Flu Vaccine Response in Patients on Biologic Therapies

Stony Brook University

Status and phase: Completed; Phase 2

Conditions: Rheumatologic Disorder; Immune Complex Diseases; Inflammatory Bowel Diseases

Treatments: Biological: Influenza vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT03277703

1077651

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 3 to 22 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Group 1 - Booster

Experimental group

Description:

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

Treatment:

Biological: Influenza vaccine

Group 2 - Standard

Active Comparator group

Description:

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.

Treatment:

Biological: Influenza vaccine