Project 1: Characterization of the Antibody Response to SARS-CoV-2 in 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 新冠肺炎候选疫苗接种诱导针对病毒刺突蛋白的抗体反应 这应该可以预防未来的感染。感染SARS的肺癌患者- 冠状病毒2型似乎发展成严重的新冠肺炎，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，我们有主要的知识空白需要填补 为这类疫苗研究做准备。这些包括：肺癌中SARS-CoV-2的发病率是否较高 患者与普通人群相比？肺癌患者会产生类似的抗体反应吗？ 在数量、质量和寿命方面对没有肺癌的人来说？同样重要的是信息在 肺癌患者年龄、性别、吸烟状况、组织学及治疗类型对肺癌的影响 肿瘤对SARS-CoV-2感染率和抗体生成的影响。通过潜在客户 肺癌病例(N=1,000)和配对对照(N=1,000)的分析 肺癌患者对SARS-CoV-2的抗体反应“将为这些重要的问题提供答案 通过研究4个具体目标和使用我们的U54管理、临床和数据来提出问题 科学是核心。目标1：描述抗体反应的发生率、大小和功能 肺癌患者与非肺癌患者SARS-CoV-2的对照研究目标2：比较 肺癌患者与非肺癌患者对SARS-CoV-2抗体应答的比较。目标3： 评估患者人口统计学和癌症相关临床因素对抗体反应的影响 在肺癌患者中。和目标4：表征肺部接种SARS-CoV-2疫苗的抗体反应 癌症患者与非肺癌对照。病人的血清样本也将进行病毒检测。 与U54 Project 2合作中和功能。我们组建了一支世界级的肺团队 癌症临床翻译研究人员、血清学和病毒学专家以及患者权益倡导者 这些关键问题。该项目的成果将对肺癌患者的管理产生重大影响 在新冠肺炎大流行期间，以及对设计最优SARS-CoV-2疫苗的影响更大 肺癌患者的治疗方案。

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.