Phase 1 Study to Assess Safety, Reactogenicity and Immunogenicity of the HDT-301 Vaccine Against COVID-19
This is a phase I, open label, dose ranging clinical trial in healthy males and non-pregnant females, 18 to 55 years of age, inclusive, who are SARS-CoV-2 seronegative at screening. The trial is designed to assess the safety, reactogenicity and immunogenicity of HDT-301, which is a novel Lipid-Inorganic Nanoparticle (LION™) formulated replicating RNA-based vaccine that encodes for a full-length spike (S) protein of the SARS-CoV-2 virus. As a replicating mRNA vaccine, HDT-301 has the potential to allow the advantages of dose sparing, and possibly administration as a single dose, compared with other mRNA platforms. Enrollment will occur at one domestic site. 78 subjects will receive two intramuscular (IM) injections of HDT-301 at a dose of 1 µg, 5 µg and 25 µg on either Days 1 and 29 or on Days 1 and 57. ELISA IgG responses will be the primary endpoint assessed for dose-response and, for post dose one responses, as an initial exploration of feasibility of a one-dose strategy. Scheduled interim immunogenicity evaluations will be conducted for pre-specified timepoints. Subjects will be followed for safety and immunogenicity through 12 months after the second vaccination. The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of HDT-301, with the second dose given at a 28 or 56 day interval, across 3 dosages in healthy adults.
Start: May 2021