Flu Vaccine Response in Patients on Biologic Therapies

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03277703
• Other study ID #: 1077651
• Status: Completed
• Phase: Phase 2
• Start date: November 3, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: February 2022
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• Immune Complex Diseases
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Rheumatic Diseases
• Rheumatologic Disorder

Intervention

Biological:
• Influenza vaccine
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

Locations

Country	Name	City	State
United States	Clinical Research Center	East Setauket	New York

Sponsors (2)

Lead Sponsor	Collaborator
Stony Brook University	University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (8)

Aikawa NE, Campos LM, Silva CA, Carvalho JF, Saad CG, Trudes G, Duarte A, Miraglia JL, Timenetsky Mdo C, Viana VS, França 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. — View Citation

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. — View Citation

Cordero E, Roca-Oporto C, Bulnes-Ramos A, Aydillo T, Gavaldà J, Moreno A, Torre-Cisneros J, Montejo JM, Fortun J, Muñoz P, Sabé N, Fariñas MC, Blanes-Julia M, López-Medrano F, Suárez-Benjumea A, Martinez-Atienza J, Rosso-Fernández C, Pérez-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. — View Citation

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. — View Citation

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). pii: e20164244. doi: 10.1542/peds.2016-4244. Epub 2017 Apr 3. — View Citation

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. — View Citation

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-a inhibitors: systematic review of the literature. Clin Infect Dis. 2013 Nov;57(9):1318-30. doi: 10.1093/cid/cit489. Epub 2013 Jul 29. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influenza hemagglutination inhibition (HAI) titer	immunological vaccine response	4 weeks post vaccination
Secondary	Clinical efficacy of vaccine	decreased influenza rates	through study completion, an average of 2 years