tetano
Editor, Senior Moderator
Front Immunol
. 2022 Jul 5;13:873067.
doi: 10.3389/fimmu.2022.873067. eCollection 2022.
ACTIVATE-2: A Double-Blind Randomized Trial of BCG Vaccination Against COVID-19 in Individuals at Risk
Maria Tsilika[SUP] 1 [/SUP], Esther Taks[SUP] 2 [/SUP], Konstantinos Dolianitis[SUP] 3 [/SUP], Antigone Kotsaki[SUP] 1 [/SUP], Konstantinos Leventogiannis[SUP] 1 [/SUP], Christina Damoulari[SUP] 1 [/SUP], Maria Kostoula[SUP] 1 [/SUP], Maria Paneta[SUP] 1 [/SUP], Georgios Adamis[SUP] 4 [/SUP], Ilias Papanikolaou[SUP] 5 [/SUP], Kimon Stamatelopoulos[SUP] 6 [/SUP], Amalia Bolanou[SUP] 1 [/SUP], Konstantinos Katsaros[SUP] 7 [/SUP], Christina Delavinia[SUP] 6 [/SUP], Ioannis Perdios[SUP] 4 [/SUP], Aggeliki Pandi[SUP] 5 [/SUP], Konstantinos Tsiakos[SUP] 8 [/SUP], Nektarios Proios[SUP] 1 [/SUP], Emmanouela Kalogianni[SUP] 6 [/SUP], Ioannis Delis[SUP] 9 [/SUP], Efstathios Skliros[SUP] 10 [/SUP], Karolina Akinosoglou[SUP] 11 [/SUP], Aggeliki Perdikouli[SUP] 1 [/SUP], Garyfallia Poulakou[SUP] 8 [/SUP], Haralampos Milionis[SUP] 12 [/SUP], Eva Athanassopoulou[SUP] 1 [/SUP], Eleftheria Kalpaki[SUP] 1 [/SUP], Leda Efstratiou[SUP] 13 [/SUP], Varvara Perraki[SUP] 13 [/SUP], Antonios Papadopoulos[SUP] 1 [/SUP], Mihai G Netea[SUP] 2 14 [/SUP], Evangelos J Giamarellos-Bourboulis[SUP] 1 13 [/SUP]
Affiliations
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. These data indicate that BCG vaccination confers some protection against possible COVID-19 among patients older than 50 years with comorbidities. BCG vaccination may be a promising approach against the COVID-19 pandemic.
Keywords: BCG; COVID-19; SARS-CoV-2; elderly vaccination; trained immunity.
. 2022 Jul 5;13:873067.
doi: 10.3389/fimmu.2022.873067. eCollection 2022.
ACTIVATE-2: A Double-Blind Randomized Trial of BCG Vaccination Against COVID-19 in Individuals at Risk
Maria Tsilika[SUP] 1 [/SUP], Esther Taks[SUP] 2 [/SUP], Konstantinos Dolianitis[SUP] 3 [/SUP], Antigone Kotsaki[SUP] 1 [/SUP], Konstantinos Leventogiannis[SUP] 1 [/SUP], Christina Damoulari[SUP] 1 [/SUP], Maria Kostoula[SUP] 1 [/SUP], Maria Paneta[SUP] 1 [/SUP], Georgios Adamis[SUP] 4 [/SUP], Ilias Papanikolaou[SUP] 5 [/SUP], Kimon Stamatelopoulos[SUP] 6 [/SUP], Amalia Bolanou[SUP] 1 [/SUP], Konstantinos Katsaros[SUP] 7 [/SUP], Christina Delavinia[SUP] 6 [/SUP], Ioannis Perdios[SUP] 4 [/SUP], Aggeliki Pandi[SUP] 5 [/SUP], Konstantinos Tsiakos[SUP] 8 [/SUP], Nektarios Proios[SUP] 1 [/SUP], Emmanouela Kalogianni[SUP] 6 [/SUP], Ioannis Delis[SUP] 9 [/SUP], Efstathios Skliros[SUP] 10 [/SUP], Karolina Akinosoglou[SUP] 11 [/SUP], Aggeliki Perdikouli[SUP] 1 [/SUP], Garyfallia Poulakou[SUP] 8 [/SUP], Haralampos Milionis[SUP] 12 [/SUP], Eva Athanassopoulou[SUP] 1 [/SUP], Eleftheria Kalpaki[SUP] 1 [/SUP], Leda Efstratiou[SUP] 13 [/SUP], Varvara Perraki[SUP] 13 [/SUP], Antonios Papadopoulos[SUP] 1 [/SUP], Mihai G Netea[SUP] 2 14 [/SUP], Evangelos J Giamarellos-Bourboulis[SUP] 1 13 [/SUP]
Affiliations
- PMID: 35865520
- PMCID: PMC9294453
- DOI: 10.3389/fimmu.2022.873067
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. These data indicate that BCG vaccination confers some protection against possible COVID-19 among patients older than 50 years with comorbidities. BCG vaccination may be a promising approach against the COVID-19 pandemic.
Keywords: BCG; COVID-19; SARS-CoV-2; elderly vaccination; trained immunity.