Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency
Recruiting · NCT07135427 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Alabama at Birmingham
View the official record on ClinicalTrials.gov →Interventions studied
20-valent pneumococcal conjugate vaccine
What this trial is 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.
Who can take part
Age range
19 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- University of Alabama at Birmingham - Birmingham, Alabama, United States