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; Nathalie de Schrevel; Laurence Fissette; Marie-Pierre David; Marie Van der Wielen; Lusine Kostanyan; Veronica Hulstrøm; Mark Adams; Michael Adams; Elaine Jacqueline Akite; Ingrid Alt; Charles Andrews; Rafaelle Antonelli-Incalzi; Asmik Asatryan; Eugene Athan; Ghazaleh Bahrami; Elena Bargagli; Qasim Bhorat; Paul Bird; Przemyslaw Borowy; Celine Boutry; Carles Brotons Cuixart; David Browder; Judith Brown; Erik Buntinx; Donald Cameron; Kenneth Chinsky; Melissa Choi; Eun-Ju Choo; Delphine Collete; Maria Corral Carrillo; Matthew G Davis; Magali de Heusch; Ferdinandus de Looze; Marc De Meulemeester; Ferdinando De Negri; David DeAtkine; Viktoriya Dedkova; Dominique Descamps; Peter Dzongowski; Tamara Eckermann; Brandon Essink; Karen Faulkner; Robert Feldman; Murdo Ferguson; Gregory Fuller; Isabel Maria Galan Melendez; Ivan Gentile; Wayne Ghesquiere; Doria Grimard; Olivier Gruselle; Scott Halperin; Amardeep Heer; Laura Helman; Andre Hotermans; Tomas Jelinek; Jackie Kamerbeek; Hyo Youl Kim; Murray Kimmel; Mark Koch; Satu Kokko; Susanna Koski; Shady Kotb; Antonio Lalueza; Jin-Soo Lee; Muriel Lins; Johannes Lombaard; Akbar Mahomed; Mario MALERBA; Celine Marechal; Jean-Benoit Martinot; Cristina Masuet-Aumatell; Damien McNally; Carlos Eduardo Medina Pech; Jorge Mendez Galvan; Narcisa Elena Mesaros; Dieter Mesotten; Essack Mitha; Kathryn Mngadi; Beate Moeckesch; Barnaby Montgomery; Linda Murray; Rhiannon Nally; Silvia Narejos Perez; Joseph Newberg; Paul Nugent; Dolores Ochoa Mazarro; Harunori Oda; Aurelie Olivier; Maurizio Orso; Jacinto Ortiz Molina; Tatiana Pak; Dae Won Park; Meenakshi Patel; Minesh Patel; Anna Maria Pedro Pijoan; Merce Perez Vera; Alberto Borobia Perez; Lina Perez-Breva; Claudia Pileggi; Fabrizio Pregliasco; Carol Pretswell; Dean Quinn; Michele Reynolds; Viktor Romanenko; Jeffrey Rosen; Nathalie Roy; Belen Ruiz Antoran; Hideaki Sakata; Joachim Sauter; Axel Schaefer; Izabela Sein Anand; Jose Antonio Serra Rexach; David Shu; Andres Siig; William Simon; Svetlana Smakotina; Katie Steenackers; Brigitte Stephan; Silvio Tafuri; Kenji Takazawa; Guy Tellier; Wim Terryn; Leslie Tharenos; Nick Thomas; Nicole Toursarkissian; Benita Ukkonen; Noah Vale; Pieter-Jan Van Landegem; Carline Vanden Abeele; Celine Verheust; Lode Vermeersch; Miguel Vicco; Francesco Vitale; Olga Voloshyna; Judith White; Seong-Heon Wie; Jonathan Wilson; Pedro Ylisastigui

