Vanderbilt Vaccine and Treatment Evaluation Unit - KidCOVE

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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