Vanderbilt Vaccine and Treatment Evaluation Unit

项目总监/首席研究员（最后、第一、中间）：Creech, Clarence B 补充摘要 SARS-CoV-2 变异疫苗的安全性和免疫原性的第一阶段、开放标签、随机研究 (mRNA-1273.351) 在未接种疫苗和之前接种过疫苗的成人中 该项目支持 Vanderbilt UM1 应用程序的具体目标 2、3 和 4，并且与 奖励条款。更具体地说，本次活动的目的是评估变异 SARS-CoV-2 疫苗 (mRNA-1273.351) 在未接种疫苗的个体中。 COVID-19 导致了广泛的发病率和死亡率， 尽管目前授权的疫苗非常有效，但可能逃脱的变异病毒的出现 疾病和疫苗诱导的免疫力需要评估额外的疫苗。 具体目标 2：进行多中心和单中心研究，评估安全性、有效性和 新干预措施的免疫原性。我们建议在 VUMC 建立一个单一站点，大约可招收 30 名健康成年人参与了 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反应 行政管理。这项工作的核心是评估对新型疫苗的免疫反应 候选人。 具体目标 4：培养未来疫苗学和临床试验领域的领导者。与其他研究类似 迄今为止针对新冠病毒进行的培训，初级教员和研究员将接受疫苗临床试验和 流行病应对能力。 此请求是为了支持 COVID-19 临床研究，包括 CoVPN 场地准备、试验实施、 上述 COVID-19 临床研究参与者的招募。工作将包括但不包括 仅限于：场地准备活动；协议制定/修订；临床试验活动；药房支持； 实验室样品处理和储存；实验室化验；质量监督；和手稿 酌情发展。 PHS 398/2590（修订版 06/09） 页面延续 格式页面

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