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| ID | Type | Description | Link |
|---|---|---|---|
| R21AI168980 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Jeffrey Modell Foundation | UNKNOWN |
| University of North Carolina, Chapel Hill | OTHER |
| University of South Florida | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 wild-type peptides (measured as a percentage of total T cells). | 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). | 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). | 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). | 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). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| S-specific T cell responses (as a percentage of total T cells) to SARS-CoV-2 vaccination in primary antibody deficiency over time. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
(1) History of other chronic disease with depressed immune function or immune suppressive medication
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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.
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| Name | Affiliation | Role |
|---|---|---|
| John Sleasman, MD | Duke University | Principal Investigator |
| Kristina De Paris, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | St. Petersburg | Florida | 33701 | United States | ||
| University of North Carolina, Chapel Hill |
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| ID | Term |
|---|---|
| C537409 | Bruton type agammaglobulinemia |
| D000081207 | Primary Immunodeficiency Diseases |
| D017074 | Common Variable Immunodeficiency |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| NIH |
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| 2 years |
| S-specific T cell responses (as a percentage of total T cells) to SARS-CoV-2 in infected participants. | 2 years |
| S-specific T cell responses (as a percentage of total T cells) to SARS-CoV-2 in vaccinated participants. | 2 years |
| Number of vaccinated participants who develop severe COVID-19 clinical outcomes. | 2 years |
| Number of infected participants who develop severe COVID-19 clinical outcomes. | 2 years |
| Number of antibody deficiency participants who develop severe COVID-19 clinical outcomes. | 2 years |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| Duke University | Durham | North Carolina | 27708 | United States |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |