COVIDITY is a prophylactic DNA vaccine product developed to produce a durable immune response against the SARS-CoV-2 virus, the causative agent of COVID-19, and has two components (SCOV1 and SCOV2). SCOV1 is anticipated to be active against the original SARS-CoV-2 strain and the Alpha variant, and to a slightly lesser extent against the Beta and Gamma variants. SCOV2 is anticipated to boost the effects of SCOV1 while providing further enhanced protection against the Beta and Gamma variants. Antibodies induced by SCOV1 and SCOV2 also show strong binding to the Delta variant in pre-clinical models.
COVIDITY will be administered via needle-free injection devices developed by PharmaJet given by either the intradermal (ID) or intramuscular (IM) route, which have been shown to induce both T cell and antibody responses when used to administer plasmid DNA vaccines for other diseases. Needle-free injection is an attractive mode of delivery for a global vaccine.
The design of SCOV1 and SCOV2 utilises a modified version of the clinically tested ImmunoBody® platform. As such, COVIDITY incorporates a dual mechanism of action to induce a high avidity T cell response as well as potent virus-neutralising antibodies (VNAbs) against SARS-CoV-2. Through the targeting of two protein targets found within the SARS-CoV-2 virus there is a significant advantage over other approved vaccines, which only induce immune responses against the spike (S) protein component of the virus. The inclusion of two protein targets, including the more highly conserved nucleocapsid (N) protein component of SARS-CoV-2, is likely to minimise the risk of mutations within the virus reducing the efficacy of the vaccine comparative to a product targeting only the S protein, which has been shown to be susceptible to mutation.
The first in human (FIH) study is designed to explore the safety, tolerability, and immunogenicity of COVIDITY in healthy adults when administered by needle-free injection. Further information can be found here - A First Time in Human Phase 1 Open-Label Study of the COVIDITY Vaccine Administered by Needle-free Injection