Vanderbilt Vaccine and Treatment Evaluation Unit - KidCOVE

项目主任/首席调查员(最后、第一、中间)：克里奇，克拉伦斯B 增刊摘要 阶段2/3，两部分，开放标签，剂量递增，年龄递减和随机化，观察者盲， 评价阿司匹林的安全性、耐受性、反应性和有效性的安慰剂对照扩大研究 6月龄至12岁以下健康儿童接种SARS-CoV-2基因疫苗。 该项目支持Vanderbilt UM1应用程序的特定目标2、3和4，并与 奖励条款。更具体地说，这项活动的目的是评估一种变种的SARS-CoV-2疫苗 (m RNA-1273.351)在疫苗幼稚的个体中。新冠肺炎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需要评估更多的疫苗。 具体目标2：进行多站点和单站点研究，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(Lead)儿童中心进行多站点响应 费城医院、匹兹堡儿童医院和华盛顿大学将招收 大约390名参与者。 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一种新型疫苗的免疫反应。 候选人。 具体目标4：培养未来的疫苗和临床试验领导者。与其他研究类似 到目前为止，为COVID进行的初级教员和研究员将接受疫苗临床试验和 大流行应对能力。 此请求是为了支持新冠肺炎临床研究，包括CoVPN站点准备、试验实施、 以及上述新冠肺炎临床研究的参与者招募情况。工作将包括，但不是 仅限于现场准备活动；方案制定/修订；临床试验活动；药房支持； 样品的实验室处理和储存；实验室分析；质量监督；手稿 酌情发展。 PHS 398/2590(06/09版)页面续格式页面

Program Director/Principal Investigator (Last, First, Middle): Creech, Clarence B Supplement Abstract Phase 2/3, Two-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age. 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 multisite response at VUMC (lead), Children’s Hospital of Philadelphia, Children’s Hospital of Pittsburgh, and Washington University that will enroll approximately 390 participants. 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