An interventional study of Monitoring of the immune response in Hospital Staff and Vaccined Againt COVID-19, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-24.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Prevention
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.
The study includes:
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
Immune response controlled with blood sample at 3, 6, 12, 18 and 24 months
Biological: 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
the blood level of anti-S1 / RBD antibodies
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.
Time frame: 3 months
the blood level of anti-S1 / RBD antibodies
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.
Time frame: 6 months
the blood level of anti-S1 / RBD antibodies
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.
Time frame: 12 months
the blood level of anti-S1 / RBD antibodies
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.
Time frame: 24 months
relationship between the level of antibodies detected by serological tests (ELISA) and the antibodies titrated using an in vitro neutralization test
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.
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months
anti-S lymphocyte response induced by the anti-COVID-19 vaccine
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).
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months
effect of age on immune response
Study the effect of age on the various immune parameters studied, in general and in their temporal course
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months
Intensity of immune response according to different comorbidities
Study the effect of comorbidities on the various immune parameters studied, in general and in their temporal course
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months
Intensity of immune response according to a previous COVID-19 infection or not
Study the effect of a previous COVID-19 infection on the various immune parameters studied, in general and in their temporal course
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months
Intensity of immune response according to the type of vaccine administered
Study the effect of the type of vaccine administered on the various immune parameters studied, in general and in their temporal course
Time frame: 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
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
Time frame: Day 1
genomic characteristics of the strain of SARS-CoV-2 in case of proven COVID-19 infection during follow-up
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).
Time frame: up to 24 months
This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand