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Immunogenicity of Influenza, Pneumococcal and Hepatitis B Vaccines in IBD Patients Treated With Vedolizumab

NCT03056924 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 173

Last updated 2019-12-30

No results posted yet for this study

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.

Conditions

  • Inflammatory Bowel Diseases

Interventions

BIOLOGICAL

Pneumococcal Pneumonia vaccine

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.

BIOLOGICAL

Influenza vaccine

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.

BIOLOGICAL

Hepatitis B vaccine

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.

Sponsors & Collaborators

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Sharmeel K Wasan, MD · Boston Medical Center

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-05
Primary Completion
2019-01-15
Completion
2019-01-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03056924 on ClinicalTrials.gov