Vaccination Against COVID-19 in Cancer

Summary

Participation Requirements

Description

Rationale: Patients with cancer have an increased risk of adverse outcome of COVID-19, which is determined by their underlying disease and/or cancer treatment. Therefore, vaccination of cancer patients against COVID-19 needs to be prioritized. However, (ongoing) phase III studies, that will be the b...

Rationale: Patients with cancer have an increased risk of adverse outcome of COVID-19, which is determined by their underlying disease and/or cancer treatment. Therefore, vaccination of cancer patients against COVID-19 needs to be prioritized. However, (ongoing) phase III studies, that will be the basis of vaccine registrations, will not provide robust information on efficacy and safety in this vulnerable population. In patients with cancer, the disease itself, but also immunotherapy and chemotherapy, may have a significant impact on the ability to develop an effective immune response to COVID-19 vaccination, and could even increase the risk of adverse events. Objective: To assess immune response and adverse events after administration of one approved vaccine against COVID-19 in patients with cancer treated with immunotherapy and/or chemotherapy. Study design: This is a prospective multicenter, multicohort study. Study population: Four cohorts will receive vaccination against COVID-19: A. Individuals without cancer (N=246, i.e., partners of patients in cohort B, C, and D) B. Patients with cancer treated with immunotherapy (N=135) C. Patients with cancer treated with chemotherapy (N=246) D. Patients with cancer treated with chemo-immunotherapy (N=246) Intervention: Participants will be vaccinated against COVID-19 with an approved vaccine. Blood will be drawn at 4 different time points by venipuncture and at 1 time point by a finger prick and mucosal lining fluid will be collected at 2 time points. Main study parameters/endpoints: The primary endpoint is the antibody based immune response on day 28 after the second vaccination. Participants will be classified as responders or non-responders. The definition of response is seroconversion defined as presence of SARS-CoV-2 spike S1-specific IgG antibodies in individuals without measurable anti-S antibodies at baseline. Participants who are seropositive at baseline will not be included in the analysis of the primary endpoint. The percentage of responders of each patient cohort will be compared with the percentage responders in the control group. Safety is a secondary endpoint which will be reported in terms of percentage of solicited local and systemic adverse events (AEs) graded according to severity. Other secondary endpoints include longevity at 6 months and levels of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific T cell responses. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants will have to visit the hospital at 4 time points. The vaccine will be administered two times with an interval specified by the manufacturer. Blood will be drawn (~230 ml in total) prior to both vaccinations and at day 28 and 6 months after the second vaccination. Twelve months after vaccination participants will receive a finger prick set with instructions for self-collection of a blood sample. Blood sampling will give minor discomfort. Vaccination can cause AEs including fatigue, chills, headache, myalgia, and pain at the injection site. For seven days after each vaccination, participants will be asked to record local and systemic reactions using a questionnaire. At baseline and at 3, 6, 9 and 12 months after vaccination, patients will be asked to complete questionnaires about potential subsequent testing for SARS-CoV-2, diagnosis of COVID-19, and severity of COVID-19. Participants will be informed about their antibody titer in a letter that includes an explanation about what this means to them. This will be done after antibody measurements have been completed for day 28 after vaccination, and again after 6 months and after 12 months.

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