HealthDay News — A single dose of an AS01E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based candidate vaccine (RSVPreF3 OA) prevents RSV-related acute respiratory infection and lower respiratory tract disease in adults aged 60 years and older, according to a study published in the February 16 issue of the New England Journal of Medicine.
Alberto Papi, MD, from the University of Ferrera and St. Anna University Hospital in Italy, and colleagues conducted an ongoing international, placebo-controlled, phase 3 trial involving adults aged 60 years or older who received a single dose of RSVPreF3 OA or placebo before the RSV season. A total of 24,966 participants were randomly assigned to one dose of vaccine (12,467 participants) or placebo (12,499 participants).
The researchers found that vaccine efficacy against reverse-transcriptase polymerase chain reaction-confirmed RSV-related lower respiratory tract disease was 82.6%, with seven and 40 cases in the vaccine and placebo groups, respectively (1.0 versus 5.8 per 1,000 participant-years). Vaccine efficacy was 94.1 and 71.7% against severe RSV-related lower respiratory tract disease and RSV-related acute respiratory infection, respectively. Vaccine efficacy was similar against the RSV A and B subtypes (84.6 and 80.9%, respectively, for RSV-related lower respiratory tract disease; 71.9 and 70.6%, respectively, for RSV-related acute respiratory infection). Vaccine efficacy was high in various age groups and especially among those with coexisting conditions. Most adverse events reported were transient, with mild-to-moderate severity, although the vaccine was more reactogenic than placebo.
“The RSVPreF3 OA vaccine provided protection across the clinical spectrum of RSV disease, from mild upper respiratory tract infection to severe lower respiratory tract disease,” the authors write.
The study was funded by GlaxoSmithKline Biologicals, the manufacturer of the RSVPreF3 OA vaccine.
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