NCT03277703

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 3, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

2.2 years

First QC Date

August 30, 2017

Last Update Submit

February 23, 2022

Conditions

Rheumatologic DisorderInflammatory Bowel DiseasesImmune Complex Diseases

Keywords

Influenza vaccineBooster doseimmunocompromisedBiologic therapyRheumatologic diseaseinflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

  • Influenza hemagglutination inhibition (HAI) titer

    immunological vaccine response

    4 weeks post vaccination

Secondary Outcomes (1)

  • Clinical efficacy of vaccine

    through study completion, an average of 2 years

Study Arms (2)

Group 1 - Booster

EXPERIMENTAL

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

Biological: Influenza vaccine

Group 2 - Standard

ACTIVE COMPARATOR

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.

Biological: Influenza vaccine

Interventions

Influenza vaccineBIOLOGICAL

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 1 - BoosterGroup 2 - Standard

Eligibility Criteria

Age3 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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®)
  • mercaptopurine (Purinethol®)
  • Cyclosporine
  • Leflunomide
  • Mycophenolate
  • methotrexate (Otrexup® or Rasuvo®)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center

East Setauket, New York, 11733, United States

Location

Related Publications (8)

  • Walters HM, Pan N, Lehman TJ, Adams A, Huang WT, Sitaras L, Cunningham-Rundles S, Walsh TJ, Toussi SS. A prospective study comparing infection risk and disease activity in children with juvenile idiopathic arthritis treated with and without tumor necrosis factor-alpha inhibitors. Clin Rheumatol. 2015 Mar;34(3):457-64. doi: 10.1007/s10067-014-2779-8. Epub 2014 Sep 18.

    PMID: 25227771BACKGROUND

  • Toussi SS, Pan N, Walters HM, Walsh TJ. Infections in children and adolescents with juvenile idiopathic arthritis and inflammatory bowel disease treated with tumor necrosis factor-alpha inhibitors: systematic review of the literature. Clin Infect Dis. 2013 Nov;57(9):1318-30. doi: 10.1093/cid/cit489. Epub 2013 Jul 29.

    PMID: 23899685BACKGROUND

  • Carvalho LM, de Paula FE, Silvestre RV, Roberti LR, Arruda E, Mello WA, Ferriani VP. Prospective surveillance study of acute respiratory infections, influenza-like illness and seasonal influenza vaccine in a cohort of juvenile idiopathic arthritis patients. Pediatr Rheumatol Online J. 2013 Mar 7;11:10. doi: 10.1186/1546-0096-11-10. eCollection 2013.

    PMID: 23510667BACKGROUND

  • Aikawa NE, Campos LM, Silva CA, Carvalho JF, Saad CG, Trudes G, Duarte A, Miraglia JL, Timenetsky Mdo C, Viana VS, Franca IL, Bonfa E, Pereira RM. Glucocorticoid: major factor for reduced immunogenicity of 2009 influenza A (H1N1) vaccine in patients with juvenile autoimmune rheumatic disease. J Rheumatol. 2012 Jan;39(1):167-73. doi: 10.3899/jrheum.110721. Epub 2011 Nov 15.

    PMID: 22089462BACKGROUND

  • Flannery B, Reynolds SB, Blanton L, Santibanez TA, O'Halloran A, Lu PJ, Chen J, Foppa IM, Gargiullo P, Bresee J, Singleton JA, Fry AM. Influenza Vaccine Effectiveness Against Pediatric Deaths: 2010-2014. Pediatrics. 2017 May;139(5):e20164244. doi: 10.1542/peds.2016-4244. Epub 2017 Apr 3.

    PMID: 28557757BACKGROUND

  • Ogimi C, Tanaka R, Saitoh A, Oh-Ishi T. Immunogenicity of influenza vaccine in children with pediatric rheumatic diseases receiving immunosuppressive agents. Pediatr Infect Dis J. 2011 Mar;30(3):208-11. doi: 10.1097/INF.0b013e3181f7ce44.

    PMID: 20861757BACKGROUND

  • deBruyn J, Fonseca K, Ghosh S, Panaccione R, Gasia MF, Ueno A, Kaplan GG, Seow CH, Wrobel I. Immunogenicity of Influenza Vaccine for Patients with Inflammatory Bowel Disease on Maintenance Infliximab Therapy: A Randomized Trial. Inflamm Bowel Dis. 2016 Mar;22(3):638-47. doi: 10.1097/MIB.0000000000000615.

    PMID: 26595551BACKGROUND

  • Cordero E, Roca-Oporto C, Bulnes-Ramos A, Aydillo T, Gavalda J, Moreno A, Torre-Cisneros J, Montejo JM, Fortun J, Munoz P, Sabe N, Farinas MC, Blanes-Julia M, Lopez-Medrano F, Suarez-Benjumea A, Martinez-Atienza J, Rosso-Fernandez C, Perez-Romero P; TRANSGRIPE 1-2 Study Group. Two Doses of Inactivated Influenza Vaccine Improve Immune Response in Solid Organ Transplant Recipients: Results of TRANSGRIPE 1-2, a Randomized Controlled Clinical Trial. Clin Infect Dis. 2017 Apr 1;64(7):829-838. doi: 10.1093/cid/ciw855.

    PMID: 28362949BACKGROUND

MeSH Terms

Conditions

Collagen DiseasesInflammatory Bowel DiseasesImmune Complex DiseasesInfluenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesHypersensitivityImmune System DiseasesRespiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

August 30, 2017

First Posted

September 11, 2017

Study Start

November 3, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

February 25, 2022

Record last verified: 2022-02

Locations

US(1)