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.
Efficacy and Safety of Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine (RSVPreF3 OA) in Older Adults Over 2 RSV Seasons / M.G. Ison, A. Papi, E. Athan, R.G. Feldman, J.M. Langley, D. Lee, I. Leroux-Roels, F. Martinon-Torres, T.F. Schwarz, R.N. van Zyl-Smit, C. Verheust, N. Dezutter, O. Gruselle, L. Fissette, M. David, L. Kostanyan, V. Hulstrøm, A. Olivier, M. Van der Wielen, D. Descamps, M. Adams, M. Adams, C. Agutu, E.J. Akite, I. Alt, C. Andrews, R. Antonelli-Incalzi, A. Asatryan, 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, C. Cartier, K. Chinsky, M. Choi, E. Choo, D. Collete, M. Corral Carrillo, S. Cuadripani, M.G. Davis, M. de Heusch, F. de Looze, M. De Meulemeester, F. De Negri, N. de Schrevel, D. Deatkine, V. Dedkova, P. Dzongowski, T. Eckermann, B. Essink, K. Faulkner, M. Ferguson, G. Fuller, I.M. Galan Melendez, I. Gentile, W. Ghesquiere, D. Grimard, 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. Lee, M. Lins, J. Lombaard, A. Mahomed, M. Malerba, C. Marechal, S. Marion, J. Martinot, C. Masuet-Aumatell, D. Mcnally, C.E. Medina Pech, J. Mendez Galvan, L. Mercati, 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, M. Orso, J. Ortiz Molina, T. Pak, D.W. Park, M. Patel, M. Patel, A.M. Pedro Pijoan, A.B. Perez, L. Perez-Breva, M. Perez Vera, C. Pileggi, F. Pregliasco, C. Pretswell, D. Quinn, M. Reynolds, V. Romanenko, J. Rosen, N. Roy, B. Ruiz Antoran, V. Sahakyan, H. Sakata, J. Sauter, A. Schaefer, I. Sein Anand, J.A. Serra Rexach, D. Shu, A. Siig, W. Simon, S. Smakotina, K. Steenackers, B. Stephan, S. Tafuri, K. Takazawa, G. Tellier, W. Terryn, L. Tharenos, N. Thomas, N. Toursarkissian, B. Ukkonen, N. Vale, P. Van Landegem, C. Vanden Abeele, L. Vermeersch, F. Vitale, O. Voloshyna, J. White, S. Wie, J. Wilson, P. Ylisastigui, M. Zocco. - In: CLINICAL INFECTIOUS DISEASES. - ISSN 1058-4838. - 78:6(2024 Jun 14), pp. 1732-1744. [10.1093/cid/ciae010]
Efficacy and Safety of Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine (RSVPreF3 OA) in Older Adults Over 2 RSV Seasons
F. Pregliasco;F. Vitale;
2024
Abstract
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.
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