The respiratory syncytial virus prefusion F protein vaccine attenuates the severity of respiratory syncytial virus‐associated disease in breakthrough infections in adults ≥60 years of age

Desmond Curran; Sean Matthews; Eliazar Sabater Cabrera; Silvia Narejos Pérez; Lina Pérez Breva; Mika Rämet; Laura Helman; Dae Won Park; Tino F. Schwarz; Isabel Maria Galan Melendez; Axel Schaefer; Nathalie Roy; Brigitte Stephan; Daniel Molnar; Lusine Kostanyan; John H. Powers; 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; Laura Campora; Kenneth Chinsky; Melissa Choi; Eun-Ju Choo; Delphine Collete; Maria Corral Carrillo; Marie-Pierre David; 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; Robert Feldman; Murdo Ferguson; Laurence Fissette; Gregory Fuller; Ivan Gentile; Wayne Ghesquiere; Doria Grimard; Olivier Gruselle; Scott Halperin; Amardeep Heer; Andre Hotermans; Michael G Ison; Tomas Jelinek; Jackie Kamerbeek; Hyo Youl Kim; Murray Kimmel; Mark Koch; Satu Kokko; Susanna Koski; Shady Kotb; Antonio Lalueza; Joanne M Langley; Dong-Gun Lee; 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; Joseph Newberg; Paul Nugent; Dolores Ochoa Mazarro; Harunori Oda; Aurelie Olivier; Maurizio Orso; Jacinto Ortiz Molina; Tatiana Pak; Alberto Papi; Meenakshi Patel; Minesh Patel; Anna Maria Pedro Pijoan; Merce Perez Vera; Alberto Borobia Perez; Claudia Pileggi; Fabrizio Pregliasco; Carol Pretswell; Dean Quinn; Michele Reynolds; Viktor Romanenko; Jeffrey Rosen; Belen Ruiz Antoran; Hideaki Sakata; Joachim Sauter; Izabela Sein Anand; Jose Antonio Serra Rexach; David Shu; Andres Siig; William Simon; Svetlana Smakotina; Katie Steenackers; Silvio Tafuri; Kenji Takazawa; Guy Tellier; Wim Terryn; Leslie Tharenos; Nick Thomas; Nicole Toursarkissian; Benita Ukkonen; Noah Vale; Marie Van der Wielen; 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:10.1111/irv.13236

The respiratory syncytial virus prefusion F protein vaccine attenuates the severity of respiratory syncytial virus‐associated disease in breakthrough infections in adults ≥60 years of age

