Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Jan 25;78(1):202-209.
doi: 10.1093/cid/ciad471.

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

Robert G Feldman  1 , Raffaele Antonelli-Incalzi  2 , Katie Steenackers  3 , Dong-Gun Lee  4 , Alberto Papi  5 , Michael G Ison  6 , Laurence Fissette  7 , Marie-Pierre David  7 , Céline Maréchal  7 , Marie Van der Wielen  7 , Lusine Kostanyan  7 , Veronica Hulstrøm  7 ; AReSVi-006 Study Group
Collaborators, Affiliations

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

Robert G Feldman et al. Clin Infect Dis. .

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.

Keywords: RSV; cardiorespiratory; comorbidity; respiratory tract illness; vaccination.

PubMed Disclaimer

Conflict of interest statement

Potential conflicts of interest. R. G. F. declares having received payment from GSK as a speaker for promotional programs and support for travel related to these activities. R. A. I. declares that his institution received a grant from GSK for conducting the trial. K. S. declares that her institution received funding from GSK for conducting the trial and that she is a member of the independent data monitoring committee for the AReSVi-006 trial (without receiving payment). D. G. L. and A. P. declare funding from GSK for conducting the trial. A. P. declares that his institution received grants from Chiesi, AstraZeneca, GSK, Sanofi, and Agenzia Italiana del Farmaco; that he received consulting fees from Chiesi, AstraZeneca, GSK, Novartis, Sanofi, Avillion, and ELPEN Pharmaceuticals; payment for participation in data safety monitoring boards or advisory boards from Chiesi, AstraZeneca, GSK, MSD, Novartis, Sanofi, IQVIA, Avillion, and ELPEN Pharmaceuticals; and honoraria from Chiesi, AstraZeneca, GSK, Menarini, Novartis, Zambon, Mundipharma, Sanofi, Edmond Pharmaceuticals, IQVIA, Avillion, and ELPEN Pharmaceuticals. M. G. I. declares that his institution received funding from GSK for RSV vaccine trials; he also received author royalties from UpToDate, consulting fees from Adagio Therapeutics, ADMA Biologics, AlloVir, Atea, Cidara Therapeutics, Genentech/Roche, Janssen, Shionogi, Takeda, and Eurofins Viracor, and payment for participating in data safety monitoring boards or advisory boards from Adamis Pharmaceuticals, AlloVir, CSL Behring, Janssen, Merck, Seqirus, Takeda, and Talaris. L. F., M. P. D., C. M., M. V. d. W., L. K., and V. H. are employed by GSK; L. F., M. P. D., C. M., M. V. d. W., V. H., and L. K. have stock options or shares from GSK. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

Graphical Abstract
Graphical Abstract
Figure 1.
Figure 1.
Participant flow diagram. Numbers between asterisks (eg, *1*) indicate that data by group are blinded to avoid participant-level unblinding of the study team; the number between the asterisks shows the total number across the 2 groups. AE, adverse event; RSV, respiratory syncytial virus; RSV-ARI, respiratory syncytial virus–related acute respiratory illness; RSVPreF3 OA, AS01E-adjuvanted respiratory syncytial virus prefusion F protein–based vaccine. aMore than 1 reason for elimination can occur for 1 participant.
Figure 2.
Figure 2.
RSV-A and RSV-B neutralizing titers before and 1 month after RSVPreF3 OA or placebo administration, by coexisting medical conditions of interest (per-protocol population for immunogenicity). Graphs show respiratory syncytial virus (RSV) subtypes A and B neutralizing titers before (day 1) and 1 month after (day 31) administration of the AS01E-adjuvanted RSV prefusion F protein–based vaccine (RSVPreF3 OA) or placebo for the subgroups of participants without any of the coexisting medical conditions of interest (no condition) or with at least 1 of these conditions (≥1 condition); conditions of interest were cardiorespiratory conditions (chronic obstructive pulmonary disease [COPD], asthma, any chronic respiratory or pulmonary disease [including COPD, asthma, and other conditions], chronic heart failure) and endocrine and metabolic conditions (diabetes mellitus type 1 or type 2 and advanced liver or renal disease) that are associated with an increased risk of severe RSV disease. Error bars depict 95% confidence intervals. Rectangles above the bars contain geometric mean increases (GMIs) from day 1 to day 31 with 95% confidence intervals. ED60, estimated dilution 60.
See this image and copyright information in PMC

References

    1. Falsey AR, Hennessey PA, Formica MA, Cox C, Walsh EE. Respiratory syncytial virus infection in elderly and high-risk adults. N Engl J Med 2005; 352:1749–59. - PubMed
    1. Falsey AR, McElhaney JE, Beran J, et al. . Respiratory syncytial virus and other respiratory viral infections in older adults with moderate to severe influenza-like illness. J Infect Dis 2014; 209:1873–81. - PMC - PubMed
    1. Nam HH, Ison MG. Respiratory syncytial virus infection in adults. BMJ 2019; 366:l5021. - PubMed
    1. Branche AR, Falsey AR. Respiratory syncytial virus infection in older adults: an under-recognized problem. Drugs Aging 2015; 32:261–9. - PubMed
    1. Savic M, Penders Y, Shi T, Branche A, Pirçon JY. Respiratory syncytial virus disease burden in adults aged 60 years and older in high-income countries: a systematic literature review and meta-analysis. Influenza Other Respir Viruses 2023; 17:e13031. - PMC - PubMed

Publication types

MeSH terms

Substances

Associated data

Grants and funding