Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions

Robert G Feldman; Raffaele Antonelli-Incalzi; Katie Steenackers; Dong-Gun Lee; Alberto Papi; Michael G Ison; Laurence Fissette; Marie-Pierre David; Céline Maréchal; Marie Van der Wielen; Lusine Kostanyan; Veronica Hulstrøm; Mark Adams; Michael Adams; Elaine Jacqueline Akite; Ingrid Alt; Charles Andrews; 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; Laura Campora; 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; Nathalie De Schrevel; David DeAtkine; Viktoriya Dedkova; Dominique Descamps; Nancy Dezutter; Peter Dzongowski; Tamara Eckermann; Brandon Essink; Karen Faulkner; 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; Joanne M Langley; Jin-Soo Lee; Isabel Leroux-Roels; Muriel Lins; Johannes Lombaard; Akbar Mahomed; Mario MALERBA; Celine Marechal; Federico Martinon-Torres; 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; Tino F Schwarz; Izabela Sein Anand; Jose Antonio Serra Rexach; David Shu; Andres Siig; William Simon; Svetlana Smakotina; Brigitte Stephan; Silvio Tafuri; Kenji Takazawa; Guy Tellier; Wim Terryn; Leslie Tharenos; Nick Thomas; Nicole Toursarkissian; Benita Ukkonen; Noah Vale; Pieter-Jan Van Landegem; Richard N van Zyl-Smit; Carline Vanden Abeele; Celine Verheust; Lode Vermeersch; Miguel Vicco; Francesco Vitale; Olga Voloshyna; Judith White; Seong-Heon Wie; Jonathan Wilson; Pedro Ylisastigui

doi:10.1093/cid/ciad471

Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions

Robert G Feldman, Raffaele Antonelli-Incalzi, Katie Steenackers, Dong-Gun Lee, Alberto Papi, Michael G Ison, Laurence Fissette, Marie-Pierre David, Céline Maréchal, Marie Van der Wielen, Lusine Kostanyan, Veronica Hulstrøm, Mark Adams, Michael Adams, Elaine Jacqueline Akite, Ingrid Alt, Charles Andrews, Asmik Asatryan, Eugene Athan, Ghazaleh BahramiElena Bargagli, Qasim Bhorat, Paul Bird, Przemyslaw Borowy, Celine Boutry, Carles Brotons Cuixart, David Browder, Judith Brown, Erik Buntinx, Donald Cameron, Laura Campora, 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, Nathalie De Schrevel, David DeAtkine, Viktoriya Dedkova, Dominique Descamps, Nancy Dezutter, Peter Dzongowski, Tamara Eckermann, Brandon Essink, Karen Faulkner, 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, Joanne M Langley, Jin-Soo Lee, Isabel Leroux-Roels, Muriel Lins, Johannes Lombaard, Akbar Mahomed, Mario MALERBA, Celine Marechal, Federico Martinon-Torres, 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, Tino F Schwarz, Izabela Sein Anand, Jose Antonio Serra Rexach, David Shu, Andres Siig, William Simon, Svetlana Smakotina, Brigitte Stephan, Silvio Tafuri, Kenji Takazawa, Guy Tellier, Wim Terryn, Leslie Tharenos, Nick Thomas, Nicole Toursarkissian, Benita Ukkonen, Noah Vale, Pieter-Jan Van Landegem, Richard N van Zyl-Smit, Carline Vanden Abeele, Celine Verheust, Lode Vermeersch, Miguel Vicco, Francesco Vitale, Olga Voloshyna, Judith White, Seong-Heon Wie, Jonathan Wilson, Pedro Ylisastigui

Dipartimento di Medicina Traslazionale

Risultato della ricerca: Contributo su rivista › Articolo in rivista › peer review

