Immunogenicity of PPSV-23 After PCV-13 Vaccination in Adult Asthmatic Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16.
研究概览
简要总结
Investigators are assessing if patients with asthma respond better to the Pneumovax vaccine if they are given Prevnar initially.
详细描述
Patients will be randomized into either PCV13 and PPSV23 (Experimental) or PPSV23 alone (Active comparator). At the Week 0 time point, the patients will receive either PCV13 (Experimental) or PPSV23 (Active comparator) and undergo a blood draw of 5ml for assessment of pre-vacation serotype titers. The Active Comparator group will undergo a 5ml draw of blood for assessment of titers at week 8, 16, and 24 following vaccination. The Experimental group will undergo vaccination with PPSV23 at week 8 with 5 ml blood draw for pneumococcal serotype titers as well as a blood draw at week 16 and week 24.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of asthma
排除标准
- •Research exemption requested
- •History of PCV-13 vaccination
- •History of cochlear implant
- •Cerebrospinal Fluid (CSF) leak
- •Congestive Heart Failure (CHF)
- •Diabetes Mellitus (DM)
- •Chronic Kidney Disease (CKD)
- •Human Immunodeficiency Virus (HIV)
- •Common Variable Immune Deficiency (CVID)
- •Patients who have received the PPSV23 vaccine in the last 5 years
- •Women who are pregnant will also be excluded from the study by performing 2 point of care urine pregnancy tests ( prior to vaccinations)
结局指标
主要结局
Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16.
时间窗: Baseline, week 0, week 8, week 16
5 ml blood draw for assessment of IgG specific Antibody titers for serotypes unique to PPSV23. Measured as mcg/mL.
Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16
时间窗: Baseline, week 0, week 8, week 16
5 ml blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/dL.
Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16
时间窗: Baseline, week 0, week 8, week 16
5 ml blood draw for assessment of IgG specific Antibody titers to all 23 serotypes. Measured as mcg/mL.
Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16
时间窗: Baseline, week 0, week 8, week 16
5 ml blood draw for assessment of IgG specific Antibody titers for serotypes common PCV13 \& PPSV23. Measured as mcg/mL.
次要结局
未报告次要终点