Genetic Variation in IgG as a Mechanism for Immune Deficiency and Exacerbations in AATD
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Antibody response
研究概览
简要总结
The goal of this study is to learn whether patients who have a genetic mutation in the genes that cause alpha 1 antitrypsin deficiency also have genetic variation in nearby genes that can increase risk for reduced immune function and respiratory infections.
To investigate this hypothesis, we will compare immune responses to the 20-valent pneumococcal conjugate vaccine (PCV20, Pfizer) between participants who have one abnormal copy of the SERPINA1 gene and either no COPD exacerbations, vs those with 2 or more COPD exacerbations in the past year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults who are heterozygous for a SERPINA1 Z allele
- •Have either had no COPD exacerbations or 2 or more exacerbations in the previous year
- •Has not received a pneumococcal conjugate vaccine within the past 5 years, or has only received the pneumococcal polysaccharide vaccine in the past
排除标准
- •Received a pneumococcal conjugate vaccine within the past 5 years
- •Known allergy, severe adverse reaction, or other sensitivity to pneumococcal conjugate vaccines
研究组 & 干预措施
SERPINA1 'Z' heterozygotes
Participants who are heterozygous for the SERPINA1 'Z' allele with either 0 or 2+ exacerbations in the previous year, and have not received pneumococcal vaccination within 5 years will be given PCV20.
干预措施: 20-valent pneumococcal conjugate vaccine (Biological)
结局指标
主要结局
Antibody response
时间窗: 4 weeks from baseline measurement
Pneumococcal antibody levels/function, total IgG levels, IgG subclass levels; magnitude of change from baseline
次要结局
- Lymphocyte profile(Baseline, 4 weeks post-vaccination)
研究者
David Lafon
Assistant Professor
University of Alabama at Birmingham