ACTIVATE-2: A DOUBLE-BLIND RANDOMIZED TRIAL OF BCG VACCINATION AGAINST COVID19 IN INDIVIDUALS AT RISK

Author:

Tsilika Maria,Taks Esther,Dolianitis Konstantinos,Kotsaki Antigone,Leventogiannis Konstantinos,Damoulari Christina,Kostoula Maria,Paneta Maria,Adamis Georgios,Papanikolaou Ilias C.,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

SUMMARYBCG vaccination induces heterologous protection against respiratory tract infections, and in children improves survival independently of tuberculosis prevention. The phase III ACTIVATE-2 study assessed whether BCG could also protect against COVID19 in the elderly. In this double-blind, randomized trial, elderly Greek patients were randomized (1:1) to receive either BCG revaccination or placebo at hospital discharge, followed by 6 months observation for incidence of COVID19 infection. BCG revaccination resulted in 68% risk reduction for total COVID19 clinical and microbiological diagnoses (OR 0.32, 95% CI 0.13-0.79). Five patients in the placebo group and one in the BCG-vaccinated group had severe COVID19 that necessitated hospitalization. 3 months after BCG vaccination 1.3% of placebo and 4.7% of BCG-vaccinated volunteers had anti-SARS-CoV-2 antibodies. These data argue that BCG revaccination is safe and protects the elderly against COVID19. BCG revaccination may represent a viable preventive measure against COVID19.

Publisher

Cold Spring Harbor Laboratory

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