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RECRUITINGPhase 4INTERVENTIONAL

Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency

Genetic Variation in IgG as a Mechanism for Immune Deficiency and Exacerbations in AATD

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - Received a pneumococcal conjugate vaccine within the past 5 years - Known allergy, severe adverse reaction, or other sensitivity to pneumococcal conjugate vaccines Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BIOLOGICAL

20-valent pneumococcal conjugate vaccine

Administration of PCV20

Locations (1)

University of Alabama at Birmingham
Birmingham, Alabama, United States