Alpha 1-AntitrypsinPhase 4IgG in AATDNCT07135427
Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency
A Phase 4 study testing 20-valent pneumococcal conjugate vaccine in people with Alpha 1-Antitrypsin and COPD, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Alpha 1-Antitrypsin, COPD, Antibody Deficiency
- What is being tested?
- 20-valent pneumococcal conjugate vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2025to Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Received a pneumococcal conjugate vaccine within the past 5 years
- Known allergy, severe adverse reaction, or other sensitivity to pneumococcal conjugate vaccines
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
David LaFon, 2059343411, dlafon@uabmc.edu
David C LaFon, MD
About this study
Official title: Genetic Variation in IgG as a Mechanism for Immune Deficiency and Exacerbations in AATD
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.
- Conditions
- Alpha 1-Antitrypsin, COPD, Antibody Deficiency
- Being tested
- 20-valent pneumococcal conjugate vaccine
- Medical subject headings
- alpha 1-Antitrypsin Deficiency, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20-valent pneumococcal conjugate vaccineBiological
Administration of PCV20
| Study group | Role | What they receive |
|---|---|---|
| SERPINA1 'Z' heterozygotes | Experimental | Participants who are heterozygous for the SERPINA1 'Z' allele with either 0 or 2+ exacerbations in the previous year, and have not received pneumococcal vaccination within 5 years will be given PCV20. Receives: Biological: 20-valent pneumococcal conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody response
Pneumococcal antibody levels/function, total IgG levels, IgG subclass levels; magnitude of change from baseline
Measured: 4 weeks from baseline measurement
Secondary outcomes (1)
Lymphocyte profile
B and T cell lymphocyte subsets
Measured: Baseline, 4 weeks post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start3 Sep 2025
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alpha 1-AntitrypsinStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Alpha-1 Foundation
- Responsible party
- Principal investigator, David Lafon, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135427
- Sponsor's protocol ID
- IRB-300008528(000547878)
- Other IDs
- Research award
- Acronym
- IgG in AATD
- Status last verified
- Oct 2026
- First submitted
- 14 Aug 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Variation in IgG as a Mechanism for Immune Deficiency and Exacerbations in AATD
- ClinicalTrials.gov ID
- NCT07135427
- Acronym / sponsor ID
- IgG in AATD / IRB-300008528(000547878)
- Conditions
- Alpha 1-Antitrypsin, COPD, Antibody Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Alpha-1 Foundation
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SERPINA1 'Z' heterozygotes | Experimental | Biological: 20-valent pneumococcal conjugate vaccineParticipants who are heterozygous for the SERPINA1 'Z' allele with either 0 or 2+ exacerbations in the previous year, and have not received pneumococcal vaccination within 5 years will be given PCV20. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Received a pneumococcal conjugate vaccine within the past 5 years
- Known allergy, severe adverse reaction, or other sensitivity to pneumococcal conjugate vaccines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20-valent pneumococcal conjugate vaccineAdministration of PCV20 | Biological | SERPINA1 'Z' heterozygotes |
Primary outcome
Antibody response
Time frame: 4 weeks from baseline measurement
Pneumococcal antibody levels/function, total IgG levels, IgG subclass levels; magnitude of change from baseline
1 secondary outcome
Lymphocyte profile
Time frame: Baseline, 4 weeks post-vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 20-valent pneumococcal conjugate vaccine in people with Alpha 1-Antitrypsin and COPD, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David LaFon, MD (2059343411, dlafon@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody response (time frame: 4 weeks from baseline measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.