X-linked AgammaglobulinemiaNCT05321407
COVID-19 Vaccine Responses in PIDD Subjects
An observational study of X-linked Agammaglobulinemia and XLA, run by Duke University at 3 sites in United States.
Trial summary
The goal of our study is to assess the cellular immune responses of participants with antibody deficiency disease before and after immunization with SARS-CoV-2 mRNA vaccines. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- X-linked Agammaglobulinemia, XLA, Primary Immune Deficiency
- Type of treatment
- Vaccines
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Sep 2021to 31 Jul 2026
- Phase
- Observational
- 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 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Approximately 50 subjects with primary antibody deficiency diseases and 50 healthy controls will be enrolled through the Duke University Medical Center's Allergy and Immunology clinics for the Departments of Medicine and Pediatrics, in addition to collaboration with University of North Carolina, Chapel Hill and University of South Florida.
Who may be able to join
- Diagnosis of antibody deficiency with confirmatory lab or genetic testing
- Stable on immunoglobulin replacement therapy
- Age >6 months and able to provide consent, or assent with parental consent if <18 years
- Willing and able to receive the Pfizer BioNTech BNT162b2 mRNA or the Moderna mRNA-1273 vaccines
Who cannot join
- History of other chronic disease with depressed immune function or immune suppressive medication
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
Duke University
Durham, North Carolina, 27708
University of South Florida
St. Petersburg, Florida, 33701
About this study
Official title: Vaccine-induced SARS-CoV-2-specific T Cell Responses in Patients With Primary Immune Deficiency Disease
The goal of our study is to assess the cellular immune responses of participants with antibody deficiency disease before and after immunization with SARS-CoV-2 mRNA vaccines.
Read the detailed description
Individuals with primary and secondary antibody immunodeficiency are at higher risk for severe COVID-19 disease. Humoral immunity is thought to be the predominant protection against COVID-19, however mRNA vaccines have been shown to elicit both antibody and cellular responses.
The goal of our study is to assess the cellular immune responses of participants with antibody deficiency diseases, including X-linked agammaglobulinemia (XLA), common variable immunodeficiency (CVID), and secondary hypogammaglobulinemia, before and after immunization with SARS-CoV-2 mRNA vaccines.
Our aim is to examine SARS-CoV-2 spike-specific T cell immune responses before and after immunization with mRNA vaccines in a cohort of individuals with antibody deficiencies compared to healthy volunteers. Our secondary objectives include (1) detecting cellular immune response differences between immunized and infected participants, (2) observing cellular immune responses over time, and (3) comparing clinical outcomes between vaccination, infection, and underlying antibody deficiency. The results will show whether antibody deficiency individuals can mount T cell responses to SARS-CoV-2 vaccination or infection, data that are expected to inform health policy of SARS-CoV-2 implementation in immunocompromised individuals. Findings will further provide foundation for larger cohort studies of SARS-CoV-2 vaccination in other immunocompromised populations.
- Conditions
- X-linked Agammaglobulinemia, XLA, Primary Immune Deficiency, CVID, Common Variable Immunodeficiency, Primary Antibody Deficiencies
- Keywords
- X-linked Agammaglobulinemia, Primary Immune Deficiency, Common Variable Immunodeficiency, SARS CoV 2 Infection, Primary Antibody Deficiencies, COVID-19, Secondary Hypogammaglobulinemia
- Medical subject headings
- Bruton type agammaglobulinemia, Primary Immunodeficiency Diseases, Common Variable Immunodeficiency, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| X-linked agammaglobulinemia (XLA) | This study is a non-randomized observational cohort study of participants with XLA who have either received, as standard care, the Pfizer BioNTech BNT162b2 mRNA vaccine or the Moderna mRNA-1273 vaccine. In this protocol, vaccination is entirely voluntary and vaccines are not provided by the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 wild-type peptides (measured as a percentage of total T cells).
Measured: 2 years
Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 alpha variant peptides (measured as a percentage of total T cells).
Measured: 2 years
Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 beta variant peptides (measured as a percentage of total T cells).
Measured: 2 years
Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 delta variant peptides (measured as a percentage of total T cells).
Measured: 2 years
Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 omicron variant peptides (measured as a percentage of total T cells).
Measured: 2 years
Secondary outcomes (7)
S-specific T cell responses (as a percentage of total T cells) to SARS-CoV-2 vaccination in primary antibody deficiency over time.
Measured: 2 years
S-specific T cell responses (as a percentage of total T cells) to SARS-CoV-2 vaccination in secondary antibody deficiency over time.
Measured: 2 years
S-specific T cell responses (as a percentage of total T cells) to SARS-CoV-2 in infected participants.
Measured: 2 years
S-specific T cell responses (as a percentage of total T cells) to SARS-CoV-2 in vaccinated participants.
Measured: 2 years
Number of vaccinated participants who develop severe COVID-19 clinical outcomes.
Measured: 2 years
Number of infected participants who develop severe COVID-19 clinical outcomes.
