Safety, pharmacokinetics, and neutralisation activity of PGDM1400LS, a V2 specific HIV-1 broadly neutralising antibody, infused intravenously or subcutaneously in people without HIV-1 in the USA (HVTN 140/HPTN 101 part A): a first-in-human, phase 1 randomised trial.
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| Title: | Safety, pharmacokinetics, and neutralisation activity of PGDM1400LS, a V2 specific HIV-1 broadly neutralising antibody, infused intravenously or subcutaneously in people without HIV-1 in the USA (HVTN 140/HPTN 101 part A): a first-in-human, phase 1 randomised trial. |
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| Authors: | Seaton KE; Duke Center for Human Systems Immunology, Departments of Surgery, Integrative Immunobiology, Molecular Genetics and Microbiology, Durham, NC, USA. Electronic address: kelly.seaton@duke.edu., 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., Karuna ST; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA., Gamble T; HPTN Leadership and Operation Center, FHI 360, Durham, NC, USA., Miner MD; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA., Heptinstall J; Duke Center for Human Systems Immunology, Departments of Surgery, Integrative Immunobiology, Molecular Genetics and Microbiology, Durham, NC, USA., Zhang L; Duke Center for Human Systems Immunology, Departments of Surgery, Integrative Immunobiology, Molecular Genetics and Microbiology, Durham, NC, USA., Gao F; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA., Yacovone M; National Institute of Allergy and Infectious Diseases, Rockville, MD, USA., Spiegel H; Kelly Government Solutions, Rockville, MD, USA., Dumond JB; University of North Carolina at Chapel Hill, Chapel Hill, NC, USA., Anderson M; 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., Dye B; HPTN Leadership and Operation Center, FHI 360, Durham, NC, USA., Tindale I; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA., Proulx-Burns L; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA., Trahey M; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA., Takuva S; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA; School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa., Takalani A; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA., Bailey VC; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA., Kalams SA; Division of Infectious Diseases, Department of Medicine, Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, TN, USA., Scott H; San Francisco Department of Public Health, San Francisco, CA, USA., Mkhize NN; National Institute for Communicable Diseases, Durban, South Africa., Weiner JA; Thayer School of Engineering, Dartmouth College, Hanover, NH, USA., Ackerman ME; Thayer School of Engineering, Dartmouth College, Hanover, NH, USA., McElrath MJ; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA., Pensiero M; 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 D; Duke Center for Human Systems Immunology, Departments of Surgery, Integrative Immunobiology, Molecular Genetics and Microbiology, Durham, NC, USA., Tomaras GD; Duke Center for Human Systems Immunology, Departments of Surgery, Integrative Immunobiology, Molecular Genetics and Microbiology, Durham, NC, USA., Corey L; Duke Center for Human Systems Immunology, Departments of Surgery, Integrative Immunobiology, Molecular Genetics and Microbiology, Durham, NC, USA., Cohen MS; University of North Carolina at Chapel Hill, Chapel Hill, NC, USA., Huang Y; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA., Mahomed S; Centre for the AIDS Programme of Research in South Africa, Durban, South Africa., Siegel M; George Washington University School of Medicine and Health Sciences, Washington, DC, USA., Kelley CF; Division of Infectious Diseases, Department of Medicine, Emory University, Atlanta, GA, USA. |
| Corporate Authors: | HVTN 140/HPTN 101 study team |
| Source: | The lancet. HIV [Lancet HIV] 2025 Jun; Vol. 12 (6), pp. e405-e415. |
| 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 Cited Medium: Internet ISSN: 2352-3018 (Electronic) Linking ISSN: 23523018 NLM ISO Abbreviation: Lancet HIV Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
| FullText | Text: Availability: 0 |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 40441807 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Safety, pharmacokinetics, and neutralisation activity of PGDM1400LS, a V2 specific HIV-1 broadly neutralising antibody, infused intravenously or subcutaneously in people without HIV-1 in the USA (HVTN 140/HPTN 101 part A): a first-in-human, phase 1 randomised trial. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Seaton+KE%22">Seaton KE</searchLink>; Duke Center for Human Systems Immunology, Departments of Surgery, Integrative Immunobiology, Molecular Genetics and Microbiology, Durham, NC, USA. Electronic address: kelly.seaton@duke.edu.