Immune response to Covid-19 vaccination of patients with immune modulatory treatment for cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age 18 years or older Treatment for cancer within 6 month with CD20-depleting therapy and/or check-point inhibitors and/or chemotherapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: Unable to give informed consent Subject is not eligible to receive Covid-19 vaccine according to current reccommendations from the Public Health Agency of Sweden. Subject has a known hypersensitivity to the active substance or to any of the components of the investigational medical product, as specified in the product’s Summary of Product Characteristics, SmPC . Estimated life expectancy of less than three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the immunological response to Covid-19 vaccines in cancer patients treated with CD20 depleting therapy, check point inhibitors and/or chemotherapy;Secondary Objective: To determine the incidence and severity of Covid-19 infection after Covid-19 vaccination in cancer patients treated with CD20 depleting therapy, check point inhibitors and/or chemotherapy;Primary end point(s): SARS-CoV2 specific immunoglobulin responses SARS-CoV2-antigen induced T cell responses ;Timepoint(s) of evaluation of this end point: 1, 3, 6, 9, 12 months after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Incidence and severity of Covid-19 infection after vaccination ;Timepoint(s) of evaluation of this end point: 12 and 24 month after vaccination | — |
Countries
Sweden
Contacts
Department of Oncology, Uppsala University Hospita