Flu Vaccine Response in Patients on Biologic Therapies

Phase 2

Completed

• Conditions: Inflammatory Bowel Diseases; Rheumatologic Disorder; Immune Complex Diseases
• Interventions: Biological: Influenza vaccine

• Registration Number: NCT03277703
• Lead Sponsor: Stony Brook University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-30
• Study First Submitted QC: 2017-09-06
• Study First Posted: 2017-09-11
• Study Start: 2017-11-03
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 - Standard	Influenza vaccine	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 1 - Booster	Influenza vaccine	Group 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 1 and year 2.

Primary Outcome Measures

Name	Time	Method
Influenza hemagglutination inhibition (HAI) titer	4 weeks post vaccination	immunological vaccine response

Secondary Outcome Measures

Name	Time	Method
Clinical efficacy of vaccine	through study completion, an average of 2 years	decreased influenza rates

Trial Locations

Locations (1)

Clinical Research Center; 🇺🇸 East Setauket, New York, United States