Flu Vaccine Response in Patients on Biologic Therapies

Study Overview
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Brief Summary
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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.

Official Title
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Booster Vaccine Strategy to Improve Serologic Responses to Influenza Vaccination in Children With Rheumatic Diseases and Inflammatory Bowel Disease Who Are Receiving Immunosuppressive Therapies

Conditions
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Rheumatologic Disorder, Inflammatory Bowel Diseases, Immune Complex Diseases

Intervention / Treatment
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* Biological: Influenza vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 - Booster<br>Group 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 1 and year 2. | Biological: Influenza vaccine<br>* 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<br>|
| Active Comparator: Group 2 - Standard<br>Group 2 subjects will be receive the standard single dose of influenza vaccine in year 1 but will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 2. | Biological: Influenza vaccine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza hemagglutination inhibition (HAI) titer | immunological vaccine response | 4 weeks post vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy of vaccine | decreased influenza rates | through study completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza vaccine, Booster dose, immunocompromised, Biologic therapy, Rheumatologic disease, inflammatory bowel disease