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.
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
Description
ISSN:2352-3018
DOI:10.1016/S2352-3018(25)00012-8