Status:
COMPLETED
Flu Vaccine Response in Patients on Biologic Therapies
Lead Sponsor:
Stony Brook University
Collaborating Sponsors:
University of North Carolina, Chapel Hill
Conditions:
Rheumatologic Disorder
Inflammatory Bowel Diseases
Eligibility:
All Genders
3-22 years
Phase:
PHASE2
Brief Summary
This proposed study will assess the immunogenicity, safety, and clinical efficacy of an influenza vaccine booster dose strategy in patients with autoimmune diseases who are receiving immunosuppressive...
Eligibility Criteria
Inclusion
- Children ages 3-22 years
- Rheumatologic condition (JIA, Uveitis, SLE and other rheumatologic disorders) or inflammatory bowel disease (Crohn's disease or ulcerative colitis) and who are receiving immunosuppressive therapies as follows:
- TNF inhibitors \[etanercept (Enbrel), adalimumab (Humira®), infliximab (Remicade®)\]
- anti IL -1 \[anakinra (Kineret®) or canakinumab (Ilaris®)\]
- IL-6 tocilizumab (Actemra®)
- anti IL-12/23 ustekinumab (Stelara®)
- anti CTLA-4 \[abatacept (Orencia®)\]
- vedolizumab (Entyvio®)
- azathioprine (Imuran®)
- 6 mercaptopurine (Purinethol®)
- Cyclosporine
- Leflunomide
- Mycophenolate
- methotrexate (Otrexup® or Rasuvo®)
Exclusion
- Prior allergic reaction to any vaccine components
- Other contraindication to influenza vaccination
- Severe egg allergy
- Pregnancy
- Prior Guillain-Barre syndrome
- Therapy with oral corticosteroids ≥2 mg/mg/day within 4 weeks of study entry
- Prior rituximab
- Prior cyclophosphamide
- Prior IVIG within 8 weeks
- Acute febrile illness at time of study evaluation
- No prior history of two doses of influenza in the past for ages 3-8 years
Key Trial Info
Start Date :
November 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03277703
Start Date
November 3 2017
End Date
January 1 2020
Last Update
February 25 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Research Center
East Setauket, New York, United States, 11733