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

21 maj 2021 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

  • 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.

Studietyp

Interventionell

Inskrivning (Förväntat)

300

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Frankrike
    • Aura
      • Clermont-Ferrand, Aura, Frankrike, 63000
        • Rekrytering
        • Clermont-Ferrand University Hospital
        • Huvudutredare:
          • Cécile Henquell

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: Monitoring of the immune response
Immune response controlled with blood sample at 3, 6, 12, 18 and 24 months
Biologisk: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
the blood level of anti-S1 / RBD antibodies
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
relationship between the level of antibodies detected by serological tests (ELISA) and the antibodies titrated using an in vitro neutralization test
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospital, Clermont-Ferrand

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

19 maj 2021

Primärt slutförande (Förväntat)

1 november 2023

Avslutad studie (Förväntat)

1 maj 2024

Studieregistreringsdatum

Först inskickad

18 maj 2021

Först inskickad som uppfyllde QC-kriterierna

19 maj 2021

Första postat (Faktisk)

21 maj 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 maj 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 maj 2021

Senast verifierad

1 maj 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • RBHP 2021 HENQUELL

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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