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Principal Investigator: Clarence Buddy Creech
Organization: VANDERBILT UNIVERSITY MEDICAL CENTER
Fiscal Year: 2021
Award: $614,901
Funding agency: National Institute of Allergy and Infectious Diseases
Program Director/Principal Investigator (Last, First, Middle): Creech, Clarence B
Supplement Abstract
Phase 1, Open-Label, Randomized Study of the Safety and Immunogenicity of a SARS-CoV-2 Variant Vaccine
(mRNA-1273.351) in Naïve and Previously Vaccinated Adults
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 single site at VUMC that will enroll approximately
30 healthy adults into a study of mRNA-1273.351.
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
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