Author:
Tsilika Maria,Taks Esther,Dolianitis Konstantinos,Kotsaki Antigone,Leventogiannis Konstantinos,Damoulari Christina,Kostoula Maria,Paneta Maria,Adamis Georgios,Papanikolaou Ilias,Stamatelopoulos Kimon,Bolanou Amalia,Katsaros Konstantinos,Delavinia Christina,Perdios Ioannis,Pandi Aggeliki,Tsiakos Konstantinos,Proios Nektarios,Kalogianni Emmanouela,Delis Ioannis,Skliros Efstathios,Akinosoglou Karolina,Perdikouli Aggeliki,Poulakou Garyfallia,Milionis Haralampos,Athanassopoulou Eva,Kalpaki Eleftheria,Efstratiou Leda,Perraki Varvara,Papadopoulos Antonios,Netea Mihai G.,Giamarellos-Bourboulis Evangelos J.
Abstract
In a recent study of our group with the acronym ACTIVATE, Bacillus Calmete-Guérin (BCG) vaccination reduced the occurrence of new infections compared to placebo vaccination in the elderly. Most benefit was found for respiratory infections. The ACTIVATE-2 study was launched to assess the efficacy of BCG vaccination against coronavirus disease 2019 (COVID-19). In this multicenter, double-blind trial, 301 volunteers aged 50 years or older were randomized (1:1) to be vaccinated with BCG or placebo. The trial end points were the incidence of COVID-19 and the presence of anti–severe acute respiratory syndrome coronavirus 2 (anti–SARS-CoV-2) antibodies, which were both evaluated through 6 months after study intervention. Results revealed 68% relative reduction of the risk to develop COVID-19, using clinical criteria or/and laboratory diagnosis, in the group of BCG vaccine recipients compared with placebo-vaccinated controls, during a 6-month follow-up (OR 0.32, 95% CI 0.13-0.79). In total, eight patients were in need of hospitalization for COVID-19: six in the placebo group and two in the BCG group. Three months after study intervention, positive anti–SARS-CoV-2 antibodies were noted in 1.3% of volunteers in the placebo group and in 4.7% of participants in BCG-vaccinated group. The ACTIVATE II trial did not meet the primary endpoint of the reduction of the risk for COVID-19 3 months after BCG vaccination; however, the secondary endpoint of the reduction of the risk for COVID-19 6 months after BCG vaccination was met. BCG vaccination may be a promising approach against the COVID-19 pandemic.
Subject
Immunology,Immunology and Allergy
Cited by
53 articles.
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