COVID-19 Vaccine Responses in PIDD Subjects

Recruiting

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

• Registration Number: NCT05321407
• Lead Sponsor: Duke University

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 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 Timeline

• Study Start: 2021-09-24
• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-11
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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 omicron 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 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 delta variant peptides (measured as a percentage of total T cells).	2 years

Secondary Outcome Measures

Name	Time	Method
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 vaccination in secondary antibody deficiency over time.	2 years
Number of vaccinated participants who develop severe COVID-19 clinical outcomes.	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 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
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

Trial Locations

Locations (3)

University of North Carolina, Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

University of South Florida; 🇺🇸 Saint Petersburg, Florida, United States