A Phase 1/2 Study to Determine Safety and Immunogenicity of Two COVID 19 Vaccines VB10.2129 (RBD Candidate) and VB10.2210 (T Cell Candidate) Previously Vaccinated in Healthy Adult Volunteers
An open label, dose escalation, and dose expansion study to evaluate the safety, reactogenicity and immunogenicity of two SARS-CoV-2 DNA plasmid vaccine candidates, VB10.2129 (C1) and VB10.2210 (C2). Three dose levels will be tested. IM administrations 21 days apart. Part 1 is a dose escalation phase and Part 2 is a dose expansion phase. In Part 2 a selected dose will be tested further in additional healthy volunteers.
This is an open label, dose escalation, and dose expansion study designed to evaluate the safety, reactogenicity and immunogenicity of two SARS-CoV-2 or COVID-19 DNA plasmid vaccine candidates, VB10.2129 (C1) and VB10.2210 (C2). Part 1 is a dose escalation phase and Part 2 is a dose expansion phase and both vaccine candidates, i.e., VB10.2129 (C1) and VB10.2210 (C2) will be tested.
Part 1 consist of two arms: one arm with each vaccine candidate and each arm investigating three escalating dose levels. 10 subjects previously vaccinated with an mRNA vaccine will be enrolled at each dose level. Each subject in will receive two vaccinations 21 days apart.
There will also be one group of 10 subjects previously vaccinated with an mRNA vaccine who will receive only one vaccination on Day 0 at the highest dose reached.
Part 2 is a dose expansion phase with one arm for each candidate; VB10.2129 and VB01.2210, in previously vaccinated healthy adult subjects only. The dose to be investigated will be selected based on safety and initial immune response data from Part 1. All subjects will be followed for up to 1 year after the first vaccination.
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