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, Lusiné Kostanyan, Veronica Hulstrøm, for the AReSVi-006 Study Group, Mark Adams, Michael L. Adams, Elaine Jacqueline Akité, Ingrid Alt, Charles P. Andrews, Asmik Asatryan, Eugene Athan, Ghazaleh Bahrami, Elena Bargagli, Qasim Bhorat, Paul Bird, Przemysław Borowy, Céline Boutry, Carles Brotons Cuixart, David Browder, Judith C. Brown, Erik Buntinx, Donald P. Cameron, Laura Cámpora, Kenneth Chinsky, Melissa Choi, Eun Ju Choo, Delphine Collete, Maria Corral Carrillo, Matthew 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 N. Fuller, Isabel Maria Galan Melendez, Ivan Gentile, Wayne Ghesquière, Doria Grimard, Olivier Gruselle, Scott A. Halperin, Amardeep Heer, Laura Helman, Andre Hotermans, Tomáš Jelı́nek, Jackie M 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, Céline Maréchal, Federico Martinón‐Torres, Jean‐Benoît Martinot, Cristina Masuet‐Aumatell, Damien McNally, Carlos Eduardo Medina Pech, J M Gonzalez Galvan, Narcisa Mesaros, Dieter Mesotten, Essack Mitha, Kathryn Mngadi, Beate Moeckesch, Barnaby Montgomery, Linda Murray, Rhiannon Nally, Silvia Narejos Pérez, Joseph L. Newberg, Paul Nugent, Dolores Ochoa Mazarro, Harunori Oda, Aurélie Olivier, Maurizio Orso
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 ≥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 ≥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 ≥1 coexisting condition of interest. The median efficacy follow-up was 6.7 months. Efficacy against RSV-LRTD was high in participants with ≥1 condition of interest (94.6%), ≥1 cardiorespiratory (92.1%), ≥1 endocrine/metabolic (100%), and ≥2 conditions of interest (92.0%). Efficacy against RSV-ARI was 81.0% in participants with ≥1 condition of interest (88.1% for cardiorespiratory, 79.4% for endocrine/metabolic conditions) and 88.0% in participants with ≥2 conditions of interest. Postvaccination neutralizing titers were at least as high in participants with ≥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.