Biodefense and Emerging Infectious Disease Monoclonal Antibody Studies

疫苗研究中心（VRC）生物防御和新发传染病研究项目中的单克隆抗体研究旨在对与传染病病原体相关的单克隆抗体（mAb）产品进行临床评价。目前的目标包括埃博拉病毒病和疟疾。随着VRC开发针对新出现的传染病靶点的其他单克隆抗体产品，将继续进行进一步的评估。 已发表的临床产品和试验结果包括： 靶向埃博拉病毒糖蛋白（VRC 608）的治疗性单克隆抗体mAb 114的安全性、耐受性、药代动力学和免疫原性：一项开放标签的1期研究 Gaudinski MR，科茨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研究小组。柳叶刀。2019年3月2日;393（10174）：889-898。 埃博拉病毒病治疗的随机对照试验。Mulangu S，Dodd LE，Davey RT Jr，Tshiani Mbaya O，Proschan M，Mukadi D，Lusakibanza Manzo M，Nzolo D，Tshomba Oloma A，Ibanda A，Ali R，Coulibaly S，Levine AC，Grais R，迪亚兹J，Lane HC，Muyembe-Tamfum JJ; PALM Writing Group，Sivahera B，Camara M，Kojan R，步行者R，Dighero-Kemp B，Cao H，Muhanbayi P，Mbala-Kingebeni P，Ahuka S，Albert S，Bonnett T，Crozier I，Duvenhage M，Proffitt C，Teitelbaum M，Moench T，Aboulhab J，Barrett K，Cahill K，Cone K，Eckes R，Hensley L，Herpin B，Higgs E，Ledgerwood J，Pierson J，Smolskis M，Sow Y，Tierney J，Sivapalasingam S，Holman W，Gettinger N，瓦莱D，Nordwall J; PALM Consortium Study Team.新英格兰医学杂志2019年12月12日;381（24）：2293-2303。

The Vaccine Research Center (VRC) Monoclonal Antibody Studies in Biodefense and Emerging Infectious Diseases research project is aimed at the clinical evaluation of monoclonal antibody (mAb) products related to infectious disease pathogens. Current targets include Ebola virus disease and malaria. Further evaluation will continue as the VRC develops additional monoclonal anitbody products aimed at emerging infectious disease targets. Published results on clinical products and trials include: 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. A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics. Mulangu S, Dodd LE, Davey RT Jr, Tshiani Mbaya O, Proschan M, Mukadi D, Lusakibanza Manzo M, Nzolo D, Tshomba Oloma A, Ibanda A, Ali R, Coulibaly S, Levine AC, Grais R, Diaz J, Lane HC, Muyembe-Tamfum JJ; PALM Writing Group, Sivahera B, Camara M, Kojan R, Walker R, Dighero-Kemp B, Cao H, Mukumbayi P, Mbala-Kingebeni P, Ahuka S, Albert S, Bonnett T, Crozier I, Duvenhage M, Proffitt C, Teitelbaum M, Moench T, Aboulhab J, Barrett K, Cahill K, Cone K, Eckes R, Hensley L, Herpin B, Higgs E, Ledgerwood J, Pierson J, Smolskis M, Sow Y, Tierney J, Sivapalasingam S, Holman W, Gettinger N, Valle D, Nordwall J; PALM Consortium Study Team. N Engl J Med. 2019 Dec 12;381(24):2293-2303.