Vanderbilt Vaccine and Treatment Evaluation Unit - DMID 21-0012

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 接受EUA后延迟异源SARS-CoV-2疫苗给药（加强）的I/II期研究 疫苗 该项目支持范德比尔特UM1应用程序的特定目标2、3和4，并与 裁决条款。更具体地说，这项活动旨在了解安全性、耐受性和 使用具有同源或变体刺突谱系的异源平台的加强疫苗的免疫原性 EUA初次给药后给药 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。我们建议在费城儿童医院设立一个单独的研究中心 将评估孕妇对新冠疫苗的免疫反应 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COVID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相关临床研究的培训 和对流行病的反应。 该请求旨在支持COVID-19临床研究，包括研究中心准备、研究实施和 上述COVID-19临床研究的参与者招募。工作将包括但不限于： 研究中心准备活动;方案制定/修订;临床研究活动;实验室处理和 样本储存;质量监督;以及酌情编写手稿。 PHS 398/2590（Rev.06/09）

Program Director/Principal Investigator (Last, First, Middle): Creech, Clarence B Supplement Abstract A Phase 1/2 Study of Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) after Receipt of EUA Vaccines. This project supports specific aims 2, 3, and 4 from the Vanderbilt UM1 application and is consistent with the terms of award. More specifically, this activity is designed to gain knowledge of the safety, tolerability, and immunogenicity of a boost vaccine using a heterologous platform with the homologous or variant spike lineage administered after an EUA primary dosing 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 Children’s Hospital of Philadelphia that will evaluate the immune response to COVID vaccines in pregnancy 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 COVID 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-related clinical studies and pandemic responsiveness. This request is to support COVID-19 clinical research, including site preparation, study 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 study activities; laboratory processing and storage of samples; quality oversight; and manuscript development, as appropriate. PHS 398/2590 (Rev. 06/09) Page Continuation Format Page