First-in-human study of two anti-SARS CoV-2 antibodies in health volunteers

对健康志愿者中的两种抗 SARS CoV-2 抗体进行的首次人体研究

基本信息

  • 批准号:
    10291661
  • 负责人:
  • 金额:
    $ 157.16万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2021
  • 资助国家:
    美国
  • 起止时间:
    2021-02-23 至 2023-06-30
  • 项目状态:
    已结题

项目摘要

Project Summary The Coronavirus Disease 2019 (COVID-19) pandemic is currently gripping the world without a known cure or prevention. Aside from the health consequences, the necessary decrease in human activity has resulted in economic losses without modern precedent, especially in the developing world where health care and sanitation were not sufficient even prior to the pandemic. Innumerable efforts are being undertaken to develop vaccines to SARS-CoV-2 and it is likely that antibodies will be essential for protection. COVID-19 antibody therapy in the form of polyclonal plasma from convalescent individuals is currently being explored as a therapeutic option and has been granted an emergency use authorization (EUA) by the FDA. Monoclonal antibodies may prove to be particularly useful in preventing SARS-CoV-2 infection in populations who may not mount protective immune responses to vaccination (e.g. advanced age, immunocompromise) and for post-exposure prophylaxis in individuals at high risk to develop severe COVID-19. C135 and C144 are recombinant, fully human mAbs that specifically bind SARS-CoV-2 spike protein receptor binding domain (RBD) and exhibit exceptional neutralizing activity in vitro against SARS-CoV-2. Two one-amino acid mutations have been introduced to prolong half-life and allow dose sparing. The C135-LS and C144-LS combination has shown remarkable activity in both prophylaxis and therapy experiments in several relevant animal models in both prophylaxis and treatment experiments. These preclinical data support the clinical evahe from SARS-CoV-2 and accelerate viral clearance and disease resolution in SARS-CoV-2-infected individuals. The proposed study is a first-in-human, open label, single dose, dose-escalation phase 1 trial to evaluate the safety and pharmacokinetics of the C135-LS and C144-LS combination in healthy volunteers.
项目总结

项目成果

期刊论文数量(24)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Host Immune Responses in HIV-1 Infection: The Emerging Pathogenic Role of Siglecs and Their Clinical Correlates.
  • DOI:
    10.3389/fimmu.2017.00314
  • 发表时间:
    2017
  • 期刊:
  • 影响因子:
    7.3
  • 作者:
    Mikulak J;Di Vito C;Zaghi E;Mavilio D
  • 通讯作者:
    Mavilio D
Measuring replication competent HIV-1: advances and challenges in defining the latent reservoir.
  • DOI:
    10.1186/s12977-018-0404-7
  • 发表时间:
    2018-02-13
  • 期刊:
  • 影响因子:
    3.3
  • 作者:
    Wang Z;Simonetti FR;Siliciano RF;Laird GM
  • 通讯作者:
    Laird GM
Cell-Mediated Immunity to Target the Persistent Human Immunodeficiency Virus Reservoir.
针对持续性人类免疫缺陷病毒库的细胞介导的免疫。
  • DOI:
    10.1093/infdis/jix002
  • 发表时间:
    2017
  • 期刊:
  • 影响因子:
    0
  • 作者:
    Riley,JamesL;Montaner,LuisJ
  • 通讯作者:
    Montaner,LuisJ
Ultrasensitive antigen density discrimination by synNotch.
通过 synNotch 进行超灵敏抗原密度辨别。
  • DOI:
    10.1038/s41422-021-00511-y
  • 发表时间:
    2021
  • 期刊:
  • 影响因子:
    44.1
  • 作者:
    Shukla,Divanshu;Riley,JamesL
  • 通讯作者:
    Riley,JamesL
Susceptibility to 3BNC117 and 10-1074 in ART suppressed chronically infected persons.
ART 中对 3BNC117 和 10-1074 的敏感性抑制了慢性感染者。
  • DOI:
    10.1097/qad.0000000000003575
  • 发表时间:
    2023
  • 期刊:
  • 影响因子:
    0
  • 作者:
    Tebas,Pablo;Lynn,Kenn;Azzoni,Livio;Cocchella,Giorgio;Papasavvas,Emmanouil;Fair,Matthew;Karanam,Brijesh;Sharma,Paridhima;Reeves,JacquelineD;Petropoulos,ChristosJ;Lalley-Chareczko,Linden;Kostman,JayR;Short,William;Mounzer,Karam
  • 通讯作者:
    Mounzer,Karam
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Luis J Montaner其他文献

