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COVALIA (COVid vaccine trial for austrALIA): A phase I, double-blind, dose-ranging, randomised, placebo-controlled trial to study the safety and immunogenicity of a DNA-based vaccine against COVID-19 (COVIGEN) in healthy participants aged 18 to 75 years o

Investigator: Peter Richmond

Project description

To address the urgent need for a vaccine for COVID-19, BioNet’s gene-based vaccine, COVIGEN, will be investigated in this first-in-human, Phase I study. The study will evaluate the safety, reactogenicity and immunogenicity of 3 different doses of COVIGEN, administered by IM and ID route- using Pharmajet Stratis® or Tropis® , respectively , 28 days apart. It will be an observer-blinded, dose-ranging, randomised, placebo-controlled trial in healthy adults aged 18 to 75 years. The findings from this study will be used to determine the dose and route of administration to be utilised in subsequent Phase II trials of COVIGEN.

Collaborators

  • University of Sydney

Funders of the project

  • USBioNet