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

Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions / R.G. Feldman, R. Antonelli-Incalzi, K. Steenackers, D. Lee, A. Papi, M.G. Ison, L. Fissette, M. David, C. Maréchal, M. Van der Wielen, L. Kostanyan, V. Hulstrøm, M. Adams, M. Adams, E.J. Akite, I. Alt, C. Andrews, A. Asatryan, E. Athan, G. Bahrami, E. Bargagli, Q. Bhorat, P. Bird, P. Borowy, C. Boutry, C. Brotons Cuixart, D. Browder, J. Brown, E. Buntinx, D. Cameron, L. Campora, K. Chinsky, M. Choi, E. Choo, D. Collete, M. Corral Carrillo, M.G. Davis, M. de Heusch, F. de Looze, M. De Meulemeester, F. De Negri, N. De Schrevel, D. Deatkine, V. Dedkova, D. Descamps, N. Dezutter, P. Dzongowski, T. Eckermann, B. Essink, K. Faulkner, M. Ferguson, G. Fuller, I.M. Galan Melendez, I. Gentile, W. Ghesquiere, D. Grimard, O. Gruselle, S. Halperin, A. Heer, L. Helman, A. Hotermans, T. Jelinek, J. Kamerbeek, H.Y. Kim, M. Kimmel, M. Koch, S. Kokko, S. Koski, S. Kotb, A. Lalueza, J.M. Langley, J. Lee, I. Leroux-Roels, M. Lins, J. Lombaard, A. Mahomed, M. Malerba, C. Marechal, F. Martinon-Torres, J. Martinot, C. Masuet-Aumatell, D. Mcnally, C.E. Medina Pech, J. Mendez Galvan, N.E. Mesaros, D. Mesotten, E. Mitha, K. Mngadi, B. Moeckesch, B. Montgomery, L. Murray, R. Nally, S. Narejos Perez, J. Newberg, P. Nugent, D. Ochoa Mazarro, H. Oda, A. Olivier, M. Orso, J. Ortiz Molina, T. Pak, D.W. Park, M. Patel, M. Patel, A.M. Pedro Pijoan, M. Perez Vera, A.B. Perez, L. Perez-Breva, C. Pileggi, F. Pregliasco, C. Pretswell, D. Quinn, M. Reynolds, V. Romanenko, J. Rosen, N. Roy, B. Ruiz Antoran, H. Sakata, J. Sauter, A. Schaefer, T.F. Schwarz, I. Sein Anand, J.A. Serra Rexach, D. Shu, A. Siig, W. Simon, S. Smakotina, B. Stephan, S. Tafuri, K. Takazawa, G. Tellier, W. Terryn, L. Tharenos, N. Thomas, N. Toursarkissian, B. Ukkonen, N. Vale, P. Van Landegem, R.N. van Zyl-Smit, C. Vanden Abeele, C. Verheust, L. Vermeersch, M. Vicco, F. Vitale, O. Voloshyna, J. White, S. Wie, J. Wilson, P. Ylisastigui, N. Null. - In: CLINICAL INFECTIOUS DISEASES. - ISSN 1058-4838. - 78:1(2024 Jan 15), pp. 202-209. [10.1093/cid/ciad471]

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

F. Pregliasco;F. Vitale;
2024

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
RSV; cardiorespiratory; comorbidity; respiratory tract illness; vaccination
Settore MED/42 - Igiene Generale e Applicata
15-gen-2024
set-2023
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/1045368
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