doi:10.1056/NEJMoa2209604

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, Nathalie de Schrevel, Laurence Fissette, Marie-Pierre David, Marie Van der Wielen, Lusine Kostanyan, Veronica Hulstrøm, Mark Adams, Michael Adams, Elaine Jacqueline Akite, Ingrid AltCharles Andrews, Rafaelle Antonelli-Incalzi, Asmik Asatryan, Eugene Athan, Ghazaleh Bahrami, Elena Bargagli, Qasim Bhorat, Paul Bird, Przemyslaw Borowy, Celine Boutry, Carles Brotons Cuixart, David Browder, Judith Brown, Erik Buntinx, Donald Cameron, Kenneth Chinsky, Melissa Choi, Eun-Ju Choo, Delphine Collete, Maria Corral Carrillo, Matthew G Davis, Magali de Heusch, Ferdinandus de Looze, Marc De Meulemeester, Ferdinando De Negri, David DeAtkine, Viktoriya Dedkova, Dominique Descamps, Peter Dzongowski, Tamara Eckermann, Brandon Essink, Karen Faulkner, Robert Feldman, Murdo Ferguson, Gregory Fuller, Isabel Maria Galan Melendez, Ivan Gentile, Wayne Ghesquiere, Doria Grimard, Olivier Gruselle, Scott Halperin, Amardeep Heer, Laura Helman, Andre Hotermans, Tomas Jelinek, Jackie Kamerbeek, Hyo Youl Kim, Murray Kimmel, Mark Koch, Satu Kokko, Susanna Koski, Shady Kotb, Antonio Lalueza, Jin-Soo Lee, Muriel Lins, Johannes Lombaard, Akbar Mahomed, Mario MALERBA, Celine Marechal, Jean-Benoit Martinot, Cristina Masuet-Aumatell, Damien McNally, Carlos Eduardo Medina Pech, Jorge Mendez Galvan, Narcisa Elena Mesaros, Dieter Mesotten, Essack Mitha, Kathryn Mngadi, Beate Moeckesch, Barnaby Montgomery, Linda Murray, Rhiannon Nally, Silvia Narejos Perez, Joseph Newberg, Paul Nugent, Dolores Ochoa Mazarro, Harunori Oda, Aurelie Olivier, Maurizio Orso, Jacinto Ortiz Molina, Tatiana Pak, Dae Won Park, Meenakshi Patel, Minesh Patel, Anna Maria Pedro Pijoan, Merce Perez Vera, Alberto Borobia Perez, Lina Perez-Breva, Claudia Pileggi, Fabrizio Pregliasco, Carol Pretswell, Dean Quinn, Michele Reynolds, Viktor Romanenko, Jeffrey Rosen, Nathalie Roy, Belen Ruiz Antoran, Hideaki Sakata, Joachim Sauter, Axel Schaefer, Izabela Sein Anand, Jose Antonio Serra Rexach, David Shu, Andres Siig, William Simon, Svetlana Smakotina, Katie Steenackers, Brigitte Stephan, Silvio Tafuri, Kenji Takazawa, Guy Tellier, Wim Terryn, Leslie Tharenos, Nick Thomas, Nicole Toursarkissian, Benita Ukkonen, Noah Vale, Pieter-Jan Van Landegem, Carline Vanden Abeele, Celine Verheust, Lode Vermeersch, Miguel Vicco, Francesco Vitale, Olga Voloshyna, Judith White, Seong-Heon Wie, Jonathan Wilson, Pedro Ylisastigui

Department of Translational Medicine

Research output: Contribution to journal › Article › peer-review

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 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. 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.

Original language	English
Pages (from-to)	595-608
Number of pages	14
Journal	THE NEW ENGLAND JOURNAL OF MEDICINE
Volume	388
Issue number	7
DOIs	https://doi.org/10.1056/NEJMoa2209604
Publication status	Published - 2023

Keywords

Geriatrics/Aging
Geriatrics/Aging General
Global Health
Infectious Disease
Infectious Disease General
Vaccines
Viral Infections

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1056/NEJMoa2209604

https://hdl.handle.net/11579/203202

Cite this

Papi, A., Ison, M. G., Langley, J. M., Lee, D.-G., Leroux-Roels, I., Martinon-Torres, F., Schwarz, T. F., van Zyl-Smit, R. N., Campora, L., Dezutter, N., de Schrevel, N., Fissette, L., David, M.-P., Van der Wielen, M., Kostanyan, L., Hulstrøm, V., Adams, M., Adams, M., Akite, E. J., ... Ylisastigui, P. (2023). Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. THE NEW ENGLAND JOURNAL OF MEDICINE, 388(7), 595-608. https://doi.org/10.1056/NEJMoa2209604

