Authors
Kelly E Seaton, Yunda Huang, Shelly Karuna, Jack R Heptinstall, Caroline Brackett, Kelvin Chiong, Lily Zhang, Nicole L Yates, Mark Sampson, Erika Rudnicki, Michal Juraska, Allan C deCamp, Paul T Edlefsen, James I Mullins, Carolyn Williamson, Raabya Rossenkhan, Elena E Giorgi, Avi Kenny, Heather Angier, April Randhawa, Joshua A Weiner, Michelle Rojas, Marcella Sarzotti-Kelsoe, Lu Zhang, Sheetal Sawant, Margaret E Ackerman, Adrian B McDermott, John R Mascola, John Hural, M Julianna McElrath, Philip Andrew, Jose A Hidalgo, Jesse Clark, Fatima Laher, Catherine Orrell, Ian Frank, Pedro Gonzales, Srilatha Edupuganti, Nyaradzo Mgodi, Lawrence Corey, Lynn Morris, David Montefiori, Myron S Cohen, Peter B Gilbert, Georgia D Tomaras
Publication date
2023/7/1
Journal
EBioMedicine
Volume
93
Publisher
Elsevier
Description
Background
The phase 2b proof-of-concept Antibody Mediated Prevention (AMP) trials showed that VRC01, an anti-HIV-1 broadly neutralising antibody (bnAb), prevented acquisition of HIV-1 sensitive to VRC01. To inform future study design and dosing regimen selection of candidate bnAbs, we investigated the association of VRC01 serum concentration with HIV-1 acquisition using AMP trial data.
Methods
The case–control sample included 107 VRC01 recipients who acquired HIV-1 and 82 VRC01 recipients who remained without HIV-1 during the study. We measured VRC01 serum concentrations with a qualified pharmacokinetic (PK) Binding Antibody Multiplex Assay. We employed nonlinear mixed effects PK modelling to estimate daily-grid VRC01 concentrations. Cox regression models were used to assess the association of VRC01 concentration at exposure and baseline body weight, with the hazard of HIV-1 …
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Scholar articles
KE Seaton, Y Huang, S Karuna, JR Heptinstall… - EBioMedicine, 2023