{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T02:23:07Z","timestamp":1790043787756,"version":"4.0.1"},"reference-count":43,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2021,2,1]],"date-time":"2021-02-01T00:00:00Z","timestamp":1612137600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2021,2,1]],"date-time":"2021-02-01T00:00:00Z","timestamp":1612137600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2020,12,22]],"date-time":"2020-12-22T00:00:00Z","timestamp":1608595200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005895","name":"Fred Hutchinson Cancer Research Center","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005895","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["thelancet.com","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["EBioMedicine"],"published-print":{"date-parts":[[2021,2]]},"DOI":"10.1016\/j.ebiom.2020.103203","type":"journal-article","created":{"date-parts":[[2021,1,23]],"date-time":"2021-01-23T03:46:26Z","timestamp":1611373586000},"page":"103203","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":31,"special_numbering":"C","title":["Pharmacokinetics and predicted neutralisation coverage of VRC01 in HIV-uninfected participants of the Antibody Mediated Prevention (AMP) trials"],"prefix":"10.1016","volume":"64","author":[{"given":"Yunda","family":"Huang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Logashvari","family":"Naidoo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lily","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0333-5925","authenticated-orcid":false,"given":"Lindsay N.","family":"Carpp","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erika","family":"Rudnicki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2652-3734","authenticated-orcid":false,"given":"April","family":"Randhawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pedro","family":"Gonzales","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adrian","family":"McDermott","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie","family":"Ledgerwood","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margarita M.Gomez","family":"Lorenzo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Burns","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allan","family":"DeCamp","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0920-2915","authenticated-orcid":false,"given":"Michal","family":"Juraska","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Mascola","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Srilatha","family":"Edupuganti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nyaradzo","family":"Mgodi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Myron","family":"Cohen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence","family":"Corey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip","family":"Andrew","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shelly","family":"Karuna","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter B.","family":"Gilbert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathryn","family":"Mngadi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4965-0624","authenticated-orcid":false,"given":"Erica","family":"Lazarus","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.ebiom.2020.103203_bib0001","unstructured":"UNAIDS. Global HIV & AIDS statistics - 2020 fact sheet. https:\/\/www.unaids.org\/en\/resources\/fact-sheet Access date Sept 11, 2020. [Available from: http:\/\/www.unaids.org\/en\/resources\/fact-sheet."},{"key":"10.1016\/j.ebiom.2020.103203_bib0002","doi-asserted-by":"crossref","first-page":"1163","DOI":"10.1377\/hlthaff.2018.05391","article-title":"Twenty years of antiretroviral therapy for people living with hiv: global costs, health achievements, economic benefits","volume":"38","author":"Forsythe","year":"2019","journal-title":"Health Aff (Millwood)"},{"key":"10.1016\/j.ebiom.2020.103203_bib0003","doi-asserted-by":"crossref","first-page":"j5011","DOI":"10.1136\/bmj.j5011","article-title":"Recent advances in pre-exposure prophylaxis for HIV","volume":"359","author":"Desai","year":"2017","journal-title":"BMJ"},{"key":"10.1016\/j.ebiom.2020.103203_bib0004","doi-asserted-by":"crossref","first-page":"312","DOI":"10.1016\/S0140-6736(18)31070-5","article-title":"Advancing global health and strengthening the HIV response in the era of the sustainable development goals: the international AIDS society-lancet