Assessing COVID-19 vaccine responses in patients with antibody deficiencies
Vaccine-induced SARS-CoV-2-specific T Cell Responses in Patients With Primary Immune Deficiency Disease
This study is testing how well COVID-19 vaccines work for people with antibody deficiencies by looking at their immune responses compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 6 Months and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 3 sites (Saint Petersburg, Florida and 2 other locations) |
| Trial ID | NCT05321407 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the cellular immune responses of individuals with primary and secondary antibody deficiencies, such as X-linked agammaglobulinemia and common variable immunodeficiency, before and after receiving mRNA COVID-19 vaccines. Participants will be compared to healthy volunteers to determine the effectiveness of the vaccines in eliciting T cell responses. The study will also explore differences in immune responses between vaccinated and infected individuals, track these responses over time, and assess clinical outcomes related to vaccination and infection. The findings are expected to inform health policies regarding COVID-19 vaccination in immunocompromised populations.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with antibody deficiency diseases who are stable on immunoglobulin replacement therapy and willing to receive mRNA vaccines.
Not a fit: Patients with other chronic diseases that cause depressed immune function or those on immune-suppressive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the immune responses of patients with antibody deficiencies to COVID-19 vaccines, potentially improving vaccination strategies for this vulnerable group.
How similar studies have performed: Other studies have shown varying success in assessing vaccine responses in immunocompromised populations, but this specific focus on antibody deficiencies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Saint Petersburg, Florida and 2 other locations
- University of South Florida — Saint Petersburg, Florida, United States (Recruiting)
- University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: John Sleasman, MD — Duke University
- Study coordinator: Guglielmo Venturi, PhD
- Email: XLACOVIDvax@duke.edu
- Phone: 919-613-6818
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.