@article{c1fd8a54365d4f36b5225b6318196fa5,

title = "Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults",

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 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. 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.",

keywords = "Geriatrics/Aging, Geriatrics/Aging General, Global Health, Infectious Disease, Infectious Disease General, Vaccines, Viral Infections, Geriatrics/Aging, Geriatrics/Aging General, Global Health, Infectious Disease, Infectious Disease General, Vaccines, Viral Infections",

author = "Alberto Papi and Ison, {Michael G} and Langley, {Joanne M} and Dong-Gun Lee and Isabel Leroux-Roels and Federico Martinon-Torres and Schwarz, {Tino F} and {van Zyl-Smit}, {Richard N} and Laura Campora and Nancy Dezutter and {de Schrevel}, Nathalie and Laurence Fissette and Marie-Pierre David and {Van der Wielen}, Marie and Lusine Kostanyan and Veronica Hulstr{\o}m and Mark Adams and Michael Adams and Akite, {Elaine Jacqueline} and Ingrid Alt and Charles Andrews and Rafaelle Antonelli-Incalzi and Asmik Asatryan and Eugene Athan and Ghazaleh Bahrami and Elena Bargagli and Qasim Bhorat and Paul Bird and Przemyslaw Borowy and Celine Boutry and Cuixart, {Carles Brotons} and David Browder and Judith Brown and Erik Buntinx and Donald Cameron and Kenneth Chinsky and Melissa Choi and Eun-Ju Choo and Delphine Collete and Carrillo, {Maria Corral} and Davis, {Matthew G} and {de Heusch}, Magali and {de Looze}, Ferdinandus and Meulemeester, {Marc De} and Negri, {Ferdinando De} and David DeAtkine and Viktoriya Dedkova and Dominique Descamps and Peter Dzongowski and Tamara Eckermann and Brandon Essink and Karen Faulkner and Robert Feldman and Murdo Ferguson and Gregory Fuller and Melendez, {Isabel Maria Galan} and Ivan Gentile and Wayne Ghesquiere and Doria Grimard and Olivier Gruselle and Scott Halperin and Amardeep Heer and Laura Helman and Andre Hotermans and Tomas Jelinek and Jackie Kamerbeek and Kim, {Hyo Youl} and Murray Kimmel and Mark Koch and Satu Kokko and Susanna Koski and Shady Kotb and Antonio Lalueza and Jin-Soo Lee and Muriel Lins and Johannes Lombaard and Akbar Mahomed and Mario MALERBA and Celine Marechal and Jean-Benoit Martinot and Cristina Masuet-Aumatell and Damien McNally and Pech, {Carlos Eduardo Medina} and Galvan, {Jorge Mendez} and Mesaros, {Narcisa Elena} and Dieter Mesotten and Essack Mitha and Kathryn Mngadi and Beate Moeckesch and Barnaby Montgomery and Linda Murray and Rhiannon Nally and Perez, {Silvia Narejos} and Joseph Newberg and Paul Nugent and Mazarro, {Dolores Ochoa} and Harunori Oda and Aurelie Olivier and Maurizio Orso and Molina, {Jacinto Ortiz} and Tatiana Pak and Park, {Dae Won} and Meenakshi Patel and Minesh Patel and Pijoan, {Anna Maria Pedro} and Vera, {Merce Perez} and Perez, {Alberto Borobia} and Lina Perez-Breva and Claudia Pileggi and Fabrizio Pregliasco and Carol Pretswell and Dean Quinn and Michele Reynolds and Viktor Romanenko and Jeffrey Rosen and Nathalie Roy and Antoran, {Belen Ruiz} and Hideaki Sakata and Joachim Sauter and Axel Schaefer and Anand, {Izabela Sein} and Rexach, {Jose Antonio Serra} and David Shu and Andres Siig and William Simon and Svetlana Smakotina and Katie Steenackers and Brigitte Stephan and Silvio Tafuri and Kenji Takazawa and Guy Tellier and Wim Terryn and Leslie Tharenos and Nick Thomas and Nicole Toursarkissian and Benita Ukkonen and Noah Vale and Landegem, {Pieter-Jan Van} and Abeele, {Carline Vanden} and Celine Verheust and Lode Vermeersch and Miguel Vicco and Francesco Vitale and Olga Voloshyna and Judith White and Seong-Heon Wie and Jonathan Wilson and Pedro Ylisastigui",

