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Monitoring of the Post-vaccination Immune Response to COVID-19 Among Hospital Staff (COVIDIM)

2021年5月21日 更新者：University Hospital, Clermont-Ferrand

Vaccination against COVID-19 is a major public health issue to control the epidemic and reduce the number of severe infections and deaths. Three vaccines currently received use authorization in France: two mRNA vaccines and one recombinant viral vector vaccine. Immunogenicity data demonstrate that they induce the development of neutralizing antibodies and IgG directed against the viral S1 protein and the receptor binding domain (RBD). However, there are currently no data on the persistence over time of the humoral response induced by vaccination, and data are still incomplete on cellular immunogenicity. No immune correlate of protection has been established for COVID-19.

In addition, these data come from assays carried out with current vaccines developed against a lineage of SARS-CoV-2 known as wild type (without genetic mutations).

The main objective of this study is to monitor in hospital staff the temporal evolution of humoral immunity induced by anti-COVID-19 vaccines by using enzyme-linked immunosorbent assays (ELISA), at 3, 6, 12 and 24 months after the last injection of vaccine.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

  • All medical, para-medical, medico-technical and administrative staff of the Clermont-Ferrand university hospital will be informed of the protocol through intra-hospital communication. The inclusion visit will be scheduled within 3 months +/- 14 days after the last injection of the vaccine. For volunteers who have not received their first injection, they will be offered to participate in the sub-study including an additional visit on the day of vaccination. They will be free to accept or refuse.
  • As recruitment is consecutive, an anonymous list of potentially eligible subjects (with demographic data: age, sex; nature of the vaccine received) will be kept, in order to verify afterwards if the sample is representative.

  • The study includes:

    1. Five visits over 21 months, 6 over 24 months for the subgroup included on the day of vaccination
    2. An interview with an investigator during the first visit, to collect the following data: hospital function, age, sex, weight, height, possible comorbidities exposing to a serious COVID-19 infection, possible COVID-19 infection prior to vaccination, date of vaccination and type of vaccine
    3. A self-questionnaire to update clinical data if necessary during the following visits

    4. A blood test at each visit, i.e. 2 tubes of 5 mL (antibody assays) and 4 tubes of 1 mL (cellular immunity assay).

      Blood samples will be stored at -80°C, before destruction at the end of the study.

  • In the case of suspecting symptoms of COVID-19 during follow-up, molecular testing of SARS-CoV-2 infection will be offered and performed from nasopharyngeal swab or saliva sample.

研究の種類

介入

入学 (予想される)

300

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • フランス
    • Aura
      • Clermont-Ferrand、Aura、フランス、63000
        • 募集
        • Clermont-Ferrand University Hospital
        • 主任研究者：
          • Cécile Henquell

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～65年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Adult person, man or woman, staff of the Clermont-Ferrand University Hospital (medical or paramedical, medico-technical or administrative caregiver), having received the second dose of vaccine (or the single dose if the single-dose vaccination schedule) against COVID- 19 3 months +/- 15 days before the inclusion visit, as part of the national vaccination campaign, regardless of the type of vaccine administered.
  • For the subgroup included before vaccination (study of the pre-vaccination cellular response): Adult person, man or woman, staff of Clermont-Ferrand University Hospital (medical or paramedical, medico-technical or administrative caregiver), receiving the 1st injection on the same day or in the 7 days before the inclusion visit, regardless of the type of vaccine administered
  • Commitment to respect the schedule of visits provided for in the research protocol
  • Able to give informed consent to participate in research
  • Affiliation to a social security scheme

Exclusion Criteria:

  • Pregnancy or breastfeeding in progress at inclusion, or planned during follow-up
  • Person under guardianship, guardianship or legal protection
  • Whether the vaccine received was experimental or not authorized
  • Refusal of participation

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
他の：Monitoring of the immune response
Immune response controlled with blood sample at 3, 6, 12, 18 and 24 months
生物学的：Monitoring of the immune response
Blood sample at 3,6,12,18 and 24 months in order to assess the blood level of anti-S1 / RBD anticoprs

