Project 1: Characterization of the Antibody Response to SARS-CoV-2 in Lung Cancer Patients

项目 1：肺癌患者对 SARS-CoV-2 抗体反应的表征

• 批准号: 10688379
• 负责人: Florian Krammer
• 金额: $ 22.66万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10688379
• 关键词: 2019-nCoV; Address; Advocate; Age; Antibodies; Antibody Response; Binding; Biological Assay; COVID-19; COVID-19 pandemic; COVID-19 vaccination; COVID-19 vaccine; Cancer Control; Cancer Patient; Cells; Clinical; Clinical Sciences; Clinical Trials; Collaborations; Complement; Coronavirus; Data Science Core; Demographic Impact; Development; Epithelial Cells; Ethnic Origin; Fc Receptor; Future; Gender; General Population; Generations; Glycoproteins; Hamsters; Histology; Immune; Immune response; Immunity; Incidence; Individual; Infection; Kinetics; Knowledge; Longevity; Lung; Malignant Neoplasms; Malignant neoplasm of lung; Mediating; Modeling; Patients; Persons; Policies; Population; Predisposition; Preparation; Race; Regimen; Role; SARS-CoV-2 antibody; SARS-CoV-2 infection; Serology; Smoking History; Smoking Status; Specimen; Statistical Data Interpretation; Testing; Vaccinated; Vaccination; Vaccines; Viral; Viral Antigens; Viral Proteins; Virus; Vulnerable Populations; Work; base; cancer therapy; case control; comorbidity; comparative; cytokine; demographics; design; infection rate; insight; inter-individual variation; lung cancer cell; mortality; neutralizing antibody; patient response; power analysis; prospective; protective efficacy; receptor; response; seropositive; severe COVID-19; trait; translational scientist; vaccine candidate; vaccine response; vaccine trial; viral entry inhibitor; virology

PROJECT 1: ABSTRACT Current information indicates that, in persons without cancer, natural infection with SARS-CoV-2 as well as vaccination with COVID-19 vaccine candidates induce antibody responses to the spike protein of the virus which should be protective against future infection. Lung cancer patients who become infected with SARS- CoV-2 appear to develop severe COVID-19 with a high (35-40%) mortality rate indicating we urgently need to plan for vaccine trials in this vulnerable population. Currently we have major knowledge gaps to fill in preparation for such vaccine studies. These include: is there a higher incidence of SARS-CoV-2 in lung cancer patients compared to the general population? Do lung cancer patients mount a comparable antibody response in terms of quantity, quality, and longevity to people without lung cancer? Equally important are information in lung cancer patients on the role of age, gender, smoking status, histology, and types of treatment for lung cancer on both SARS-CoV-2 infection rate and generation of antibody responses. Through prospective analyses of lung cancer cases (N= 1,000) and matched controls (N = 1,000) this Project “Characterization of the Antibody Response to SARS-CoV-2 in Lung Cancer Patients” will provide answers to these important questions through study of 4 specific aims and the use of our U54 Administrative, Clinical, and Data Sciences Cores. Aim 1: Characterize the incident, magnitude and functionality of the antibody response to SARS-CoV-2 in lung cancer patients versus non-lung cancer controls. Aim 2: Compare the longevity of the antibody response against SARS-CoV-2 in lung cancer patients versus non-lung cancer controls. Aim 3: Evaluate the impact of patient demographics and cancer-associated clinical factors on the antibody response in lung cancer patients. And Aim 4: Characterize antibody responses to SARS-CoV-2 vaccination in lung cancer patients versus non-lung cancer controls. The patient serology specimens will also be studied for viral neutralizing functionality in collaboration with U54 Project 2. We have assembled a world-class team of lung cancer clinical translational investigators, serology and virology experts, and patient advocates to address these key issues. The results of this Project will have a significant impact on lung cancer patient management during the COVID-19 pandemic, and even greater impact on designing optimal SARS-CoV-2 vaccination regimens for lung cancer patients.

项目1：摘要 目前的信息表明，在没有癌症的人中，自然感染SARS-CoV-2以及 接种COVID-19候选疫苗可诱导针对病毒刺突蛋白的抗体应答 可以预防未来的感染感染SARS的肺癌患者- CoV-2似乎发展为严重的COVID-19，死亡率很高（35-40%），这表明我们迫切需要 计划在这一脆弱人群中进行疫苗试验。目前，我们有重大的知识空白，以填补 为此类疫苗研究做准备。其中包括：肺癌中SARS-CoV-2的发病率是否更高 与普通人群相比，患者？肺癌患者是否会产生类似的抗体反应 在数量、质量和寿命方面对没有肺癌的人有什么影响？同样重要的是， 肺癌患者的年龄、性别、吸烟状况、组织学和肺治疗类型对肺癌的作用 癌症对SARS-CoV-2感染率和抗体反应产生的影响。通过前瞻性 肺癌病例（N= 1，000）和匹配对照（N = 1，000）的分析，本项目“表征 肺癌患者对SARS-CoV-2的抗体反应”将为这些重要问题提供答案 通过研究4个具体目标和使用我们的U 54管理，临床和数据来解决问题 科学核心。目的1：表征抗体应答的事件、幅度和功能性， SARS-CoV-2在肺癌患者与非肺癌对照中的比较目标2：比较 肺癌患者与非肺癌对照中针对SARS-CoV-2的抗体反应。目标三： 评价患者人口统计学和癌症相关临床因素对抗体应答的影响 在肺癌患者中。目的4：研究SARS冠状病毒2型疫苗接种后肺内抗体的变化 癌症患者与非肺癌对照。还将研究患者血清学标本的病毒 与U 54项目2合作的中和功能。我们已经组建了一个世界级的团队， 癌症临床转化研究人员、血清学和病毒学专家以及患者倡导者， 这些关键问题。该项目的结果将对肺癌患者的管理产生重大影响 在COVID-19大流行期间，甚至对设计最佳SARS-CoV-2疫苗接种产生更大影响 肺癌患者的治疗方案。