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Items: 1 to 20 of 125

1.

Safety, pharmacokinetics and neutralization of the broadly neutralizing HIV-1 human monoclonal antibody VRC01 in healthy adults.

Ledgerwood JE, Coates EE, Yamshchikov G, Saunders JG, Holman L, Enama ME, DeZure A, Lynch RM, Gordon I, Plummer S, Hendel CS, Pegu A, Conan-Cibotti M, Sitar S, Bailer RT, Narpala S, McDermott A, Louder M, O'Dell S, Mohan S, Pandey JP, Schwartz RM, Hu Z, Koup RA, Capparelli E, Mascola JR, Graham BS; VRC 602 Study Team.

Clin Exp Immunol. 2015 Dec;182(3):289-301. doi: 10.1111/cei.12692. Epub 2015 Sep 24.

2.

Safety and pharmacokinetics of the Fc-modified HIV-1 human monoclonal antibody VRC01LS: A Phase 1 open-label clinical trial in healthy adults.

Gaudinski MR, Coates EE, Houser KV, Chen GL, Yamshchikov G, Saunders JG, Holman LA, Gordon I, Plummer S, Hendel CS, Conan-Cibotti M, Lorenzo MG, Sitar S, Carlton K, Laurencot C, Bailer RT, Narpala S, McDermott AB, Namboodiri AM, Pandey JP, Schwartz RM, Hu Z, Koup RA, Capparelli E, Graham BS, Mascola JR, Ledgerwood JE; VRC 606 Study Team.

PLoS Med. 2018 Jan 24;15(1):e1002493. doi: 10.1371/journal.pmed.1002493. eCollection 2018 Jan.

3.

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.

Mayer KH, Seaton KE, Huang Y, Grunenberg N, Isaacs A, Allen M, Ledgerwood JE, Frank I, Sobieszczyk ME, Baden LR, Rodriguez B, Van Tieu H, Tomaras GD, Deal A, Goodman D, Bailer RT, Ferrari G, Jensen R, Hural J, Graham BS, Mascola JR, Corey L, Montefiori DC; HVTN 104 Protocol Team; and the NIAID HIV Vaccine Trials Network.

PLoS Med. 2017 Nov 14;14(11):e1002435. doi: 10.1371/journal.pmed.1002435. eCollection 2017 Nov.

4.

Population pharmacokinetics analysis of VRC01, an HIV-1 broadly neutralizing monoclonal antibody, in healthy adults.

Huang Y, Zhang L, Ledgerwood J, Grunenberg N, Bailer R, Isaacs A, Seaton K, Mayer KH, Capparelli E, Corey L, Gilbert PB.

MAbs. 2017 Jul;9(5):792-800. doi: 10.1080/19420862.2017.1311435. Epub 2017 Apr 3.

5.

Virologic effects of broadly neutralizing antibody VRC01 administration during chronic HIV-1 infection.

Lynch RM, Boritz E, Coates EE, DeZure A, Madden P, Costner P, Enama ME, Plummer S, Holman L, Hendel CS, Gordon I, Casazza J, Conan-Cibotti M, Migueles SA, Tressler R, Bailer RT, McDermott A, Narpala S, O'Dell S, Wolf G, Lifson JD, Freemire BA, Gorelick RJ, Pandey JP, Mohan S, Chomont N, Fromentin R, Chun TW, Fauci AS, Schwartz RM, Koup RA, Douek DC, Hu Z, Capparelli E, Graham BS, Mascola JR, Ledgerwood JE; VRC 601 Study Team.

Sci Transl Med. 2015 Dec 23;7(319):319ra206. doi: 10.1126/scitranslmed.aad5752.

PMID:
26702094
6.

Pharmacokinetics and Preliminary Safety of Pod-Intravaginal Rings Delivering the Monoclonal Antibody VRC01-N for HIV Prophylaxis in a Macaque Model.

Zhao C, Gunawardana M, Villinger F, Baum MM, Remedios-Chan M, Moench TR, Zeitlin L, Whaley KJ, Bohorov O, Smith TJ, Anderson DJ, Moss JA.