Abstract

Background Older adults with chronic cardiorespiratory or endocrine/metabolic conditions are at increased risk of respiratory syncytial virus (RSV)-related acute respiratory illness (RSV-ARI) and severe respiratory disease. In an ongoing, randomized, placebo-controlled, multicountry, phase 3 trial in & GE;60-year-old participants, an AS01E-adjuvanted RSV prefusion F protein-based vaccine (RSVPreF3 OA) was efficacious against RSV-related lower respiratory tract disease (RSV-LRTD), severe RSV-LRTD, and RSV-ARI. We evaluated efficacy and immunogenicity among participants with coexisting cardiorespiratory or endocrine/metabolic conditions that increase the risk of severe RSV disease ("conditions of interest").Methods Medically stable & GE;60-year-old participants received 1 dose of RSVPreF3 OA or placebo. Efficacy against first RSV-LRTD and RSV-ARI episodes was assessed in subgroups with/without coexisting cardiorespiratory or endocrine/metabolic conditions of interest. Immunogenicity was analyzed post hoc in these subgroups.Results In total, 12 467 participants received RSVPreF3 OA and 12 499 received placebo. Of these, 39.6% (RSVPreF3 OA) and 38.9% (placebo) had & GE;1 coexisting condition of interest. The median efficacy follow-up was 6.7 months. Efficacy against RSV-LRTD was high in participants with & GE;1 condition of interest (94.6%), & GE;1 cardiorespiratory (92.1%), & GE;1 endocrine/metabolic (100%), and & GE;2 conditions of interest (92.0%). Efficacy against RSV-ARI was 81.0% in participants with & GE;1 condition of interest (88.1% for cardiorespiratory, 79.4% for endocrine/metabolic conditions) and 88.0% in participants with & GE;2 conditions of interest. Postvaccination neutralizing titers were at least as high in participants with & GE;1 condition of interest as in those without.Conclusions RSVPreF3 OA was efficacious against RSV-LRTD and RSV-ARI in older adults with coexisting medical conditions associated with an increased risk of severe RSV disease.Clinical Trials Registration ClinicalTrials.gov: NCT04886596.Graphical Abstract

Lingua originale	Inglese
pagine (da-a)	202-209
Numero di pagine	8
Rivista	Clinical Infectious Diseases
Volume	78
Numero di pubblicazione	1
DOI	https://doi.org/10.1093/cid/ciad471
Stato di pubblicazione	Pubblicato - 2024

Keywords

RSV
cardiorespiratory
comorbidity
respiratory tract illness
vaccination

OSS delle Nazioni Unite

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Accesso al documento

10.1093/cid/ciad471

https://hdl.handle.net/11579/203122

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Feldman, R. G., Antonelli-Incalzi, R., Steenackers, K., Lee, D.-G., Papi, A., Ison, M. G., Fissette, L., David, M.-P., Maréchal, C., Van der Wielen, M., Kostanyan, L., Hulstrøm, V., Adams, M., Adams, M., Akite, E. J., Alt, I., Andrews, C., Asatryan, A., Athan, E., ... Ylisastigui, P. (2024). Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions. Clinical Infectious Diseases, 78(1), 202-209. https://doi.org/10.1093/cid/ciad471

@article{5a35dd06efbf4ffdb6e155f559ae9307,

title = "Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions",

abstract = "Background Older adults with chronic cardiorespiratory or endocrine/metabolic conditions are at increased risk of respiratory syncytial virus (RSV)-related acute respiratory illness (RSV-ARI) and severe respiratory disease. In an ongoing, randomized, placebo-controlled, multicountry, phase 3 trial in & GE;60-year-old participants, an AS01E-adjuvanted RSV prefusion F protein-based vaccine (RSVPreF3 OA) was efficacious against RSV-related lower respiratory tract disease (RSV-LRTD), severe RSV-LRTD, and RSV-ARI. We evaluated efficacy and immunogenicity among participants with coexisting cardiorespiratory or endocrine/metabolic conditions that increase the risk of severe RSV disease ({"}conditions of interest{"}).Methods Medically stable & GE;60-year-old participants received 1 dose of RSVPreF3 OA or placebo. Efficacy against first RSV-LRTD and RSV-ARI episodes was assessed in subgroups with/without coexisting cardiorespiratory or endocrine/metabolic conditions of interest. Immunogenicity was analyzed post hoc in these subgroups.Results In total, 12 467 participants received RSVPreF3 OA and 12 499 received placebo. Of these, 39.6% (RSVPreF3 OA) and 38.9% (placebo) had & GE;1 coexisting condition of interest. The median efficacy follow-up was 6.7 months. Efficacy against RSV-LRTD was high in participants with & GE;1 condition of interest (94.6%), & GE;1 cardiorespiratory (92.1%), & GE;1 endocrine/metabolic (100%), and & GE;2 conditions of interest (92.0%). Efficacy against RSV-ARI was 81.0% in participants with & GE;1 condition of interest (88.1% for cardiorespiratory, 79.4% for endocrine/metabolic conditions) and 88.0% in participants with & GE;2 conditions of interest. Postvaccination neutralizing titers were at least as high in participants with & GE;1 condition of interest as in those without.Conclusions RSVPreF3 OA was efficacious against RSV-LRTD and RSV-ARI in older adults with coexisting medical conditions associated with an increased risk of severe RSV disease.Clinical Trials Registration ClinicalTrials.gov: NCT04886596.Graphical Abstract",

