Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Received a pneumococcal conjugate vaccine within the past 5 years
Known allergy, severe adverse reaction, or other sensitivity to pneumococcal conjugate vaccines
Trial design
Treatments tested in this trial
- 20-valent pneumococcal conjugate vaccine
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Alabama at Birmingham
Lead sponsor
Alpha-1 Foundation
Collaborator
Source ClinicalTrials.gov