Vanderbilt Vaccine and Treatment Evaluation Unit - DMID 21-0004

范德比尔特疫苗和治疗评估单位 - DMID 21-0004

• 批准号: 10404421
• 负责人: Clarence Buddy Creech
• 金额: $ 65.85万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-10 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10404421
• 关键词: 2019-nCoV; Award; COVID-19; COVID-19 vaccine; Clinical Research; Clinical Trials; Coronavirus; Development; Evaluation; Faculty; Future; Immune response; Infant; Infection; Intervention; Laboratories; Manuscripts; Measures; Morbidity - disease rate; Pediatric Hospitals; Philadelphia; Postpartum Period; Pregnancy; Preparation; Principal Investigator; Prospective cohort study; Research; Safety; Sampling; Site; Training; Vaccines; Work; antibody transfer; coronavirus disease; immunogenicity; mortality; novel; pandemic disease; participant enrollment; programs; protocol development; research study; vaccine candidate; vaccine evaluation; vaccinology; 2019-nCoV; Award; COVID-19; COVID-19 vaccine; Clinical Research; Clinical Trials; Coronavirus; Development; Evaluation; Faculty; Future; Immune response; Infant; Infection; Intervention; Laboratories; Manuscripts; Measures; Morbidity - disease rate; Pediatric Hospitals; Philadelphia; Postpartum Period; Pregnancy; Preparation; Principal Investigator; Prospective cohort study; Research; Safety; Sampling; Site; Training; Vaccines; Work; antibody transfer; coronavirus disease; immunogenicity; mortality; novel; pandemic disease; participant enrollment; programs; protocol development; research study; vaccine candidate; vaccine evaluation; vaccinology

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

计划主任/首席研究员（最后，第一，中间）：Creech，Clarence B 补充摘要 SARS-COV-2疫苗的免疫原性和安全性观测，前瞻性队列研究 在怀孕期间或产后服用，并评估婴儿的抗体转移和耐用性。 该项目支持范德比尔特UM1应用程序的特定目标2、3和4 奖励条款。更具体地，这项活动的目的是评估 妊娠或产后施用的SARS-COV-2疫苗并评估抗体转移。 特定目的2：进行多站点和单一站点研究，以评估安全性，效率和 新干预措施的免疫原性。我们在费城儿童医院提出了一个地点 这将评估怀孕期间对卷疫苗的免疫响应 特定目标3：评估自然感染或疫苗引起的免疫调查 行政。这项工作的核心将是评估对共同疫苗的免疫反应 候选人。 特定目标4：培训未来的疫苗学和临床试验领导者。类似于其他研究 到目前为止，针对Covid进行的，初级教师和研究员将接受与疫苗相关的临床研究的培训 和大流行的响应能力。 该请求是支持Covid-199临床研究，包括现场准备，研究实施和 参与者参加了上述COVID-19-19临床研究研究。工作将包括但不限于： 现场准备活动；协议开发/修订；临床研究活动；实验室处理和 样品的存储；优质监督；和手稿开发，适当地。 PHS 398/2590（修订版06/09）页面延续格式页面