Standard Versus High Dose Inactivated Influenza Vaccine in RA (IV-RA)
Improving Influenza Immunization Responses in Rheumatoid Arthritis: A Strategy To Enhance Protection Against A Preventable Cause Of Death In An At Risk Population?
Influenza, a vaccine-preventable respiratory disease, is ranked 8th among the causes of death in the Canadian population. Among rheumatoid arthritis (RA) patients, the incidence of both seasonal influenza and serious influenza-related illness (IRI) are increased. Despite being a high priority group targeted for vaccination, the diagnosis of RA and other patient-specific factors (i.e. older age, treatment, current smoking) are linked to impaired vaccination responses.
Thus the burden of influenza among people with RA is disproportionally high, and interventions to improve responses to influenza vaccination are urgently needed. Strategies to optimize protection in another vulnerable group, the elderly, include the use of quadrivalent vaccines, higher antigen doses, and adjuvants. A high-dose, trivalent, inactivated influenza vaccine (HD-TIV) has recently been shown to have a similar safety profile to standard dose vaccine (SD-TIV) with improved immunogenicity and protection in adults ≥65 years of age. Whether or not analogous strategies to improve responses to influenza vaccine will enhance protection in people with RA is unknown. The investigators hypothesize that the use of the HD-influenza vaccine will improve vaccine-induced protection (i.e. seroconversion and seroprotection) in people with RA compared to SD-influenza vaccine. The investigators propose to conduct a stratified, randomized, modified double blind, active-controlled trial to assess immune responses to two commercial influenza vaccines containing different antigen doses in individuals with RA.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Quebec
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Montreal、Quebec、カナダ、H4A 3J1
- McGill University Health Centre
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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
説明
Inclusion Criteria:
- Diagnosis of seropositive RA (rheumatoid factor (RF) and/or anti-CCP antibody positive) based on the 2010 ACR-EULAR criteria.
- At least 6 months of treatment including anti-TNF agents, abatacept, rituximab (dose received within the previous 6 months) and/or methotrexate.
- Informed consent form signed and dated.
- Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria:
- Vaccination against influenza in the 6 months preceding the trial vaccination.
- Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to TIV or to a vaccine containing any of the same substances.
- History of Guillain-Barré syndrome within six weeks of a previous influenza vaccination.
- Dementia or any other cognitive condition that could interfere with the trial procedures.
- Thrombocytopenia or bleeding disorder contraindicating IM vaccination (according to treating rheumatologist).
- Current alcohol abuse or drug addiction.
- Moderate or severe acute illness with or without fever. If this exists, vaccination will be deferred until the individual has been medically stable and/or afebrile for at least 24 hours.
- Signs and symptoms of an acute infectious respiratory illness. If this exists, vaccination will be deferred until the symptoms resolve.
- Pregnant women (the rationale for excluding this group is not their lack of indication for vaccination but the changes of maternal immune responses during pregnancy)
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
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:Standard dose influenza vaccine
Patients will receive one dose of FLUZONE® Standard Dose Quadrivalent Inactivated Influenza Vaccine (SD-QIV)
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アクティブコンパレータ:High dose influenza vaccine
Patients will receive one dose of FLUZONE® High Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)
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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 |
---|---|---|
Seroconversion rate to HD- versus SD-IV in people with RA
時間枠:Day 28
|
Seroconversion rate (SCR): proportion of subjects in a given treatment group (SD- or HD) with either a ≥4-fold increase in reciprocal HI titres between D0 and D28 or a rise of undetectable HI titre (i.e.
<1:10) pre-vaccination (D0) to an HI titre of ≥1:40 at D28 post vaccination.
|
Day 28
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Seroprotection rate to HD- versus SD-IV in people with RA
時間枠:Day 28
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Seroprotection rate (SPR): the proportion of subjects in a given treatment group attaining a reciprocal HI titre of ≥1:40 at D28 post-vaccination.
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Day 28
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Seroconversion factor in people with RA who received HD- versus SD-IV
時間枠:Day 28
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Seroconversion factor or GMFR: the geometric mean of the ratio of GMTs (D28/ D0).
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Day 28
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Geometric mean titres (GMTs) of HI in people with RA who received HD- versus SD-IV
時間枠:Day 0 and Day 28
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Geometric mean titres (GMTs) of HI at D0 and D28.
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Day 0 and Day 28
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Durability of HI antibody responses for SD- and HD- IV.
時間枠:Day 186
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Day 186
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Rates of side effects during the surveillance period in SD- and HD-IV.
時間枠:Day 28
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Day 28
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その他の成果指標
結果測定 |
時間枠 |
---|---|
Performance of the micro-neutralization assay in comparison to the HI assay.
時間枠:Day 186
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Day 186
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Rates of health care use in patients receiving SD- or HD-IV.
時間枠:Day 186
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Day 186
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協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (予想される)
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 (見積もり)
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- MP-37-2017-2773
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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。
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