Vanderbilt Vaccine and Treatment Evaluation Unit

项目负责人/主要研究者（最后一名、第一名、中间名）：Creech，Clarence B 补充摘要 SARS-CoV-2变异疫苗安全性和免疫原性的I期、开放标签、随机研究 （mRNA-1273.351）在初治和既往接种过疫苗的成人中 该项目支持范德比尔特UM 1应用程序的特定目标2、3和4，并与 裁决条款。更具体地说，这项活动的目的是评估SARS-CoV-2变异疫苗 （mRNA-1273.351）。COVID-19导致了广泛的发病率和死亡率， 尽管目前批准的疫苗非常有效，但出现了可能逃逸的变异病毒， 疾病和疫苗诱导的免疫力需要评价额外的疫苗。 具体目标2：开展多中心和单中心研究，评价安全性、有效性和 新干预措施的免疫原性。我们建议在VUMC设立一个研究中心， 30名健康成人参与mRNA-1273.351的研究。 具体目标3：评估自然感染或疫苗引起的免疫应答 局这项工作的核心将是评估对一种新疫苗的免疫反应 候选人 具体目标4：培养疫苗学和临床试验领域的未来领导者。与其他研究相似 到目前为止，初级教师和研究员将接受疫苗临床试验的培训， 应对大流行病。 此请求是为了支持COVID-19临床研究，包括CoVPN网站准备，试验实施， 以及上述COVID-19临床研究参与者的招募。工作将包括，但不是 限于：研究中心准备活动;方案制定/修订;临床试验活动;药房支持; 样本的实验室处理和储存;实验室分析;质量监督;以及手稿 发展，酌情。 PHS 398/2590（Rev.06/09）

Program Director/Principal Investigator (Last, First, Middle): Creech, Clarence B Supplement Abstract Phase 1, Open-Label, Randomized Study of the Safety and Immunogenicity of a SARS-CoV-2 Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults This project supports specific aims 2, 3, and 4 from the Vanderbilt UM1 application and is consistent with the terms of award. More specifically, the purpose of this activity is to evaluate a variant SARS-CoV-2 vaccine (mRNA-1273.351) in vaccine-naïve individuals. COVID-19 has led to widespread morbidity and mortality and though currently authorized vaccines are highly efficacious, the emergence of variant viruses that may escape disease- and vaccine-induced immunity requires additional vaccines to be evaluated. Specific Aim 2: Conduct multi-site and single site research evaluating the safety, efficacy, and immunogenicity of novel interventions. We propose a single site at VUMC that will enroll approximately 30 healthy adults into a study of mRNA-1273.351. Specific Aim 3: Evaluate immune responses resulting from natural infection or vaccine administration. Central to this work will be the evaluation of immune responses to a novel vaccine candidate. Specific Aim 4: Train future leaders in vaccinology and clinical trials. Similar to other studies conducted for COVID thus far, junior faculty and fellows will be trained in vaccine clinical trials and pandemic responsiveness. This request is to support COVID-19 clinical research, including CoVPN site preparation, trial implementation, and enrollment of participants in the above COVID-19 clinical research study. Work will include, but is not limited to: site preparation activities; protocol development/revision; clinical trial activities; pharmacy support; laboratory processing and storage of samples; laboratory assays; quality oversight; and manuscript development, as appropriate. PHS 398/2590 (Rev. 06/09) Page Continuation Format Page