Trials / Active Not Recruiting

Active Not RecruitingNCT05321407

COVID-19 Vaccine Responses in PIDD Subjects

Vaccine-induced SARS-CoV-2-specific T Cell Responses in Patients With Primary Immune Deficiency Disease

Status: Active Not Recruiting
Phase: —
Study type: Observational
Enrollment: 100 (estimated)

Sponsor: Duke University · Academic / Other
Sex: All
Age: 6 Months
Healthy volunteers: Accepted

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 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

Timeline

Start date: 2021-09-30
Primary completion: 2026-06-30
Completion: 2026-07-31
First posted: 2022-04-11
Last updated: 2025-06-03

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT05321407. Inclusion in this directory is not an endorsement.