year = "2023",

doi = "10.1056/NEJMoa2209604",

language = "English",

volume = "388",

pages = "595--608",

journal = "THE NEW ENGLAND JOURNAL OF MEDICINE",

issn = "1533-4406",

number = "7",

}

Papi, A, Ison, MG, Langley, JM, Lee, D-G, Leroux-Roels, I, Martinon-Torres, F, Schwarz, TF, van Zyl-Smit, RN, Campora, L, Dezutter, N, de Schrevel, N, Fissette, L, David, M-P, Van der Wielen, M, Kostanyan, L, Hulstrøm, V, Adams, M, Adams, M, Akite, EJ, Alt, I, Andrews, C, Antonelli-Incalzi, R, Asatryan, A, Athan, E, Bahrami, G, Bargagli, E, Bhorat, Q, Bird, P, Borowy, P, Boutry, C, Cuixart, CB, Browder, D, Brown, J, Buntinx, E, Cameron, D, Chinsky, K, Choi, M, Choo, E-J, Collete, D, Carrillo, MC, Davis, MG, de Heusch, M, de Looze, F, Meulemeester, MD, Negri, FD, DeAtkine, D, Dedkova, V, Descamps, D, Dzongowski, P, Eckermann, T, Essink, B, Faulkner, K, Feldman, R, Ferguson, M, Fuller, G, Melendez, IMG, Gentile, I, Ghesquiere, W, Grimard, D, Gruselle, O, Halperin, S, Heer, A, Helman, L, Hotermans, A, Jelinek, T, Kamerbeek, J, Kim, HY, Kimmel, M, Koch, M, Kokko, S, Koski, S, Kotb, S, Lalueza, A, Lee, J-S, Lins, M, Lombaard, J, Mahomed, A, MALERBA, M, Marechal, C, Martinot, J-B, Masuet-Aumatell, C, McNally, D, Pech, CEM, Galvan, JM, Mesaros, NE, Mesotten, D, Mitha, E, Mngadi, K, Moeckesch, B, Montgomery, B, Murray, L, Nally, R, Perez, SN, Newberg, J, Nugent, P, Mazarro, DO, Oda, H, Olivier, A, Orso, M, Molina, JO, Pak, T, Park, DW, Patel, M, Patel, M, Pijoan, AMP, Vera, MP, Perez, AB, Perez-Breva, L, Pileggi, C, Pregliasco, F, Pretswell, C, Quinn, D, Reynolds, M, Romanenko, V, Rosen, J, Roy, N, Antoran, BR, Sakata, H, Sauter, J, Schaefer, A, Anand, IS, Rexach, JAS, Shu, D, Siig, A, Simon, W, Smakotina, S, Steenackers, K, Stephan, B, Tafuri, S, Takazawa, K, Tellier, G, Terryn, W, Tharenos, L, Thomas, N, Toursarkissian, N, Ukkonen, B, Vale, N, Landegem, P-JV, Abeele, CV, Verheust, C, Vermeersch, L, Vicco, M, Vitale, F, Voloshyna, O, White, J, Wie, S-H, Wilson, J & Ylisastigui, P 2023, 'Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults', THE NEW ENGLAND JOURNAL OF MEDICINE, vol. 388, no. 7, pp. 595-608. https://doi.org/10.1056/NEJMoa2209604

