COVID-19 Clinical Trial
Official title:
A Phase I/II, Placebo-Controlled, Randomized, Double-Blind, Dose-Finding Study to Evaluate the Safety, Tolerability, and Immunogenicity of AdimrSC-2f Vaccine in Healthy Adults
AdimrSC-2f is a subunit protein-based vaccine produced using the baculovirus insect cells manufacturing process to prevent Coronavirus disease 2019 (COVID-19). The primary goal of this Phase I/II study is to evaluate the vaccine safety and immunogenicity of AdimrSC-2f in healthy adult individuals, as compared to placebo.
This will be a Phase I/II, placebo-controlled, randomized, double-blind within dose cohort, dose-finding study to evaluate the safety, tolerability, and immune response of AdimrSC-2f vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in healthy adults aged from 18 to 60. Two hundred forty (240) subjects will be sequentially enrolled from low dose to high dose cohort and then randomized into AdimrSC-2f vaccine group or matched placebo in a 3:1 ratio. Each enrolled subject will receive a total of 3 doses with 3-week apart by 0.5 mL intramuscular (IM) injection to the deltoid region of non-dominant arm preferably. All enrolled subjects will be follow their safety and immune response for six months. ;
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