- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03056924
Immunogenicity of Influenza, Pneumococcal and Hepatitis B Vaccines in IBD Patients Treated With Vedolizumab
Immunogenicity of Influenza, Pneumococcal and Hepatitis B Vaccines in Inflammatory Bowel Disease Patients Treated With Vedolizumab
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion 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.
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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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.
Other Names:
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.
Other Names:
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.
Other Names:
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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.
|
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.
Other Names:
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.
Other Names:
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.
Other Names:
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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.
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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.
Other Names:
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.
Other Names:
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.
Other Names:
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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.
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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.
Other Names:
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.
Other Names:
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of immune seroconversion after influenza, pneumococcal, or hepatitis B vaccine among the four groups of patients
Time Frame: baseline and 3 - 4 weeks
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The primary outcome is percent change in IgG titer from baseline to 3 weeks post vaccination.
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baseline and 3 - 4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sharmeel K Wasan, MD, Boston Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Gastrointestinal Diseases
- Liver Diseases
- Gastroenteritis
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Hepatitis
- Hepatitis B
- Inflammatory Bowel Diseases
- Intestinal Diseases
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- H-35669
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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