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CoVigi is a multi-centre, phase IV post-marketing intervention trial that aims to monitor long-term safety and efficacy after vaccination against COVID-19. The trial was initiated by Masaryk University in cooperation with the University Hospital Brno and the Masaryk Memorial Cancer Institute. A total of 561 patients will be enrolled and will undergo a total of 8 blood draws in predefined time windows within 2 years. Antibody levels and evolving cellular immunity are then determined in the blood samples. In addition, the circulating immune profile is monitored in cancer patients.
Once any medicine has been authorized, it is essential that its effectiveness and safety continue to be monitored (so-called pharmacovigilance supervision). This also applies to COVID-19 vaccines, and therefore the results of trials such as the CoVigi clinical trial make an important contribution to obtaining important information on the substances being monitored.
Recruitment for the CoVigi clinical trial has already been completed. Enrolled patients continue their visits to the centers and the development of their immunity over time is monitored.