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Page 1
A Randomised Clinical Trial of the Safety and Pharmacokinetics of VRC07-523LS Administered via Different Routes and Doses (HVTN 127/HPTN 087).
Walsh SR, Gay CL, Karuna ST, Hyrien O, Skalland T, Mayer KH, Sobieszczyk ME, Baden LR, Goepfert PA, Del Rio C, Pantaleo G, Andrew P, Karg C, He Z, Lu H, Paez CA, Baumblatt JAG, Polakowski LL, Chege W, Janto S, Han X, Huang Y, Dumond J, Ackerman ME, McDermott AB, Flach B, Piwowar-Manning E, Seaton K, Tomaras GD, Montefiori DC, Gama L, Mascola JR; HVTN 127/HPTN 087 Study Team. Walsh SR, et al. Among authors: karuna st. medRxiv [Preprint]. 2024 Jan 11:2024.01.10.23299799. doi: 10.1101/2024.01.10.23299799. medRxiv. 2024. PMID: 38260276 Free PMC article. Preprint.
Calibration of Two Validated SARS-CoV-2 Pseudovirus Neutralization Assays for COVID-19 Vaccine Evaluation.
Huang Y, Borisov O, Kee JJ, Carpp LN, Wrin T, Cai S, Sarzotti-Kelsoe M, McDanal C, Eaton A, Pajon R, Hural J, Posavad CM, Gill K, Karuna S, Corey L, McElrath MJ, Gilbert PB, Petropoulos CJ, Montefiori DC. Huang Y, et al. medRxiv [Preprint]. 2021 Sep 14:2021.09.09.21263049. doi: 10.1101/2021.09.09.21263049. medRxiv. 2021. PMID: 34545372 Free PMC article. Updated. Preprint.
Safety and immunogenicity of a recombinant oligomeric gp145 subtype C Env protein (gp145 C.6980) HIV vaccine candidate in healthy, HIV-1-uninfected adult participants in the US.
Tieu HV, Karuna S, Huang Y, Sobieszczyk ME, Zheng H, Tomaras GD, Montefiori DC, Shen M, DeRosa S, Cohen K, Isaacs MB, Regenold S, Heptinstall J, Seaton KE, Sawant S, Furch B, Pensiero M, Corey L, Bar KJ; HVTN 122 Study Team. Tieu HV, et al. Vaccine. 2023 Oct 6;41(42):6309-6317. doi: 10.1016/j.vaccine.2023.07.046. Epub 2023 Sep 9. Vaccine. 2023. PMID: 37679276
High monoclonal neutralization titers reduced breakthrough HIV-1 viral loads in the Antibody Mediated Prevention trials.
Reeves DB, Mayer BT, deCamp AC, Huang Y, Zhang B, Carpp LN, Magaret CA, Juraska M, Gilbert PB, Montefiori DC, Bar KJ, Cardozo-Ojeda EF, Schiffer JT, Rossenkhan R, Edlefsen P, Morris L, Mkhize NN, Williamson C, Mullins JI, Seaton KE, Tomaras GD, Andrew P, Mgodi N, Ledgerwood JE, Cohen MS, Corey L, Naidoo L, Orrell C, Goepfert PA, Casapia M, Sobieszczyk ME, Karuna ST, Edupuganti S. Reeves DB, et al. Among authors: karuna st. Nat Commun. 2023 Dec 14;14(1):8299. doi: 10.1038/s41467-023-43384-y. Nat Commun. 2023. PMID: 38097552 Free PMC article.
Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition.
Corey L, Gilbert PB, Juraska M, Montefiori DC, Morris L, Karuna ST, Edupuganti S, Mgodi NM, deCamp AC, Rudnicki E, Huang Y, Gonzales P, Cabello R, Orrell C, Lama JR, Laher F, Lazarus EM, Sanchez J, Frank I, Hinojosa J, Sobieszczyk ME, Marshall KE, Mukwekwerere PG, Makhema J, Baden LR, Mullins JI, Williamson C, Hural J, McElrath MJ, Bentley C, Takuva S, Gomez Lorenzo MM, Burns DN, Espy N, Randhawa AK, Kochar N, Piwowar-Manning E, Donnell DJ, Sista N, Andrew P, Kublin JG, Gray G, Ledgerwood JE, Mascola JR, Cohen MS; HVTN 704/HPTN 085 and HVTN 703/HPTN 081 Study Teams. Corey L, et al. Among authors: karuna st. N Engl J Med. 2021 Mar 18;384(11):1003-1014. doi: 10.1056/NEJMoa2031738. N Engl J Med. 2021. PMID: 33730454 Free PMC article. Clinical Trial.
