Cochrane COVID-19 Study Register
Study record
NCT05132907First Published: 2021 Nov 24Updated Date: 2021 Nov 24

Phase 1, Dose-Escalation Study Of Nanoparticle Carrier-Formulated Self- Replicating Replicon RNA (repRNA) SARS-CoV-2 Vaccine (HDT-301) Targeting A Variant Spike Protein In Unvaccinated Or Previously Vaccinated Healthy Adults

  1. Study Type
  2. Interventional
  1. Study Aim
  2. Prevention
  1. Study Design
  2. Parallel/Crossover
  1. Intervention Assignment
  2. Non-randomised
Reference record

Safety And Immunogenicity Of HDT-301 Targeting A SARS-CoV-2 Variant Spike Protein

Trial registry record
No Results
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-naive 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