Flu Vaccine Response in Patients on Biologic Therapies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-03

Study Completion Date

2020-01-01

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.

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Detailed Description

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Conditions

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Rheumatologic Disorder Inflammatory Bowel Diseases Immune Complex Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1 - Booster

Group 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 1 and year 2.

Group Type EXPERIMENTAL

Influenza vaccine

Intervention Type BIOLOGICAL

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

Group 2 - Standard

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.

Group Type ACTIVE_COMPARATOR

Influenza vaccine

Intervention Type BIOLOGICAL

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

Interventions

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Influenza vaccine

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

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No