commission","volume":"392","author":"Bekker","year":"2018","journal-title":"Lancet"},{"key":"10.1016\/j.ebiom.2020.103203_bib0005","doi-asserted-by":"crossref","DOI":"10.1126\/scitranslmed.aaz2686","article-title":"Multiple roles for HIV broadly neutralizing antibodies","volume":"11","author":"Haynes","year":"2019","journal-title":"Sci Transl Med"},{"key":"10.1016\/j.ebiom.2020.103203_bib0006","doi-asserted-by":"crossref","first-page":"70","DOI":"10.1186\/s12977-018-0453-y","article-title":"The expanding array of HIV broadly neutralizing antibodies","volume":"15","author":"McCoy","year":"2018","journal-title":"Retrovirology"},{"key":"10.1016\/j.ebiom.2020.103203_bib0007","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1111\/imr.12484","article-title":"Identification and specificity of broadly neutralizing antibodies against HIV","volume":"275","author":"McCoy","year":"2017","journal-title":"Immunol Rev"},{"key":"10.1016\/j.ebiom.2020.103203_bib0008","doi-asserted-by":"crossref","first-page":"1179","DOI":"10.1038\/s41590-018-0235-7","article-title":"Recent progress in broadly neutralizing antibodies to HIV","volume":"19","author":"Sok","year":"2018","journal-title":"Nat Immunol"},{"key":"10.1016\/j.ebiom.2020.103203_bib0009","first-page":"127","article-title":"Passive and active antibody studies in primates to inform HIV vaccines","volume":"17","author":"Hessell","year":"2018","journal-title":"Expert Rev Vaccines"},{"key":"10.1016\/j.ebiom.2020.103203_bib0010","doi-asserted-by":"crossref","first-page":"296","DOI":"10.1111\/imr.12511","article-title":"Use of broadly neutralizing antibodies for HIV-1 prevention","volume":"275","author":"Pegu","year":"2017","journal-title":"Immunol Rev"},{"key":"10.1016\/j.ebiom.2020.103203_bib0011","doi-asserted-by":"crossref","DOI":"10.1126\/scitranslmed.3008992","article-title":"Neutralizing antibodies to HIV-1 envelope protect more effectively in vivo than those to the CD4 receptor","volume":"6","author":"Pegu","year":"2014","journal-title":"Sci Transl Med"},{"key":"10.1016\/j.ebiom.2020.103203_bib0012","doi-asserted-by":"crossref","first-page":"856","DOI":"10.1126\/science.1187659","article-title":"Rational design of envelope identifies broadly neutralizing human monoclonal antibodies to HIV-1","volume":"329","author":"Wu","year":"2010","journal-title":"Science"},{"key":"10.1016\/j.ebiom.2020.103203_bib0013","doi-asserted-by":"crossref","first-page":"811","DOI":"10.1126\/science.1192819","article-title":"Structural basis for broad and potent neutralization of HIV-1 by antibody VRC01","volume":"329","author":"Zhou","year":"2010","journal-title":"Science"},{"key":"10.1016\/j.ebiom.2020.103203_bib0014","doi-asserted-by":"crossref","first-page":"642","DOI":"10.1038\/nature13612","article-title":"Enhanced neonatal Fc receptor function improves protection against primate SHIV infection","volume":"514","author":"Ko","year":"2014","journal-title":"Nature"},{"key":"10.1016\/j.ebiom.2020.103203_bib0015","doi-asserted-by":"crossref","first-page":"18921","DOI":"10.1073\/pnas.1214785109","article-title":"Highly potent HIV-specific antibody neutralization in vitro translates into effective protection against mucosal SHIV challenge in vivo","volume":"109","author":"Moldt","year":"2012","journal-title":"Proc Natl Acad Sci U S A"},{"key":"10.1016\/j.ebiom.2020.103203_bib0016","doi-asserted-by":"crossref","first-page":"289","DOI":"10.1111\/cei.12692","article-title":"Safety, pharmacokinetics and neutralization of the broadly neutralizing HIV-1 human monoclonal antibody VRC01 in healthy adults","volume":"182","author":"Ledgerwood","year":"2015","journal-title":"Clin Exp Immunol"},{"key":"10.1016\/j.ebiom.2020.103203_bib0017","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pmed.1002435","article-title":"Safety, pharmacokinetics, and immunological activities of multiple intravenous or subcutaneous doses of an anti-HIV monoclonal antibody, VRC01, administered to HIV-uninfected adults: results of a phase 1 randomized trial","volume":"14","author":"Mayer","year":"2017","journal-title":"PLoS Med"},{"key":"10.1016\/j.ebiom.2020.103203_bib0018","doi-asserted-by":"crossref","first-page":"792","DOI":"10.1080\/19420862.2017.1311435","article-title":"Population pharmacokinetics analysis of VRC01, an HIV-1 broadly neutralizing monoclonal antibody, in healthy adults","volume":"9","author":"Huang","year":"2017","journal-title":"MAbs"},{"key":"10.1016\/j.ebiom.2020.103203_bib0019","doi-asserted-by":"crossref","first-page":"576","DOI":"10.1002\/psp4.12224","article-title":"Pharmacokinetics