Efficacy, immunogenicity, and safety of the live attenuated nasal pertussis vaccine, BPZE1, in the UK: a randomised, placebo-controlled, phase 2b trial using a controlled human infection model with virulent Bordetella pertussis.

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Title: Efficacy, immunogenicity, and safety of the live attenuated nasal pertussis vaccine, BPZE1, in the UK: a randomised, placebo-controlled, phase 2b trial using a controlled human infection model with virulent Bordetella pertussis.
Authors: Gbesemete D; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Controlled Human Infection Group, School of Clinical & Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK., Ramasamy MN; Oxford Vaccine Group, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford University Hospitals NHS Foundation Trust, Oxford, UK., Ibrahim M; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Controlled Human Infection Group, School of Clinical & Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK; Department of Infection, University Hospital Southampton NHS Foundation Trust, Southampton, UK., Hill AR; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Controlled Human Infection Group, School of Clinical & Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK., Raud L; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Controlled Human Infection Group, School of Clinical & Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK., Ferreira DM; Oxford Vaccine Group, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford University Hospitals NHS Foundation Trust, Oxford, UK., Guy J; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Controlled Human Infection Group, School of Clinical & Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK., Dale AP; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Controlled Human Infection Group, School of Clinical & Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK., Laver JR; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Controlled Human Infection Group, School of Clinical & Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK., Coutinho T; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Controlled Human Infection Group, School of Clinical & Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK., Faust SN; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Faculty of Medicine and Institute for Life Science, University of Southampton, Southampton, UK., Reed TAN; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK., Babbage G; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK., Weissfeld L; WCG Clinical, Princeton, NJ, USA., Lang W; WCG Clinical, Princeton, NJ, USA., Locht C; Institut Pasteur de Lille, Inserm U1019, CNRS UMR9017, Centre for Infection and Immunity of Lille, CHU Lille, Inserm, University of Lille, Lille, France. Electronic address: camille.locht@pasteur-lille.fr., Samal V; ILiAD Biotechnologies, Weston, FL, USA., Goldstein P; ILiAD Biotechnologies, Weston, FL, USA., Solovay K; ILiAD Biotechnologies, Weston, FL, USA., Rubin K; ILiAD Biotechnologies, Weston, FL, USA., Noviello S; ILiAD Biotechnologies, Weston, FL, USA., Read RC; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Controlled Human Infection Group, School of Clinical & Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
Source: The Lancet. Microbe [Lancet Microbe] 2025 Dec; Vol. 6 (12), pp. 101211. Date of Electronic Publication: 2025 Dec 01.
Publication Type: Journal Article; Randomized Controlled Trial; Clinical Trial, Phase II
Journal Info: Publisher: Elsevier Ltd Country of Publication: England NLM ID: 101769019 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2666-5247 (Electronic) Linking ISSN: 26665247 NLM ISO Abbreviation: Lancet Microbe Subsets: MEDLINE
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  Data: Efficacy, immunogenicity, and safety of the live attenuated nasal pertussis vaccine, BPZE1, in the UK: a randomised, placebo-controlled, phase 2b trial using a controlled human infection model with virulent Bordetella pertussis.
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  Data: <searchLink fieldCode="AU" term="%22Gbesemete+D%22">Gbesemete D</searchLink>; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Controlled Human Infection Group, School of Clinical & Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.<br /><searchLink fieldCode="AU" term="%22Ramasamy+MN%22">Ramasamy MN</searchLink>; Oxford Vaccine Group, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Ibrahim+M%22">Ibrahim M</searchLink>; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Controlled Human Infection Group, School of Clinical & Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK; Department of Infection, University Hospital Southampton NHS Foundation Trust, Southampton, UK.<br /><searchLink fieldCode="AU" term="%22Hill+AR%22">Hill AR</searchLink>; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Controlled Human Infection Group, School of Clinical & Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.<br /><searchLink fieldCode="AU" term="%22Raud+L%22">Raud L</searchLink>; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Controlled Human Infection Group, School of Clinical & Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.<br /><searchLink fieldCode="AU" term="%22Ferreira+DM%22">Ferreira DM</searchLink>; Oxford Vaccine Group, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Guy+J%22">Guy J</searchLink>; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Controlled Human Infection Group, School of Clinical & Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.<br /><searchLink fieldCode="AU" term="%22Dale+AP%22">Dale AP</searchLink>; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Controlled Human Infection Group, School of Clinical & Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.<br /><searchLink fieldCode="AU" term="%22Laver+JR%22">Laver JR</searchLink>; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Controlled Human Infection Group, School of Clinical & Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.<br /><searchLink fieldCode="AU" term="%22Coutinho+T%22">Coutinho T</searchLink>; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Controlled Human Infection Group, School of Clinical & Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.<br /><searchLink fieldCode="AU" term="%22Faust+SN%22">Faust SN</searchLink>; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Faculty of Medicine and Institute for Life Science, University of Southampton, Southampton, UK.<br /><searchLink fieldCode="AU" term="%22Reed+TAN%22">Reed TAN</searchLink>; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.<br /><searchLink fieldCode="AU" term="%22Babbage+G%22">Babbage G</searchLink>; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.<br /><searchLink fieldCode="AU" term="%22Weissfeld+L%22">Weissfeld L</searchLink>; WCG Clinical, Princeton, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Lang+W%22">Lang W</searchLink>; WCG Clinical, Princeton, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Locht+C%22">Locht C</searchLink>; Institut Pasteur de Lille, Inserm U1019, CNRS UMR9017, Centre for Infection and Immunity of Lille, CHU Lille, Inserm, University of Lille, Lille, France. Electronic address: camille.locht@pasteur-lille.fr.<br /><searchLink fieldCode="AU" term="%22Samal+V%22">Samal V</searchLink>; ILiAD Biotechnologies, Weston, FL, USA.<br /><searchLink fieldCode="AU" term="%22Goldstein+P%22">Goldstein P</searchLink>; ILiAD Biotechnologies, Weston, FL, USA.<br /><searchLink fieldCode="AU" term="%22Solovay+K%22">Solovay K</searchLink>; ILiAD Biotechnologies, Weston, FL, USA.<br /><searchLink fieldCode="AU" term="%22Rubin+K%22">Rubin K</searchLink>; ILiAD Biotechnologies, Weston, FL, USA.<br /><searchLink fieldCode="AU" term="%22Noviello+S%22">Noviello S</searchLink>; ILiAD Biotechnologies, Weston, FL, USA.<br /><searchLink fieldCode="AU" term="%22Read+RC%22">Read RC</searchLink>; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Controlled Human Infection Group, School of Clinical & Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
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  Data: <searchLink fieldCode="JN" term="%22101769019%22">The Lancet. Microbe</searchLink> [Lancet Microbe] 2025 Dec; Vol. 6 (12), pp. 101211. <i>Date of Electronic Publication: </i>2025 Dec 01.
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