Recruiting

PCV20 vs. COPD

Sponsor:

University of Alabama at Birmingham

Code:

NCT07135427

Conditions

Alpha 1-Antitrypsin

COPD

Antibody Deficiency

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

20-valent pneumococcal conjugate vaccine

Study Details

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.

Conditions

Alpha 1-Antitrypsin

COPD

Antibody Deficiency

Study ID

NCT07135427

Start date

Sep 3, 2025

Status verified date

Aug, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

20-valent pneumococcal conjugate vaccine

Administration of PCV20

Primary outcome measure

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

Central Contacts and Locations

Central contacts

David LaFon, MD

2059343411dlafon@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

LaFon

2059343411dlafon@uabmc.edu

Principal Investigator:

David C LaFon, MD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Nov 10, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-11-10.