Health TrialsbyHealthPanel

Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency

ConditionsAlpha 1-AntitrypsinCOPDAntibody 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 20-valent pneumococcal conjugate vaccine

    Biological/Vaccine

    Administration of PCV20

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: SERPINA1 'Z' heterozygotesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Antibody response

Pneumococcal antibody levels/function, total IgG levels, IgG subclass levels; magnitude of change from baseline

Time frame
4 weeks from baseline measurement

Secondary outcomes

1

Lymphocyte profile

B and T cell lymphocyte subsets

Time frame
Baseline, 4 weeks post-vaccination

Other outcomes

1

Gene variants

Variants in SERPINA1, IGHG genes

Time frame
Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Alpha-1 Foundation

Collaborator

Source ClinicalTrials.gov
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