NCT07135427

Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alpha 1-Antitrypsin
• COPD
• Antibody Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	20-valent pneumococcal conjugate vaccine	Administration of PCV20

Timeline

• Start date: 2025-09-03
• Primary completion: 2027-03-01
• Completion: 2027-06-01
• First posted: 2025-08-22
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study