Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency (IgG in AATD)

The University of Alabama at Birmingham

Status and phase: Enrolling; Phase 4

Conditions: Antibody Deficiency; COPD; Alpha 1-Antitrypsin

Treatments: Biological: 20-valent pneumococcal conjugate vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT07135427

Research award (Other Identifier)

IRB300008528(000547878)

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

SERPINA1 'Z' heterozygotes

Experimental group

Description:

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.

Treatment:

Biological: 20-valent pneumococcal conjugate vaccine