• Alberto Papi, Michael G Ison, Joanne M Langley, Dong-Gun Lee, Isabel Leroux-Roels, Federico Martinon-Torres, Tino F Schwarz, Richard N van Zyl-Smit, Laura Campora, Nancy Dezutter, Nathalie de Schrevel, Laurence Fissette, Marie-Pierre David, Marie Van der Wielen, Lusine Kostanyan, Veronica Hulstrøm, and AReSVi-006 Study Group.
• From the Pulmonary Division, University of Ferrara, St. Anna University Hospital, Ferrara, Italy (A.P.); the Divisions of Infectious Diseases and Organ Transplantation, Northwestern University Feinberg School of Medicine, Chicago (M.G.I.); the Canadian Center for Vaccinology, Dalhousie University, IWK Health and Nova Scotia Health, Halifax, Canada (J.M.L.); the Division of Infectious Diseases, Department of Internal Medicine, the Catholic University of Korea, Seoul, South Korea (D.-G.L.); the Center for Vaccinology, Ghent University, and Ghent University Hospital, Ghent (I.L.-R.), GSK, Wavre (L.C., N.D., L.F., M.-P.D., M.V.W., L.K., V.H.), and GSK, Rixensart (N.S.) - all in Belgium; Translational Pediatrics and Infectious Diseases, Pediatrics Department, Hospital Clínico Universitario de Santiago, Santiago de Compostela, the Genetics, Vaccines, Infectious Diseases, and Pediatrics Research Group, Instituto de Investigación Sanitaria de Santiago, Universidad de Santiago de Compostela, Santiago de Compostela, Consorcio Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid (F.M.-T.); the Institute of Laboratory Medicine and Vaccination Centre, Klinikum Würzburg Mitte, Campus Juliusspital, Würzburg, Germany (T.F.S.); and the Division of Pulmonology and University of Cape Town Lung Institute, Department of Medicine, University of Cape Town, and Groote Schuur Hospital, Cape Town, South Africa (R.N.Z.-S.).
• N. Engl. J. Med. 2023 Feb 16; 388 (7): 595608595-608.

BackgroundRespiratory syncytial virus (RSV) is an important cause of acute respiratory infection, lower respiratory tract disease, clinical complications, and death in older adults. There is currently no licensed vaccine against RSV infection.MethodsIn an ongoing, international, placebo-controlled, phase 3 trial, we randomly assigned, in a 1:1 ratio, adults 60 years of age or older to receive a single dose of an AS01E-adjuvanted RSV prefusion F protein-based candidate vaccine (RSVPreF3 OA) or placebo before the RSV season. The primary objective was to show vaccine efficacy of one dose of the RSVPreF3 OA vaccine against RSV-related lower respiratory tract disease, confirmed by reverse-transcriptase polymerase chain reaction (RT-PCR), during one RSV season. The criterion for meeting the primary objective was a lower limit of the confidence interval around the efficacy estimate of more than 20%. Efficacy against severe RSV-related lower respiratory tract disease and RSV-related acute respiratory infection was assessed, and analyses according to RSV subtype (A and B) were performed. Safety was evaluated.ResultsA total of 24,966 participants received one dose of the RSVPreF3 OA vaccine (12,467 participants) or placebo (12,499). Over a median follow-up of 6.7 months, vaccine efficacy against RT-PCR-confirmed RSV-related lower respiratory tract disease was 82.6% (96.95% confidence interval [CI], 57.9 to 94.1), with 7 cases (1.0 per 1000 participant-years) in the vaccine group and 40 cases (5.8 per 1000 participant-years) in the placebo group. Vaccine efficacy was 94.1% (95% CI, 62.4 to 99.9) against severe RSV-related lower respiratory tract disease (assessed on the basis of clinical signs or by the investigator) and 71.7% (95% CI, 56.2 to 82.3) against RSV-related acute respiratory infection. Vaccine efficacy was similar against the RSV A and B subtypes (for RSV-related lower respiratory tract disease: 84.6% and 80.9%, respectively; for RSV-related acute respiratory infection: 71.9% and 70.6%, respectively). High vaccine efficacy was observed in various age groups and in participants with coexisting conditions. The RSVPreF3 OA vaccine was more reactogenic than placebo, but most adverse events for which reports were solicited were transient, with mild-to-moderate severity. The incidences of serious adverse events and potential immune-mediated diseases were similar in the two groups.ConclusionsA single dose of the RSVPreF3 OA vaccine had an acceptable safety profile and prevented RSV-related acute respiratory infection and lower respiratory tract disease and severe RSV-related lower respiratory tract disease in adults 60 years of age or older, regardless of RSV subtype and the presence of underlying coexisting conditions. (Funded by GlaxoSmithKline Biologicals; AReSVi-006 ClinicalTrials.gov number, NCT04886596.).Copyright © 2023 Massachusetts Medical Society.

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