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.
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 will receive two vaccinations 21 days apart (Day 0 and Day 21). In Part 2 is a dose expansion phase with one arm for each candidate; VB10.2129 and VB10.2210, in previously vaccinated healthy 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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
68
Haukeland University Hospital, Klinisk Forskningspost
Bergen, Norway
Oslo University Hospital Ullevål Sykehus, Dept. Infection Diseases
Oslo, Norway
Incidence and frequency of local and systemic solicited adverse events (AEs)
As self reported in eDiary
Time frame: Day 0 to Day 7 days after each vaccination
Incidence and frequency of local and systemic unsolicited AEs
As elicited by investigator
Time frame: Day 0 to Day 49
Incidence and frequency of serious AEs (SAEs)
As elicited by investigator
Time frame: Day 0 to 1 year
Humoral responses against SARS-CoV-2
Number participants with increase in Ab titre and neutralizing Ab responses after first and second vaccine and long term responses (VB10.2129)
Time frame: Day 0 (before Dose 1) up to 1 year
Cellular responses (T-cell responses) to SARS-CoV-2 RBD epitopes by ELISpot
Number of participants with change from baseline in Antigen-Specific T-cell cytokine production and long term T-cell responses
Time frame: Day 0 (before Dose 1) up to 1 year
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