Antimicrob Agents Chemother. 2017 Jun 27;61(7). pii: e02465-16. doi: 10.1128/AAC.02465-16. Print 2017 Jul.

7.

Effect of HIV Antibody VRC01 on Viral Rebound after Treatment Interruption.

Bar KJ, Sneller MC, Harrison LJ, Justement JS, Overton ET, Petrone ME, Salantes DB, Seamon CA, Scheinfeld B, Kwan RW, Learn GH, Proschan MA, Kreider EF, Blazkova J, Bardsley M, Refsland EW, Messer M, Clarridge KE, Tustin NB, Madden PJ, Oden K, O'Dell SJ, Jarocki B, Shiakolas AR, Tressler RL, Doria-Rose NA, Bailer RT, Ledgerwood JE, Capparelli EV, Lynch RM, Graham BS, Moir S, Koup RA, Mascola JR, Hoxie JA, Fauci AS, Tebas P, Chun TW.

N Engl J Med. 2016 Nov 24;375(21):2037-2050. Epub 2016 Nov 9.

8.

Modeling cumulative overall prevention efficacy for the VRC01 phase 2b efficacy trials.

Huang Y, Karuna S, Carpp LN, Reeves D, Pegu A, Seaton K, Mayer K, Schiffer J, Mascola J, Gilbert PB.

Hum Vaccin Immunother. 2018;14(9):2116-2127. doi: 10.1080/21645515.2018.1462640. Epub 2018 May 24.

9.

Viraemia suppressed in HIV-1-infected humans by broadly neutralizing antibody 3BNC117.

Caskey M, Klein F, Lorenzi JC, Seaman MS, West AP Jr, Buckley N, Kremer G, Nogueira L, Braunschweig M, Scheid JF, Horwitz JA, Shimeliovich I, Ben-Avraham S, Witmer-Pack M, Platten M, Lehmann C, Burke LA, Hawthorne T, Gorelick RJ, Walker BD, Keler T, Gulick RM, Fätkenheuer G, Schlesinger SJ, Nussenzweig MC.

Nature. 2015 Jun 25;522(7557):487-91. doi: 10.1038/nature14411. Epub 2015 Apr 8. Erratum in: Nature. 2016 Jul 28;535(7613):580.

10.

Antibody 10-1074 suppresses viremia in HIV-1-infected individuals.

Caskey M, Schoofs T, Gruell H, Settler A, Karagounis T, Kreider EF, Murrell B, Pfeifer N, Nogueira L, Oliveira TY, Learn GH, Cohen YZ, Lehmann C, Gillor D, Shimeliovich I, Unson-O'Brien C, Weiland D, Robles A, Kümmerle T, Wyen C, Levin R, Witmer-Pack M, Eren K, Ignacio C, Kiss S, West AP Jr, Mouquet H, Zingman BS, Gulick RM, Keler T, Bjorkman PJ, Seaman MS, Hahn BH, Fätkenheuer G, Schlesinger SJ, Nussenzweig MC, Klein F.

Nat Med. 2017 Feb;23(2):185-191. doi: 10.1038/nm.4268. Epub 2017 Jan 16.

11.

Safety, tolerability, pharmacokinetics, and immunogenicity of the therapeutic monoclonal antibody mAb114 targeting Ebola virus glycoprotein (VRC 608): an open-label phase 1 study.

Gaudinski MR, Coates EE, Novik L, Widge A, Houser KV, Burch E, Holman LA, Gordon IJ, Chen GL, Carter C, Nason M, Sitar S, Yamshchikov G, Berkowitz N, Andrews C, Vazquez S, Laurencot C, Misasi J, Arnold F, Carlton K, Lawlor H, Gall J, Bailer RT, McDermott A, Capparelli E, Koup RA, Mascola JR, Graham BS, Sullivan NJ, Ledgerwood JE; VRC 608 Study team.

Lancet. 2019 Mar 2;393(10174):889-898. doi: 10.1016/S0140-6736(19)30036-4. Epub 2019 Jan 24.

PMID:
30686586
12.

Pharmacokinetics, pharmacodynamics and safety of a human anti-IL-6 monoclonal antibody (sirukumab) in healthy subjects in a first-in-human study.

