COVID-19 Vaccine Responses in PIDD Subjects

Sponsor

Duke University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05321407

Collaborator

Jeffrey Modell Foundation (Other), University of North Carolina, Chapel Hill (Other), University of South Florida (Other)

100

Enrollment

Locations

23.7

Anticipated Duration (Months)

33.3

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
X-linked Agammaglobulinemia XLA Primary Immune Deficiency CVID Common Variable Immunodeficiency Primary Antibody Deficiencies Secondary Hypogammaglobulinemia

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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 24, 2021

Anticipated Primary Completion Date :

Sep 16, 2023

Anticipated Study Completion Date :

Sep 16, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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. [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Diagnosis of antibody deficiency with confirmatory lab or genetic testing
Stable on immunoglobulin replacement therapy
Age >5 years 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 Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Florida	Saint 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