Specific IgG Antibody in Patients With Primary Antibody Deficiencies Treated With Subcutaneous Immunoglobulin - Full Text View

Sponsors and Collaborators:	Federal University of São Paulo CSL Behring
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00661401

Purpose

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.

Condition	Intervention
Common Variable Immunodeficiency Agammaglobulinemia	Biological: gammaglobulin

Genetics Home Reference related topics: aceruloplasminemia X-linked agammaglobulinemia

MedlinePlus related topics: Flu Pneumonia Tetanus

Drug Information available for: Tetanus Vaccine Immunoglobulins Globulin, Immune Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]

Enrollment:	5
Study Start Date:	January 2002
Study Completion Date:	November 2002
Primary Completion Date:	November 2002 (Final data collection date for primary outcome measure)

Intervention Details:

They were administered a polyvalent, pasteurized liquid immune globulin subcutaneously (human 16% Beriglobin ®, Germany) with doses ranging from 57 to 132 mg/kg/week in order to maintain the same dosage they received by intravenous route monthly previous to this protocol. After a wash-out period (15 weeks) of the subcutaneous immunoglobulin administration, blood was collected every 4 weeks immediately before infusions. The infusions were administered using battery-powered ambulatory syringe drivers together with 10 or 20 ml syringe and infusions sets according to a pre-defined protocol (Gardulf et al, 2006).

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	2 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

a diagnosis of a primary immunodeficiency disease with hypo-or agammaglobulinemia
diagnosis performed according to the WHO definitions
already been treated with Intravenous immunoglobulin or subcutaneous immunoglobulin for at least 6 months prior to enrollment into this study
documented IgG trough levels (at least two values), type of used IgG preparation, dosage and dosage interval over a period of 6 months prior to enrollment into this study

Exclusion Criteria:

history of hypersensitivity to the study medication or to drugs with similar chemical structures
hypersensitivity to IgA
subjects currently requiring <400 or > 600 mg/kg/b.w. immunoglobulin per month
subjects whose dosage intervals for IV Ig are < 3 weeks
know pregnancy or positive pregnancy test
nursing mothers
childbearing potential, if an acceptable birth control is not practiced
history of chronic or persisting renal insufficiency (serum creatinine above upper limit of normal)
history of chronic or persisting hepatic insufficiency (ALT> 2 times the upper limit of normal)
risk of developing acute renal failure (Diabetes mellitus, volume depletion, sepsis, paraproteinemia)
any symptomatic heart disease requiring treatment (NYHA class II or above)
history of seizure disorder
history or risk for occlusive vascular disease
indication of active hepatitis A, B, or C at screening (HAV-PCR, HBV-PCR, or HCV-PCR positive)
detection of HIV-1 PCR positive
likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
progressive fatal disease/life expectancy of less than 12 months
history of drug or alcohol abuse
pathological mental condition rendering the subject unable to understand, scope and possible consequences of the study and/or evidence of an uncooperative attitude
treatment with nephrotoxic drugs during the last 3 weeks
treatment with any other investigational drug in the last 3 months before study entry or likelihood of treatment with another investigational grug during the study period
evidence of uncooperative attitude
vaccination against hepatitis B within 3 months before enrollment into the study
former participation in this trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661401

Locations

Brazil
Division of Allergy, Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of São Paulo
São Paulo, Brazil, Cep 04025-002

Sponsors and Collaborators

Federal University of São Paulo

CSL Behring

Investigators

Study Director:	Beatriz T Costa Carvalho, md PhD	Federal University of São Paulo
Study Chair:	Charles K Naspitz, md MSc	Federal University of São Paulo
Principal Investigator:	Albertina RB Pizzamiglio, md MSc	Federal University of São Paulo
Study Director:	Aparecida T Nagao-Dias	Federal University of Ceará

More Information

Publications:

Gardulf A, Nicolay U, Asensio O, Bernatowska E, Böck A, Carvalho BC, Granert C, Haag S, Hernández D, Kiessling P, Kus J, Pons J, Niehues T, Schmidt S, Schulze I, Borte M. Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies--a prospective, multi-national study. J Clin Immunol. 2006 Mar;26(2):177-85. Epub 2006 Apr 26.

Sorensen RU, Leiva LE, Javier FC 3rd, Sacerdote DM, Bradford N, Butler B, Giangrosso PA, Moore C. Influence of age on the response to Streptococcus pneumoniae vaccine in patients with recurrent infections and normal immunoglobulin concentrations. J Allergy Clin Immunol. 1998 Aug;102(2):215-21.

Käyhty H, Peltola H, Karanko V, Mäkelä PH. The protective level of serum antibodies to the capsular polysaccharide of Haemophilus influenzae type b. J Infect Dis. 1983 Jun;147(6):1100. No abstract available.

Pichichero ME, Anderson EL, Rennels MB, Edwards KM, England JA. Fifth vaccination with dipthteria, tetanus and acellular pertussis is beneficial in four- to six-year-olds. Pediatr Infect Dis J. 2001 Apr;20(4):427-33.

Responsible Party:	Federal University of São Paulo ( Albertina da Rosa Borges Pizzamiglio )
Study ID Numbers:	310570, 315970
Study First Received:	April 14, 2008
Last Updated:	April 15, 2008
ClinicalTrials.gov Identifier:	NCT00661401
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:

gammaglobulin
subcutaneous infusion
specific antibodies
primary antibody deficiency

Study placed in the following topic categories:

Gamma-Globulins
Agammaglobulinemia
Haemophilus influenzae
Common variable immunodeficiency
Blood Protein Disorders
Hematologic Diseases
Benzocaine
Tetanus

Immunologic Deficiency Syndromes
Lymphatic Diseases
Antibodies
Influenza, Human
Lymphoproliferative Disorders
Pneumonia
Common Variable Immunodeficiency
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009