1. ACTIVATE-2: A DOUBLE-BLIND RANDOMIZED TRIAL OF BCG VACCINATION AGAINST COVID19 IN INDIVIDUALS AT RISK
- Author
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Ioannis Perdios, Maria Kostoula, Mihai G. Netea, Eleftheria Kalpaki, Varvara Perraki, Maria Paneta, Gerogios Adamis, Esther Taks, Emmanouela Kalogianni, Amalia Bolanou, Maria Tsilika, Haralampos J. Milionis, Leda Efstratiou, Kimon Stamatelopoulos, Efstathios Skliros, Nektarios Proios, Antonios Papadopoulos, Christina Damoulari, Konstantinos Leventogiannis, Antigone Kotsaki, Ioannis Delis, Christina Delavinia, Ilias Papanikolaou, Karolina Akinosoglou, Aggeliki Perdikouli, Konstantinos Tsiakos, Konstantinos Katsaros, Evangelos J. Giamarellos-Bourboulis, Konstantinos Dolianitis, Aggeliki Pandi, Garyfallia Poulakou, and Eva Athanasopoulou
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medicine.medical_specialty ,Respiratory tract infections ,business.industry ,Incidence (epidemiology) ,Placebo ,complex mixtures ,Placebo group ,law.invention ,Vaccination ,Double blind ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Hospital discharge ,business - 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.
- Published
- 2021
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