Impact of malaria on shaping immunity to EBV in the etiology of Burkitt lymphoma

本行政补充文件是对NOT-CA-21-033的回应，旨在调查 2019冠状病毒病大流行，肯尼亚儿童被诊断患有地方性伯基特淋巴瘤（eBL）。父R 01 CA 189806 -06研究疟疾诱导的影响T细胞细胞毒性的免疫调节机制 针对EBV感染的B细胞和eBL肿瘤。被诊断患有eBL的肯尼亚儿童和一组健康儿童， 进行纵向随访，以检验母研究目标。及时增加新冠肺炎相关研究 将决定肯尼亚政府4月实施的新冠肺炎公共卫生协议的影响 2020年，关于肯尼亚eBL儿童获得护理和总体生存的问题。补充活动 包括：1）进行一项知识、态度和行为（KAP）社会心理调查，询问家长 参加我们关于COVID-19和COVID-19疫苗研究的儿童，以评估促进 诊断、门诊治疗依从性和研究参与情况; 2）SARS-CoV-2每月 血清调查可以轻松添加到我们现有的多重Luminex血清分析检测试剂盒中，该检测试剂盒已 由Moormann博士与Frederick的NCI SeroNet合作伙伴关系（NIH/NCI 1U 01 CA 261276 -01）验证 国家实验室标准; 3）SARS-CoV-2分子检测，以比较感染癌症的变体 患者与健康年龄匹配的对照组相比，可能对疫苗有效性有影响; 4） 测试使用创新和低成本的数字健康技术来监测健康指标（皮肤 温度，呼吸和心率等）的eBL患者在他们的护理过程中，当他们外出时- 5）社区参与活动，如主要知情人访谈和焦点小组讨论， 了解更多关于COVID-19大流行对癌症预防和控制计划的影响， 在肯尼亚建立了良好的基础。这项补充研究的直接结果将在 年我们将确定COVID-19公共卫生措施如何无意中影响了医疗保健 癌症诊断和eBL生存率的特定访问。在社区的建议下，我们将实施战略 为了克服这些障碍，包括探索可持续利用遥感，数字医学 监测癌症康复的技术。如果我们研究中的儿童感染了SARS-CoV-2，那么我们 在测试与免疫调节相关的机械目标时， 在父母的研究中提出。我们不认为SARS-CoV-2会增加eBL的发病率;然而， 我们仍在了解这种病毒的能力及其对多个器官的长期影响。另外我们 研究将评估与健康儿童相比，eBL患者的COVID-19变异和疫苗有效性。 2021年3月，肯尼亚引入了COVID-19疫苗，我们预计儿童疫苗接种将 建议阻止大流行。这是免疫功能低下的癌症患者的担忧，他们可能 需要加强剂来实现对SARS-CoV-2的免疫保护。

This administrative supplement is in response to NOT-CA-21-033 and aims to investigate the impact of the COVID-19 pandemic on Kenyan children diagnosed with endemic Burkitt lymphoma (eBL). The parent R01 CA189806-06 investigates malaria-induced immunoregulatory mechanisms that influence T cell cytotoxicity against EBV-infected B cells and eBL tumors. Kenyan children diagnosed with eBL and a cohort of healthy are being followed longitudinally to test the parent study objectives. The timely addition of COVID-related studies will determine the impact of COVID-19 public health protocols put into place by the Kenyan government in April 2020, on access to care and overall survival for Kenyan children with eBL. The supplemental activities include: 1) implementing a Knowledge, Attitude and Practices (KAP) psychosocial survey to ask parents of children enrolled in our study about COVID-19 and COVID-19 vaccines in order to assess barriers to prompt diagnosis, out-patient treatment compliance and research study participation; 2) SARS-CoV-2 monthly serosurveys which are easily added to our existing multiplex Luminex seroprofiling assay that has been validated by Dr. Moormann’s NCI SeroNet partnership (NIH/NCI 1U01 CA261276-01) with the Frederick National Laboratory standards; 3) SARS-CoV-2 molecular testing to compare variants that infect cancer patients compared to healthy age-matched controls and which may have implications for vaccine efficacy; 4) testing the use of innovative and low-cost digital health technologies to monitor health metrics (skin temperature, breathing and heart rate, etc) of eBL patients during the course of their care when they are out- patients; 5) community engagement activities such as key-informant interviews and focus group discussions to learn more about the impact of the COVID-19 pandemic on cancer prevention and control programs that are well established in Kenya. The immediate outcomes from this supplemental study will be achieved within the year. We will determine how the COVID-19 public health measures have inadvertently impacted health-care access specific to cancer diagnosis and eBL survivorship. With community advice, we will implement strategies to overcome these obstacles, including exploring sustainable use of remote sensing, digital medicine technologies to monitor cancer recovery. If children in our study have been infected with SARS-CoV-2, then we will include this as a cofactor when testing the mechanistic objectives pertaining to immune regulation proposed in the parent study. We do not believe that SARS-CoV-2 will increase the incidence of eBL; however, we are still learning what this virus is capable of and its prolonged effects on multiple organs. In addition, our study will assess COVID-19 variants and vaccine efficacy for eBL patients compared to healthy children. COVID-19 vaccines were introduced in Kenya during March 2021 and we anticipate childhood vaccinations will be recommended to stop the pandemic. This is of concern for immunocompromised cancer patients, who may require a booster to achieve immune protection against SARS-CoV-2.