TY - JOUR

T1 - Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults

AU - Papi, Alberto

AU - Ison, Michael G

AU - Langley, Joanne M

AU - Lee, Dong-Gun

AU - Leroux-Roels, Isabel

AU - Martinon-Torres, Federico

AU - Schwarz, Tino F

AU - van Zyl-Smit, Richard N

AU - Campora, Laura

AU - Dezutter, Nancy

AU - de Schrevel, Nathalie

AU - Fissette, Laurence

AU - David, Marie-Pierre

AU - Van der Wielen, Marie

AU - Kostanyan, Lusine

AU - Hulstrøm, Veronica

AU - Adams, Mark

AU - Adams, Michael

AU - Akite, Elaine Jacqueline

AU - Alt, Ingrid

AU - Andrews, Charles

AU - Antonelli-Incalzi, Rafaelle

AU - Asatryan, Asmik

AU - Athan, Eugene

AU - Bahrami, Ghazaleh

AU - Bargagli, Elena

AU - Bhorat, Qasim

AU - Bird, Paul

AU - Borowy, Przemyslaw

AU - Boutry, Celine

AU - Cuixart, Carles Brotons

AU - Browder, David

AU - Brown, Judith

AU - Buntinx, Erik

AU - Cameron, Donald

AU - Chinsky, Kenneth

AU - Choi, Melissa

AU - Choo, Eun-Ju

AU - Collete, Delphine

AU - Carrillo, Maria Corral

AU - Davis, Matthew G

AU - de Heusch, Magali

AU - de Looze, Ferdinandus

AU - Meulemeester, Marc De

AU - Negri, Ferdinando De

AU - DeAtkine, David

AU - Dedkova, Viktoriya

AU - Descamps, Dominique

AU - Dzongowski, Peter

AU - Eckermann, Tamara

AU - Essink, Brandon

AU - Faulkner, Karen

AU - Feldman, Robert

AU - Ferguson, Murdo

AU - Fuller, Gregory

AU - Melendez, Isabel Maria Galan

AU - Gentile, Ivan

AU - Ghesquiere, Wayne

AU - Grimard, Doria

AU - Gruselle, Olivier

AU - Halperin, Scott

AU - Heer, Amardeep

AU - Helman, Laura

AU - Hotermans, Andre

AU - Jelinek, Tomas

AU - Kamerbeek, Jackie

AU - Kim, Hyo Youl

AU - Kimmel, Murray

AU - Koch, Mark

AU - Kokko, Satu

AU - Koski, Susanna

AU - Kotb, Shady

AU - Lalueza, Antonio

AU - Lee, Jin-Soo

AU - Lins, Muriel

AU - Lombaard, Johannes

AU - Mahomed, Akbar

AU - MALERBA, Mario

AU - Marechal, Celine

AU - Martinot, Jean-Benoit

AU - Masuet-Aumatell, Cristina

AU - McNally, Damien

AU - Pech, Carlos Eduardo Medina

AU - Galvan, Jorge Mendez

AU - Mesaros, Narcisa Elena

AU - Mesotten, Dieter

AU - Mitha, Essack

AU - Mngadi, Kathryn

AU - Moeckesch, Beate

AU - Montgomery, Barnaby

AU - Murray, Linda

AU - Nally, Rhiannon

AU - Perez, Silvia Narejos

AU - Newberg, Joseph

AU - Nugent, Paul

AU - Mazarro, Dolores Ochoa

AU - Oda, Harunori

AU - Olivier, Aurelie

AU - Orso, Maurizio

AU - Molina, Jacinto Ortiz

AU - Pak, Tatiana

AU - Park, Dae Won

AU - Patel, Meenakshi

AU - Patel, Minesh

AU - Pijoan, Anna Maria Pedro

AU - Vera, Merce Perez

AU - Perez, Alberto Borobia

AU - Perez-Breva, Lina

AU - Pileggi, Claudia

AU - Pregliasco, Fabrizio

AU - Pretswell, Carol

AU - Quinn, Dean

AU - Reynolds, Michele

AU - Romanenko, Viktor

AU - Rosen, Jeffrey

AU - Roy, Nathalie

AU - Antoran, Belen Ruiz

AU - Sakata, Hideaki

AU - Sauter, Joachim

AU - Schaefer, Axel

AU - Anand, Izabela Sein

AU - Rexach, Jose Antonio Serra

AU - Shu, David

AU - Siig, Andres

AU - Simon, William

AU - Smakotina, Svetlana

AU - Steenackers, Katie

AU - Stephan, Brigitte

AU - Tafuri, Silvio

AU - Takazawa, Kenji

AU - Tellier, Guy

AU - Terryn, Wim

AU - Tharenos, Leslie

AU - Thomas, Nick

AU - Toursarkissian, Nicole

AU - Ukkonen, Benita

AU - Vale, Noah

AU - Landegem, Pieter-Jan Van

AU - Abeele, Carline Vanden

AU - Verheust, Celine

AU - Vermeersch, Lode

AU - Vicco, Miguel

AU - Vitale, Francesco

AU - Voloshyna, Olga

AU - White, Judith

AU - Wie, Seong-Heon

AU - Wilson, Jonathan

AU - Ylisastigui, Pedro

PY - 2023

Y1 - 2023

N2 - 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 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. 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.

AB - 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 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. 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.

KW - Geriatrics/Aging

KW - Geriatrics/Aging General

KW - Global Health

KW - Infectious Disease

KW - Infectious Disease General

KW - Vaccines

KW - Viral Infections

KW - Geriatrics/Aging

KW - Geriatrics/Aging General

KW - Global Health

KW - Infectious Disease

KW - Infectious Disease General

KW - Vaccines

KW - Viral Infections

UR - https://iris.uniupo.it/handle/11579/203202

U2 - 10.1056/NEJMoa2209604

DO - 10.1056/NEJMoa2209604

M3 - Article

SN - 1533-4406

VL - 388

SP - 595

EP - 608

JO - THE NEW ENGLAND JOURNAL OF MEDICINE

JF - THE NEW ENGLAND JOURNAL OF MEDICINE

IS - 7

ER -

Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults

Abstract

Keywords

UN SDGs

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