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.
If you are interested, please contact the study team at XLACOVIDvax@duke.edu.
Who Can Participate?
Eligibility
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
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
- 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
John
Sleasman
Protocol Number
PRO00108422
NCT ID
NCT05321407
Enrollment Status
OPEN TO ACCRUAL