The Polysaccharide Antibody Response Study: Typhim Vi Response and Allohemagglutinins Versus Pneumovax 23 Vaccine Response in the Diagnosis of Specific Polysaccharide Antibody Deficiency
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Typhim Vi response specific anti-Vi IgG as measured by ELISA
研究概览
简要总结
Specific polysaccharide antibody deficiency (SPAD) is a primary immunodeficiency characterized by a deficient antibody production to capsular polysaccharides with normal total immunoglobulin levels. Patients suffer from recurrent ear-nose and throat infections and lung infections. SPAD can also occur as part of a primary immunodeficiency affecting other components of the immune system. Diagnosis of SPAD is hampered by difficulties with the interpretation of the Pneumovax 23 antibody response. The purpose of this study is to assess the diagnostic value of the Typhim Vi antibody response and allohemagglutinin titers as an alternative to the Pneumovax 23 response to detect polysaccharide specific antibody deficiency.
详细描述
Healthy controls (n = 100) and patients with suspected SPAD (n = 100) will be immunized with both Pneumovax 23 and Typhim Vi (age 18 months - 55 years). Analyses of anti-pneumococcal polysaccharide antibodies and anti-Vi antibodies are performed before and 3-4 weeks after vaccination. Also bloodgroup and anti-A/anti-B are assessed. Relevant clinical information (ENT infections, lung infections, bronchiectasis, invasive infections) is obtained from the patient file and history and is noted in a Case Report Form.
The diagnostic performance of Typhim Vi response and allohemagglutinins will be analyzed by calculating sensitivity, specificity, predictive values, likelihood ratios and Receiver Operating Characteristic curves for Typhim Vi and allohemagglutinins using pneumococcal antibody response as the reference standard. The association between low Typhim Vi response or low allohemagglutinins and clinical signs of polysaccharide antibody deficiency will be studied by multiple logistic regression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Assessment of polysaccharide antibody response is indicated for the clinical care of the patient (not for healthy volunteers)
- •Informed consent given
排除标准
- •History of serious adverse reaction to a vaccine
- •Vaccination with Typhim Vi or Pneumovax 23 in 5 years prior to the study
- •(Potential) pregnancy
结局指标
主要结局
Typhim Vi response specific anti-Vi IgG as measured by ELISA
时间窗: 3-4 weeks
specific anti-Vi IgG as measured by ELISA
Pneumovax 23 response specific pneumococcal polysaccharide IgG as measured by ELISA
时间窗: 3-4 weeks
specific pneumococcal polysaccharide IgG as measured by ELISA
次要结局
- ENT infections (number of ENT infections obtained by history and medical file)(12 months before inclusion untill inclusion)
- bronchiectasis (presence or absence of bronchiectasis (diagnosed by high resolution CT) obtained by history and medical file)(5 years before inclusion untill inclusion)
- adverse effects(4 weeks)
- allohemaglutinin titer as measured by column agglutination(1 day)
- pneumonia (number of lung infections, confirmed on chest radiography, obtained by history and medical file)(5 years before inclusion untill inclusion)
- invasive infections (number and infection site of invasive infections obtained by history and medical file)(5 years before inclusion untill inclusion)