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

The purpose of this study is to determine immune response rates to (a) influenza, (b) pneumococcal, and (c) hepatitis B vaccines in IBD patients receiving vedolizumab therapy compared to patients on other therapies for IBD.

Four study groups will be established -- 1. Group A - IBD patients on vedolizumab monotherapy. 2. Group B - IBD patients receiving combination treatment with vedolizumab and concomitant immunomodulator therapt (methotrexate, azathioprine, or 6-mercaptopurine). 3. Group C - IBD patients on other biologic therapy (infliximab, adalimumab, certolizumab, golimumab, and ustekinumab). 4. Group D - IBD patients not taking any immunosuppressive therapy. Patients in all groups should have been on stable treatment for IBD for at least three months.

For each of the four vaccines included in this study (influenza, PCV-13, PSV-23, hepatitis B), a total of 220 samples will be collected. Given that more than one of these vaccines may be clinically indicated for an individual patient, a single patient may receive more than one vaccine, and therefore can be included in the immune response analysis for each vaccine they receive.

Once the subject has signed consent and enrolled in the study, the following procedures will take place:

Baseline/enrollment visit: The subject will have a comprehensive medical history and physical exam performed at their baseline clinic visit. During this visit they will also fill out the 10 question IBD quality of life questionnaire, a baseline serum sample will be obtained, and then receive the vaccine(s) indicated based on their vaccination history. These vaccines include, for pneumococcal pneumonia - PSV-23 and PCV-13 (both given as a single dose of 0.5 mL intramuscularly in the deltoid region of the upper arm), for influenza - Afluria or Fluzone for patients over 65 year of ago (both given as a single dose of 0.5 mL intramuscularly in the deltoid region of the upper arm), and for hepatitis B - Energix (administered in a three dose series with 1.0 mL given at 0, 1, and 6 months, or for patients receiving a booster a single intramuscular dose of 1.0 mL will be given). Subjects will be instructed to call the study team for any concerns or any development of fever, chills, rash or other concerning symptom.

Follow up phone call: Subjects will receive a follow-up phone call 2 weeks after vaccination to identify any adverse effects including fevers or chills, rash, and visits to the emergency room or to their primary care physicians.

Follow up visit: At 3-4 weeks after vaccination, patients will have a visit where serum will again be obtained. Patients will also be asked about any adverse events such as fevers or vaccine reactions, as well as complete the 10 question IBD quality of life questionnaire (IBDQ).