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

21 mei 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

  • 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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

300

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Frankrijk
    • Aura
      • Clermont-Ferrand, Aura, Frankrijk, 63000
        • Werving
        • Clermont-Ferrand University Hospital
        • Hoofdonderzoeker:
          • Cécile Henquell

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: Monitoring of the immune response
Immune response controlled with blood sample at 3, 6, 12, 18 and 24 months
Biologisch: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
the blood level of anti-S1 / RBD antibodies
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
relationship between the level of antibodies detected by serological tests (ELISA) and the antibodies titrated using an in vitro neutralization test
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital, Clermont-Ferrand

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

19 mei 2021

Primaire voltooiing (Verwacht)

1 november 2023

Studie voltooiing (Verwacht)

1 mei 2024

Studieregistratiedata

Eerst ingediend

18 mei 2021

Eerst ingediend dat voldeed aan de QC-criteria

19 mei 2021

Eerst geplaatst (Werkelijk)

21 mei 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 mei 2021

Laatste update ingediend die voldeed aan QC-criteria

21 mei 2021

Laatst geverifieerd

1 mei 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • RBHP 2021 HENQUELL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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