Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 20-valent pneumococcal conjugate vaccine.
- Who it may be relevant to
- Registry conditions: Alpha 1-Antitrypsin, COPD, Antibody Deficiency. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Genetic Variation in IgG as a Mechanism for Immune Deficiency and Exacerbations in AATD
Overview
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.
Interventions
- Biological 20-valent pneumococcal conjugate vaccine
Administration of PCV20
Primary outcome measures
- Antibody response [Time frame: 4 weeks from baseline measurement]
Secondary outcome measures (1)
- Lymphocyte profile [Time frame: Baseline, 4 weeks post-vaccination]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT07135427 · IRB300008528(000547878) · Research award