NCT07135427PHASE4Recruiting
Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency
University of Alabama at Birmingham
Start Date
9/3/2025
Completion Date
6/1/2027
Summary
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.
Eligibility Criteria
Age Range: 19 years to No maximum
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
Interventions
BIOLOGICAL
20-valent pneumococcal conjugate vaccine
Conditions
Alpha 1-AntitrypsinCOPDAntibody Deficiency
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294
United States