Status:
ACTIVE_NOT_RECRUITING
COVID-19 Vaccine Responses in PIDD Subjects
Lead Sponsor:
Duke University
Collaborating Sponsors:
Jeffrey Modell Foundation
University of North Carolina, Chapel Hill
Conditions:
X-linked Agammaglobulinemia
XLA
Eligibility:
All Genders
6+ years
Brief 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.
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- (1) History of other chronic disease with depressed immune function or immune suppressive medication
Key Trial Info
Start Date :
September 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05321407
Start Date
September 30 2021
End Date
July 31 2026
Last Update
June 3 2025
Active Locations (3)
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1
University of South Florida
St. Petersburg, Florida, United States, 33701
2
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
3
Duke University
Durham, North Carolina, United States, 27708