NCT05069623

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

A Phase 1/2, Open Label, Dose Escalation Study to Determine Safety and Immunogenicity of Two (Prophylactic) COVID 19 DNA Vaccine Candidates (VB10.2129 [C1], a RBD Candidate and VB10.2210 [C2], a T Cell Candidate), in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Nykode Therapeutics ASA · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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 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.

Conditions

• COVID-19
• Infection Viral
• Infections

Interventions

Type	Name	Description
BIOLOGICAL	VB10.2129	0.3 mg, 1 mg or 3 mg on Day 0 and Day 21 or 3 mg on Day 0
BIOLOGICAL	VB10.2210	3 doses (dose to be determined) on Day 0 and Day 21 or highest dose (TBD) on Day 0

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-12-16
• Completion: 2023-05-30
• First posted: 2021-10-06
• Last updated: 2024-04-11

Locations

2 sites across 1 country: Norway