Investigation to reveal the immunerReaction upon COVID-vaccination in the Belgian cancer population: COVID protection and vaccine safety (REAL-V).

COVID-19 is a disease caused by an infectious outbreak of SARS-CoV-2. It was first reported in the City of Wuhan, People's Republic on 31 December 2019. Today, the virus is widely spread throughout the world and declared by the World Health Organisation (WHO) as a pandemic. There are a broad range of clinical presentations of a viral SARS-CoV-2 infection, ranging from asymptomatic, sensation of a mild cold or flu to severe bilateral pneumonia and death. Cancer patients are at high risk to develop serious illness after infection with SARS-CoV-2. Therefore, it is of high importance to protect these patients by following hygiene measurements and social distancing. But, as indicated by the guidelines of the Belgian and European Society for Medical Oncology, it is also important to vaccinate cancer patients. Although, not many studies that elevated the vaccine efficacy of COVID-19 vaccines in cancer patients have bene performed. Due to the cancer or the treatment, it could be possible that the efficacy of the vaccines is lower in cancer patients or that they develop more side effects as a result of vaccination. To investigate this, we will monitor the reaction of the immune system of current and ex oncological and haematological patients on the different COVID-19 vaccines (Pfizer, Moderna, AstraZeneca, Janssen Pharmaceutica). The adverse effects as a reaction on vaccination will be investigated in this population as well. Clinical data of the patients will be collected and a blood drawn will be performed at different time points: before vaccination and 4, 6 and 12 months after receiving the first vaccination dose. The blood samples will be used to determine the amount and efficacy of the antibodies against SARS-CoV-2. Patients will also be asked to report side effects after vaccination. This will be done with a questionnaire that will be sent to the patients three days after each vaccination. The primary endpoint of the study is the quantification of different anti SARS-CoV-2 specific IgG antibodies per study cohort at 4 months after the first vaccination. Depending on the availability, antibody titers will be quantified using a MULTIPLEX SARS-CoV-2 Immunoassay, Siemens Healthineers Atellica IM SARS-CoV-2 IgG (sCOVG) assay or an in-house developed anti-RBD ELISA (Sciensano). The secondary endpoints of the study are to investigate the evolution and duration of the immune response after vaccination in the patient cohort using serological assays to analyse anti-RBD IgG titers 12 months after the first vaccination. Another secondary endpoint is to analyse the titers of neutralizing antibodies both 4,6 and 12 months after receiving the first vaccination dose. Furthermore, it is aimed to investigate the efficacy of the immune response in the patient cohort for each different vaccine. This will be assessed by the SARS-CoV-2 infection rate based on information collected through questionnaires on incidence of (PCR-confirmed or chest CT scan confirmed) SARS-CoV-2 infection within a time frame of 12 months after the start of the study. At last, we will investigate the safety of the different COVID-19 vaccines that are commercially available in Belgium. Safety will be reported in terms of incidence and severity of adverse effects (AEs) using a questionnaire which will be sent via REDCap. Patients will be asked to enter their adverse events over a period of 3 days after the vaccination day. If the patient does not have an email address, the questionnaire can be completed on paper. Only patients who had their baseline visit prior to their vaccination will be asked to complete these questionnaires. To end, serious vaccine-related adverse events which lead to hospitalization or further examination will be reported in the eCRF. This research project will provide knowledge on how the immune reaction after vaccination develops in cancer patients and patients with oncological or haematological history.

Keywords:COVID-19, CANCER

Disciplines:Vaccinology, Oncology not elsewhere classified, Public health care not elsewhere classified