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Safety, tolerability, pharmacokinetics, and neutralisation activities of the anti-HIV-1 monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS in adults without HIV in the USA (HVTN 136/HPTN 092): a first-in-human, open-label, randomised controlled phase 1 trial.

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Title: Safety, tolerability, pharmacokinetics, and neutralisation activities of the anti-HIV-1 monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS in adults without HIV in the USA (HVTN 136/HPTN 092): a first-in-human, open-label, randomised controlled phase 1 trial.
Authors: Edupuganti S; Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta, GA, USA. Electronic address: sedupug@emory.edu., Hurt CB; Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA., Stephenson KE; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA., Huang Y; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA; Department of Global Health, University of Washington, Seattle, WA, USA., Paez CA; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA., Yu C; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA., Yen C; National Institute of Allergy and Infectious Diseases, Rockville, MD, USA., Hanscom B; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA., He Z; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA., Miner MD; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA., Gamble T; FHI 360, HPTN Leadership and Operations Center, Durham, NC, USA., Heptinstall J; Duke University Medical Center, Durham, NC, USA., Seaton KE; Duke University Medical Center, Durham, NC, USA., Domin E; Duke University Medical Center, Durham, NC, USA., Lin BC; National Institute of Allergy and Infectious Diseases, Rockville, MD, USA., McKee K; National Institute of Allergy and Infectious Diseases, Rockville, MD, USA., Doria-Rose N; National Institute of Allergy and Infectious Diseases, Rockville, MD, USA., Regenold S; National Institute of Allergy and Infectious Diseases, Rockville, MD, USA., Spiegel H; Kelly Government Solutions, Rockville, MD, USA., Anderson M; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA., McClosky N; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA., Zhang L; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA., Piwowar-Manning E; Department of Pathology, School of Medicine, Johns Hopkins University, Baltimore, MD, USA., Ackerman ME; Dartmouth College, Hanover, NH, USA., Pensiero M; National Institute of Allergy and Infectious Diseases, Rockville, MD, USA., Dye BJ; FHI 360, HPTN Leadership and Operations Center, Durham, NC, USA., Landovitz RJ; UCLA Center for Clinical AIDS Research and Education, Los Angeles, CA, USA., Mayer K; Fenway Health, Harvard Medical School, Boston, MA, USA., Siegel M; George Washington University School of Medicine and Health Sciences, Washington, DC, USA., Sobieszczyk M; Columbia University Irving Medical Center, New York, NY, USA., Walsh SR; Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA., Gama L; National Institute of Allergy and Infectious Diseases, Rockville, MD, USA., Barouch DH; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA., Montefiori DC; Duke University Medical Center, Durham, NC, USA., Tomaras GD; Duke University Medical Center, Durham, NC, USA.
Corporate Authors: HVTN 136/HPTN 092 Study Team
Source: The lancet. HIV [Lancet HIV] 2025 Jan; Vol. 12 (1), pp. e13-e25. Date of Electronic Publication: 2024 Dec 10.
Publication Type: Journal Article; Clinical Trial, Phase I; Randomized Controlled Trial; Multicenter Study
Journal Info: Publisher: Elsevier B.V Country of Publication: Netherlands NLM ID: 101645355 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2352-3018 (Electronic) Linking ISSN: 23523018 NLM ISO Abbreviation: Lancet HIV Subsets: MEDLINE
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  Data: Safety, tolerability, pharmacokinetics, and neutralisation activities of the anti-HIV-1 monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS in adults without HIV in the USA (HVTN 136/HPTN 092): a first-in-human, open-label, randomised controlled phase 1 trial.
