Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency
Purpose
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.
Conditions
- Alpha 1-Antitrypsin
- COPD
- Antibody Deficiency
Eligibility
- Eligible Ages
- Over 19 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Exclusion Criteria
- Received a pneumococcal conjugate vaccine within the past 5 years - Known allergy, severe adverse reaction, or other sensitivity to pneumococcal conjugate vaccines
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
Recruiting Locations
University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35294
Birmingham 4049979, Alabama 4829764 35294
More Details
- Status
- Recruiting
- Sponsor
- University of Alabama at Birmingham