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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 559 patients were enrolled and underwent a total of 8 blood draws in predefined time windows within 2 years. Antibody levels and evolving cellular immunity were then determined in the blood samples. In addition, the circulating immune profile was 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 continued to be visited at the centers and the development of their immunity was monitored over time.
Participating centres: Masaryk Memorial Cancer Institute, Department of Internal Hematology and Oncology (UH Brno), Department of Clinical Microbiology and immunology (FN Brno)
Visit of enrolled patients were ended and collected data are being prepared for analysis.