COVID-19 Vaccine Responses in PIDD Subjects

NCT05321407 | Active Not Recruiting DMC

• 2 other identifiers: Pro00108422R21AI168980
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

X-linked Agammaglobulinemia; Primary Immune Deficiency; Common Variable Immunodeficiency; SARS CoV 2 Infection; Primary Antibody Deficiencies; COVID-19; Secondary Hypogammaglobulinemia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Diagnosis of antibody deficiency with confirmatory lab or genetic testing
• Stable on immunoglobulin replacement therapy
• Age \>6 months 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• Jeffrey Modell Foundation: collaborator
• University of North Carolina, Chapel Hill: collaborator
• University of South Florida: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (3)

University of South Florida

St. Petersburg, Florida, 33701, United States

Location

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Conditions

Bruton type agammaglobulinemia; Primary Immunodeficiency Diseases; Common Variable Immunodeficiency; COVID-19

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• John Sleasman, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Kristina De Paris, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 11, 2022
• Study Start: September 30, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

US (3)