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Title
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Respiratory syncytial virus prefusion F protein vaccine is efficacious in older adults with underlying medical conditions
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Author
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Institution/Organisation
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AReSVi 006 Study Group
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Abstract
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| 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 & GE;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 & GE;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 & GE;1 coexisting condition of interest. The median efficacy follow-up was 6.7 months. Efficacy against RSV-LRTD was high in participants with & GE;1 condition of interest (94.6%), & GE;1 cardiorespiratory (92.1%), & GE;1 endocrine/metabolic (100%), and & GE;2 conditions of interest (92.0%). Efficacy against RSV-ARI was 81.0% in participants with & GE;1 condition of interest (88.1% for cardiorespiratory, 79.4% for endocrine/metabolic conditions) and 88.0% in participants with & GE;2 conditions of interest. Postvaccination neutralizing titers were at least as high in participants with & GE;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. Graphical Abstract |
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Language
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English
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Source (journal)
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Clinical infectious diseases. - Chicago, Ill.
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Publication
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Cary
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Oxford univ press inc
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2024
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ISSN
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1058-4838
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DOI
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10.1093/CID/CIAD471
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Volume/pages
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78
:1
(2024)
, p. 202-209
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ISI
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001063465900001
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Pubmed ID
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37698366
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Full text (Publisher's DOI)
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Full text (open access)
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