<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="%22Karuna+ST%22">Karuna ST</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Gamble+T%22">Gamble T</searchLink>; HPTN Leadership and Operation Center, FHI 360, Durham, NC, 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="%22Heptinstall+J%22">Heptinstall J</searchLink>; Duke Center for Human Systems Immunology, Departments of Surgery, Integrative Immunobiology, Molecular Genetics and Microbiology, Durham, NC, USA.<br /><searchLink fieldCode="AU" term="%22Zhang+L%22">Zhang L</searchLink>; Duke Center for Human Systems Immunology, Departments of Surgery, Integrative Immunobiology, Molecular Genetics and Microbiology, Durham, NC, USA.<br /><searchLink fieldCode="AU" term="%22Gao+F%22">Gao F</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Yacovone+M%22">Yacovone M</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="%22Dumond+JB%22">Dumond JB</searchLink>; University of North Carolina at Chapel Hill, Chapel Hill, NC, 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="%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="%22Dye+B%22">Dye B</searchLink>; HPTN Leadership and Operation Center, FHI 360, Durham, NC, USA.<br /><searchLink fieldCode="AU" term="%22Tindale+I%22">Tindale I</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Proulx-Burns+L%22">Proulx-Burns L</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Trahey+M%22">Trahey M</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Takuva+S%22">Takuva S</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA; School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa.<br /><searchLink fieldCode="AU" term="%22Takalani+A%22">Takalani A</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Bailey+VC%22">Bailey VC</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Kalams+SA%22">Kalams SA</searchLink>; Division of Infectious Diseases, Department of Medicine, Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, TN, USA.<br /><searchLink fieldCode="AU" term="%22Scott+H%22">Scott H</searchLink>; San Francisco Department of Public Health, San Francisco, CA, USA.<br /><searchLink fieldCode="AU" term="%22Mkhize+NN%22">Mkhize NN</searchLink>; National Institute for Communicable Diseases, Durban, South Africa.<br /><searchLink fieldCode="AU" term="%22Weiner+JA%22">Weiner JA</searchLink>; Thayer School of Engineering, Dartmouth College, Hanover, NH, USA.<br /><searchLink fieldCode="AU" term="%22Ackerman+ME%22">Ackerman ME</searchLink>; Thayer School of Engineering, Dartmouth College, Hanover, NH, USA.<br /><searchLink fieldCode="AU" term="%22McElrath+MJ%22">McElrath MJ</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, 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="%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+D%22">Montefiori D</searchLink>; Duke Center for Human Systems Immunology, Departments of Surgery, Integrative Immunobiology, Molecular Genetics and Microbiology, Durham, NC, USA.<br /><searchLink fieldCode="AU" term="%22Tomaras+GD%22">Tomaras GD</searchLink>; Duke Center for Human Systems Immunology, Departments of Surgery, Integrative Immunobiology, Molecular Genetics and Microbiology, Durham, NC, USA.<br /><searchLink fieldCode="AU" term="%22Corey+L%22">Corey L</searchLink>; Duke Center for Human Systems Immunology, Departments of Surgery, Integrative Immunobiology, Molecular Genetics and Microbiology, Durham, NC, USA.<br /><searchLink fieldCode="AU" term="%22Cohen+MS%22">Cohen MS</searchLink>; University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.<br /><searchLink fieldCode="AU" term="%22Huang+Y%22">Huang Y</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Mahomed+S%22">Mahomed S</searchLink>; Centre for the AIDS Programme of Research in South Africa, Durban, South Africa.<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="%22Kelley+CF%22">Kelley CF</searchLink>; Division of Infectious Diseases, Department of Medicine, Emory University, Atlanta, GA, USA. – Name: AuthorCorporate Label: Corporate Authors Group: Au Data: <searchLink fieldCode="CA" term="%22HVTN+140%2FHPTN+101+study+team%22">HVTN 140/HPTN 101 study team</searchLink> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22101645355%22">The lancet. HIV</searchLink> [Lancet HIV] 2025 Jun; Vol. 12 (6), pp. e405-e415. – Name: TypePub Label: Publication Type Group: TypPub Data: Journal Article; Clinical Trial, Phase I; Randomized Controlled Trial; Multicenter Study – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier+B%2EV%22">Elsevier B.V </searchLink><i>Country of Publication: </i>Netherlands <i>NLM ID: </i>101645355 <i>Publication Model: </i>Print <i>Cited Medium: </i>Internet <i>ISSN: </i>2352-3018 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2223523018%22">23523018 </searchLink><i>NLM ISO Abbreviation: </i>Lancet HIV <i>Subsets: </i>MEDLINE |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=40441807 |
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