COVID-19 Vaccine Responses in PIDD Subjects

Duke University

Status: Active, not recruiting

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05321407

Pro00108422

R21AI168980 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 1 patient group

X-linked agammaglobulinemia (XLA)

Description:

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.