Neutralization titer biomarker for antibody-mediated prevention of HIV-1 acquisition.
Gilbert PB, Huang Y, deCamp AC, Karuna S, Zhang Y, Magaret CA, Giorgi EE, Korber B, Edlefsen PT, Rossenkhan R, Juraska M, Rudnicki E, Kochar N, Huang Y, Carpp LN, Barouch DH, Mkhize NN, Hermanus T, Kgagudi P, Bekker V, Kaldine H, Mapengo RE, Eaton A, Domin E, West C, Feng W, Tang H, Seaton KE, Heptinstall J, Brackett C, Chiong K, Tomaras GD, Andrew P, Mayer BT, Reeves DB, Sobieszczyk ME, Garrett N, Sanchez J, Gay C, Makhema J, Williamson C, Mullins JI, Hural J, Cohen MS, Corey L, Montefiori DC, Morris L. Gilbert PB, et al. Nat Med. 2022 Sep;28(9):1924-1932. doi: 10.1038/s41591-022-01953-6. Epub 2022 Aug 22. Nat Med. 2022. PMID: 35995954 Free PMC article.
Pharmacokinetic serum concentrations of VRC01 correlate with prevention of HIV-1 acquisition.
Seaton KE, Huang Y, Karuna S, Heptinstall JR, Brackett C, Chiong K, Zhang L, Yates NL, Sampson M, Rudnicki E, Juraska M, deCamp AC, Edlefsen PT, Mullins JI, Williamson C, Rossenkhan R, Giorgi EE, Kenny A, Angier H, Randhawa A, Weiner JA, Rojas M, Sarzotti-Kelsoe M, Zhang L, Sawant S, Ackerman ME, McDermott AB, Mascola JR, Hural J, McElrath MJ, Andrew P, Hidalgo JA, Clark J, Laher F, Orrell C, Frank I, Gonzales P, Edupuganti S, Mgodi N, Corey L, Morris L, Montefiori D, Cohen MS, Gilbert PB, Tomaras GD. Seaton KE, et al. EBioMedicine. 2023 Jul;93:104590. doi: 10.1016/j.ebiom.2023.104590. Epub 2023 Jun 8. EBioMedicine. 2023. PMID: 37300931 Free PMC article.
Prediction of serum HIV-1 neutralization titers of VRC01 in HIV-uninfected Antibody Mediated Prevention (AMP) trial participants.
Huang Y, Zhang L, Eaton A, Mkhize NN, Carpp LN, Rudnicki E, DeCamp A, Juraska M, Randhawa A, McDermott A, Ledgerwood J, Andrew P, Karuna S, Edupuganti S, Mgodi N, Cohen M, Corey L, Mascola J, Gilbert PB, Morris L, Montefiori DC. Huang Y, et al. Hum Vaccin Immunother. 2022 Dec 31;18(1):1908030. doi: 10.1080/21645515.2021.1908030. Epub 2021 Jul 2. Hum Vaccin Immunother. 2022. PMID: 34213402 Free PMC article.
Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine.
Hammer SM, Sobieszczyk ME, Janes H, Karuna ST, Mulligan MJ, Grove D, Koblin BA, Buchbinder SP, Keefer MC, Tomaras GD, Frahm N, Hural J, Anude C, Graham BS, Enama ME, Adams E, DeJesus E, Novak RM, Frank I, Bentley C, Ramirez S, Fu R, Koup RA, Mascola JR, Nabel GJ, Montefiori DC, Kublin J, McElrath MJ, Corey L, Gilbert PB; HVTN 505 Study Team. Hammer SM, et al. Among authors: karuna st. N Engl J Med. 2013 Nov 28;369(22):2083-92. doi: 10.1056/NEJMoa1310566. Epub 2013 Oct 7. N Engl J Med. 2013. PMID: 24099601 Free PMC article. Clinical Trial.
52 results