Vanderbilt Vaccine and Treatment Evaluation Unit - KidCOVE

范德比尔特疫苗和治疗评估单位 - KidCOVE

基本信息

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
项目类别：
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

项目摘要

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

计划主任/首席研究员（最后，第一，中间）：Creech，Clarence B 补充摘要阶段2/3，两部分，开放标签，剂量升级，年龄降级和随机，观察者盲，安慰剂对照扩张研究，以评估安全性，耐受性，反应生成性和有效性 MRNA-1273 SARS-COV-2疫苗在健康儿童中6个月至12岁以下。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。更具体地说，此活动的目的是评估变体SARS-COV-2疫苗（mRNA-1273.351）在没有疫苗的个体中。 Covid-19导致宽度的发病率和死亡率，尽管目前授权的疫苗高效，但可能逃脱的变体病毒的出现疾病和疫苗诱导的免疫力需要评估其他疫苗。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VUMC（LEAD），儿童的vumc提出了多站点响应费城医院，匹兹堡儿童医院和将入学的华盛顿大学大约390名参与者。特定目标3：评估自然感染或疫苗引起的免疫调查行政。这项工作的中心将是对新型疫苗的免疫反应的评估候选人。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疫苗临床试验的培训，并且大流行的反应能力。该请求是为了支持COVID-19的临床研究，包括COVPN站点准备，试验实施，以及参与者参加以上COVID-19-19临床研究研究。工作将包括，但不包括仅限于现场准备活动；协议开发/修订；临床试验活动；药房支持；样品的实验室加工和存储；实验室测定；优质监督；和手稿适当的发展。 PHS 398/2590（修订版06/09）页面延续格式页面