Cancer Clinical Trial
— IVACOVOfficial title:
Pharmaco-epidemiological Study of COVID 19 Vaccines in Patients Undergoing Immunotherapy for Cancer. A Retrospective Open Cohort Study.
The investigators wish to set up a pharmaco-epidemiological cohort within the Hospital Territorial Groups of the Cévennes-Gard Camargue, East-Hérault and Haute-Garonne and West Tarn on a specific population, patients undergoing immunotherapy for cancer, as currently there is no data available under "real life" conditions following anti-COVID vaccination19. The hypothesis is that patients undergoing immunotherapy will not develop more vaccine-related adverse events than those observed in the efficacy and safety validation studies of the BNT162b2 mRNA Covid-19, mRNA-1273 SARS CoV-2, Oxford/AstraZeneca and Ad26COV2.S, JMJ Vaccine or J & J COVID-19 Vaccine.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | June 1, 2024 |
Est. primary completion date | January 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient having been vaccinated or eligible for inoculation with one of the available anti-COVID19 vaccines (except live attenuated virus) while they were or are undergoing immunotherapy with anti-PD1, anti-PDL1 or anti-CTLA4 immunotherapy whatever the tumor (solid, liquid) managed within the medical oncology services of the Occitanie region. - Patients affiliated to or beneficiaries of a health insurance scheme. - Patients who have received written and oral information about the study and who have no objection to participation. - Adult patients (= 18 years). Exclusion Criteria: - Patients who have been vaccinated with a live attenuated vaccine. - Patients with a contraindication to inclusion (including hypersensitivity to the active substance or to one of the excipients, COVID+ PCR test in the last 3 months). - Minor patients, pregnant women, parturients, nursing mothers, persons in nursing mothers, persons in emergency situations, persons unable to persons unable to express their consent and persons under persons under court protection, subguardianship or subguardianship may not be included in this research. - Patients in an exclusion period determined by another study. - Patients for whom it is impossible to give clear information. - Patients who have expressed an objection to participating in the study. |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier d'Albi | Albi | |
France | Clinique Claude Bernard | Albi | |
France | Centre Hospitalier d'Alès | Alès | |
France | CH d'Auch | Auch | |
France | CH de Bagnols sur Cèze | Bagnols-sur-Cèze | |
France | CH de Cahors | Cahors | |
France | Clinique des Cèdres - Capio | Cornebarrieu | |
France | Institut de Cancer de Montpellier | Montpellier | |
France | Clinique La Croix du Sud | Quint-Fonsegrives | |
France | Centre Hospitalier COMMINGES PYRENEES | Saint-Gaudens | |
France | Centre Hospitalier du bassin de Thau | Sete | |
France | CH de Bigorre | Tarbes Cedex 9 | |
France | Centre Hospitalier de Toulouse | Toulouse |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes | Centre Hospitalier Ales, CENTRE HOSPITALIER COMMINGES PYRENEES, Centre Hospitalier d'Albi, Centre Hospitalier d'Auch, Centre Hospitalier de Bagnols-sur-Cèze, Centre Hospitalier de Bigorre - Tarbes, Centre Hospitalier de Cahors, Centre Hospitalier du Bassin de Thau, Centre Hospitalier Intercommunal de Castres, Clinique Claude Bernard, Albi, Clinique La Croix du Sud Quint-Fonsegrives, Clinique Les Cèdres Cornebarrieu, Institut du Cancer de Montpellier - Val d'Aurelle, University Hospital, Montpellier, University Hospital, Toulouse |
France,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Sex of patients | Male/Female | Day 0 | |
Other | Age of patients | In years | Day 0 | |
Other | Weight of patients | In kilograms | Day 0 | |
Other | Height of patients | In centimeters | Day 0 | |
Other | Patients' WHO status | The clinical status on the WHO COVID-19 ordinal scale. The WHO ordinal scale ranges from 0 to 8 in which 0 = no COVID-19 infection and 8 = death | Day 0 | |
