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. |
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| 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 |
| Database: | MEDLINE Ultimate |
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