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  Data: <searchLink fieldCode="AU" term="%22Edupuganti+S%22">Edupuganti S</searchLink>; Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta, GA, USA. Electronic address: sedupug@emory.edu.<br /><searchLink fieldCode="AU" term="%22Hurt+CB%22">Hurt CB</searchLink>; Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.<br /><searchLink fieldCode="AU" term="%22Stephenson+KE%22">Stephenson KE</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Huang+Y%22">Huang Y</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA; Department of Global Health, University of Washington, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Paez+CA%22">Paez CA</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Yu+C%22">Yu C</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Yen+C%22">Yen C</searchLink>; National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.<br /><searchLink fieldCode="AU" term="%22Hanscom+B%22">Hanscom B</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22He+Z%22">He Z</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Miner+MD%22">Miner MD</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Gamble+T%22">Gamble T</searchLink>; FHI 360, HPTN Leadership and Operations Center, Durham, NC, USA.<br /><searchLink fieldCode="AU" term="%22Heptinstall+J%22">Heptinstall J</searchLink>; Duke University Medical Center, Durham, NC, USA.<br /><searchLink fieldCode="AU" term="%22Seaton+KE%22">Seaton KE</searchLink>; Duke University Medical Center, Durham, NC, USA.<br /><searchLink fieldCode="AU" term="%22Domin+E%22">Domin E</searchLink>; Duke University Medical Center, Durham, NC, USA.<br /><searchLink fieldCode="AU" term="%22Lin+BC%22">Lin BC</searchLink>; National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.<br /><searchLink fieldCode="AU" term="%22McKee+K%22">McKee K</searchLink>; National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.<br /><searchLink fieldCode="AU" term="%22Doria-Rose+N%22">Doria-Rose N</searchLink>; National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.<br /><searchLink fieldCode="AU" term="%22Regenold+S%22">Regenold S</searchLink>; National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.<br /><searchLink fieldCode="AU" term="%22Spiegel+H%22">Spiegel H</searchLink>; Kelly Government Solutions, Rockville, MD, USA.<br /><searchLink fieldCode="AU" term="%22Anderson+M%22">Anderson M</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22McClosky+N%22">McClosky N</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Zhang+L%22">Zhang L</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Piwowar-Manning+E%22">Piwowar-Manning E</searchLink>; Department of Pathology, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.<br /><searchLink fieldCode="AU" term="%22Ackerman+ME%22">Ackerman ME</searchLink>; Dartmouth College, Hanover, NH, USA.<br /><searchLink fieldCode="AU" term="%22Pensiero+M%22">Pensiero M</searchLink>; National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.<br /><searchLink fieldCode="AU" term="%22Dye+BJ%22">Dye BJ</searchLink>; FHI 360, HPTN Leadership and Operations Center, Durham, NC, USA.<br /><searchLink fieldCode="AU" term="%22Landovitz+RJ%22">Landovitz RJ</searchLink>; UCLA Center for Clinical AIDS Research and Education, Los Angeles, CA, USA.<br /><searchLink fieldCode="AU" term="%22Mayer+K%22">Mayer K</searchLink>; Fenway Health, Harvard Medical School, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Siegel+M%22">Siegel M</searchLink>; George Washington University School of Medicine and Health Sciences, Washington, DC, USA.<br /><searchLink fieldCode="AU" term="%22Sobieszczyk+M%22">Sobieszczyk M</searchLink>; Columbia University Irving Medical Center, New York, NY, USA.<br /><searchLink fieldCode="AU" term="%22Walsh+SR%22">Walsh SR</searchLink>; Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Gama+L%22">Gama L</searchLink>; National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.<br /><searchLink fieldCode="AU" term="%22Barouch+DH%22">Barouch DH</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Montefiori+DC%22">Montefiori DC</searchLink>; Duke University Medical Center, Durham, NC, USA.<br /><searchLink fieldCode="AU" term="%22Tomaras+GD%22">Tomaras GD</searchLink>; Duke University Medical Center, Durham, NC, USA.
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  Data: <searchLink fieldCode="CA" term="%22HVTN+136%2FHPTN+092+Study+Team%22">HVTN 136/HPTN 092 Study Team</searchLink>
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  Data: <searchLink fieldCode="JN" term="%22101645355%22">The lancet. HIV</searchLink> [Lancet HIV] 2025 Jan; Vol. 12 (1), pp. e13-e25. <i>Date of Electronic Publication: </i>2024 Dec 10.
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