COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring (SAPIENZAVAX)
Primary objective:
1. Monitor adverse events (Adverse Event Following Immunization - AEFI) in vaccinated subjects and analyze the associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities.
Secondary objectives:
- Monitor the antibody response in vaccinated subjects and analyze the associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities.
- Assess the quantity (antibody titer) and quality of the anti-Spike immune response induced by vaccination.
- Evaluate the dynamics of the infection and the protective efficacy of the vaccine against infection / disease by studying the incidence and titre of antibodies against Nucleoprotein (N) induced by natural infection;
- Evaluate the neutralizing capacity of sera vs. a panel of sera selected and analyzed in house and in in vitro microneutralization systems with live virus;
- To evaluate the cell-mediated immune response (CMI) to vaccination against SARS-CoV-2 in a subgroup of vaccinees.
Methodology:
- Administration at baseline of a questionnaire for the collection of clinical data.
- Perform a blood sample to measure antibody response in vaccinated subjects
- Administer a questionnaire to evaluate adverse events after vaccination
- Reassess the antibody response 1 month after complete vaccination and 6 and 12 months after the start of vaccination
- An antibody assay will be drawn in a subgroup before subjecting the subject to the vaccine.
- In a subgroup, the blood collected will also be collected in a heparinized tube for the study of cell-mediated immunity.
- In the event that a subject participating in the study presents during the course of the observation the positivity for the molecular research of SARS-CoV-2 RNA to the oro-nasopharyngeal swab, a new sample will be performed and sent to the Istituto Superiore di Sanità for the search for viral variants.
調査の概要
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Stefania Basili, MD
- 電話番号:+393393452523
- メール:stefania.basili@uniroma1.it
研究場所
-
-
-
Roma、イタリア、00161
- 募集
- AOU Policlinico Umberto I
-
コンタクト:
- Stefania Basili, MD
- メール:stefania.basili@uniroma1.it
-
-
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
Subjects (age> 18) booked for anti-SARS-CoV-2 vaccination at the AOU Policlinico Umberto I.
Subjects will include healthcare personnel, medical students and university staff recruited from Sapienza University of Rome and Umberto I university hospital.
説明
Inclusion Criteria:
All subjects vaccinated or to be vaccinated at the AOU Policlinico Umberto I and who will agree to join the study.
Exclusion Criteria:
All subjects who refuse to give consent or who have contraindications to vaccination.
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
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 |
---|---|---|
Adverse Event Following Immunization - AEFI
時間枠:12 months from immunization
|
Adverse events (Adverse Event Following Immunization - AEFI) monitoring in vaccinated subjects and analyze associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities.
|
12 months from immunization
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Antibody response in vaccinated subject
時間枠:1, 3, 6, 12 months from immunization
|
To monitor the antibody response in vaccinated subjects and analyze the associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities.
|
1, 3, 6, 12 months from immunization
|
Anti-Spike immune response
時間枠:1, 3, 6, 12 months from immunization
|
Assess the quantity (antibody titer) and quality of the anti-Spike immune response induced by vaccination.
|
1, 3, 6, 12 months from immunization
|
Anti- Nucleoprotein (N) induced by natural infection evaluation
時間枠:1, 3, 6, 12 months from immunization
|
To assess the dynamics of the infection and the protective efficacy of the vaccine against infection / disease by studying the incidence and titre of antibodies against Nucleoprotein (N) induced by natural infection;
|
1, 3, 6, 12 months from immunization
|
Neutralizing capacity of sera
時間枠:1, 3, 6, 12 months from immunization
|
to evaluate the neutralizing capacity of sera vs. a panel of sera selected and analyzed in house and in in vitro microneutralization systems with live virus
|
1, 3, 6, 12 months from immunization
|
Cell-mediated immune response
時間枠:Time 0 (before immunization) 3, 10, 21, 30 days; 1, 3, 6 months from immunization
|
To evaluate the cell-mediated immune response (CMI) to vaccination against SARS-CoV-2 in a subgroup of vaccinees.
|
Time 0 (before immunization) 3, 10, 21, 30 days; 1, 3, 6 months from immunization
|
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
- COVID19 vaccination_Sapienza
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?
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。
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