Immunogenicity of Influenza, Pneumococcal and Hepatitis B Vaccines in IBD Patients Treated With Vedolizumab
1 other identifier
observational
173
1 country
1
Brief Summary
Patients with Crohn's disease (CD) and ulcerative colitis (UC) are often treated with medications that suppress the immune system. These patients are therefore at increased risk for developing infections, such as influenza, pneumonia, and hepatitis B, which may be prevented by vaccination. While awareness is increasing among gastroenterologists of the importance of vaccinations in the IBD patient, there continues to be some question of the effectiveness of vaccination in immunosuppressed patients. It has been previously shown that patients on immunosuppressive therapy with certain biologic medications (the TNF-blockers: infliximab and adalimumab) had an impaired immune response to vaccination as compared to healthy controls, as the mechanism of immunosuppression for these agents is systemic. Vedolizumab, a biologic medication for CD and UC approved in May 2014, targets the α4β7 integrin, a key component of gut immunity, and as such it has been hypothesized that with this agent effects are gut specific. There is limited data that suggests that in healthy patients given vedolizumab do not have an altered response to parentally administered vaccines, however there are no studies in the CD and UC population describing this. Additionally, IBD patients treated with vedolizumab are frequently also on concomitant therapy with an immunomodulator (6-mercaptopurine, azathioprine, or methotrexate), and these patients ability to mount an immune response has not been demonstrated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2017
CompletedFirst Posted
Study publicly available on registry
February 17, 2017
CompletedStudy Start
First participant enrolled
July 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2019
CompletedDecember 30, 2019
December 1, 2019
1.5 years
February 15, 2017
December 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of immune seroconversion after influenza, pneumococcal, or hepatitis B vaccine among the four groups of patients
The primary outcome is percent change in IgG titer from baseline to 3 weeks post vaccination.
baseline and 3 - 4 weeks
Study Arms (4)
Vedolizumab monotherapy
IBD patients on vedolizumab monotherapy, all patients will be treated with the standard vedolizumab dosing regimen of 300 mg infusions at 8 week intervals and receive Pneumococcal Pneumonia vaccine and/or Influenza vaccine and/or Hepatitis B vaccine.
vedolizumab + immunomodulator
IBD patients receiving combination treatment with vedolizumab and concomitant immunomodulator therapy (methotrexate, azathioprine, or 6-mercaptopurine), will be treated with the standard vedolizumab dosing regimen of 300 mg infusions at 8 week intervals and/or receive Pneumococcal Pneumonia vaccine and/or Influenza vaccine and/or Hepatitis B vaccine.
biologic + immunomodulator
IBD patients on other biologic therapy (infliximab, adalimumab, certolizumab, golimumab, ustekinumab) with concomitant immunomodulator therapy (methotrexate, azathioprine, or 6-mercaptopurine) and receivePneumococcal Pneumonia vaccine and/or Influenza vaccine and/or Hepatitis B vaccine.
non-immunosuppressive therapy
IBD patients not taking any immunosuppressive therapy (these patients may be taking oral or topical 5-aminosalicylates) and recive Pneumococcal Pneumonia vaccine and/or Influenza vaccine and/or Hepatitis B vaccine.
Interventions
Vaccination for pneumococcal pneumonia will be carried out with either the PSV-23 (Pneumovax, Merck, Whitehouse Station, NJ) or the PCV-13 (Prevnar 13, Pfizer, Philadelphia, PA). Either vaccine is administered in a single dose of 0.5 mL intramuscularly.
Influenza vaccination will be carried out with the 2017-2018 trivalent component vaccine (Afluria, Seqirus USA Inc., King of Prussia, PA) or for patients over 65 years of age (Fluzone, Sanofi Pasteur, Swiftwater, PA). Both of these vaccines are administered in a single dose of 0.5 mL intramuscularly.
Hepatitis B vaccination with be carried out with a single antigen, recombinant hepatitis B vaccine (Energix B, GlaxoSmithKline, Research Triangle Park, NC). This vaccine is administered in a three dose series with 1.0 mL given intramuscularly at 0, 1, and 6 months. For patients receiving a booster, a single intramuscular dose of 1.0 mL will be given.
Eligibility Criteria
Adult patients aged 18-75 with IBD (diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria) receiving care at Boston Medical Center, Center for Digestive Disorders.
You may qualify if:
- Adult patients aged 18-75 with IBD (diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria) receiving care at Boston Medical Center, Center for Digestive Disorders.
- Patients receiving one of the following treatments for their IBD - vedolizumab monotherapy, combination treatment with vedolizumab and concomitant immunomodulator therapy (methotrexate, azathioprine, or 6-mercaptopurine), combination treatment with a TNF inhibitor and concomitant immunomodulator therapy (methotrexate, azathioprine, or 6-mercaptopurine), or no immunosuppressive therapy (these patients may be taking oral or topical 5-aminosalicylates). Patients in all groups should have been on stable treatment for IBD for at least three months.
You may not qualify if:
- Any patients with prior vaccination with the intended vaccine, with the exception of those receiving a hepatitis B booster.
- Any patient with an allergy to the vaccine components.
- Patients who cannot provide informed consent.
- Patients who are being administered any non-licensed or experimental immunomodulators
- Patients taking steroids orally or intravenously (more than 20mg prednisone or equivalent dose of other corticosteroids) for at least 10 days, within the 30 days prior to vaccination.
- Patients who have received immunoglobulin therapy or blood products within the past one month.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Medical Center
Boston, Massachusetts, 02118, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharmeel K Wasan, MD
Boston Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2017
First Posted
February 17, 2017
Study Start
July 5, 2017
Primary Completion
January 15, 2019
Study Completion
January 15, 2019
Last Updated
December 30, 2019
Record last verified: 2019-12