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
調査の概要
状態
条件
詳細な説明
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).
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02118
- Boston Medical Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
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.
他の名前：
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.
他の名前：
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.
他の名前：
|
|
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.
他の名前：
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.
他の名前：
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.
他の名前：
|
|
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.
|
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.
他の名前：
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.
他の名前：
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.
他の名前：
|
|
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.
|
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.
他の名前：
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.
他の名前：
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rate of immune seroconversion after influenza, pneumococcal, or hepatitis B vaccine among the four groups of patients
時間枠：baseline and 3 - 4 weeks
|
The primary outcome is percent change in IgG titer from baseline to 3 weeks post vaccination.
|
baseline and 3 - 4 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Sharmeel K Wasan, MD、Boston Medical Center
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。