Flu Vaccine Response in Patients on Biologic Therapies

Completed · Phase 2

Conditions studied: Rheumatologic Disorder, Inflammatory Bowel Diseases, Immune Complex Diseases

In brief

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 therapies. Investigators will compare serologic responses to single versus a booster dose of influenza vaccine in patients with inflammatory bowel disease (IBD- Crohn's Disease or Ulcerative Colitis) or rheumatologic diseases who are receiving immunosuppressive therapies. Subjects will be randomized to receive either one or two doses of influenza vaccination in year #1. In year# 2, all participants will be given two doses of influenza vaccine. Serologic responses will be measured pre and 4-6 weeks post vaccination. This study will also assess the immunogenicity and safety of a booster vaccine strategy in the prevention of influenza-like illness (ILI). Investigators anticipate that booster dose strategy will improve both clinical and serologic responses in this vulnerable population.

Key facts

Study ID

NCT03277703

Run by

Stony Brook University

People needed

30

Starts

2017-11-03

Expected to finish

2019-12-30

Last updated by the study team

2026-08-06

Who can join

Age: 3 and older, up to 22. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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®)

You may not qualify if…

• 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

Where it is running

• Clinical Research Center — East Setauket, New York, United States

Full record on ClinicalTrials.gov

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