Clinical Trial: Specific IgG Antibody in Patients With Primary Antibody Deficiencies Treated With Subcutaneous Immunoglobulin

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Serum IgG Antibody to Streptococcus Pneumoniae, Haemophilus Influenzae Type b and Tetanus Toxoid in Patients With Primary Antibody Deficiencies Treated With Subcutaneous Immunoglobulin Infusions

Brief Summary: Objective: 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.

Detailed Summary: Therapy with polyvalent immunoglobulin (Ig) has been established as the standard therapy for antibody deficiencies for several decades now. Although subcutaneous infusions were originally proposed as an alternative to intramuscular injections, more recently, this method has been proven as a safe and convenient method for providing immunoglobulin levels in adults and children. Subcutaneous administration of immunoglobulins has some clinical advantages over intravenous immunoglobulin infusions (IVIG) , including a more benign side effect profile, better sustained levels of IgG in the blood and reduced cost. An additional benefit is an improvement in the quality of life, which is in part secondary to the feasibility of the patients to administer it themselves at home. The most common infections in primary antibody deficiency patients involves encapsulated bacteria, mainly Streptococcus pneumoniae and Haemophilus influenzae type b. The aim of this study is to verify if patients with antibody deficiency receiving subcutaneous immunoglobulin (SCIG) infusions keep protective antibody levels to Streptococcus pneumoniae, Haemophilus influenzae type b (Hib) and tetanus toxoid.
Sponsor: Federal University of São Paulo

Current Primary Outcome: Specific IgG levels were measured using ELISA. Adequate response was arbitrarily defined as equal to or higher than 1.3 mg/L to pneumococci (Sorensen RU et al 1998), 1.0 mg/L to Hib (Takano AO 1997) and 0.1 IU/mL to tetanus toxoid (Kayhtyh et al 1983). [ Time Frame: Samples from patients blood was collected every 4 weeks on 7 different occasions immediately before infusions.All patients were treated with subcutaneous immunoglobulin for 43 weeks. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Federal University of São Paulo

Dates:
Date Received: April 14, 2008
Date Started: January 2002
Date Completion:
Last Updated: April 15, 2008
Last Verified: April 2008