Abstract The novel SARS-CoV-2 is the cause of the coronavirus (CoV) disease (COVID-19) outbreak that currently pose a serious pandemic threat to public health. A safe vaccine that rapidly induces long-lasting virus-specific immune responses is urgently needed. The CoV spike (S) protein, a characteristic structural component of the viral envelope, is considered a key target for vaccines against CoV infection, as we and others have previously demonstrated for severe acute respiratory syndrome (SARS) and middle east respiratory syndrome (MERS) CoV infections. The safety profile of non-infectious recombinant protein subunit vaccines makes them suitable for SARS-CoV-2 vaccine candidates for preclinical testing. To develop a SARS-CoV-2 vaccine, we constructed SARS-CoV-2-S1 subunit constructs and established an intracutaneous delivery platform using a novel, dissolving microneedle array (MNA) that enhances the immunogenicity of these subunit vaccines in mice, as determined by S1 specific viral titers in serum. Here, we propose to evaluate this PittCoVacc vaccine in a phase I clinical trial through a single specific aim designed to complete ongoing IND enabling studies, any additional parallel studies recommended by the FDA, and then to conduct a Phase 1 clinical trial in healthy volunteers.

Project Narrative The novel coronavirus, previously dubbed 2019-nCoV, and now officially named SARS-CoV-2 which caused the corona virus disease (COVID-19) pandemic outbreak and was first detected in Wuhan, China in December 2019. Safe vaccines that rapidly induce long-lasting virus-specific immune responses are urgently needed. We have recently established that intracutaneous delivery using a novel, dissolving microneedle array the SARS-CoV-2 Spike 1 subunit vaccine (PittCoVacc) is immunogenic in a murine mouse model. Here, we propose to evaluate the PittCoVacc vaccine in an investigator-initiated phase I clinical trial. This research project will provide critically important information on the safety and immunogenicity of the PittCoVacc.