keywords = "RSV, cardiorespiratory, comorbidity, respiratory tract illness, vaccination, RSV, cardiorespiratory, comorbidity, respiratory tract illness, vaccination",

author = "Feldman, {Robert G} and Raffaele Antonelli-Incalzi and Katie Steenackers and Dong-Gun Lee and Alberto Papi and Ison, {Michael G} and Laurence Fissette and Marie-Pierre David and C{\'e}line Mar{\'e}chal 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 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 Laura Campora 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 Schrevel, {Nathalie De} and David DeAtkine and Viktoriya Dedkova and Dominique Descamps and Nancy Dezutter and Peter Dzongowski and Tamara Eckermann and Brandon Essink and Karen Faulkner 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 Langley, {Joanne M} and Jin-Soo Lee and Isabel Leroux-Roels and Muriel Lins and Johannes Lombaard and Akbar Mahomed and Mario MALERBA and Celine Marechal and Federico Martinon-Torres 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 Schwarz, {Tino F} and Anand, {Izabela Sein} and Rexach, {Jose Antonio Serra} and David Shu and Andres Siig and William Simon and Svetlana Smakotina 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 {van Zyl-Smit}, {Richard N} 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 = "2024",

doi = "10.1093/cid/ciad471",

language = "English",

volume = "78",

pages = "202--209",

journal = "Clinical Infectious Diseases",

issn = "1058-4838",

publisher = "Oxford University Press",

number = "1",

}

Feldman, RG, Antonelli-Incalzi, R, Steenackers, K, Lee, D-G, Papi, A, Ison, MG, Fissette, L, David, M-P, Maréchal, C, Van der Wielen, M, Kostanyan, L, Hulstrøm, V, Adams, M, Adams, M, Akite, EJ, Alt, I, Andrews, C, 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, Campora, L, Chinsky, K, Choi, M, Choo, E-J, Collete, D, Carrillo, MC, Davis, MG, de Heusch, M, de Looze, F, Meulemeester, MD, Negri, FD, Schrevel, ND, DeAtkine, D, Dedkova, V, Descamps, D, Dezutter, N, Dzongowski, P, Eckermann, T, Essink, B, Faulkner, K, 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, Langley, JM, Lee, J-S, Leroux-Roels, I, Lins, M, Lombaard, J, Mahomed, A, MALERBA, M, Marechal, C, Martinon-Torres, F, 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, Schwarz, TF, Anand, IS, Rexach, JAS, Shu, D, Siig, A, Simon, W, Smakotina, S, Stephan, B, Tafuri, S, Takazawa, K, Tellier, G, Terryn, W, Tharenos, L, Thomas, N, Toursarkissian, N, Ukkonen, B, Vale, N, Landegem, P-JV, van Zyl-Smit, RN, Abeele, CV, Verheust, C, Vermeersch, L, Vicco, M, Vitale, F, Voloshyna, O, White, J, Wie, S-H, Wilson, J & Ylisastigui, P 2024, 'Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions', Clinical Infectious Diseases, vol. 78, n. 1, pagg. 202-209. https://doi.org/10.1093/cid/ciad471

TY - JOUR

T1 - Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions

AU - Feldman, Robert G

AU - Antonelli-Incalzi, Raffaele

AU - Steenackers, Katie

AU - Lee, Dong-Gun

AU - Papi, Alberto

AU - Ison, Michael G

AU - Fissette, Laurence

AU - David, Marie-Pierre

AU - Maréchal, Céline

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 - 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 - Campora, Laura

