Flu Vaccine Response in Patients on Biologic Therapies
| Status: | Recruiting |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Gastrointestinal, Rheumatology |
| Therapuetic Areas: | Gastroenterology, Rheumatology |
| Healthy: | No |
| Age Range: | 3 - 22 |
| Updated: | 9/9/2018 |
| Start Date: | November 3, 2017 |
| End Date: | August 2020 |
| Contact: | Christy A Beneri, DO |
| Email: | Christy.Beneri@stonybrookmedicine.edu |
| Phone: | (631) 444-7692 |
Booster Vaccine Strategy to Improve Serologic Responses to Influenza Vaccination in Children With Rheumatic Diseases and Inflammatory Bowel Disease Who Are Receiving Immunosuppressive Therapies
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.
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.
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
We found this trial at
1
site
3 Edmund D. Pellegrino Road
East Setauket, New York 11794
East Setauket, New York 11794
Phone: 631-444-6900
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