Biodefense and Emerging Infectious Disease Monoclonal Antibody Studies

生物防御和新发传染病单克隆抗体研究

• 批准号: 10273023
• 负责人: Julie E. Ledgerwood
• 金额: $ 342.3万
• 依托单位: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10273023
• 关键词: Clinical; Clinical Trials; Communicable Diseases; Cone; Drug Kinetics; Ebola Hemorrhagic Fever; Ebola virus; Emerging Communicable Diseases; Evaluation; Glycoproteins; Infectious Diseases Research; Malaria; Monoclonal Antibodies; Publishing; Randomized Controlled Trials; Research Project Grants; Safety; Therapeutic; Therapeutic Monoclonal Antibodies; Vaccine Research; Virus; Walkers; Writing; biodefense; clinical center; immunogenicity; novel strategies; open label; pathogen; phase 1 study; programs; research clinical testing

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.

疫苗研究中心（VRC）生物防御和新发传染病中的单克隆抗体研究研究项目旨在对与传染病病原体相关的单克隆抗体（mAb）产品进行临床评估。目前的目标包括埃博拉病毒病和疟疾。随着 VRC 针对新出现的传染病目标开发更多单克隆抗体产品，进一步的评估将继续进行。 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 mAb114 的安全性、耐受性、药代动力学和免疫原性：一项开放标签 1 期研究。 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 研究团队。柳叶刀。 2019年3月2日；393(10174):889-898。 埃博拉病毒疾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、Diaz J、Lane HC、Muyembe-Tamfum JJ； PALM 写作小组、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、Profitt C、Teitelbaum M、Moench T、Abouulhab 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 联盟研究团队。 N 英格兰医学杂志。 2019 年 12 月 12 日；381(24):2293-2303。