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 - Schrevel, Nathalie De

AU - DeAtkine, David

AU - Dedkova, Viktoriya

AU - Descamps, Dominique

AU - Dezutter, Nancy

AU - Dzongowski, Peter

AU - Eckermann, Tamara

AU - Essink, Brandon

AU - Faulkner, Karen

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 - Langley, Joanne M

AU - Lee, Jin-Soo

AU - Leroux-Roels, Isabel

AU - Lins, Muriel

AU - Lombaard, Johannes

AU - Mahomed, Akbar

AU - MALERBA, Mario

AU - Marechal, Celine

AU - Martinon-Torres, Federico

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 - Schwarz, Tino F

AU - Anand, Izabela Sein

AU - Rexach, Jose Antonio Serra

AU - Shu, David

AU - Siig, Andres

AU - Simon, William

AU - Smakotina, Svetlana

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 - van Zyl-Smit, Richard N

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 - 2024

Y1 - 2024

N2 - Background Older adults with chronic cardiorespiratory or endocrine/metabolic conditions are at increased risk of respiratory syncytial virus (RSV)-related acute respiratory illness (RSV-ARI) and severe respiratory disease. In an ongoing, randomized, placebo-controlled, multicountry, phase 3 trial in & GE;60-year-old participants, an AS01E-adjuvanted RSV prefusion F protein-based vaccine (RSVPreF3 OA) was efficacious against RSV-related lower respiratory tract disease (RSV-LRTD), severe RSV-LRTD, and RSV-ARI. We evaluated efficacy and immunogenicity among participants with coexisting cardiorespiratory or endocrine/metabolic conditions that increase the risk of severe RSV disease ("conditions of interest").Methods Medically stable & GE;60-year-old participants received 1 dose of RSVPreF3 OA or placebo. Efficacy against first RSV-LRTD and RSV-ARI episodes was assessed in subgroups with/without coexisting cardiorespiratory or endocrine/metabolic conditions of interest. Immunogenicity was analyzed post hoc in these subgroups.Results In total, 12 467 participants received RSVPreF3 OA and 12 499 received placebo. Of these, 39.6% (RSVPreF3 OA) and 38.9% (placebo) had & GE;1 coexisting condition of interest. The median efficacy follow-up was 6.7 months. Efficacy against RSV-LRTD was high in participants with & GE;1 condition of interest (94.6%), & GE;1 cardiorespiratory (92.1%), & GE;1 endocrine/metabolic (100%), and & GE;2 conditions of interest (92.0%). Efficacy against RSV-ARI was 81.0% in participants with & GE;1 condition of interest (88.1% for cardiorespiratory, 79.4% for endocrine/metabolic conditions) and 88.0% in participants with & GE;2 conditions of interest. Postvaccination neutralizing titers were at least as high in participants with & GE;1 condition of interest as in those without.Conclusions RSVPreF3 OA was efficacious against RSV-LRTD and RSV-ARI in older adults with coexisting medical conditions associated with an increased risk of severe RSV disease.Clinical Trials Registration ClinicalTrials.gov: NCT04886596.Graphical Abstract

AB - Background Older adults with chronic cardiorespiratory or endocrine/metabolic conditions are at increased risk of respiratory syncytial virus (RSV)-related acute respiratory illness (RSV-ARI) and severe respiratory disease. In an ongoing, randomized, placebo-controlled, multicountry, phase 3 trial in & GE;60-year-old participants, an AS01E-adjuvanted RSV prefusion F protein-based vaccine (RSVPreF3 OA) was efficacious against RSV-related lower respiratory tract disease (RSV-LRTD), severe RSV-LRTD, and RSV-ARI. We evaluated efficacy and immunogenicity among participants with coexisting cardiorespiratory or endocrine/metabolic conditions that increase the risk of severe RSV disease ("conditions of interest").Methods Medically stable & GE;60-year-old participants received 1 dose of RSVPreF3 OA or placebo. Efficacy against first RSV-LRTD and RSV-ARI episodes was assessed in subgroups with/without coexisting cardiorespiratory or endocrine/metabolic conditions of interest. Immunogenicity was analyzed post hoc in these subgroups.Results In total, 12 467 participants received RSVPreF3 OA and 12 499 received placebo. Of these, 39.6% (RSVPreF3 OA) and 38.9% (placebo) had & GE;1 coexisting condition of interest. The median efficacy follow-up was 6.7 months. Efficacy against RSV-LRTD was high in participants with & GE;1 condition of interest (94.6%), & GE;1 cardiorespiratory (92.1%), & GE;1 endocrine/metabolic (100%), and & GE;2 conditions of interest (92.0%). Efficacy against RSV-ARI was 81.0% in participants with & GE;1 condition of interest (88.1% for cardiorespiratory, 79.4% for endocrine/metabolic conditions) and 88.0% in participants with & GE;2 conditions of interest. Postvaccination neutralizing titers were at least as high in participants with & GE;1 condition of interest as in those without.Conclusions RSVPreF3 OA was efficacious against RSV-LRTD and RSV-ARI in older adults with coexisting medical conditions associated with an increased risk of severe RSV disease.Clinical Trials Registration ClinicalTrials.gov: NCT04886596.Graphical Abstract

KW - RSV

KW - cardiorespiratory

KW - comorbidity

KW - respiratory tract illness

KW - vaccination

KW - RSV

KW - cardiorespiratory

KW - comorbidity

KW - respiratory tract illness

KW - vaccination

UR - https://iris.uniupo.it/handle/11579/203122

U2 - 10.1093/cid/ciad471

DO - 10.1093/cid/ciad471

M3 - Article

SN - 1058-4838

VL - 78

SP - 202

EP - 209

JO - Clinical Infectious Diseases

JF - Clinical Infectious Diseases

IS - 1

ER -

Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions

Abstract

Keywords

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