Vanderbilt Vaccine and Treatment Evaluation Unit - DMID 21-0004

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 SARS-CoV-2疫苗免疫原性和安全性的观察性前瞻性队列研究 孕期或产后给药以及婴儿抗体转移和持久性的评估。 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免疫原性和安全性 在孕期或产后接种SARS-CoV-2疫苗，并评估抗体转移。 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。我们建议在费城儿童医院建一个单一地点 这将评估怀孕期间对COVID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反应 行政管理。这项工作的中心将是评估对新城疫疫苗的免疫反应 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，初级教员和研究员将接受与疫苗相关的临床研究方面的培训 以及对大流行的反应能力。 该请求是为了支持新冠肺炎临床研究，包括场地准备、研究实施和 上述新冠肺炎临床研究的参与者招募情况。工作将包括但不限于： 场地准备活动；方案制定/修订；临床研究活动；实验室处理和 样品的储存；质量监督；以及酌情的手稿开发。 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 Observational, Prospective Cohort Study of the Immunogenicity and Safety of SARS-CoV-2 Vaccines Administered during Pregnancy or Postpartum and Evaluation of Antibody Transfer and Durability in Infants. 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 the immunogenicity and safety of SARS-CoV-2 vaccines administered during pregnancy or post-partum and evaluate antibody transfer. 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