Vanderbilt Vaccine and Treatment Evaluation Unit - KidCOVE

范德比尔特疫苗和治疗评估单位 - KidCOVE

• 批准号: 10381372
• 负责人: Clarence Buddy Creech
• 金额: $ 524.54万
• 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: 2021-05-14 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10381372
• 关键词: 12 year old; 2019-nCoV; Age; Award; Biological Assay; COVID-19; COVID-19 Prevention Network; COVID-19 vaccine; Child; Clinical Research; Clinical Trials; Coronavirus; Development; Disease; Dose; Effectiveness; Enrollment; Evaluation; Faculty; Future; Immune response; Individual; Infection; Intervention; Laboratories; Lead; Manuscripts; Measures; Moderna COVID-19 vaccine; Morbidity - disease rate; Participant; Pediatric Hospitals; Pharmacy facility; Phase; Philadelphia; Placebos; Preparation; Principal Investigator; Randomized; Research; SARS-CoV-2 variant; Safety; Sampling; Site; Training; Universities; Vaccine Clinical Trial; Vaccines; Variant; Virus; Washington; Work; blind; coronavirus disease; immunogenicity; mortality; novel; novel vaccines; open label; pandemic disease; participant enrollment; programs; protocol development; research study; response; vaccine candidate; vaccine evaluation; vaccine-induced immunity; vaccinology

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

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 II/III期、两部分、开放标签、剂量递增、年龄递减和随机化、观察者设盲， 安慰剂对照扩展研究，以评价安全性、耐受性、反应原性和有效性 mRNA-1273 SARS-CoV-2疫苗在6个月至12岁以下健康儿童中的应用 该项目支持范德比尔特UM 1应用程序的特定目标2、3和4，并与 裁决条款。更具体地说，这项活动的目的是评估SARS-CoV-2变异疫苗 （mRNA-1273.351）。COVID-19导致了广泛的发病率和死亡率， 尽管目前批准的疫苗非常有效，但变异病毒的出现， 疾病和疫苗诱导的免疫力需要评价额外的疫苗。 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VUMC（领导），儿童 费城医院、匹兹堡儿童医院和华盛顿大学将招收 约390人参加。 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一种新疫苗的免疫反应 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临床试验的培训， 应对大流行病。 此请求是为了支持COVID-19临床研究，包括CoVPN网站准备，试验实施， 以及上述COVID-19临床研究参与者的招募。工作将包括，但不是 仅限于研究中心准备活动;方案制定/修订;临床试验活动;药房支持; 样本的实验室处理和储存;实验室分析;质量监督;以及手稿 发展，酌情。 PHS 398/2590（Rev.06/09）