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Efficacy and Safety of Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine (RSVPreF3 OA) in Older Adults Over 2 RSV Seasons
Version 2 2024-06-14, 15:13
Version 1 2024-03-08, 03:26
journal contribution
posted on 2024-06-14, 15:13 authored by Michael G Ison, Alberto Papi, Eugene AthanEugene Athan, Robert G Feldman, Joanne M Langley, Dong-Gun Lee, Isabel Leroux-Roels, Federico Martinon-Torres, Tino F Schwarz, Richard N van Zyl-Smit, Céline Verheust, Nancy Dezutter, Olivier Gruselle, Laurence Fissette, Marie-Pierre David, Lusine Kostanyan, Veronica Hulstrøm, Aurélie Olivier, Marie Van der Wielen, Dominique Descamps, Mark Adams, Michael Adams, Clara Agutu, Elaine Jacqueline Akite, Ingrid Alt, Charles Andrews, Rafaelle Antonelli-Incalzi, Asmik Asatryan, 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, Cyrille Cartier, Kenneth Chinsky, Melissa Choi, Eun-Ju Choo, Delphine Collete, Maria Corral Carrillo, Susanna Cuadripani, Matthew G Davis, Magali de Heusch, Ferdinandus de Looze, Marc De Meulemeester, Ferdinando De Negri, Nathalie de Schrevel, David DeAtkine, Viktoriya Dedkova, Peter Dzongowski, Tamara Eckermann, Brandon Essink, Karen Faulkner, Murdo Ferguson, Gregory Fuller, Isabel Maria Galan Melendez, Ivan Gentile, Wayne Ghesquiere, Doria Grimard, 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, Jin-Soo Lee, Muriel Lins, Johannes Lombaard, Akbar Mahomed, Mario Malerba, Celine Marechal, Sandie Marion, Jean-Benoit Martinot, Cristina Masuet-Aumatell, Damien McNally, Carlos Eduardo Medina Pech, Jorge Mendez Galvan, Lise Mercati, 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, Maurizio Orso, Jacinto Ortiz Molina, Tatiana Pak, Dae Won Park, Meenakshi Patel, Minesh Patel, Anna Maria Pedro Pijoan, Alberto Borobia Perez, Lina Perez-Breva, Merce Perez Vera, Claudia Pileggi, Fabrizio Pregliasco, Carol Pretswell, Dean Quinn, Michele Reynolds, Viktor Romanenko, Jeffrey Rosen, Nathalie Roy, Belen Ruiz Antoran, Vardine Sahakyan, Hideaki Sakata, Joachim Sauter, Axel Schaefer, Izabela Sein Anand, Jose Antonio Serra Rexach, David Shu, Andres Siig, William Simon, Svetlana Smakotina, Katie Steenackers, Brigitte Stephan, Silvio Tafuri, Kenji Takazawa, Guy Tellier, Wim Terryn, Leslie Tharenos, Nick Thomas, Nicole Toursarkissian, Benita Ukkonen, Noah Vale, Pieter-Jan Van Landegem, Carline Vanden Abeele, Lode Vermeersch, Francesco Vitale, Olga Voloshyna, Judith White, Seong-Heon Wie, Jonathan Wilson, Pedro Ylisastigui, Manuel ZoccoAbstract
Background
The adjuvanted RSV prefusion F protein–based vaccine (RSVPreF3 OA) was efficacious against RSV-related lower respiratory tract disease (RSV-LRTD) in ≥60-years-olds over 1 RSV season. We evaluated efficacy and safety of 1 RSVPreF3 OA dose and of 2 RSVPreF3 OA doses given 1 year apart against RSV-LRTD over 2 RSV seasons post–dose 1.
Methods
In this phase 3, blinded trial, ≥60-year-olds were randomized (1:1) to receive RSVPreF3 OA or placebo pre–season 1. RSVPreF3 OA recipients were re-randomized (1:1) to receive a second RSVPreF3 OA dose (RSV_revaccination group) or placebo (RSV_1dose group) pre–season 2; participants who received placebo pre–season 1 received placebo pre–season 2 (placebo group). Efficacy of both vaccine regimens against RSV-LRTD was evaluated over 2 seasons combined (confirmatory secondary objective, success criterion: lower limits of 2-sided CIs around efficacy estimates >20%).
Results
The efficacy analysis comprised 24 967 participants (RSV_1dose: 6227; RSV_revaccination: 6242; placebo: 12 498). Median efficacy follow-up was 17.8 months. Efficacy over 2 seasons of 1 RSVPreF3 OA dose was 67.2% (97.5% CI: 48.2–80.0%) against RSV-LRTD and 78.8% (95% CI: 52.6–92.0%) against severe RSV-LRTD. Efficacy over 2 seasons of a first dose followed by revaccination was 67.1% (97.5% CI: 48.1–80.0%) against RSV-LRTD and 78.8% (95% CI: 52.5–92.0%) against severe RSV-LRTD. Reactogenicity/safety of the revaccination dose were similar to dose 1.
Conclusions
One RSVPreF3 OA dose was efficacious against RSV-LRTD over 2 RSV seasons in ≥60-year-olds. Revaccination 1 year post–dose 1 was well tolerated but did not seem to provide additional efficacy benefit in the overall study population.
Clinical Trials Registration
ClinicalTrials.gov: NCT04886596.
