Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency | NCT07135427

Studies
Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency

NCT07135427

Sponsor

University of Alabama at Birmingham

Status

Recruiting

Last Update Posted

Nov 10, 2025Actual

Enrollment

30Estimated

Phase

Phase 4

Conditions

Alpha 1-Antitrypsin
COPD
Antibody Deficiency

Interventions

20-valent pneumococcal conjugate vaccine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Research award	Other Identifier	Alpha-1 Foundation

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 3, 2025Actual

Primary Completion Date

Mar 2027Estimated

Completion Date

Jun 2027Estimated

First Submitted Date

Aug 14, 2025

First Submission Date that Met QC Criteria

Aug 14, 2025

First Posted Date

Aug 22, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2025

Last Update Posted Date

Nov 10, 2025Actual

Name	Class
Alpha-1 Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Biological: 20-valent pneumococcal conjugate vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
20-valent pneumococcal conjugate vaccine	Biological	Administration of PCV20	SERPINA1 'Z' heterozygotes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Antibody response	Pneumococcal antibody levels/function, total IgG levels, IgG subclass levels; magnitude of change from baseline	4 weeks from baseline measurement

Secondary Outcomes

Measure	Description	Time Frame
Lymphocyte profile	B and T cell lymphocyte subsets	Baseline, 4 weeks post-vaccination

Other Outcomes

Measure	Description	Time Frame
Gene variants	Variants in SERPINA1, IGHG genes	Baseline

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David LaFon, MD	Contact	2059343411		dlafon@uabmc.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham	Recruiting	Birmingham	Alabama	35294	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019896	alpha 1-Antitrypsin Deficiency
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

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