Monitoring of the Post-vaccination Immune Response to COVID-19 Among Hospital Staff (COVIDIM)
21 de mayo de 2021 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
- 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:
- Five visits over 21 months, 6 over 24 months for the subgroup included on the day of vaccination
- 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
- A self-questionnaire to update clinical data if necessary during the following visits
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.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
300
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Aura
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Clermont-Ferrand, Aura, Francia, 63000
- Reclutamiento
- Clermont-Ferrand University Hospital
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Investigador principal:
- Cécile Henquell
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Monitoring of the immune response
Immune response controlled with blood sample at 3, 6, 12, 18 and 24 months
|
Blood sample at 3,6,12,18 and 24 months in order to assess the blood level of anti-S1 / RBD anticoprs
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
the blood level of anti-S1 / RBD antibodies
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
relationship between the level of antibodies detected by serological tests (ELISA) and the antibodies titrated using an in vitro neutralization test
Periodo de tiempo: 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.
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3 months, 6 months, 12 months, 18 months, 24 months
|
|
anti-S lymphocyte response induced by the anti-COVID-19 vaccine
Periodo de tiempo: 3 months, 6 months, 12 months, 18 months, 24 months
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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).
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3 months, 6 months, 12 months, 18 months, 24 months
|
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effect of age on immune response
Periodo de tiempo: 3 months, 6 months, 12 months, 18 months, 24 months
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Study the effect of age on the various immune parameters studied, in general and in their temporal course
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3 months, 6 months, 12 months, 18 months, 24 months
|
|
Intensity of immune response according to different comorbidities
Periodo de tiempo: 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
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3 months, 6 months, 12 months, 18 months, 24 months
|
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Intensity of immune response according to a previous COVID-19 infection or not
Periodo de tiempo: 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
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3 months, 6 months, 12 months, 18 months, 24 months
|
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Intensity of immune response according to the type of vaccine administered
Periodo de tiempo: 3 months, 6 months, 12 months, 18 months, 24 months
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Study the effect of the type of vaccine administered on the various immune parameters studied, in general and in their temporal course
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3 months, 6 months, 12 months, 18 months, 24 months
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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
Periodo de tiempo: Day 1
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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
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Day 1
|
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genomic characteristics of the strain of SARS-CoV-2 in case of proven COVID-19 infection during follow-up
Periodo de tiempo: up to 24 months
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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).
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up to 24 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
19 de mayo de 2021
Finalización primaria (Anticipado)
1 de noviembre de 2023
Finalización del estudio (Anticipado)
1 de mayo de 2024
Fechas de registro del estudio
Enviado por primera vez
18 de mayo de 2021
Primero enviado que cumplió con los criterios de control de calidad
19 de mayo de 2021
Publicado por primera vez (Actual)
21 de mayo de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de mayo de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
21 de mayo de 2021
Última verificación
1 de mayo de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RBHP 2021 HENQUELL
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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