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Active, not recruitingNCT05321407Updated Jun 3, 2025

COVID-19 Vaccine Responses in PIDD Subjects

An observational study in X-linked Agammaglobulinemia, XLA and Primary Immune Deficiency, sponsored by Duke University. Active, not recruiting at 3 sites in United States. Open to participants aged 6 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-03.

Sponsored by Duke University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
6 Months and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • X-linked Agammaglobulinemia
  • XLA
  • Primary Immune Deficiency
  • CVID
  • Common Variable Immunodeficiency
  • Primary Antibody Deficiencies
  • Secondary Hypogammaglobulinemia

Keywords

  • X-linked Agammaglobulinemia
  • Primary Immune Deficiency
  • Common Variable Immunodeficiency
  • SARS CoV 2 Infection
  • Primary Antibody Deficiencies
  • COVID-19
  • Secondary Hypogammaglobulinemia
03

In context

Primary Immunodeficiency Diseases

211 studies on the registry are indexed under Primary Immunodeficiency Diseases; 51 are open to participants now.

This study's planned enrollment of 100 is below the median of 137 across 77 observational studies indexed under Primary Immunodeficiency Diseases.

Browse Primary Immunodeficiency Diseases studies →

Lead sponsor

Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.

Browse Duke University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Diagnosis of antibody deficiency with confirmatory lab or genetic testing
  2. Stable on immunoglobulin replacement therapy
  3. Age >6 months and able to provide consent, or assent with parental consent if \<18 years
  4. Willing and able to receive the Pfizer BioNTech BNT162b2 mRNA or the Moderna mRNA-1273 vaccines

Exclusion criteria

Exclusion Criteria:

(1) History of other chronic disease with depressed immune function or immune suppressive medication

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. 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

  2. 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

  3. S-specific T cell responses (as a percentage of total T cells) to SARS-CoV-2 in infected participants.

    Time frame: 2 years

  4. S-specific T cell responses (as a percentage of total T cells) to SARS-CoV-2 in vaccinated participants.

    Time frame: 2 years

  5. Number of vaccinated participants who develop severe COVID-19 clinical outcomes.

    Time frame: 2 years

  6. Number of infected participants who develop severe COVID-19 clinical outcomes.

    Time frame: 2 years

  7. Number of antibody deficiency participants who develop severe COVID-19 clinical outcomes.

    Time frame: 2 years

07

Study locations

3 sites
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2021 (actual). Primary completion is estimated for Jun 2026, 57 months after the start.

Of 50 observational studies under Primary Immunodeficiency Diseases, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 30. This study's planned 57 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 7, 2022
First posted
Apr 11, 2022
StartActual
Sep 30, 2021
Primary completionEst.
Jun 30, 2026
CompletionEst.
Jul 31, 2026
Last update
Jun 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05321407
Lead sponsor
Duke University
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
First posted
Apr 11, 2022
Start date
Sep 30, 2021
Primary completion
Jun 30, 2026 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
Jun 3, 2025

Study contacts

John Sleasman, MD
principal investigator · Duke University
Kristina De Paris, PhD
principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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