Evidence map›Paper›PMID 36791160›Full record

Trial reportThe New England journal of medicine2023

Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults.

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 and 7 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04886596 (A Phase 3, Randomized, Placebo-controlled, Observer-blind, Multi-country Study to Demonstrate the Efficacy of a Single Dose and Annual Revaccination Doses of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Above), which is not on this map. Cited by 430 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
430citing papers in PubMed, 6 pooled it
148.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04886596 phase3completednot on this map

A Phase 3, Randomized, Placebo-controlled, Observer-blind, Multi-country Study to Demonstrate the Efficacy of a Single Dose and Annual Revaccination Doses of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Above

TypeinterventionalSponsorGlaxoSmithKlineRan2021 to 2024Enrolled26,675ConditionsRespiratory Syncytial Virus InfectionsArmsPlacebo, RSVPreF3 OA vaccine
3 · Its place in the literature

Who cites it

430 citing papers in PubMed, 6 syntheses or guidelines pooled it, 692 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Efficacy and safety of respiratory syncytial virus vaccines.The Cochrane database of systematic reviews · 2025
    Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Immune persistence and safety of the AS01Human vaccines & immunotherapeutics · 2025
    Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Vaccination in systemic lupus erythematosus.Human vaccines & immunotherapeutics · 2026
    Review
  17. Article
  18. Article
  19. Article
  20. Article

370 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 4 institutions in 8 countries.

Alberto PapiFrom 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.).ORCID 0000-0002-6924-4500
Michael G IsonFrom 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.).ORCID 0000-0003-3347-9671
Joanne M LangleyFrom 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.).
Dong-Gun LeeFrom 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.).
Isabel Leroux-RoelsFrom 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.).
Federico Martinon-TorresFrom 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.).
Tino F SchwarzFrom 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.).
Richard N van Zyl-SmitFrom 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.).
Laura CamporaFrom 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.).
Nancy DezutterFrom 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.).
Nathalie de SchrevelFrom 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.).
Laurence FissetteFrom 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.).
Marie-Pierre DavidFrom 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.).
Marie Van der WielenFrom 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.).
Lusine KostanyanFrom 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.).
Veronica HulstrømFrom 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.).
AReSVi-006 Study Group
University of Ferrara · ITDalhousie University · CANorthwestern University · USUniversidade de Santiago de Compostela · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 AS01

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.).

Indexed as

Respiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesRespiratory Tract InfectionsAdjuvants, ImmunologicAgedAntibodies, ViralHumansInternationalityVaccine EfficacyAdjuvants, ImmunologicAntibodies, ViralRespiratory Syncytial Virus Vaccines

Identifiers

PMID36791160
OpenAlexW4320892455

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