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Clinical Trials/NCT03277703
NCT03277703
Completed
Phase 2

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

Stony Brook University1 site in 1 country30 target enrollmentNovember 3, 2017

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Rheumatologic Disorder
Sponsor
Stony Brook University
Enrollment
30
Locations
1
Primary Endpoint
Influenza hemagglutination inhibition (HAI) titer
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 3, 2017
End Date
January 1, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christy Beneri

Assistant Professor of Pediatrics

Stony Brook University

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®)

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

Outcomes

Primary Outcomes

Influenza hemagglutination inhibition (HAI) titer

Time Frame: 4 weeks post vaccination

immunological vaccine response

Secondary Outcomes

  • Clinical efficacy of vaccine(through study completion, an average of 2 years)

Study Sites (1)

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