Other | Type of cancer and its location | The type of cancer and its location will be recorded | Day 0 | |
Other | Treatment type | The type of treatment will be recorded | Day 0 | |
Other | Therapeutic line | The therapeutic line will be noted | Day 0 | |
Other | Other vaccinations | All vaccinations received other than anti-COVID-19 in the previous 6 months will be recorded. | Day 0 | |
Other | Lymphocyte count | A lymphocyte count will be made at the time of vaccination and measured as the number of cells/µL | Day 0 | |
Other | COVID-19 serology test | A COVID-19 serology test will be made and COVID-19-specific antibodies will be measured in µg/mL | Day 0 | |
Primary | Tolerance of immunotherapy following anti-COVID-19 vaccination | All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded. | 24 hours after the vaccination | |
Primary | Tolerance of immunotherapy following anti-COVID-19 vaccination | All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded. | 48 hours after the vaccination | |
Primary | Tolerance of immunotherapy following anti-COVID-19 vaccination | All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded. | 8 days after the vaccination | |
Primary | Tolerance of immunotherapy following anti-COVID-19 vaccination | All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded. | 24 hours after the following vaccination | |
Primary | Tolerance of immunotherapy following anti-COVID-19 vaccination | All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded. | 48 hours after the following vaccination | |
Primary | Tolerance of immunotherapy following anti-COVID-19 vaccination | All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded. | 8 days after the following vaccination | |
Primary | Tolerance of immunotherapy following anti-COVID-19 vaccination | All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded. | 1 month after the following vaccination | |
Primary | Tolerance of immunotherapy following anti-COVID-19 vaccination | All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded. | 3 months after the following vaccination | |
Primary | Tolerance of immunotherapy following anti-COVID-19 vaccination | All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded. | 6 months after the following vaccination | |
Secondary | A. Tolerance of immunotherapy after anti-COVID-19 vaccination | Any adverse events related to the immunotherapy qualified as Grade =3 according to the Common Terminology Criteria for Adverse Events classification (NCI CTCAE V5.0) will be recorded. | 24 hours after the vaccination | |
Secondary | A. Tolerance of immunotherapy after anti-COVID-19 vaccination | Any adverse events related to the immunotherapy qualified as Grade =3 according to the Common Terminology Criteria for Adverse Events classification (NCI CTCAE V5.0) will be recorded. | 48 hours after the vaccination | |
Secondary | A. Tolerance of immunotherapy after anti-COVID-19 vaccination | Any adverse events related to the immunotherapy qualified as Grade =3 according to the Common Terminology Criteria for Adverse Events classification (NCI CTCAE V5.0) will be recorded. | 8 days after the vaccination | |
Secondary | A. Tolerance of immunotherapy after anti-COVID-19 vaccination | Any adverse events related to the immunotherapy qualified as Grade =3 according to the Common Terminology Criteria for Adverse Events classification (NCI CTCAE V5.0) will be recorded. | 24 hours after the following vaccination | |
Secondary | A. Tolerance of immunotherapy after anti-COVID-19 vaccination | Any adverse events related to the immunotherapy qualified as Grade =3 according to the Common Terminology Criteria for Adverse Events classification (NCI CTCAE V5.0) will be recorded. | 48 hours after the following vaccination | |
Secondary | A. Tolerance of immunotherapy after anti-COVID-19 vaccination | Any adverse events related to the immunotherapy qualified as Grade =3 according to the Common Terminology Criteria for Adverse Events classification (NCI CTCAE V5.0) will be recorded. | 1 month after the following vaccination | |
