ACV01 - COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders - Clinical Trial

What is the Purpose of this Study?

We want to find out how autoimmune disorders in adults and children affect booster shots for COVID-19. Some conditions and medications might affect the immune system's response. You or your child might be eligible to join if you/they have not gotten a booster yet.

What is the Condition Being Studied?

The Effects of COVID-19 Vaccine Boosters in People with Autoimmune Conditions

Who Can Participate in the Study?

Adults ages 18+ who:
- Are diagnosed with Lupus, Systemic Sclerosis (Scleroderma), Rheumatoid Arthritis, Multiple Sclerosis, or Pemphigus
- Are treated with methotrexate; OR
-- Mycophenolate mofetil (Cellcept); OR
-- A B cell depleting agent like rituximab or ocrelizumab

Children ages 5-17 who:
- Are diagnosed with Pediatric Systemic Lupus Erythematosus, Juvenile Idiopathic Arthritis (JIA), or Juvenile Dermatomyositis
- Are treated with methotrexate; OR
-- Mycophenolate mofetil (Cellcept); OR
-- A B cell depleting agent like rituximab or ocrelizumab

For more information about who can join this study, please contact the study team at 919-668-0926 or sarah.oxendine@duke.edu.

Age Group
Adults

What is Involved?

If you or your child choose to join the study, we will test your/your child's response to the initial COVID-19 vaccination. If the response was below normal, you/your child will be eligible to continue.

If you or your child is eligible, you/they will:
- Receive a booster shot
- Have blood draws to measure the immune response
- Get a random assignment (like a coin flip) to stop using certain medications for a short time or continue as normal

There will be up to 8 clinic visits during the study. Participation will last up to 13 months.

We will pay you for your or your child's time on the study.

Study Details

Full Title
ACV01 - Booster Effects with Autoimmune Treatments in Patients with Poor Response to Initial COVID-19 Vaccine
Principal Investigator
Allergy & Immunology Specialist
Protocol Number
IRB: PRO00109349
NCT: NCT05000216
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698