Published Studies Related to Vivaglobin (Immune Globulin Subcutaneous Human)
Treatment of diffuse systemic sclerosis with hyperimmune caprine serum (AIMSPRO):
a phase II double-blind placebo-controlled trial. 
biomarkers... CONCLUSIONS: These results confirm tolerability and safety of this novel
Increasing the time of exposure to aerosol measles vaccine elicits an immune response equivalent to that seen in 9-month-old Mexican children given the same dose subcutaneously. [2011.08.01]
BACKGROUND: A 30-second aerosol measles vaccination successfully primes children 12 months of age and older but is poorly immunogenic when given to 9-month-old children. We examined the immune responses when increasing the duration to aerosol exposure in 9-month-olds... CONCLUSIONS: Increasing exposure time to aerosol measles vaccine elicits immune responses that are comparable to those seen when an equivalent dose is administered by the subcutaneous route in 9-month-old infants.
Effects of ustekinumab administration on primate/human antigen-recall and humoral immune response functions. [2010.06]
BACKGROUND: Ustekinumab, a fully human immunoglobulin (Ig) G1K monoclonal antibody directed against the p40 subunit of interleukin (IL)-12/23, has demonstrated efficacy in patients with moderate-to-severe psoriasis. OBJECTIVE: To evaluate the effect of IL-12/23 inhibition on immunocompetency by antigen-recall response in a preclinical multiple-dose toxicology study and three single-dose, phase 1 studies... CONCLUSION: Results in nonhuman primates and human patients suggest that ustekinumab treatment does not significantly impair recall humoral immune system functions.
GAD65 vaccination: 5 years of follow-up in a randomised dose-escalating study in adult-onset autoimmune diabetes. [2009.07]
AIMS/HYPOTHESIS: The aim of this study was to ascertain whether treatment of GAD65 autoantibody (GADA)-positive diabetic patients with alum-formulated recombinant GAD65 (GAD-alum) is safe and does not compromise beta cell function... INTERPRETATION: The primary outcome of safety was achieved, since no severe study-related adverse events occurred. TRIAL REGISTRATION: Because the study was initiated before 1 July 2005, the protocol was not registered in a registry.
Effect of therapeutic integrin (CD11a) blockade with efalizumab on immune responses to model antigens in humans: results of a randomized, single blind study. [2008.11]
Efalizumab is a humanized monoclonal CD11a antibody approved for treatment of psoriasis. Its immunomodulatory effects led us study how immune responses are modified and the possible consequences for vaccinations in clinical practice... These results expand our knowledge of how immune responses are modulated in humans by CD11a blockade and have implications for vaccinations of patients treated with this agent.
Clinical Trials Related to Vivaglobin (Immune Globulin Subcutaneous Human)
Evaluation of Efficacy and Tolerability of Hizentra� [Recruiting]
Subconjunctival IVIg (Gamunex-C) Injection for Corneal Neovascularization and Inflammatory Conditions [Recruiting]
The purpose of the study is to test the investigational drug Gamunex-C on the growth of
blood vessels over the cornea. This study is being conducted by Dr. Balamurali Ambati at the
Moran Eye Center at the University of Utah.
The cornea is the clear outer front part of the eye. In corneal neovascularization, blood
vessels grow over the cornea. Corneal neovascularization and ocular anterior segment
inflammations are sight-threatening conditions. Lipid deposition and edema with subsequent
scar formation can compromise corneal clarity irreversibly. Corneal neovascularization is
also a well recognized risk factor for corneal graft failure. In its natural state, the
cornea is a site of immune privilege well suited to tissue transplantation. Once
vascularized, there is direct exposure of corneal antigens to circulating host immune
mechanisms greatly increasing the chance of rejection [Collaborative Corneal Transplantation
Melting or inflammation in the anterior chamber, cornea, or ocular surface can cause
irreversible scarring or destruction of the optical elements of the eye, which can
Current standard of care for such conditions includes use of topical steroids and sometimes
immunosuppressants (e. g., cyclosporine). These do not address a common underlying corneal
neovascularization or melting.
This is a Phase 1 clinical trial of subconjunctival IVIg (Gamunex-C) injection for treatment
of corneal neovascularization in the setting of corneal transplantation with
neovascularization. Candidates for corneal transplantation with corneal neovascularization
in one or more quadrants crossing more than 0. 5mm over the limbus will be identified for
inclusion in our study.
Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency [Completed]
The purpose of this open-label study is to evaluate the pharmacokinetics, safety, and
tolerability of subcutaneously (SC; under the skin) administered GAMUNEX-C compared to
intravenously (IV; through the vein) administered GAMUNEX-C in subjects 2-16 years of age
with Primary Immunodeficiency.
Open Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia Gravis [Recruiting]
The purpose of this study is to determine whether Hizentra is a safe and effective treatment
for people with myasthenia gravis (MG).
Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study) [Completed]
The purpose of this study is to assess the long-term efficacy, tolerability, and safety of
IgPro20 in subjects with primary immunodeficiency (PID) as an extension to the preceding
follow-up study ZLB07_001CR (NCT01458171).
Reports of Suspected Vivaglobin (Immune Globulin Subcutaneous Human) Side Effects
OFF Label USE (4),
Infusion Site Swelling (4),
Transmission of AN Infectious Agent VIA A Medicinal Product (4),
Back Pain (3),
Herpes Simplex Serology Positive (3),
Vertigo (3), more >>