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

Phase 1

Completed

• Conditions: COVID-19; Infection Viral; Infections
• Interventions: Biological: VB10.2210; Biological: VB10.2129

• Registration Number: NCT05069623
• Lead Sponsor: Nykode Therapeutics ASA

Brief 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.

Study Timeline

• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-04
• Study First Posted: 2021-10-06
• Study Start: 2021-11-01
• Primary Completion: 2022-12-16
• Study Completion: 2023-05-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VB10.2210 Part 1 Dose escalation	VB10.2210	0.3 mg, 1 mg or 3 mg will be administered by two IM injections 21 days apart.
VB10.2129 Part 1 Dose escalaton	VB10.2129	0.3 mg, 1 mg or 3 mg will be administered by two IM injections 21 days apart.
VB10.2129 Part 2 Dose expansion	VB10.2129	The seleceted dose from Part 1 will be administered IM in a two-dose schedule.
VB10.2210 Part 2 Dose expansion	VB10.2210	The seleceted dose from Part 1 will be administed IM in a two-dose schedule.

Primary Outcome Measures

Name	Time	Method
Incidence and frequency of serious AEs (SAEs)	Day 0 to 1 year	As elicited by investigator
Incidence and frequency of local and systemic unsolicited AEs	Day 0 to Day 49	As elicited by investigator
Incidence and frequency of local and systemic solicited adverse events (AEs)	Day 0 to Day 7 days after each vaccination	As self reported in eDiary

Secondary Outcome Measures

Name	Time	Method
Cellular responses (T-cell responses) to SARS-CoV-2 RBD epitopes by ELISpot	Day 0 (before Dose 1) up to 1 year	Number of participants with change from baseline in Antigen-Specific T-cell cytokine production and long term T-cell responses
Humoral responses against SARS-CoV-2	Day 0 (before Dose 1) up to 1 year	Number participants with increase in Ab titre and neutralizing Ab responses after first and second vaccine and long term responses (VB10.2129)

Trial Locations

Locations (2)

Oslo University Hospital Ullevål Sykehus, Dept. Infection Diseases; 🇳🇴 Oslo, Norway

Haukeland University Hospital, Klinisk Forskningspost; 🇳🇴 Bergen, Norway