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Open Access
Peer-reviewed
Research Article
Safety and pharmacokinetics of VRC07-523LS administered via different routes and doses (HVTN 127/HPTN 087): A Phase I randomized clinical trial
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Stephen R. Walsh ,
Contributed equally to this work with: Stephen R. Walsh, Cynthia L. Gay
Roles Conceptualization, Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Writing – original draft, Writing – review & editing
* E-mail: swalsh@bwh.harvard.edu
Affiliations Division of Infectious Diseases, Brigham and Women’s Hospital, Boston, Massachusetts, United States of America, Harvard Medical School, Boston, Massachusetts, United States of America
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Cynthia L. Gay ,
Contributed equally to this work with: Stephen R. Walsh, Cynthia L. Gay
Roles Conceptualization, Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Writing – original draft, Writing – review & editing
Affiliation Division of Infectious Diseases, University of North Carolina, Chapel Hill, North Carolina, United States of America
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Shelly T. Karuna,
Roles Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Project administration, Writing – original draft, Writing – review & editing
Affiliation Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America
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Ollivier Hyrien,
Roles Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Writing – original draft, Writing – review & editing
Affiliation Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America
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Timothy Skalland,
Roles Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Writing – review & editing
Affiliation Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America
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Kenneth H. Mayer,
Roles Investigation, Methodology, Project administration, Writing – review & editing
Affiliations Harvard Medical School, Boston, Massachusetts, United States of America, Fenway Institute, Boston, Massachusetts, United States of America
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Magdalena E. Sobieszczyk,
Roles Investigation, Methodology, Project administration, Writing – review & editing
Affiliation Division of Infectious Diseases, Columbia University, New York, New York, United States of America
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Lindsey R. Baden,
Roles Investigation, Methodology, Project administration, Writing – review & editing
Affiliations Division of Infectious Diseases, Brigham and Women’s Hospital, Boston, Massachusetts, United States of America, Harvard Medical School, Boston, Massachusetts, United States of America
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Paul A. Goepfert,
Roles Investigation, Methodology, Project administration, Writing – review & editing
Affiliation Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, Alabama, United States of America
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Carlos del Rio,
Roles Investigation, Methodology, Project administration, Writing – review & editing
Affiliation Emory University School of Medicine and Ponce de Leon Center of the Grady Health System, Atlanta, Georgia, United States of America
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Guiseppe Pantaleo,
Roles Investigation, Methodology, Project administration, Writing – review & editing
Affiliation Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
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Philip Andrew,
Roles Conceptualization, Investigation, Methodology, Project administration, Writing – review & editing
Affiliation FHI 360, Durham, North Carolina, United States of America
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Carissa Karg,
Roles Investigation, Methodology, Project administration, Writing – review & editing
Affiliation Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America
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Zonglin He,
Roles Data curation, Formal analysis, Writing – review & editing
Affiliation Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America
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Huiyin Lu,
Roles Data curation, Formal analysis, Writing – review & editing
Affiliation Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America
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Carmen A. Paez,
Roles Project administration, Writing – review & editing
Affiliation Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America
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Jane A. G. Baumblatt,
Roles Conceptualization, Investigation, Methodology, Project administration, Writing – review & editing
Affiliation Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, United States of America
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Laura L. Polakowski,
Roles Investigation, Methodology, Project administration, Writing – review & editing
Affiliation Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, United States of America
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Wairimu Chege,
Roles Investigation, Methodology, Project administration, Writing – review & editing
Affiliation Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, United States of America
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Maija A. Anderson,
Roles Methodology, Project administration, Supervision, Writing – review & editing
Affiliation Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America
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Sophie Janto,
Roles Project administration, Writing – review & editing
Affiliation Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America
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Xue Han,
Roles Data curation, Formal analysis, Writing – review & editing
Current address: Atara Biotherapeutics, Thousand Oaks, California, United States of America
Affiliation Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America
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Yunda Huang,
Roles Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Project administration, Writing – review & editing
Affiliation Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America
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Julie Dumond,
Roles Methodology, Writing – review & editing
Affiliation Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina, United States of America
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Margaret E. Ackerman,
Roles Formal analysis, Methodology, Resources, Writing – review & editing
Affiliation Thayer School of Engineering, Dartmouth College, Hanover, New Hampshire, United States of America
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Adrian B. McDermott,
Roles Formal analysis, Methodology, Resources, Writing – review & editing
Affiliation Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, United States of America
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Britta Flach,
Roles Data curation, Formal analysis, Methodology, Writing – review & editing
Affiliation Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, United States of America
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Estelle Piwowar-Manning,
Roles Project administration, Writing – review & editing
Affiliation Johns Hopkins University, Baltimore, Maryland, United States of America
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Kelly Seaton,
Roles Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Project administration, Writing – review & editing
Affiliations Department of Surgery, Duke University, Durham, North Carolina, United States of America, Duke Human Vaccine Institute, Duke University, Durham, North Carolina, United States of America
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Georgia D. Tomaras,
Roles Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Writing – review & editing
Affiliations Department of Surgery, Duke University, Durham, North Carolina, United States of America, Duke Human Vaccine Institute, Duke University, Durham, North Carolina, United States of America
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David C. Montefiori,
Roles Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Project administration, Writing – review & editing
Affiliations Department of Surgery, Duke University, Durham, North Carolina, United States of America, Duke Human Vaccine Institute, Duke University, Durham, North Carolina, United States of America
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Lucio Gama,
Roles Conceptualization, Investigation, Methodology, Project administration, Resources, Writing – review & editing
Affiliation Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, United States of America
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John R. Mascola,
Roles Conceptualization, Investigation, Methodology, Project administration, Resources, Writing – review & editing
Current address: ModeX Therapeutics, Natick, Massachusetts, United States of America
Affiliation Vaccine Research Center, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, United States of America
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for the HVTN 127/HPTN 087 Study Team
¶Membership of the HVTN 127/HPTN 087 Study Team is provided in the Acknowledgments.
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Safety and pharmacokinetics of VRC07-523LS administered via different routes and doses (HVTN 127/HPTN 087): A Phase I randomized clinical trial
- Stephen R. Walsh,
- Cynthia L. Gay,
- Shelly T. Karuna,
- Ollivier Hyrien,
- Timothy Skalland,
- Kenneth H. Mayer,
- Magdalena E. Sobieszczyk,
- Lindsey R. Baden,
- Paul A. Goepfert,
- Carlos del Rio
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- Published: June 24, 2024
- https://doi.org/10.1371/journal.pmed.1004329