Desmond Curran, Sean Matthews, Eliazar Sabater Cabrera, Silvia Narejos Pérez, Lina Pérez Breva, Mika Rämet, Laura Helman, Dae Won Park, Tino F. Schwarz, Isabel Maria Galan Melendez, Axel Schaefer, Nathalie Roy, Brigitte Stephan, Daniel Molnar, Lusine Kostanyan, John H. Powers, Veronica Hulstrøm, Mark Adams, Michael Adams, Elaine Jacqueline AkiteIngrid 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, Laura Campora, Kenneth Chinsky, Melissa Choi, Eun-Ju Choo, Delphine Collete, Maria Corral Carrillo, Marie-Pierre David, 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, Robert Feldman, Murdo Ferguson, Laurence Fissette, Gregory Fuller, Ivan Gentile, Wayne Ghesquiere, Doria Grimard, Olivier Gruselle, Scott Halperin, Amardeep Heer, Andre Hotermans, Michael G Ison, Tomas Jelinek, Jackie Kamerbeek, Hyo Youl Kim, Murray Kimmel, Mark Koch, Satu Kokko, Susanna Koski, Shady Kotb, Antonio Lalueza, Joanne M Langley, Dong-Gun Lee, 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, Joseph Newberg, Paul Nugent, Dolores Ochoa Mazarro, Harunori Oda, Aurelie Olivier, Maurizio Orso, Jacinto Ortiz Molina, Tatiana Pak, Alberto Papi, Meenakshi Patel, Minesh Patel, Anna Maria Pedro Pijoan, Merce Perez Vera, Alberto Borobia Perez, Claudia Pileggi, Fabrizio Pregliasco, Carol Pretswell, Dean Quinn, Michele Reynolds, Viktor Romanenko, Jeffrey Rosen, Belen Ruiz Antoran, Hideaki Sakata, Joachim Sauter, Izabela Sein Anand, Jose Antonio Serra Rexach, David Shu, Andres Siig, William Simon, Svetlana Smakotina, Katie Steenackers, Silvio Tafuri, Kenji Takazawa, Guy Tellier, Wim Terryn, Leslie Tharenos, Nick Thomas, Nicole Toursarkissian, Benita Ukkonen, Noah Vale, Marie Van der Wielen, 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: Respiratory syncytial virus (RSV) is a contagious pathogen causing acute respiratory infections (ARIs). Symptoms range from mild upper respiratory tract infections to potentially life-threatening lower respiratory tract disease (LRTD). In adults ≥60 years old, vaccine efficacy of a candidate vaccine for older adults (RSVPreF3 OA) was 71.7% against RSV-ARI and 82.6% against RSV-LRTD (AReSVi-006/NCT04886596). We present the patient-reported outcomes (PROs) from the same trial at the end of the first RSV season in the northern hemisphere (April 2022). Methods: In this phase 3 trial, adults aged ≥60 years were randomized (1:1) to receive one dose of RSVPreF3 OA vaccine or placebo. PROs were assessed using InFLUenza Patient-Reported Outcome (FLU-PRO), Short Form-12 (SF-12), and EuroQol-5 Dimension (EQ-5D) questionnaires. Peak FLU-PRO Chest/Respiratory scores during the first 7 days from ARI episode onset were compared using a Wilcoxon test. Least squares mean (LSMean) of SF-12 physical functioning (PF) and EQ-5D health utility scores were estimated using mixed effects models. Results: In the RSVPreF3 OA group (N = 12,466), 27 first RSV-ARI episodes were observed versus 95 in the Placebo group (N = 12,494). Median peak FLU-PRO Chest/Respiratory scores were lower in RSVPreF3 OA (1.07) versus Placebo group (1.86); p = 0.0258. LSMean group differences for the PF and EQ-5D health utility score were 7.00 (95% confidence interval [CI]: −9.86, 23.85; p = 0.4125) and 0.0786 (95% CI: −0.0340, 0.1913; p = 0.1695). Conclusions: The RSVPreF3 OA vaccine, in addition to preventing infection, attenuated the severity of RSV-associated symptoms in breakthrough infections, with trends of reduced impact on PF and health utility.

Lingua originale	Inglese
Rivista	Influenza and other Respiratory Viruses
Volume	18
Numero di pubblicazione	2
DOI	https://doi.org/10.1111/irv.13236
Stato di pubblicazione	Pubblicato - 2024

Keywords

acute respiratory infections
older adults
patient‐reported outcome
quality of life
respiratory syncytial virus

OSS delle Nazioni Unite

Questo processo contribuisce al raggiungimento dei seguenti obiettivi di sviluppo sostenibile

Accesso al documento

10.1111/irv.13236

https://hdl.handle.net/11579/203183

Altri file e collegamenti

handle

Cita questo

Curran, D., Matthews, S., Cabrera, E. S., Pérez, S. N., Breva, L. P., Rämet, M., Helman, L., Park, D. W., Schwarz, T. F., Melendez, I. M. G., Schaefer, A., Roy, N., Stephan, B., Molnar, D., Kostanyan, L., Powers, J. H., Hulstrøm, V., Adams, M., Adams, M., ... Ylisastigui, P. (2024). The respiratory syncytial virus prefusion F protein vaccine attenuates the severity of respiratory syncytial virus‐associated disease in breakthrough infections in adults ≥60 years of age. Influenza and other Respiratory Viruses, 18(2). https://doi.org/10.1111/irv.13236