of Monoclonal Antibodies","volume":"6","author":"Ryman","year":"2017","journal-title":"CPT Pharmacometrics Syst Pharmacol"},{"key":"10.1016\/j.ebiom.2020.103203_bib0020","doi-asserted-by":"crossref","first-page":"75","DOI":"10.1016\/j.ddtec.2016.09.004","article-title":"Translational pharmacokinetics and pharmacodynamics of monoclonal antibodies","volume":"21-22","author":"Kamath","year":"2016","journal-title":"Drug Discov Today Technol"},{"key":"10.1016\/j.ebiom.2020.103203_bib0021","article-title":"Basis and statistical design of the passive HIV-1 antibody mediated prevention (AMP) test-of-concept efficacy trials","volume":"9","author":"Gilbert","year":"2017","journal-title":"Stat Commun Infect Dis"},{"key":"10.1016\/j.ebiom.2020.103203_bib0022","doi-asserted-by":"crossref","first-page":"182","DOI":"10.1016\/j.molmed.2011.12.001","article-title":"The origin and diversity of the HIV-1 pandemic","volume":"18","author":"Hemelaar","year":"2012","journal-title":"Trends Mol Med"},{"key":"10.1016\/j.ebiom.2020.103203_bib0023","doi-asserted-by":"crossref","first-page":"4503","DOI":"10.1002\/sim.8310","article-title":"Assessing pharmacokinetic marker correlates of outcome, with application to antibody prevention efficacy trials","volume":"38","author":"Gilbert","year":"2019","journal-title":"Stat Med"},{"key":"10.1016\/j.ebiom.2020.103203_bib0024","doi-asserted-by":"crossref","DOI":"10.1126\/scitranslmed.aad5752","article-title":"Virologic effects of broadly neutralizing antibody VRC01 administration during chronic HIV-1 infection","volume":"7","author":"Lynch","year":"2015","journal-title":"Sci Transl Med"},{"key":"10.1016\/j.ebiom.2020.103203_bib0025","doi-asserted-by":"crossref","first-page":"W213","DOI":"10.1093\/nar\/gkv404","article-title":"CATNAP: a tool to compile, analyze and tally neutralizing antibody panels","volume":"43","author":"Yoon","year":"2015","journal-title":"Nucleic Acids Res"},{"key":"10.1016\/j.ebiom.2020.103203_bib0026","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1016\/j.jim.2011.09.007","article-title":"Development and implementation of an international proficiency testing program for a neutralizing antibody assay for HIV-1 in TZM-bl cells","volume":"375","author":"Todd","year":"2012","journal-title":"J Immunol Methods"},{"key":"10.1016\/j.ebiom.2020.103203_bib0027","doi-asserted-by":"crossref","first-page":"1","DOI":"10.2202\/1557-4679.1043","article-title":"Targeted maximum likelihood learning","volume":"2","author":"Van Der Laan","year":"2006","journal-title":"Int J Biostat"},{"key":"10.1016\/j.ebiom.2020.103203_bib0028","doi-asserted-by":"crossref","first-page":"863","DOI":"10.1093\/biomet\/asx053","article-title":"Doubly robust nonparametric inference on the average treatment effect","volume":"104","author":"Benkeser","year":"2017","journal-title":"Biometrika"},{"key":"10.1016\/j.ebiom.2020.103203_bib0029","doi-asserted-by":"crossref","first-page":"1","DOI":"10.18637\/jss.v051.i13","article-title":"tmle: an R package for targeted maximum likelihood estimation","volume":"51","author":"Gruber","year":"2012","journal-title":"J Stat Softw"},{"key":"10.1016\/j.ebiom.2020.103203_bib0030","first-page":"65","article-title":"A simple sequentially rejective multiple test procedure","volume":"6","author":"Holm","year":"1979","journal-title":"Scand J Stat"},{"key":"10.1016\/j.ebiom.2020.103203_bib0031","doi-asserted-by":"crossref","first-page":"56","DOI":"10.3390\/antib8040056","article-title":"Understanding inter-individual variability in monoclonal antibody disposition","volume":"8","author":"Thomas","year":"2019","journal-title":"Antibodies (Basel)"},{"key":"10.1016\/j.ebiom.2020.103203_bib0032","doi-asserted-by":"crossref","first-page":"114","DOI":"10.1111\/bcp.13767","article-title":"Lack of ethnic differences in the pharmacokinetics and pharmacodynamics of evolocumab between Caucasian and Asian populations","volume":"85","author":"Wang","year":"2019","journal-title":"Br J Clin Pharmacol"},{"key":"10.1016\/j.ebiom.2020.103203_bib0033","doi-asserted-by":"crossref","first-page":"640","DOI":"10.1128\/cdli.1.6.640-644.1994","article-title":"Genetic diversity in human Fc receptor II for immunoglobulin G: fc gamma receptor IIA ligand-binding polymorphism","volume":"1","author":"Reilly","year":"1994","journal-title":"Clin Diagn Lab Immunol"},{"key":"10.1016\/j.ebiom.2020.103203_bib0034","unstructured":"AVERT. Global HIV and AIDS statistics. https:\/\/www.avert.org\/global-hiv-and-aids-statistics Last update 18 Feb 2020. Accessed 3 May 2020."