Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions
Author:
Feldman Robert G1, Antonelli-Incalzi Raffaele2, Steenackers Katie3, Lee Dong-Gun4, Papi Alberto5, Ison Michael G6, Fissette Laurence7, David Marie-Pierre7, Maréchal Céline7, Van der Wielen Marie7, Kostanyan Lusine7, Hulstrøm Veronica7, Adams Mark, Adams Michael, Akite Elaine Jacqueline, Alt Ingrid, Andrews Charles, Asatryan Asmik, Athan Eugene, Bahrami Ghazaleh, Bargagli Elena, Bhorat Qasim, Bird Paul, Borowy Przemyslaw, Boutry Celine, Brotons Cuixart Carles, Browder David, Brown Judith, Buntinx Erik, Cameron Donald, Campora Laura, Chinsky Kenneth, Choi Melissa, Choo Eun-Ju, Collete Delphine, Corral Carrillo Maria, Davis Matthew G, de Heusch Magali, de Looze Ferdinandus, De Meulemeester Marc, De Negri Ferdinando, De Schrevel Nathalie, DeAtkine David, Dedkova Viktoriya, Descamps Dominique, Dezutter Nancy, Dzongowski Peter, Eckermann Tamara, Essink Brandon, Faulkner Karen, Ferguson Murdo, Fuller Gregory, Galan Melendez Isabel Maria, Gentile Ivan, Ghesquiere Wayne, Grimard Doria, Gruselle Olivier, Halperin Scott, Heer Amardeep, Helman Laura, Hotermans Andre, Jelinek Tomas, Kamerbeek Jackie, Kim Hyo Youl, Kimmel Murray, Koch Mark, Kokko Satu, Koski Susanna, Kotb Shady, Lalueza Antonio, Langley Joanne M, Lee Jin-Soo, Leroux-Roels Isabel, Lins Muriel, Lombaard Johannes, Mahomed Akbar, Malerba Mario, Marechal Celine, Martinon-Torres Federico, Martinot Jean-Benoit, Masuet-Aumatell Cristina, McNally Damien, Medina Pech Carlos Eduardo, Mendez Galvan Jorge, Mesaros Narcisa Elena, Mesotten Dieter, Mitha Essack, Mngadi Kathryn, Moeckesch Beate, Montgomery Barnaby, Murray Linda, Nally Rhiannon, Narejos Perez Silvia, Newberg Joseph, Nugent Paul, Ochoa Mazarro Dolores, Oda Harunori, Olivier Aurelie, Orso Maurizio, Ortiz Molina Jacinto, Pak Tatiana, Park Dae Won, Patel Meenakshi, Patel Minesh, Pedro Pijoan Anna Maria, Perez Vera Merce, Perez Alberto Borobia, Perez-Breva Lina, Pileggi Claudia, Pregliasco Fabrizio, Pretswell Carol, Quinn Dean, Reynolds Michele, Romanenko Viktor, Rosen Jeffrey, Roy Nathalie, Ruiz Antoran Belen, Sakata Hideaki, Sauter Joachim, Schaefer Axel, Schwarz Tino F, Sein Anand Izabela, Serra Rexach Jose Antonio, Shu David, Siig Andres, Simon William, Smakotina Svetlana, Stephan Brigitte, Tafuri Silvio, Takazawa Kenji, Tellier Guy, Terryn Wim, Tharenos Leslie, Thomas Nick, Toursarkissian Nicole, Ukkonen Benita, Vale Noah, Van Landegem Pieter-Jan, van Zyl-Smit Richard N, Vanden Abeele Carline, Verheust Celine, Vermeersch Lode, Vicco Miguel, Vitale Francesco, Voloshyna Olga, White Judith, Wie Seong-Heon, Wilson Jonathan, Ylisastigui Pedro,
Affiliation:
1. Senior Clinical Trials Inc. , Laguna Hills, California , USA 2. Department of Internal Medicine and Geriatrics, Università Campus Bio-Medico di Roma , Rome , Italy 3. University of Antwerp Centre for the Evaluation of Vaccination, , Antwerp , Belgium 4. Division of Infectious Diseases, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea , Seoul , South Korea 5. Pulmonary Division, University of Ferrara, St. Anna University Hospital , Ferrara , Italy 6. Respiratory Diseases Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health , Rockville, Maryland , USA 7. Vaccines R&D, GSK , Wavre , Belgium
Abstract
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.
Publisher
Oxford University Press (OUP)
Subject
Infectious Diseases,Microbiology (medical)
Cited by
16 articles.
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