Luis J Montaner的其他文献

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{{ truncateString('Luis J Montaner', 18)}}的其他基金

Purchase of MVE Fusion Self-Sustaining Cryogenic Freezers
购买 MVE Fusion 自持式低温冷冻机
  • 批准号:
    10533525
  • 财政年份:
    2022
  • 资助金额:
    $ 157.16万
  • 项目类别:
BEAT-HIV: Delaney Collaboratory to Cure HIV-1 Infection by Combination Immunotherapy
BEAT-HIV:Delaney 合作实验室通过联合免疫疗法治愈 HIV-1 感染
  • 批准号:
    10469617
  • 财政年份:
    2021
  • 资助金额:
    $ 157.16万
  • 项目类别:
BEAT-HIV: Delaney Collaboratory to Cure HIV-1 Infection by Combination Immunotherapy
BEAT-HIV:Delaney 合作实验室通过联合免疫疗法治愈 HIV-1 感染
  • 批准号:
    10609926
  • 财政年份:
    2021
  • 资助金额:
    $ 157.16万
  • 项目类别:
BEAT-HIV: Delaney Collaboratory to Cure HIV-1 Infection by Combination Immunotherapy
BEAT-HIV:Delaney 合作实验室通过联合免疫疗法治愈 HIV-1 感染
  • 批准号:
    10313067
  • 财政年份:
    2021
  • 资助金额:
    $ 157.16万
  • 项目类别:
Effects of Mu-opiate receptor engagement on the persistence of HIV-associated activation and viral reservoirs in individuals receiving medication assisted treatment for opioid use disorder
Mu-阿片受体参与对接受阿片类药物使用障碍药物辅助治疗的个体中 HIV 相关激活和病毒库持续性的影响
  • 批准号:
    10621847
  • 财政年份:
    2019
  • 资助金额:
    $ 157.16万
  • 项目类别:
Effects of Mu-opiate receptor engagement on the persistence of HIV-associated activation and viral reservoirs in individuals receiving medication assisted treatment for opioid use disorder
Mu-阿片受体参与对接受阿片类药物使用障碍药物辅助治疗的个体中 HIV 相关激活和病毒库持续性的影响
  • 批准号:
    10381326
  • 财政年份:
    2019
  • 资助金额:
    $ 157.16万
  • 项目类别:
Effects of Mu-opiate receptor engagement on the persistence of HIV-associated activation and viral reservoirs in individuals receiving medication assisted treatment for opioid use disorder
Mu-阿片受体参与对接受阿片类药物使用障碍药物辅助治疗的个体中 HIV 相关激活和病毒库持续性的影响
  • 批准号:
    10406244
  • 财政年份:
    2019
  • 资助金额:
    $ 157.16万
  • 项目类别:
Towards Eradication: Reducing Proviral HIV DNA with Interferon-a Immunotherapy
走向根除:用干扰素-a 免疫疗法减少 HIV 病毒 DNA 前体
  • 批准号:
    8671884
  • 财政年份:
    2014
  • 资助金额:
    $ 157.16万
  • 项目类别:
Purchase a Beckman Coulter MoFlo Astrios Flow Cytometer
购买 Beckman Coulter MoFlo Astrios 流式细胞仪
  • 批准号:
    8639790
  • 财政年份:
    2014
  • 资助金额:
    $ 157.16万
  • 项目类别:
Towards Eradication: Reducing Proviral HIV DNA with Interferon-α Immunotherapy
走向根除:用干扰素-α 免疫疗法减少 HIV 病毒 DNA 前体
  • 批准号:
    8988529
  • 财政年份:
    2014
  • 资助金额:
    $ 157.16万
  • 项目类别:

