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 新冠肺炎大流行肯尼亚被诊断为地方性伯基特淋巴瘤的儿童。父级R01 CA189806-06研究疟疾诱导的影响T细胞毒性的免疫调节机制 抗EBV感染的B细胞和EBL肿瘤。被诊断为EBL的肯尼亚儿童和一群健康的 被纵向跟踪，以检验家长的研究目标。及时增加与COVID相关的研究 将确定肯尼亚政府4月份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)实施知识、态度和行为(KAP)心理社会调查，询问父母 儿童参加我们关于新冠肺炎和新冠肺炎疫苗的研究，以评估提示的障碍 诊断、门诊治疗依从性和参与研究；2)SARS-CoV-2月刊 可以很容易地添加到我们现有的多路Luminex血清分析中的血清调查 经Moormann博士与Frederick的NCI SeroNet合作伙伴关系(NIH/NCI 1U01 CA261276-01)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异 将患者与年龄匹配的健康对照组进行比较，这可能对疫苗效果有影响；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 EBL患者出院时在护理过程中的体温、呼吸、心率等 患者；5)社区参与活动，如关键线人访谈和焦点小组讨论，以 了解有关新冠肺炎大流行对癌症预防和控制计划的影响的更多信息 在肯尼亚很有名气。这项补充研究的即时结果将在 年。我们将确定新冠肺炎公共卫生措施是如何无意中影响医疗保健的 获取特定于癌症诊断和EBL生存的信息。在社会各界的意见下，我们会推行策略 为了克服这些障碍，包括探索可持续利用遥感、数字医学 监测癌症恢复的技术。如果我们研究中的儿童感染了SARS-CoV-2，那么我们 在测试与免疫调节有关的机械性目标时，将把这一点作为辅助因素 在家长研究中提出的。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。此外，我们的 这项研究将评估新冠肺炎变异和EBL患者与健康儿童的疫苗效力。 新冠肺炎疫苗于2021年3月引入肯尼亚，我们预计儿童疫苗接种将 被推荐用来阻止大流行。这是免疫功能低下的癌症患者的担忧，他们可能 需要一个助推器来实现对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.