Serum IgG Antibody to Streptococcus Pneumoniae, Haemophilus Influenzae Type b and Tetanus Toxoid in Patients With Primary Antibody Deficiencies Treated With Subcutaneous Immunoglobulin Infusions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- 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).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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).
时间窗: 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.
次要结局
未报告次要终点