Xu Z, Bouman-Thio E, Comisar C, Frederick B, Van Hartingsveldt B, Marini JC, Davis HM, Zhou H.

Br J Clin Pharmacol. 2011 Aug;72(2):270-81. doi: 10.1111/j.1365-2125.2011.03964.x.

13.

Safety, Tolerability, and Pharmacokinetics of MEDI4893, an Investigational, Extended-Half-Life, Anti-Staphylococcus aureus Alpha-Toxin Human Monoclonal Antibody, in Healthy Adults.

Yu XQ, Robbie GJ, Wu Y, Esser MT, Jensen K, Schwartz HI, Bellamy T, Hernandez-Illas M, Jafri HS.

Antimicrob Agents Chemother. 2016 Dec 27;61(1). pii: e01020-16. doi: 10.1128/AAC.01020-16. Print 2017 Jan.

14.

Topical gel formulation of broadly neutralizing anti-HIV-1 monoclonal antibody VRC01 confers protection against HIV-1 vaginal challenge in a humanized mouse model.

Veselinovic M, Neff CP, Mulder LR, Akkina R.

Virology. 2012 Oct 25;432(2):505-10. doi: 10.1016/j.virol.2012.06.025. Epub 2012 Jul 24.

15.

Two first-in-human, open-label, phase I dose-escalation safety trials of MEDI-528, a monoclonal antibody against interleukin-9, in healthy adult volunteers.

White B, Leon F, White W, Robbie G.

Clin Ther. 2009 Apr;31(4):728-40. doi: 10.1016/j.clinthera.2009.04.019.

PMID:
19446146
16.

Selection pressure on HIV-1 envelope by broadly neutralizing antibodies to the conserved CD4-binding site.

Wu X, Wang C, O'Dell S, Li Y, Keele BF, Yang Z, Imamichi H, Doria-Rose N, Hoxie JA, Connors M, Shaw GM, Wyatt RT, Mascola JR.

J Virol. 2012 May;86(10):5844-56. doi: 10.1128/JVI.07139-11. Epub 2012 Mar 14.

17.

Mechanism of neutralization by the broadly neutralizing HIV-1 monoclonal antibody VRC01.

Li Y, O'Dell S, Walker LM, Wu X, Guenaga J, Feng Y, Schmidt SD, McKee K, Louder MK, Ledgerwood JE, Graham BS, Haynes BF, Burton DR, Wyatt RT, Mascola JR.

J Virol. 2011 Sep;85(17):8954-67. doi: 10.1128/JVI.00754-11. Epub 2011 Jun 29.

18.

Efficacy, pharmacokinetic, and safety assessment of adalimumab, a fully human anti-tumor necrosis factor-alpha monoclonal antibody, in adults with rheumatoid arthritis receiving concomitant methotrexate: a pilot study.

Weisman MH, Moreland LW, Furst DE, Weinblatt ME, Keystone EC, Paulus HE, Teoh LS, Velagapudi RB, Noertersheuser PA, Granneman GR, Fischkoff SA, Chartash EK.

Clin Ther. 2003 Jun;25(6):1700-21.

PMID:
12860493
19.

Passive transfer of neutralizing mAb KD-247 reduces plasma viral load in patients chronically infected with HIV-1.

Matsushita S, Yoshimura K, Ramirez KP, Pisupati J, Murakami T; KD-1002 Study Group.

AIDS. 2015 Feb 20;29(4):453-62. doi: 10.1097/QAD.0000000000000570.

PMID:
25630040
20.

Safety and Upper Respiratory Pharmacokinetics of the Hemagglutinin Stalk-Binding Antibody VIS410 Support Treatment and Prophylaxis Based on Population Modeling of Seasonal Influenza A Outbreaks.

Wollacott AM, Boni MF, Szretter KJ, Sloan SE, Yousofshahi M, Viswanathan K, Bedard S, Hay CA, Smith PF, Shriver Z, Trevejo JM.

EBioMedicine. 2016 Feb 26;5:147-55. doi: 10.1016/j.ebiom.2016.02.021. eCollection 2016 Mar.

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