@article{640262d7c05447ebab11991084a5e4eb,

title = "The respiratory syncytial virus prefusion F protein vaccine attenuates the severity of respiratory syncytial virus‐associated disease in breakthrough infections in adults ≥60 years of age",

abstract = "Background: Respiratory syncytial virus (RSV) is a contagious pathogen causing acute respiratory infections (ARIs). Symptoms range from mild upper respiratory tract infections to potentially life-threatening lower respiratory tract disease (LRTD). In adults ≥60 years old, vaccine efficacy of a candidate vaccine for older adults (RSVPreF3 OA) was 71.7% against RSV-ARI and 82.6% against RSV-LRTD (AReSVi-006/NCT04886596). We present the patient-reported outcomes (PROs) from the same trial at the end of the first RSV season in the northern hemisphere (April 2022). Methods: In this phase 3 trial, adults aged ≥60 years were randomized (1:1) to receive one dose of RSVPreF3 OA vaccine or placebo. PROs were assessed using InFLUenza Patient-Reported Outcome (FLU-PRO), Short Form-12 (SF-12), and EuroQol-5 Dimension (EQ-5D) questionnaires. Peak FLU-PRO Chest/Respiratory scores during the first 7 days from ARI episode onset were compared using a Wilcoxon test. Least squares mean (LSMean) of SF-12 physical functioning (PF) and EQ-5D health utility scores were estimated using mixed effects models. Results: In the RSVPreF3 OA group (N = 12,466), 27 first RSV-ARI episodes were observed versus 95 in the Placebo group (N = 12,494). Median peak FLU-PRO Chest/Respiratory scores were lower in RSVPreF3 OA (1.07) versus Placebo group (1.86); p = 0.0258. LSMean group differences for the PF and EQ-5D health utility score were 7.00 (95% confidence interval [CI]: −9.86, 23.85; p = 0.4125) and 0.0786 (95% CI: −0.0340, 0.1913; p = 0.1695). Conclusions: The RSVPreF3 OA vaccine, in addition to preventing infection, attenuated the severity of RSV-associated symptoms in breakthrough infections, with trends of reduced impact on PF and health utility.",

keywords = "acute respiratory infections, older adults, patient‐reported outcome, quality of life, respiratory syncytial virus, acute respiratory infections, older adults, patient‐reported outcome, quality of life, respiratory syncytial virus",

author = "Desmond Curran and Sean Matthews and Cabrera, {Eliazar Sabater} and P{\'e}rez, {Silvia Narejos} and Breva, {Lina P{\'e}rez} and Mika R{\"a}met and Laura Helman and Park, {Dae Won} and Schwarz, {Tino F.} and Melendez, {Isabel Maria Galan} and Axel Schaefer and Nathalie Roy and Brigitte Stephan and Daniel Molnar and Lusine Kostanyan and Powers, {John H.} 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 Laura Campora and Kenneth Chinsky and Melissa Choi and Eun-Ju Choo and Delphine Collete and Carrillo, {Maria Corral} and Marie-Pierre David 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 Robert Feldman and Murdo Ferguson and Laurence Fissette and Gregory Fuller and Ivan Gentile and Wayne Ghesquiere and Doria Grimard and Olivier Gruselle and Scott Halperin and Amardeep Heer and Andre Hotermans and Ison, {Michael G} 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 Dong-Gun Lee 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 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 Alberto Papi and Meenakshi Patel and Minesh Patel and Pijoan, {Anna Maria Pedro} and Vera, {Merce Perez} and Perez, {Alberto Borobia} and Claudia Pileggi and Fabrizio Pregliasco and Carol Pretswell and Dean Quinn and Michele Reynolds and Viktor Romanenko and Jeffrey Rosen and Antoran, {Belen Ruiz} and Hideaki Sakata and Joachim Sauter 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 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 {der Wielen}, {Marie Van} 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 = "10.1111/irv.13236",

