IgG genetic differences in people with alpha-1 antitrypsin deficiency
Official title: Genetic Variation in IgG as a Mechanism for Immune Deficiency and Exacerbations in AATD
Run by University of Alabama at Birmingham · NCT07135427 · Data updated 2026-11-12
This study will test whether adults who carry one SERPINA1 Z mutation and have frequent COPD exacerbations make weaker antibody responses to the 20-valent pneumococcal vaccine than similar people without recent exacerbations.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Status | Recruiting |
| Started | September 3, 2025 |
| Main results expected | March 2027 |
| Study ends | September 2027 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07135427 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults heterozygous for the SERPINA1 Z allele who have either no COPD exacerbations or two or more exacerbations in the past year and who have not received a pneumococcal conjugate vaccine within five years are the intended participants.
✕Probably not a fit
People without the SERPINA1 Z mutation, those recently vaccinated with a pneumococcal conjugate vaccine within five years, or those with known severe allergies to the vaccine are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 4 interventional study compares immune responses to the 20-valent pneumococcal conjugate vaccine (PCV20, Pfizer) in adults heterozygous for the SERPINA1 Z allele who either had no COPD exacerbations or had two or more exacerbations in the prior year. Participants who received a pneumococcal conjugate vaccine within the past five years are excluded, although prior receipt of the pneumococcal polysaccharide vaccine is permitted. The study team will measure antibody responses after vaccination and perform genetic analyses of IgG-related loci near SERPINA1 to identify variation linked to reduced immune function and respiratory infection risk. Findings will be compared between the two exacerbation groups to determine whether genetic variation correlates with vaccine response or clinical susceptibility.
Why it matters
Potential benefit: If a link is found, this could identify people who need different vaccine strategies or closer monitoring to prevent respiratory infections.
How similar studies have gone: Prior research has linked AATD genetics to infection risk and vaccine responses, but using PCV20 responses to detect IgG gene variation in SERPINA1 heterozygotes is a relatively novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University of Alabama at Birmingham
Birmingham, Alabama, United States Recruiting
Study contacts
- Study coordinator: David LaFon, MD
- Email: dlafon@uabmc.edu
- Phone: 2059343411
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.