COVID-19 vaccine responses in PIDD subjects - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about the immune response patients with X-linked Agammaglobulinemia (XLA) have to COVID-19 vaccination. We will compare their immune responses to those of healthy people who have normal immune systems. Better understanding of cellular responses to COVID-19 vaccines by XLA patients is important since XLA patients cannot make antibodies to vaccines.

If you are interested, please contact the study team at XLACOVIDvax@duke.edu.

What is the Condition Being Studied?

Immune responses to COVID-19 vaccination in patients with Primary Immune Deficiency Disease

Who Can Participate in the Study?

People with XLA and healthy male participants are both eligible to join this study.

We are enrolling XLA patients who:
- Are diagnosed with XLA based on absence of B cells or genetic confirmation
- Are being treated with immunoglobulin replacement without recent dose change
- Have not received a COVID-19 vaccine, but plan to get one
- Have no signs or symptoms of COVID-19 infection
- Have not received any other vaccines within 2 weeks of the COVID-19 vaccine

We are enrolling healthy male participants who:
- Are 12 years and older
- Have not received a COVID-19 vaccine, but plan to get one
- Have no signs or symptoms of COVID-19 infection
- Do not have any medical conditions that affect the immune system
- Are not taking any medicine that affects the immune system
- Have not received any other vaccines within 2 weeks of the COVID-19 vaccine

What is Involved?

If you choose to join the study, you will:
- Have an eligibility assessment made by the study team
- Make an appointment for COVID-19 vaccination
- Have blood draws 7, 21, 120, and 365 days after your second dose of vaccine
- Participate in virtual, telephone, or in-person follow up visits
- Be monitored by the study team for any symptoms you might experience while in the study

Study Details

Full Title
Vaccine-induced SARS-CoV-2-specific T cell responses in patients with Primary Immune Deficiency Disease
Principal Investigator
Pediatric Allergy and Immunology Specialist
Protocol Number
IRB: PRO00108422
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698