COVID19 – TriVoice PLUS – Astra-Zeneca derde dosis, Vaccination against Covid-19 in cancer: booster shot BNT161b2 vaccine after full vaccination with ChAdOx1-S vaccine (Tri-VOICE plus).

COVID-19 is a disease caused by an infectious outbreak of SARS-CoV-2. This viral SARS-CoV-2 infection can present itself in a broad spectrum of clinical features, 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 been 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 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. The secondary endpoints of the study are to measure the SARS-Cov-2 specific T cell response and to investigate the evolution and duration of the cellular immune response after vaccination in the patient cohort. 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. Patients will be asked to report their adverse events over a period of 3 days after the vaccination day. 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, VACCINATION, CANCER, T-CELL ACTIVATION

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

Project type:Collaboration project