VICRAM (‘Covid-19 Vaccine immune and coagulation response assessment in Malta’) study aims to evaluate and compare the immune response and coagulation activation response of different patient cohorts to the COVID-19 vaccine booster.
VICRAM is being made possible by a grant awarded by the Malta Council of Science and Technology (MCST) through the Infectious Diseases Programme. The research team is led by Prof. Alex Gatt and Dr Nicoletta Riva from the Department of Pathology within the Faculty of Medicine and Surgery at the University of Malta, through a strong collaboration with Dr Christopher Barbara, Dr David J Camilleri and Prof. Michael Borg from the Pathology Department and the Department of Infection Control at Mater Dei Hospital, respectively. The Flow Cytometry team at the Haematology Laboratory,
Mater Dei Hospital, led by Ms Patricia Brincat, and Mr Kevin Vella, from the Coagulation Laboratory, have a fundamental role in this project. This grant is making it possible for Ms Riana Magri, a post-graduate student, to read for an M.Sc. Biomedical Science (Haematology) at the Faculty of Medicine and Surgery.
VICRAM will focus on monitoring the immune response to the COVID-19 booster vaccine in immunocompromised patients and in the elderly population (over 65 years of age), both considered vulnerable to the SARS-CoV-2 virus. These two cohorts will be considered as the target population for this study in comparison to the healthy adult population as the control cohort. Evidence suggests that immunocompromised patients are less likely to mount an efficient immune response when they are exposed to the SARS-CoV-2 Virus or any other foreign antigen, most often leaving them susceptible to severe infections. On the other hand, the immune response towards foreign antigens becomes less effective with the ageing process. VICRAM will answer the main question as to whether vaccinations are equally beneficial for all individuals or whether vulnerable individuals require a different approach in battling the COVID-19 pandemic.
The coagulation activation response to the COVID-19 vaccine booster will also be a main research point in VICRAM. Throughout the vaccination program around the world, there have been a few cases of vaccine induced thrombosis and thrombocytopenia (VITT). VICRAM will study the coagulation profile as well as the VITT-associated anti-PF4 antibody levels before and after vaccination to determine any vaccine associated changes that may shed more light on the mechanism leading to this condition.
In order to reach the above-mentioned study goals, peripheral blood from the target population and the control population will be collected by phlebotomy before and after vaccination, thus enabling comprehensive profiling of their immune, inflammatory and coagulation activation response over time. This study will run over a period of 24 months.