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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Contact Information
Primary
David LaFon, MD
dlafon@uabmc.edu
2059343411
Time Frame
Start Date: 2025-09-03
Estimated Completion Date: 2027-06
Participants
Target number of participants: 30
Treatments
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.
Sponsors
Collaborators: Alpha-1 Foundation
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov