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Special populations are people with a risk to dévelop severe forms of a disease. The immunogenicity and efficacy of vaccines in this population may be different compared of the general population.
For Covid-19, special populations are people with chronic diseases (obesity, diabetes, cancer, etc.) and / or immunocompromised and / or elderly. It is therefore important that the safety of new vaccines as well as their efficacy be evaluated.
Thus, in cancer, most immunosuppressions and immunosuppressive treatments (in particular chemotherapy or certain targeted therapies) risk negatively impacting the effectiveness of the anti-SARS-COV-2 vaccine both for the humoral immune responses (antibodies ) and cellular (T lymphocytes). These patients may develop an insufficient post-vaccination immunity. However, it seems that immunosenescence (ie the aging of the immune system) has little impact on the effectiveness of mRNA vaccines and viral vector vaccines.
The Canserovax study evaluates the impact of anticancer treatments on the quality of the humoral (development of antibodies) and cellular (development of a specific T response) immune response to SARS-CoV-2 in patients treated for cancer after vaccination. It is carried out in patients undergoing treatment and in subjects not suffering from cancer, and not treated for this pathology (vaccinated salaried staff of a french cancer center). The aim is to qualitatively and quantitatively compare the post-vaccination immune responses in these 2 populations.
The main objective of this study is to describe after anti-SARS-CoV-2 vaccination the humoral immune response against the virus (assay of anti-SARS-CoV-2 antibodies to detect the presence and intensity of humoral immune responses) and the cellular response against the virus (specific T response).
Several cohorts are studied:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vaccined salaried staff (group 1) | Other | vaccined salaried staff group (Distinction between
|
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| non vaccined salaried staff (group 2 - witnesses) | Other | non vaccined salaried staff group wtih positive SARS-CoV-2 |
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| vaccined patients (group 3) | Other | vaccined patient group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| serology and ELISPOT test | Biological | 27 mL blood sample to study the humoral and the cellular immune response |
|
| Measure | Description | Time Frame |
|---|---|---|
| seroprevalence of SARS-CoV-2 and ELISPOT | rate of specific SARC-Cov-2 IgM and IgG and Human IFN-γ SARS-CoV-2 ELISpot | through study completion, an average of 1 year |
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Inclusion Criteria :
Group 1
Group 2
Group 3
Patient over 18 years of age treated in Oncology at the GF Leclerc center for:
Patient vaccinated against SARS-CoV-2 for at least 1 month (last injection), AND less than 4 months (last injection) with a vaccination performed when the anti-cancer treatment had been started for at least 1 month (last injection) ) (see diagram below)
Patient having signed the informed consent for the study
Patient affiliated to the social security scheme
Exclusion Criteria:
Groups 1, 2 and 3
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Georges Francois Leclerc | Dijon | 21079 | France |
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| serology | Biological | 7 mL blood sample to study the humoral response |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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