Clinical trial NCT03277703: Flu Vaccine Response in Patients on Biologic Therapies
Official title: Booster Vaccine Strategy to Improve Serologic Responses to Influenza Vaccination in Children With Rheumatic Diseases and Inflammatory Bowel Disease Who Are Receiving Immunosuppressive Therapies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatologic Disorder
Inflammatory Bowel Diseases
Immune Complex Diseases
Keywords: Influenza vaccine
Booster dose
immunocompromised
Biologic therapy
Rheumatologic disease
inflammatory bowel disease
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2017-09-11
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Influenza hemagglutination inhibition (HAI) titer
timeFrame: 4 weeks post vaccination
Secondary outcomes:
measure: Clinical efficacy of vaccine
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: East Setauket
country: United States
facility: Clinical Research Center
state: New York
Study officials:
References:
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