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

CompletedOBSERVATIONAL
Enrollment

173

Participants

Timeline

Start Date

July 5, 2017

Primary Completion Date

January 15, 2019

Study Completion Date

January 15, 2019

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.

Trial Locations (1)

02118

Boston Medical Center, Boston

Sponsors
All Listed Sponsors
lead

Boston Medical Center

OTHER