Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency

Not Applicable

Not yet recruiting

• Conditions: Alpha 1-Antitrypsin; COPD; Antibody Deficiency
• Interventions: Biological: 20-valent pneumococcal conjugate vaccine

• Registration Number: NCT07135427
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-14
• Study First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22
• Study Start: 2025-09-01
• Primary Completion: 2027-03
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Frequent exacerbation group	20-valent pneumococcal conjugate vaccine	Participants with 2 or more exacerbations in the previous year
Exacerbation-free group	20-valent pneumococcal conjugate vaccine	No exacerbations in the previous year

Primary Outcome Measures

Name	Time	Method
Antibody response	4 weeks from baseline measurement	Pneumococcal antibody levels/function, total IgG levels, IgG subclass levels; magnitude of change from baseline

Secondary Outcome Measures

Name	Time	Method
Lymphocyte profile	Baseline, 4 weeks post-vaccination	B and T cell lymphocyte subsets

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States