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Activate: Randomized Clinical Trial of BCG Vaccination against Infection in the Elderly.
Giamarellos-Bourboulis, Evangelos J; Tsilika, Maria; Moorlag, Simone; Antonakos, Nikolaos; Kotsaki, Antigone; Domínguez-Andrés, Jorge; Kyriazopoulou, Evdoxia; Gkavogianni, Theologia; Adami, Maria-Evangelia; Damoraki, Georgia; Koufargyris, Panagiotis; Karageorgos, Athanassios; Bolanou, Amalia; Koenen, Hans; van Crevel, Reinout; Droggiti, Dionyssia-Irene; Renieris, George; Papadopoulos, Antonios; Netea, Mihai G.
Affiliation
  • Giamarellos-Bourboulis EJ; 4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece. Electronic address: egiamarel@med.uoa.gr.
  • Tsilika M; 4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.
  • Moorlag S; Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500 Nijmegen, the Netherlands.
  • Antonakos N; 4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.
  • Kotsaki A; 4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.
  • Domínguez-Andrés J; Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500 Nijmegen, the Netherlands.
  • Kyriazopoulou E; 4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.
  • Gkavogianni T; 4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.
  • Adami ME; 4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.
  • Damoraki G; 4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.
  • Koufargyris P; 4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.
  • Karageorgos A; 4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.
  • Bolanou A; 4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.
  • Koenen H; Department of Laboratory Medicine, Radboud University Medical Center, 6500 Nijmegen, the Netherlands.
  • van Crevel R; Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500 Nijmegen, the Netherlands.
  • Droggiti DI; 4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.
  • Renieris G; 4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.
  • Papadopoulos A; 4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.
  • Netea MG; Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500 Nijmegen, the Netherlands; Department of Immunology and Metabolism, Life & Medical Sciences Institute, University of Bonn, 53115 Bonn, Germany.
Cell ; 183(2): 315-323.e9, 2020 10 15.
Article in En | MEDLINE | ID: mdl-32941801
BCG vaccination in children protects against heterologous infections and improves survival independently of tuberculosis prevention. The phase III ACTIVATE trial assessed whether BCG has similar effects in the elderly. In this double-blind, randomized trial, elderly patients (n = 198) received BCG or placebo vaccine at hospital discharge and were followed for 12 months for new infections. At interim analysis, BCG vaccination significantly increased the time to first infection (median 16 weeks compared to 11 weeks after placebo). The incidence of new infections was 42.3% (95% CIs 31.9%-53.4%) after placebo vaccination and 25.0% (95% CIs 16.4%-36.1%) after BCG vaccination; most of the protection was against respiratory tract infections of probable viral origin (hazard ratio 0.21, p = 0.013). No difference in the frequency of adverse effects was found. Data show that BCG vaccination is safe and can protect the elderly against infections. Larger studies are needed to assess protection against respiratory infections, including COVID-19 (ClinicalTrials.gov NCT03296423).
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Respiratory Tract Infections / BCG Vaccine Type of study: Clinical_trials Limits: Aged / Aged80 / Female / Humans / Male / Middle aged Language: En Journal: Cell Year: 2020 Type: Article
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Respiratory Tract Infections / BCG Vaccine Type of study: Clinical_trials Limits: Aged / Aged80 / Female / Humans / Male / Middle aged Language: En Journal: Cell Year: 2020 Type: Article