language = "English",

volume = "18",

journal = "Influenza and other Respiratory Viruses",

issn = "1750-2640",

publisher = "Wiley-Blackwell Publishing Ltd",

number = "2",

}

Curran, D, Matthews, S, Cabrera, ES, Pérez, SN, Breva, LP, Rämet, M, Helman, L, Park, DW, Schwarz, TF, Melendez, IMG, Schaefer, A, Roy, N, Stephan, B, Molnar, D, Kostanyan, L, Powers, JH, 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, Campora, L, Chinsky, K, Choi, M, Choo, E-J, Collete, D, Carrillo, MC, David, M-P, 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, Feldman, R, Ferguson, M, Fissette, L, Fuller, G, Gentile, I, Ghesquiere, W, Grimard, D, Gruselle, O, Halperin, S, Heer, A, Hotermans, A, Ison, MG, Jelinek, T, Kamerbeek, J, Kim, HY, Kimmel, M, Koch, M, Kokko, S, Koski, S, Kotb, S, Lalueza, A, Langley, JM, Lee, D-G, 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, Newberg, J, Nugent, P, Mazarro, DO, Oda, H, Olivier, A, Orso, M, Molina, JO, Pak, T, Papi, A, Patel, M, Patel, M, Pijoan, AMP, Vera, MP, Perez, AB, Pileggi, C, Pregliasco, F, Pretswell, C, Quinn, D, Reynolds, M, Romanenko, V, Rosen, J, Antoran, BR, Sakata, H, Sauter, J, Anand, IS, Rexach, JAS, Shu, D, Siig, A, Simon, W, Smakotina, S, Steenackers, K, Tafuri, S, Takazawa, K, Tellier, G, Terryn, W, Tharenos, L, Thomas, N, Toursarkissian, N, Ukkonen, B, Vale, N, der Wielen, MV, 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, 'The respiratory syncytial virus prefusion F protein vaccine attenuates the severity of respiratory syncytial virus‐associated disease in breakthrough infections in adults ≥60 years of age', Influenza and other Respiratory Viruses, vol. 18, n. 2. https://doi.org/10.1111/irv.13236

The respiratory syncytial virus prefusion F protein vaccine attenuates the severity of respiratory syncytial virus‐associated disease in breakthrough infections in adults ≥60 years of age. / Curran, Desmond; Matthews, Sean; Cabrera, Eliazar Sabater et al.
In: Influenza and other Respiratory Viruses, Vol. 18, N. 2, 2024.

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

TY - JOUR

T1 - The respiratory syncytial virus prefusion F protein vaccine attenuates the severity of respiratory syncytial virus‐associated disease in breakthrough infections in adults ≥60 years of age

AU - Curran, Desmond

AU - Matthews, Sean

AU - Cabrera, Eliazar Sabater

AU - Pérez, Silvia Narejos

AU - Breva, Lina Pérez

AU - Rämet, Mika

AU - Helman, Laura

AU - Park, Dae Won

AU - Schwarz, Tino F.

AU - Melendez, Isabel Maria Galan

AU - Schaefer, Axel

AU - Roy, Nathalie

AU - Stephan, Brigitte

AU - Molnar, Daniel

AU - Kostanyan, Lusine

AU - Powers, John H.

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 - Campora, Laura

AU - Chinsky, Kenneth

AU - Choi, Melissa

AU - Choo, Eun-Ju

AU - Collete, Delphine

AU - Carrillo, Maria Corral

AU - David, Marie-Pierre

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 - Feldman, Robert

AU - Ferguson, Murdo

AU - Fissette, Laurence

AU - Fuller, Gregory

AU - Gentile, Ivan

AU - Ghesquiere, Wayne

AU - Grimard, Doria

AU - Gruselle, Olivier

AU - Halperin, Scott

AU - Heer, Amardeep

AU - Hotermans, Andre

AU - Ison, Michael G

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, Dong-Gun

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 - 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 - Papi, Alberto

AU - Patel, Meenakshi

AU - Patel, Minesh

AU - Pijoan, Anna Maria Pedro

AU - Vera, Merce Perez

AU - Perez, Alberto Borobia

AU - Pileggi, Claudia

AU - Pregliasco, Fabrizio

AU - Pretswell, Carol

AU - Quinn, Dean

AU - Reynolds, Michele

AU - Romanenko, Viktor

AU - Rosen, Jeffrey

AU - Antoran, Belen Ruiz

AU - Sakata, Hideaki

AU - Sauter, Joachim

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 - 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 - der Wielen, Marie Van

