF needed for subjects switching from prior intravenous immunoglobulin (IGIV) therapy.
Clinical and Virological Efficacy of Pegylated Interferon Alpha in the Treatment of Rhinovirus Infection...
Rhinovirus InfectionThe study will investigate the efficacy and safety of subcutaneous interferon alpha -2a to eradicate rhinovirus in patients with primary hypogammaglobulinemia. Patients with hypogammaglobulinemia have persistent rhinovirus infections. Rhinovirus may worsen pulmonary complications. Pegylated interferon alpha with ribavirin appear to effectively clear persistent rhinovirus infections in hypogammaglobulinemia patients. Patients with primary hypogammaglobulinemia and confirmed respiratory rhinovirus infection will be randomly assigned in a double-blind fashion to receive either Group 1: subcutaneous pIFNα2a Group 2: subcutaneous placebo Subjects will have scheduled study visits at 1-week and at 2-month after entry to study. In addition, possible bacterial infections will be treated with antibiotics. Each patient will be followed with weekly nasal surveillance samples for 2 months and a symptom diary. Blood draws take place at study entry, 1-week and 2-month time-points.
Cytomegalovirus Hyperimmune Globulin (CMV-Ig) Replacement in Hypogammaglobulinemic Lung Transplant...
HypogammaglobulinemiaThis is a randomized controlled trial of CMV-Ig in lung transplant recipients at the Cleveland Clinic Foundation who are hypogammaglobulinemic.