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OpenTrials
Active, Not Recruiting

NCT Number: NCT05321407

COVID-19 Vaccine Responses in PIDD Subjects

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

X-linked Agammaglobulinemia Bruton type agammaglobulinemia COVID-19 CVID Common Variable Immunodeficiency Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronaviridae Infections Coronavirus Infections Genetic Diseases, Inborn Immune System Diseases Immunologic Deficiency Syndromes Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral Primary Antibody Deficiencies Primary Immune Deficiency Primary Immunodeficiency Diseases RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Secondary Hypogammaglobulinemia Virus Diseases XLA

Age range

6 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of South Florida, St. Petersburg, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 wild-type peptides (measured as a percentage of total T cells).

    Time frame: 2 years

  2. Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 alpha variant peptides (measured as a percentage of total T cells).

    Time frame: 2 years

  3. Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 beta variant peptides (measured as a percentage of total T cells).

    Time frame: 2 years

  4. Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 delta variant peptides (measured as a percentage of total T cells).

    Time frame: 2 years

  5. Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 omicron variant peptides (measured as a percentage of total T cells).

    Time frame: 2 years

Secondary outcomes

  1. S-specific T cell responses (as a percentage of total T cells) to SARS-CoV-2 vaccination in primary antibody deficiency over time.

    Time frame: 2 years

  2. S-specific T cell responses (as a percentage of total T cells) to SARS-CoV-2 vaccination in secondary antibody deficiency over time.

    Time frame: 2 years

  3. S-specific T cell responses (as a percentage of total T cells) to SARS-CoV-2 in infected participants.

    Time frame: 2 years

  4. S-specific T cell responses (as a percentage of total T cells) to SARS-CoV-2 in vaccinated participants.

    Time frame: 2 years

  5. Number of vaccinated participants who develop severe COVID-19 clinical outcomes.

    Time frame: 2 years

  6. Number of infected participants who develop severe COVID-19 clinical outcomes.

    Time frame: 2 years

  7. Number of antibody deficiency participants who develop severe COVID-19 clinical outcomes.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2022
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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