Measured: 2 years
Number of antibody deficiency participants who develop severe COVID-19 clinical outcomes.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start30 Sep 2021
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for X-linked AgammaglobulinemiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Jeffrey Modell Foundation, University of North Carolina, Chapel Hill, University of South Florida, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- John Sleasman, MD, Principal investigator, Duke UniversityKristina De Paris, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321407
- Sponsor's protocol ID
- Pro00108422
- Other IDs
- R21AI168980
- Status last verified
- Mar 2025
- First submitted
- 7 Apr 2022
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccine-induced SARS-CoV-2-specific T Cell Responses in Patients With Primary Immune Deficiency Disease
- ClinicalTrials.gov ID
- NCT05321407
- Acronym / sponsor ID
- Pro00108422
- Conditions
- X-linked Agammaglobulinemia, XLA, Primary Immune Deficiency, CVID, Common Variable Immunodeficiency, Primary Antibody Deficiencies
- Keywords
- X-linked Agammaglobulinemia, Primary Immune Deficiency, Common Variable Immunodeficiency, SARS CoV 2 Infection, Primary Antibody Deficiencies, COVID-19, Secondary Hypogammaglobulinemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Jeffrey Modell Foundation, University of North Carolina, Chapel Hill, University of South Florida, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 11 Apr 2022 (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 our study is to assess the cellular immune responses of participants with antibody deficiency disease before and after immunization with SARS-CoV-2 mRNA vaccines.
Detailed description
Individuals with primary and secondary antibody immunodeficiency are at higher risk for severe COVID-19 disease. Humoral immunity is thought to be the predominant protection against COVID-19, however mRNA vaccines have been shown to elicit both antibody and cellular responses.
The goal of our study is to assess the cellular immune responses of participants with antibody deficiency diseases, including X-linked agammaglobulinemia (XLA), common variable immunodeficiency (CVID), and secondary hypogammaglobulinemia, before and after immunization with SARS-CoV-2 mRNA vaccines.
Our aim is to examine SARS-CoV-2 spike-specific T cell immune responses before and after immunization with mRNA vaccines in a cohort of individuals with antibody deficiencies compared to healthy volunteers. Our secondary objectives include (1) detecting cellular immune response differences between immunized and infected participants, (2) observing cellular immune responses over time, and (3) comparing clinical outcomes between vaccination, infection, and underlying antibody deficiency. The results will show whether antibody deficiency individuals can mount T cell responses to SARS-CoV-2 vaccination or infection, data that are expected to inform health policy of SARS-CoV-2 implementation in immunocompromised individuals. Findings will further provide foundation for larger cohort studies of SARS-CoV-2 vaccination in other immunocompromised populations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| X-linked agammaglobulinemia (XLA) | – | –This study is a non-randomized observational cohort study of participants with XLA who have either received, as standard care, the Pfizer BioNTech BNT162b2 mRNA vaccine or the Moderna mRNA-1273 vaccine. In this protocol, vaccination is entirely voluntary and vaccines are not provided by the study. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Approximately 50 subjects with primary antibody deficiency diseases and 50 healthy controls will be enrolled through the Duke University Medical Center's Allergy and Immunology clinics for the Departments of Medicine and Pediatrics, in addition to collaboration with University of North Carolina, Chapel Hill and University of South Florida.
Key inclusion criteria (4 listed)
- Diagnosis of antibody deficiency with confirmatory lab or genetic testing
- Stable on immunoglobulin replacement therapy
- Age >6 months and able to provide consent, or assent with parental consent if <18 years
- Willing and able to receive the Pfizer BioNTech BNT162b2 mRNA or the Moderna mRNA-1273 vaccines
Key exclusion criteria (1 listed)
- History of other chronic disease with depressed immune function or immune suppressive medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 wild-type peptides (measured as a percentage of total T cells).
Time frame: 2 years
Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 alpha variant peptides (measured as a percentage of total T cells).
Time frame: 2 years
Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 beta variant peptides (measured as a percentage of total T cells).
Time frame: 2 years
Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 delta variant peptides (measured as a percentage of total T cells).
Time frame: 2 years
Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 omicron variant peptides (measured as a percentage of total T cells).
Time frame: 2 years
7 secondary outcomes
S-specific T cell responses (as a percentage of total T cells) to SARS-CoV-2 vaccination in primary antibody deficiency over time.
Time frame: 2 years
S-specific T cell responses (as a percentage of total T cells) to SARS-CoV-2 vaccination in secondary antibody deficiency over time.
Time frame: 2 years
S-specific T cell responses (as a percentage of total T cells) to SARS-CoV-2 in infected participants.
Time frame: 2 years
S-specific T cell responses (as a percentage of total T cells) to SARS-CoV-2 in vaccinated participants.
Time frame: 2 years
Number of vaccinated participants who develop severe COVID-19 clinical outcomes.
Time frame: 2 years
Number of infected participants who develop severe COVID-19 clinical outcomes.
Time frame: 2 years
Number of antibody deficiency participants who develop severe COVID-19 clinical outcomes.
Time frame: 2 years
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 3 Jun 2025.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
John Sleasman, MD principal investigator
Duke University
Kristina De Paris, PhD principal investigator
University of North Carolina, Chapel Hill
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of X-linked Agammaglobulinemia and XLA, run by Duke University at 3 sites 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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 wild-type peptides (measured as a percentage of total T cells). (time frame: 2 years). The study lists 5 primary outcomes in all. 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 3 Jun 2025.