VOICE: Vaccination against cOvid In CancEr

Patients with cancer who are treated with immunotherapy and/or chemotherapy are at extra risk of a serious course of a COVID-19 infection. It is therefore important for them that they are optimally protected by vaccination. However, we do not know whether the COVID-19 vaccines are safe and effective for this patient group. This study aims to assess the immune response and side effects after administration of vaccination against COVID-19 in these patients. Goal To assess the immune response and side effects after administration of vaccination against COVID-19 in patients with cancer treated with immunotherapy and/or chemotherapy. Research design In this study, four groups receive the two vaccinations against COVID-19 prescribed by the manufacturer. After vaccination, the immune response and any side effects are assessed for each of them. A. Control group: the partners of the patients in groups B. C and D. B. People with cancer treated with immunotherapy. C. People with cancer who are being treated with chemotherapy. D. People with cancer who are treated with both immunotherapy and chemotherapy. The primary endpoint is the antibody-based immune response on day 28 after the second vaccination. The percentage of responders in each patient cohort is compared with the percentage of responders in the control group. The secondary objectives are 1) safety (rate of local and systemic side effects for each patient group), 2) duration of response and 3) extent of SARS-CoV-2 specific T cell responses. Participants record responses for seven days after each vaccination and blood is taken at multiple times up to 12 months after vaccination. The first results The first results will be on November 9, 2021 of the research published in the scientific journal The Lancet Oncology. The results show that most cancer patients who receive chemotherapy, immunotherapy or both against solid tumors with two mRNA vaccines produce sufficient antibodies against COVID-19. The vaccine is also safe for these patients. However, a small group is not protected and may benefit from a third injection.