Safety, pharmacokinetics and antiviral activity of PGT121, a broadly neutralizing monoclonal antibody against HIV-1: a randomized, placebo-controlled, phase 1 clinical trial.

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Title: Safety, pharmacokinetics and antiviral activity of PGT121, a broadly neutralizing monoclonal antibody against HIV-1: a randomized, placebo-controlled, phase 1 clinical trial.
Authors: Stephenson KE; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.; Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, MA, USA.; Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA., Julg B; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.; Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA.; Infectious Disease Division, Massachusetts General Hospital, Boston, MA, USA., Tan CS; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.; Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, MA, USA., Zash R; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.; Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, MA, USA., Walsh SR; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Rolle CP; Orlando Immunology Center, Orlando, FL, USA., Monczor AN; McGovern Medical School at The University of Texas Health Science Center, Houston, TX, USA., Lupo S; McGovern Medical School at The University of Texas Health Science Center, Houston, TX, USA., Gelderblom HC; International AIDS Vaccine Initiative, New York, NY, USA., Ansel JL; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Kanjilal DG; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Maxfield LF; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Nkolola J; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Borducchi EN; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Abbink P; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Liu J; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Peter L; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Chandrashekar A; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Nityanandam R; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Lin Z; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Setaro A; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Sapiente J; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Chen Z; Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA., Sunner L; International AIDS Vaccine Initiative, New York, NY, USA., Cassidy T; Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA., Bennett C; Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA., Sato A; Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA., Mayer B; Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA., Perelson AS; Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA., deCamp A; Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA., Priddy FH; International AIDS Vaccine Initiative, New York, NY, USA., Wagh K; Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA., Giorgi EE; Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA., Yates NL; Duke Human Vaccine Institute, Duke University, Durham, NC, USA.; Departments of Surgery, Immunology and Molecular Genetics and Microbiology, Duke University, Durham, NC, USA., Arduino RC; McGovern Medical School at The University of Texas Health Science Center, Houston, TX, USA., DeJesus E; Orlando Immunology Center, Orlando, FL, USA., Tomaras GD; Duke Human Vaccine Institute, Duke University, Durham, NC, USA.; Departments of Surgery, Immunology and Molecular Genetics and Microbiology, Duke University, Durham, NC, USA., Seaman MS; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Korber B; Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.; New Mexico Consortium, Los Alamos, NM, USA., Barouch DH; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA. dbarouch@bidmc.harvard.edu.; Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, MA, USA. dbarouch@bidmc.harvard.edu.; Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA. dbarouch@bidmc.harvard.edu.
Source: Nature medicine [Nat Med] 2021 Oct; Vol. 27 (10), pp. 1718-1724. Date of Electronic Publication: 2021 Oct 07.
Publication Type: Clinical Trial, Phase I; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
Journal Info: Publisher: Nature Publishing Company Country of Publication: United States NLM ID: 9502015 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1546-170X (Electronic) Linking ISSN: 10788956 NLM ISO Abbreviation: Nat Med Subsets: MEDLINE
Database: MEDLINE Ultimate
Description
ISSN:1546-170X
DOI:10.1038/s41591-021-01509-0