Safety and Immunogenicity of HDT-301 Targeting a SARS-CoV-2 Variant Spike Protein

Summary

This is Phase 1 study is to assess tolerability and immunogenicity of three dose levels of the investigational HDT-301 vaccine administered intramuscularly (IM), both in immunization-naïve participants and as a booster for those participants who previously received a SARS-CoV-2 vaccine. Safety and tolerability will be the primary endpoint assessed by incidence of adverse events at each dose through 12 months after completion of the vaccination regimen (either one dose, or two doses provided 56 days apart). Immunogenicity evaluations will be conducted for pre-specified timepoints as secondary and exploratory endpoints.

Timeline

Start

2022-01-24

Primary completion

2023-11-21

Completion

2024-05-30

Drugs

Indications