},{"key":"10.1016\/j.ebiom.2020.103203_bib0035","doi-asserted-by":"crossref","DOI":"10.1128\/AAC.01794-16","article-title":"Phase 2 randomized, double-blind, placebo-controlled trial of RG7667, a combination monoclonal antibody, for prevention of cytomegalovirus infection in high-risk kidney transplant recipients","volume":"61","author":"Ishida","year":"2017","journal-title":"Antimicrob Agents Chemother"},{"key":"10.1016\/j.ebiom.2020.103203_bib0036","doi-asserted-by":"crossref","first-page":"5922","DOI":"10.1016\/j.vaccine.2008.08.050","article-title":"First administration to humans of a monoclonal antibody cocktail against rabies virus: safety, tolerability, and neutralizing activity","volume":"26","author":"Bakker","year":"2008","journal-title":"Vaccine"},{"key":"10.1016\/j.ebiom.2020.103203_bib0037","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1016\/j.dmpk.2018.11.002","article-title":"Physiologically-based modeling of monoclonal antibody pharmacokinetics in drug discovery and development","volume":"34","author":"Glassman","year":"2019","journal-title":"Drug Metab Pharmacokinet"},{"key":"10.1016\/j.ebiom.2020.103203_bib0038","doi-asserted-by":"crossref","DOI":"10.1371\/journal.ppat.1005742","article-title":"Features of recently transmitted HIV-1 clade C viruses that impact antibody recognition: implications for active and passive immunization","volume":"12","author":"Rademeyer","year":"2016","journal-title":"PLoS Pathog"},{"key":"10.1016\/j.ebiom.2020.103203_bib0039","doi-asserted-by":"crossref","first-page":"e72054","DOI":"10.1371\/journal.pone.0072054","article-title":"A human antibody to the CD4 binding site of gp120 capable of highly potent but sporadic cross clade neutralization of primary HIV-1","volume":"8","author":"Gach","year":"2013","journal-title":"PLoS ONE"},{"key":"10.1016\/j.ebiom.2020.103203_bib0040","doi-asserted-by":"crossref","DOI":"10.1016\/j.chom.2019.08.014","article-title":"A Meta-analysis of passive immunization studies shows that serum-neutralizing antibody titer associates with protection against SHIV challenge","volume":"26","author":"Pegu","year":"2019","journal-title":"Cell Host Microbe"},{"key":"10.1016\/j.ebiom.2020.103203_bib0041","doi-asserted-by":"crossref","first-page":"607","DOI":"10.3390\/v11070607","article-title":"Combining viral genetics and statistical modeling to improve HIV-1 time-of-infection estimation towards enhanced vaccine efficacy assessment","volume":"11","author":"Rossenkhan","year":"2019","journal-title":"Viruses"},{"key":"10.1016\/j.ebiom.2020.103203_bib0042","doi-asserted-by":"crossref","first-page":"296","DOI":"10.1208\/s12248-012-9340-y","article-title":"Immunogenicity to therapeutic proteins: impact on PK\/PD and efficacy","volume":"14","author":"Chirmule","year":"2012","journal-title":"AAPS J"},{"key":"10.1016\/j.ebiom.2020.103203_bib0043","doi-asserted-by":"crossref","DOI":"10.1016\/j.ebiom.2020.102682","article-title":"Understanding the mechanisms driving the spread of subtype C HIV-1","volume":"53","author":"Gartner","year":"2020","journal-title":"EBioMedicine"}],"container-title":["EBioMedicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S235239642030579X?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S235239642030579X?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,11,6]],"date-time":"2025-11-06T19:01:11Z","timestamp":1762455671000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S235239642030579X"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,2]]},"references-count":43,"alternative-id":["S235239642030579X"],"URL":"https:\/\/doi.org\/10.1016\/j.ebiom.2020.103203","relation":{"has-preprint":[{"id-type":"doi","id":"10.1101\/2020.09.02.20182881","asserted-by":"object"}]},"ISSN":["2352-3964"],"issn-type":[{"value":"2352-3964","type":"print"}],"subject":[],"published":{"date-parts":[[2021,2]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Pharmacokinetics and predicted neutralisation coverage of VRC01 in HIV-uninfected participants of the Antibody Mediated Prevention (AMP) trials","name":"articletitle","label":"Article Title"},{"value":"EBioMedicine","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.ebiom.2020.103203","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2020 The Authors. Published by Elsevier B.V.","name":"copyright","label":"Copyright"}],"article-number":"103203"}}