Secondary | A. Tolerance of immunotherapy after anti-COVID-19 vaccination | Any adverse events related to the immunotherapy qualified as Grade =3 according to the Common Terminology Criteria for Adverse Events classification (NCI CTCAE V5.0) will be recorded. | 3 months after the following vaccination | |
Secondary | A. Tolerance of immunotherapy after anti-COVID-19 vaccination | Any adverse events related to the immunotherapy qualified as Grade =3 according to the Common Terminology Criteria for Adverse Events classification (NCI CTCAE V5.0) will be recorded. | 6 months after the following vaccination | |
Secondary | B.Response to vaccine: dosage of anti-Spike antibodies (ELISA) | Quantification of anti-Spike IgG by ELISA. | Day 0 | |
Secondary | B.Response to vaccine: dosage of anti-RBD antibodies (ELISA) | Quantification of anti-RBD IgG by ELISA. | Day 0 | |
Secondary | B. Response to vaccine: Lymphocyte count by Quantiferon | Lymphocytes will be measured in µg/ml | Day 0 | |
Secondary | B. Response to vaccine: dosage of anti-Spike antibodies (ELISA) | Quantification of anti-Spike IgG by ELISA. | 1 month after the injection | |
Secondary | B. Response to vaccine: dosage of anti-RBD antibodies (ELISA) | Quantification of anti-RBD IgG by ELISA. | 1 month after the injection | |
Secondary | B. Response to vaccine: Lymphocyte count by Quantiferon | Lymphocytes will be measured in µg/ml | 1 month after the injection | |
Secondary | B. Response to vaccine: dosage of anti-spike antibodies (ELISA) | Quantification of anti-Spike IgG by ELISA. | 1 month after the following injection | |
Secondary | B. Response to vaccine: dosage of anti-RBD antibodies (ELISA) | Quantification of anti-RBD IgG by ELISA. | 1 month after the following injection | |
Secondary | B. Response to vaccine: Lymphocyte count by Quantiferon | Lymphocytes will be measured in µg/ml | 1 month after the following injection | |
Secondary | B. Response to vaccine: dosage of anti-spike antibodies (ELISA) | Quantification of anti-Spike IgG by ELISA. | 3 months after the following injection | |
Secondary | B. Response to vaccine: dosage of anti-RBD antibodies (ELISA) | Quantification of anti-RBD IgG by ELISA. | 3 months after the following injection | |
Secondary | B. Response to vaccine: Lymphocyte count by Quantiferon | Lymphocytes will be measured in µg/ml | 3 months after the following injection | |
Secondary | B. Response to vaccine: dosage of anti-spike antibodies (ELISA) | Quantification of anti-Spike IgG by ELISA . | 6 months after the following injection | |
Secondary | B. Response to vaccine: dosage of anti-RBD antibodies (ELISA) | Quantification of anti-RBD IgG by ELISA . | 6 months after the following injection | |
Secondary | B. Response to vaccine: Lymphocyte count by Quantiferon | Lymphocytes will be measured in µg/ml | 6 months after the following injection | |
Secondary | C. Efficacy of vaccination against the incidence of COVID-19 | The efficacy of vaccination against the incidence of COVID-19 will be evaluated based on the main clinical symptoms noted and a PCR test. Qualitative: YES/NO | 1 month after vaccination | |
Secondary | C. Efficacy of vaccination against the incidence of COVID-19 | The efficacy of vaccination against the incidence of COVID-19 will be evaluated based on the main clinical symptoms noted and a PCR test. Qualitative: YES/NO | 3 months after vaccination | |
Secondary | C. Efficacy of vaccination against the incidence of COVID-19 | The efficacy of vaccination against the incidence of COVID-19 will be evaluated based on the main clinical symptoms noted and a PCR test. Qualitative: YES/NO | 6 months after vaccination | |
Secondary | D. Constitution of a biobank | Unused sample aliquots (tube bottoms) at the end of the tests will be kept; constitution of a serum library and an immune bank. Samples will be stored at -80°C (plasma) and -196°C (Peripheral Blood Mononuclear Cells) at the Biological Resource Centre at Nîmes University Hospital. | Up to 6 months after vaccination |
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