Flu Vaccine Response in Patients on Biologic Therapies

Stony Brook University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Rheumatologic Disorder Inflammatory Bowel Diseases Immune Complex Diseases

Interventions

Influenza vaccineBIOLOGICAL

The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies. Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population

Eligibility

Sex: ALLMin age: 3 YearsMax age: 22 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Influenza hemagglutination inhibition (HAI) titer

immunological vaccine response

Time frame: 4 weeks post vaccination

Secondary Outcomes

Clinical efficacy of vaccine

decreased influenza rates

Time frame: through study completion, an average of 2 years