Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients (COVATRANS)
Vaccination against SARS CoV-2 appears to be the best strategy today to control the COVID-19 pandemic. The first published studies with Pfizer, Moderna and Astra-Zeneca vaccines show very good vaccine protection in the general population and good short-term tolerance. The efficacy of these vaccines ranges from 62 to 95%, which is particularly remarkable, especially for mRNA vaccines. Nevertheless, these studies do not report the vaccine response in organ transplant patients.
It is known that transplant patients have lower vaccine responses than immunocompetent patients due to some degree of immunosuppression.
Therefore, the investigators are interested in evaluating the vaccine response of organ transplant recipients after vaccination against SARS- CoV-2. For non-responder patients, new strategies can be proposed: 3rd or 4th boost of vaccine or perfusion/injection of antiS monoclonal antibodies. These strategies must be evaluated.
調査の概要
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Strasbourg、フランス、67000
- 募集
- Hôpitaux Universitaires de Strasbourg
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コンタクト：
- Sophie Ohlmann, MD
- 電話番号：33 0369551320
- メール：sophie.ohlmann@chru-strasbourg.fr
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
- Patient, male or female, adult or child (15 years and older)
- Patient vaccinated against SARS-CoV-2 as part of routine care, and having received the 2 injections
- Solid organ transplant recipient
- Transplantation for more than 3 months
Exclusion Criteria:
- History of anaphylactic shock or known allergy to PEG
- Known history of COVID or positive Covid serology in the 3 months preceding inclusion
- Formal contraindication to an intra-muscular injection
- Impossibility to give the subject informed information (subject in emergency situation, difficulties in understanding the subject, ...)
- Subject under legal protection
- Subject under guardianship or curatorship
- Patient having expressed his opposition to participate
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 |
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Kidney transplant recipients who receive Covid-19 vaccine
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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 |
時間枠 |
|---|---|
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Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies
時間枠：One month after the 2nd injection of the COVID-19 vaccine
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One month after the 2nd injection of the COVID-19 vaccine
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Compare the seroconversion between different vaccines
時間枠：At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine
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At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine
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Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies
時間枠：At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine and at Month 1 after the 3rd and 4th injection.
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At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine and at Month 1 after the 3rd and 4th injection.
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Describe the patients characteristics associated with seroconversion
時間枠：At Month 24 after the 2nd injection of the COVID-19 vaccine
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At Month 24 after the 2nd injection of the COVID-19 vaccine
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Assess the tolerance of the 3rd and 4th doses of vaccine in transplant patients
時間枠：At the day of injection, Month 1, Month 2, Month 3, Month 6 and Month 12 post injection
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At the day of injection, Month 1, Month 2, Month 3, Month 6 and Month 12 post injection
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Percentage of patients who develop a Seroconversion for SARS Cov-2 anti Spike and anti N antibodies after injection of monoclonal antibodies
時間枠：At Month 1, Week 6, Week 8, Month 3, Month 6 and Month 12 afin injection of monoclonal antibodies
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At Month 1, Week 6, Week 8, Month 3, Month 6 and Month 12 afin injection of monoclonal antibodies
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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 (実際)
一次修了 (予想される)
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 (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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 8133
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
COVID19の臨床試験
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Ricardo Pereira MestreInstitute of Oncology Research (IOR); Istituto Cantonale di Patologia完了
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Instituto de Investigación Hospital Universitario...Instituto de Salud Carlos III; Spanish Clinical Research Network - SCReN積極的、募集していない
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Inmunova S.A.Hospital Italiano de Buenos Aires; Laboratorio Elea Phoenix S.A.; Hospital de Campaña Escuela... と他の協力者完了
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Manchester University NHS Foundation TrustUniversity of Manchester完了
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Rush University Medical CenterHospital Civil de Guadalajara完了
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Sinovac Research and Development Co., Ltd.完了
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Mabwell (Shanghai) Bioscience Co., Ltd.Shanghai Public Health Clinical Center完了