Centre Georges Francois Leclerc
Dijon, 21079, France
NCT Number: NCT04935528
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.
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Notify MeThe 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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Group 1
Group 2
Group 3
Exclusion criteria
Groups 1, 2 and 3
27 mL blood sample to study the humoral and the cellular immune response
7 mL blood sample to study the humoral response
Time frame: through study completion, an average of 1 year
rate of specific SARC-Cov-2 IgM and IgG and Human IFN-γ SARS-CoV-2 ELISpot
Centre Georges Francois Leclerc
Other
Study of Mechanisms of Anti COVID-19 Humoral and Cellular Immune Response Between 1 and 3 Months After Vaccination in a Sample of Patients and Salaried Staff From a French Anti-cancer Center
Acronym: CANSEROVAX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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