相似海外基金

Phenotypic consequences of a modern human-specific amino acid substitution in ADSL
ADSL 中现代人类特异性氨基酸取代的表型后果
  • 批准号:
    24K18167
  • 财政年份:
    2024
  • 资助金额:
    $ 157.16万
  • 项目类别:
    Grant-in-Aid for Early-Career Scientists
Estimation of stability and functional changes due to amino acid substitution using molecular simulations
使用分子模拟估计氨基酸取代引起的稳定性和功能变化
  • 批准号:
    20H03230
  • 财政年份:
    2020
  • 资助金额:
    $ 157.16万
  • 项目类别:
    Grant-in-Aid for Scientific Research (B)
Elucidation of the mechanisms of prion protein conversion caused by an amino acid substitution in glycosylphosphatidylinositol anchoring signal peptide
阐明糖基磷脂酰肌醇锚定信号肽中氨基酸取代引起的朊病毒蛋白转化机制
  • 批准号:
    16K18790
  • 财政年份:
    2016
  • 资助金额:
    $ 157.16万
  • 项目类别:
    Grant-in-Aid for Young Scientists (B)
Amino acid substitution without genetic modification
无需基因改造的氨基酸替代
  • 批准号:
    15H05491
  • 财政年份:
    2015
  • 资助金额:
    $ 157.16万
  • 项目类别:
    Grant-in-Aid for Young Scientists (A)
Study on PSII hydrogen bond networks by exhaustive amino acid substitution
穷举氨基酸取代研究PSII氢键网络
  • 批准号:
    15K07110
  • 财政年份:
    2015
  • 资助金额:
    $ 157.16万
  • 项目类别:
    Grant-in-Aid for Scientific Research (C)
Elucidation of the effect of HCV propagationa and IFN sensitivity by amino acid substitution in interferon sensitivity-determining region.
阐明干扰素敏感性决定区氨基酸取代对 HCV 传播和干扰素敏感性的影响。
  • 批准号:
    26860309
  • 财政年份:
    2014
  • 资助金额:
    $ 157.16万
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    Grant-in-Aid for Young Scientists (B)
The analysis of the restriction of amino acid substitution on the hemagglutinin molecule of influenza A virus
甲型流感病毒血凝素分子氨基酸取代限制性分析
  • 批准号:
    14370104
  • 财政年份:
    2002
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    $ 157.16万
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Changes in the Substrate Specificities of Farnesyl Diphosphate Synthase by a Single Amino Acid Substitution
单一氨基酸取代对法尼基二磷酸合酶底物特异性的变化
  • 批准号:
    12680587
  • 财政年份:
    2000
  • 资助金额:
    $ 157.16万
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Analyses of the Relationship between Amino Acid Substitution and Phenotype of the Tail Sheath Protein of Bacteriophage T4
噬菌体T4尾鞘蛋白氨基酸取代与表型关系分析
  • 批准号:
    02680125
  • 财政年份:
    1990
  • 资助金额:
    $ 157.16万
  • 项目类别:
    Grant-in-Aid for General Scientific Research (C)
Hypothesis: Both appearance and disappearance of viruses are controlled by the accumulation of amino acid substitution in receptor binding domain
假设:病毒的出现和消失都是由受体结合​​域氨基酸取代的积累控制的
  • 批准号:
    02454184
  • 财政年份:
    1990
  • 资助金额:
    $ 157.16万
  • 项目类别:
    Grant-in-Aid for General Scientific Research (B)
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