Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency
NCT ID: NCT07135427
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
30 participants
INTERVENTIONAL
2025-09-03
2027-06-30
Brief Summary
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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
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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.
20-valent pneumococcal conjugate vaccine
Administration of PCV20
Interventions
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20-valent pneumococcal conjugate vaccine
Administration of PCV20
Eligibility Criteria
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Inclusion Criteria
* 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
* Known allergy, severe adverse reaction, or other sensitivity to pneumococcal conjugate vaccines
19 Years
ALL
No
Sponsors
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Alpha-1 Foundation
OTHER
University of Alabama at Birmingham
OTHER
Responsible Party
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David Lafon
Assistant Professor
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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LaFon
Role: primary
Other Identifiers
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Research award
Identifier Type: OTHER
Identifier Source: secondary_id
IRB300008528(000547878)
Identifier Type: -
Identifier Source: org_study_id