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中的单抗研究项目旨在对与传染病病原体相关的单抗产品进行临床评估。目前的目标包括埃博拉病毒、疾病和疟疾。随着VRC开发更多针对新发传染病靶点的单抗产品，进一步的评估将继续进行。 已公布的临床产品和试验结果包括： VRC 608： 针对埃博拉病毒糖蛋白(VRC 608)的治疗性单抗mAb114的安全性、耐受性、药代动力学和免疫原性：一项开放标记的第1阶段研究。高丁斯基先生，科茨·EE，诺维克·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，Lawler 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。 手掌研究： 埃博拉病毒疾病治疗的随机对照试验。穆兰古·S、多德·勒、戴维·RT Jr、齐亚尼·姆巴亚O、普罗桑·M、穆卡迪·D、卢萨基班扎·曼佐·M、恩佐洛·D、桑巴·奥洛马·A、伊班达·A、阿里·R、古里巴利·S、莱文·AC、格雷斯·R、迪亚兹·J、莱恩·HC、穆扬贝-坦弗姆·JJ；手掌写作小组，西瓦赫拉B，卡马拉M，科詹R，沃克R，德杰罗-坎普B，曹H，穆库巴伊P，姆巴拉-金贝尼P，阿胡卡S，阿尔伯特S，邦尼特T，克罗泽I，杜文哈奇M，Proffitt C，Teitelbaum M，莫恩奇T，阿布哈布J，巴雷特K，卡希尔K，Cone K，埃克斯R，亨斯利L，赫尔平B，希格斯E，莱杰伍德J，皮尔逊J，斯莫尔斯基斯M，SOW Y，TierJ，西瓦拉辛卡姆S，霍尔曼，格丁格N，瓦勒D，NJ；棕榈树研究小组。N Engl J Med.2019年12月12日；381(24)：2293-2303。 VRC 612： 一种用于预防疟疾的单抗。高丁斯基先生，Berkowitz NM，Idris AH，Coates EE，Holman LA，Mendza F，Gordon IJ，Plummer SH，Trofymenko O，Hu Z，Campos Chagas A，O‘Connell S，Basappa M，Douek N，Narpala SR，Barry CR，Widge AT，Hicks R，Awan SF，Wu RL，Hickman S，Wycuff D，Stein JA，Case C，Evans BP，Carlton K，Gall JG，Vazquez S，Flach B，Chen GL，Francica Jr，Flynn BJ，Kisalu NK，Capparelli EV，McDermotA，Mascola Jr，Ledgerwood，Seder RA；VRC 612研究团队。 N Engl J Med.2021年8月11日。

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: VRC 608: 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. PALM Study: 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. VRC 612: A Monoclonal Antibody for Malaria Prevention. Gaudinski MR, Berkowitz NM, Idris AH, Coates EE, Holman LA, Mendoza F, Gordon IJ, Plummer SH, Trofymenko O, Hu Z, Campos Chagas A, O'Connell S, Basappa M, Douek N, Narpala SR, Barry CR, Widge AT, Hicks R, Awan SF, Wu RL, Hickman S, Wycuff D, Stein JA, Case C, Evans BP, Carlton K, Gall JG, Vazquez S, Flach B, Chen GL, Francica JR, Flynn BJ, Kisalu NK, Capparelli EV, McDermott A, Mascola JR, Ledgerwood JE, Seder RA; VRC 612 Study Team. N Engl J Med. 2021 Aug 11.