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Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults.
Papi, Alberto; Ison, Michael G; Langley, Joanne M; Lee, Dong-Gun; Leroux-Roels, Isabel; Martinon-Torres, Federico; Schwarz, Tino F; van Zyl-Smit, Richard N; Campora, Laura; Dezutter, Nancy; de Schrevel, Nathalie; Fissette, Laurence; David, Marie-Pierre; Van der Wielen, Marie; Kostanyan, Lusine; Hulstrøm, Veronica.
  • Papi A; 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, I
  • Ison MG; 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, I
  • Langley JM; 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, I
  • Lee DG; 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, I
  • Leroux-Roels I; 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, I
  • Martinon-Torres F; 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, I
  • Schwarz TF; 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, I
  • van Zyl-Smit RN; 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, I
  • Campora L; 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, I
  • Dezutter N; 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, I
  • de Schrevel N; 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, I
  • Fissette L; 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, I
  • David MP; 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, I
  • Van der Wielen M; 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, I
  • Kostanyan L; 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, I
  • Hulstrøm V; 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, I
N Engl J Med ; 388(7): 595-608, 2023 02 16.
Article in English | MEDLINE | ID: covidwho-2275568
ABSTRACT

BACKGROUND:

Respiratory 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.

METHODS:

In an ongoing, international, placebo-controlled, phase 3 trial, we randomly assigned, in a 11 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.

RESULTS:

A 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.

CONCLUSIONS:

A 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.).
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiratory Tract Infections / Respiratory Syncytial Virus, Human / Respiratory Syncytial Virus Infections / Respiratory Syncytial Virus Vaccines Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Aged / Humans Language: English Journal: N Engl J Med Year: 2023 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiratory Tract Infections / Respiratory Syncytial Virus, Human / Respiratory Syncytial Virus Infections / Respiratory Syncytial Virus Vaccines Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Aged / Humans Language: English Journal: N Engl J Med Year: 2023 Document Type: Article