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Phase 1-3 evaluation of SARS-COV-2 RNA Vaccine Candidates in Healthy Adults

PRIMARY OBJECTIVE(s)

To describe the safety and tolerability profiles of prophylactic BNT162 vaccines in healthy adults after 1 or 2 doses. A phase 1/2/3, placebo-controlled, randomized, observer-blind, dose-finding study to evaluate the safety, tolerability, immunogenicity, and efficacy of SARS-COV-2 RNA vaccine candidates against COVID-19 in healthy adults. (Duke is a contributing site for this multi-center study.)

PRINCIPAL INVESTIGATOR(S)

Emmanuel Walter, MD

CONTACT
Emily Randolph
emily.randolph@duke.edu
TREATMENT/CLINICAL & LAB INVESTIGATION

Clinical and Laboratory Investigation

POPULATION
Adult county residents, healthcare workers; Phase I: 18-55 years of age, 65-85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55, or >55 years of age]).
FULL NAME OF DIAGNOSTIC TEST
Lab Used for Diagnostic Test
Full Name of Serology/Antibody Test
Lab Used for Serology/Antibody Test
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