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: Respiratory syncytial virus (RSV) is a contagious pathogen causing acute respiratory infections (ARIs). Symptoms range from mild upper respiratory tract infections to potentially life-threatening lower respiratory tract disease (LRTD). In adults ≥60 years old, vaccine efficacy of a candidate vaccine for older adults (RSVPreF3 OA) was 71.7% against RSV-ARI and 82.6% against RSV-LRTD (AReSVi-006/NCT04886596). We present the patient-reported outcomes (PROs) from the same trial at the end of the first RSV season in the northern hemisphere (April 2022). Methods: In this phase 3 trial, adults aged ≥60 years were randomized (1:1) to receive one dose of RSVPreF3 OA vaccine or placebo. PROs were assessed using InFLUenza Patient-Reported Outcome (FLU-PRO), Short Form-12 (SF-12), and EuroQol-5 Dimension (EQ-5D) questionnaires. Peak FLU-PRO Chest/Respiratory scores during the first 7 days from ARI episode onset were compared using a Wilcoxon test. Least squares mean (LSMean) of SF-12 physical functioning (PF) and EQ-5D health utility scores were estimated using mixed effects models. Results: In the RSVPreF3 OA group (N = 12,466), 27 first RSV-ARI episodes were observed versus 95 in the Placebo group (N = 12,494). Median peak FLU-PRO Chest/Respiratory scores were lower in RSVPreF3 OA (1.07) versus Placebo group (1.86); p = 0.0258. LSMean group differences for the PF and EQ-5D health utility score were 7.00 (95% confidence interval [CI]: −9.86, 23.85; p = 0.4125) and 0.0786 (95% CI: −0.0340, 0.1913; p = 0.1695). Conclusions: The RSVPreF3 OA vaccine, in addition to preventing infection, attenuated the severity of RSV-associated symptoms in breakthrough infections, with trends of reduced impact on PF and health utility.

AB - Background: Respiratory syncytial virus (RSV) is a contagious pathogen causing acute respiratory infections (ARIs). Symptoms range from mild upper respiratory tract infections to potentially life-threatening lower respiratory tract disease (LRTD). In adults ≥60 years old, vaccine efficacy of a candidate vaccine for older adults (RSVPreF3 OA) was 71.7% against RSV-ARI and 82.6% against RSV-LRTD (AReSVi-006/NCT04886596). We present the patient-reported outcomes (PROs) from the same trial at the end of the first RSV season in the northern hemisphere (April 2022). Methods: In this phase 3 trial, adults aged ≥60 years were randomized (1:1) to receive one dose of RSVPreF3 OA vaccine or placebo. PROs were assessed using InFLUenza Patient-Reported Outcome (FLU-PRO), Short Form-12 (SF-12), and EuroQol-5 Dimension (EQ-5D) questionnaires. Peak FLU-PRO Chest/Respiratory scores during the first 7 days from ARI episode onset were compared using a Wilcoxon test. Least squares mean (LSMean) of SF-12 physical functioning (PF) and EQ-5D health utility scores were estimated using mixed effects models. Results: In the RSVPreF3 OA group (N = 12,466), 27 first RSV-ARI episodes were observed versus 95 in the Placebo group (N = 12,494). Median peak FLU-PRO Chest/Respiratory scores were lower in RSVPreF3 OA (1.07) versus Placebo group (1.86); p = 0.0258. LSMean group differences for the PF and EQ-5D health utility score were 7.00 (95% confidence interval [CI]: −9.86, 23.85; p = 0.4125) and 0.0786 (95% CI: −0.0340, 0.1913; p = 0.1695). Conclusions: The RSVPreF3 OA vaccine, in addition to preventing infection, attenuated the severity of RSV-associated symptoms in breakthrough infections, with trends of reduced impact on PF and health utility.

KW - acute respiratory infections

KW - older adults

KW - patient‐reported outcome

KW - quality of life

KW - respiratory syncytial virus

KW - acute respiratory infections

KW - older adults

KW - patient‐reported outcome

KW - quality of life

KW - respiratory syncytial virus

UR - https://iris.uniupo.it/handle/11579/203183

U2 - 10.1111/irv.13236

DO - 10.1111/irv.13236

M3 - Article

SN - 1750-2640

VL - 18

JO - Influenza and other Respiratory Viruses

JF - Influenza and other Respiratory Viruses

IS - 2

ER -