Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07135427
Phase
PHASE4
Status
Recruiting
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Conditions

  • Alpha 1-Antitrypsin
  • Antibody Deficiency
  • COPD

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 20-valent pneumococcal conjugate vaccine — BIOLOGICAL
    Administration of PCV20

Study Details

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.

Key Dates

Start date
Sep 3, 2025
Status verified
Aug 2025
Primary completion
Mar 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • 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.

Primary Outcome Measure

Antibody response [ Time Frame: 4 weeks from baseline measurement ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
LaFon
[email protected]
2059343411
David C LaFon, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
COPD
By specialty
PulmonologyLung disease
By research site
University of Alabama at Birmingham· Birmingham, AL

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