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
the blood level of anti-S1 / RBD antibodies
時間枠：3 months
temporal evolution of humoral immunity induced by the anti-COVID-19 vaccine, at 3, 6, 12 and 24 months after the second injection (or the single injection if single dose vaccination schedule), using two quantitative enzyme-linked immunosorbent assays (ELISA) targeting anti-S1 and anti-RBD antibodies.
3 months
the blood level of anti-S1 / RBD antibodies
時間枠：6 months
temporal evolution of humoral immunity induced by the anti-COVID-19 vaccine, at 3, 6, 12 and 24 months after the second injection (or the single injection if single dose vaccination schedule), using two quantitative enzyme-linked immunosorbent assays (ELISA) targeting anti-S1 and anti-RBD antibodies.
6 months
the blood level of anti-S1 / RBD antibodies
時間枠：12 months
temporal evolution of humoral immunity induced by the anti-COVID-19 vaccine, at 3, 6, 12 and 24 months after the second injection (or the single injection if single dose vaccination schedule), using two quantitative enzyme-linked immunosorbent assays (ELISA) targeting anti-S1 and anti-RBD antibodies.
12 months
the blood level of anti-S1 / RBD antibodies
時間枠：24 months
temporal evolution of humoral immunity induced by the anti-COVID-19 vaccine, at 3, 6, 12 and 24 months after the second injection (or the single injection if single dose vaccination schedule), using two quantitative enzyme-linked immunosorbent assays (ELISA) targeting anti-S1 and anti-RBD antibodies.
24 months

二次結果の測定

結果測定
メジャーの説明
時間枠
relationship between the level of antibodies detected by serological tests (ELISA) and the antibodies titrated using an in vitro neutralization test
時間枠：3 months, 6 months, 12 months, 18 months, 24 months
Comparison of the humoral response evaluated by serological tests with that analysed by neutralisation in vitro, on pairs of samples chosen to cover the variability of the response induced by vaccination between M3 and M24.
3 months, 6 months, 12 months, 18 months, 24 months
anti-S lymphocyte response induced by the anti-COVID-19 vaccine
時間枠：3 months, 6 months, 12 months, 18 months, 24 months
Cellular immune response induced by the anti-COVID-19 vaccine evaluated by the anti-S lymphocyte response reflected by the determination of IFN-γ at the 3rd, 6th, 12th, 18th and 24th months after the second injection of vaccine (or the single injection if scheme single dose vaccine).
3 months, 6 months, 12 months, 18 months, 24 months
effect of age on immune response
時間枠：3 months, 6 months, 12 months, 18 months, 24 months
Study the effect of age on the various immune parameters studied, in general and in their temporal course
3 months, 6 months, 12 months, 18 months, 24 months
Intensity of immune response according to different comorbidities
時間枠：3 months, 6 months, 12 months, 18 months, 24 months
Study the effect of comorbidities on the various immune parameters studied, in general and in their temporal course
3 months, 6 months, 12 months, 18 months, 24 months
Intensity of immune response according to a previous COVID-19 infection or not
時間枠：3 months, 6 months, 12 months, 18 months, 24 months
Study the effect of a previous COVID-19 infection on the various immune parameters studied, in general and in their temporal course
3 months, 6 months, 12 months, 18 months, 24 months
Intensity of immune response according to the type of vaccine administered
時間枠：3 months, 6 months, 12 months, 18 months, 24 months
Study the effect of the type of vaccine administered on the various immune parameters studied, in general and in their temporal course
3 months, 6 months, 12 months, 18 months, 24 months
the cellular immune response directed against the Spike peptides of T lymphocytes before vaccination, between D-7 and the day of the 1st injection of vaccine
時間枠：Day 1
Pre-vaccine anti-S cellular immune response reflected by the IFN-γ assay, for a subgroup of 50 volunteers then benefiting from the same follow-up until the 24th month
Day 1
genomic characteristics of the strain of SARS-CoV-2 in case of proven COVID-19 infection during follow-up
時間枠：up to 24 months
Clinical description of subjects presenting with COVID-19 infection during follow-up, and genomic characteristics of their strain of SARS-CoV-2 by whole genome sequencing (next-generation sequencing).
up to 24 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University Hospital, Clermont-Ferrand

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年5月19日

一次修了 (予想される)

2023年11月1日

研究の完了 (予想される)

2024年5月1日

試験登録日

最初に提出

2021年5月18日

QC基準を満たした最初の提出物

2021年5月19日

最初の投稿 (実際)

2021年5月21日

学習記録の更新

投稿された最後の更新 (実際)

2021年5月24日

QC基準を満たした最後の更新が送信されました

2021年5月21日

最終確認日

2021年5月1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

  • RBHP 2021 HENQUELL

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

いいえ

米国FDA規制機器製品の研究

いいえ

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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