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Clinical Trial Summary

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). tThree 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 healty volunteers.


Clinical Trial Description

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, ie, 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 (Day 0 and Day 21). 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. In Part 2 bis a dose expansion phase with one arm for each candidate; VB10.2129 and VB01.2210, in previousl vaccinated healthy adult subjects only. The dose to be investigated will be selected based on safety and inital immune response data from Part 1. All subjects will be folowed for up to 1 year after the first vaccination. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05069623
Study type Interventional
Source Vaccibody AS
Contact Siri Torhaug, MD
Phone +47 95113393
Email [email protected]
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date October 11, 2021
Completion date October 2023

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