No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
19 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Basic Science
Participants needed
30 (estimated)
Sponsor
University of Alabama at Birmingham · Other
Who this trial is looking for
This trial is looking for adults who have a specific genetic mutation related to alpha 1 antitrypsin deficiency. Participants will receive a pneumonia vaccine and scientists will observe their immune responses based on their history of COPD flare-ups over the past year.
Are You a Good Fit for This Trial?
You may be able to join if
I have a genetic mutation related to alpha 1 antitrypsin deficiency
I have had no COPD flare-ups or 2 or more in the last year
I have not received a pneumonia conjugate vaccine in the past 5 years
I have only received a pneumococcal polysaccharide vaccine in the past
You may not be able to join if
I have received a pneumonia conjugate vaccine in the past 5 years
I have a known allergy or severe reaction to pneumonia vaccines
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 part…
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.
Trial Locations
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Status
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…
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
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