SARS-CoV-2 recombinant spike ferritin nanoparticle vaccine adjuvanted with Army Liposome Formulation containing monophosphoryl lipid A and QS-21: a phase 1, randomised, double-blind, placebo-controlled, first-in-human clinical trial.

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Title: SARS-CoV-2 recombinant spike ferritin nanoparticle vaccine adjuvanted with Army Liposome Formulation containing monophosphoryl lipid A and QS-21: a phase 1, randomised, double-blind, placebo-controlled, first-in-human clinical trial.
Authors: Ober Shepherd BL; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA., Scott PT; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Global Clinical Development, Vaccines, Merck, Rahway, NJ, USA., Hutter JN; Walter Reed Army Institute of Research, Silver Spring, MD, USA., Lee C; Walter Reed Army Institute of Research, Silver Spring, MD, USA., McCauley MD; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA., Guzman I; Walter Reed Army Institute of Research, Silver Spring, MD, USA., Bryant C; The Emmes Company, Rockville, MD, USA., McGuire S; The Emmes Company, Rockville, MD, USA., Kennedy J; The Emmes Company, Rockville, MD, USA., Chen WH; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA., Hajduczki A; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA., Mdluli T; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA., Valencia-Ruiz A; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA., Amare MF; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA., Matyas GR; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA., Rao M; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA., Rolland M; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA., Mascola JR; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA., De Rosa SC; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Departments of Lab Medicine and Pathology, University of Washington, Seattle, WA, USA., McElrath MJ; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Departments of Lab Medicine and Pathology, University of Washington, Seattle, WA, USA., Montefiori DC; Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA; Department of Surgery, Duke University School of Medicine, Durham, NC, USA., Serebryannyy L; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA., McDermott AB; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA; Immunology, Sanofi Vaccines, Lyon, France., Peel SA; Walter Reed Army Institute of Research, Silver Spring, MD, USA., Collins ND; Walter Reed Army Institute of Research, Silver Spring, MD, USA., Joyce MG; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA., Robb ML; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA., Michael NL; Walter Reed Army Institute of Research, Silver Spring, MD, USA. Electronic address: nelson.l.michael2.civ@health.mil., Vasan S; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA., Modjarrad K; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Vaccine Research and Development, Pfizer, Pearl River, NY, USA.
Corporate Authors: EID-030 Study Group
Source: The Lancet. Microbe [Lancet Microbe] 2024 Jun; Vol. 5 (6), pp. e581-e593. Date of Electronic Publication: 2024 May 15.
Publication Type: Journal Article; Randomized Controlled Trial; Clinical Trial, Phase I; Research Support, U.S. Gov't, Non-P.H.S.; Research Support, Non-U.S. Gov't
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
Database: MEDLINE Ultimate
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  Data: SARS-CoV-2 recombinant spike ferritin nanoparticle vaccine adjuvanted with Army Liposome Formulation containing monophosphoryl lipid A and QS-21: a phase 1, randomised, double-blind, placebo-controlled, first-in-human clinical trial.
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  Data: <searchLink fieldCode="AU" term="%22Ober+Shepherd+BL%22">Ober Shepherd BL</searchLink>; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.<br /><searchLink fieldCode="AU" term="%22Scott+PT%22">Scott PT</searchLink>; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Global Clinical Development, Vaccines, Merck, Rahway, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Hutter+JN%22">Hutter JN</searchLink>; Walter Reed Army Institute of Research, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Lee+C%22">Lee C</searchLink>; Walter Reed Army Institute of Research, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22McCauley+MD%22">McCauley MD</searchLink>; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.<br /><searchLink fieldCode="AU" term="%22Guzman+I%22">Guzman I</searchLink>; Walter Reed Army Institute of Research, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Bryant+C%22">Bryant C</searchLink>; The Emmes Company, Rockville, MD, USA.<br /><searchLink fieldCode="AU" term="%22McGuire+S%22">McGuire S</searchLink>; The Emmes Company, Rockville, MD, USA.<br /><searchLink fieldCode="AU" term="%22Kennedy+J%22">Kennedy J</searchLink>; The Emmes Company, Rockville, MD, USA.<br /><searchLink fieldCode="AU" term="%22Chen+WH%22">Chen WH</searchLink>; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.<br /><searchLink fieldCode="AU" term="%22Hajduczki+A%22">Hajduczki A</searchLink>; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.<br /><searchLink fieldCode="AU" term="%22Mdluli+T%22">Mdluli T</searchLink>; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.<br /><searchLink fieldCode="AU" term="%22Valencia-Ruiz+A%22">Valencia-Ruiz A</searchLink>; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.<br /><searchLink fieldCode="AU" term="%22Amare+MF%22">Amare MF</searchLink>; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.<br /><searchLink fieldCode="AU" term="%22Matyas+GR%22">Matyas GR</searchLink>; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.<br /><searchLink fieldCode="AU" term="%22Rao+M%22">Rao M</searchLink>; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.<br /><searchLink fieldCode="AU" term="%22Rolland+M%22">Rolland M</searchLink>; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.<br /><searchLink fieldCode="AU" term="%22Mascola+JR%22">Mascola JR</searchLink>; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.<br /><searchLink fieldCode="AU" term="%22De+Rosa+SC%22">De Rosa SC</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Departments of Lab Medicine and Pathology, University of Washington, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22McElrath+MJ%22">McElrath MJ</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Departments of Lab Medicine and Pathology, University of Washington, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Montefiori+DC%22">Montefiori DC</searchLink>; Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA; Department of Surgery, Duke University School of Medicine, Durham, NC, USA.<br /><searchLink fieldCode="AU" term="%22Serebryannyy+L%22">Serebryannyy L</searchLink>; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.<br /><searchLink fieldCode="AU" term="%22McDermott+AB%22">McDermott AB</searchLink>; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA; Immunology, Sanofi Vaccines, Lyon, France.<br /><searchLink fieldCode="AU" term="%22Peel+SA%22">Peel SA</searchLink>; Walter Reed Army Institute of Research, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Collins+ND%22">Collins ND</searchLink>; Walter Reed Army Institute of Research, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Joyce+MG%22">Joyce MG</searchLink>; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.<br /><searchLink fieldCode="AU" term="%22Robb+ML%22">Robb ML</searchLink>; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.<br /><searchLink fieldCode="AU" term="%22Michael+NL%22">Michael NL</searchLink>; Walter Reed Army Institute of Research, Silver Spring, MD, USA. Electronic address: nelson.l.michael2.civ@health.mil.<br /><searchLink fieldCode="AU" term="%22Vasan+S%22">Vasan S</searchLink>; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.<br /><searchLink fieldCode="AU" term="%22Modjarrad+K%22">Modjarrad K</searchLink>; Walter Reed Army Institute of Research, Silver Spring, MD, USA; Vaccine Research and Development, Pfizer, Pearl River, NY, USA.
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  Data: <searchLink fieldCode="JN" term="%22101769019%22">The Lancet. Microbe</searchLink> [Lancet Microbe] 2024 Jun; Vol. 5 (6), pp. e581-e593. <i>Date of Electronic Publication: </i>2024 May 15.
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