COVID-19Phase 1/2NCT05069623
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 study testing VB10.2129 and VB10.2210 in people with COVID-19 and Infection Viral, run by Nykode Therapeutics ASA at 2 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Infection Viral, Infections
- What is being tested?
- VB10.2129 and VB10.2210
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Nov 2021to 30 May 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Main inclusion criteria:
- Give informed consent by signing the Informed Consent Form (ICF)
SARS CoV 2 vaccination status for Part 1:
- VB10.2129 (C1): have received 2 or 3 doses of an approved mRNA SARS CoV 2 vaccine, minimum 4.5 months (20 weeks) prior to Visit 1.
- VB10.2210 (C2): have received 2 doses (primary vaccination) or 3 (primary and boost) doses of an approved mRNA SARS CoV 2 vaccine, minimum 8 weeks prior to Visit 1.
SARS CoV 2 vaccination status for Part 2:
VB10.2129 (C1) and VB10.2210 (C2) Vaccination status prior to Visit 1 will be decided based on data from Part 1.
- Willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (eg, local law and regulations [county specific lock down rules] regarding COVID-19), and other requirements of the study.
- Healthy, in the clinical judgement of the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs (systolic/diastolic blood pressure, pulse rate, body temperature, respiratory rate), and clinical laboratory tests (blood chemistry, haematology, and urine chemistry) at Visit 0 (Screening).
- Women of childbearing potential (WOCBP) must have a negative pregnancy test and must agree to practice a highly effective form
- Agree not to be vaccinated with any other vaccine during the study until 28 days after receiving the last study vaccination
- Negative rtPCR-test for SARS-CoV-2
Main exclusion criteria:
- Have had any acute illness with or without fever, within 72 hours prior to the first vaccination
- Symptoms of upper respiratory infection, fever, persistent cough, shortness of breath, runny nose and breathing difficulties
- Breastfeeding or who plan to breastfeed during the study
- Have a known allergy, hypersensitivity, or intolerance to aminoglycosides
- Had any clinically significant or chronic medical condition or any major surgery within the past 5 years which
- Have any surgery planned during the study
- Had any chronic use of any systemic medications, including immunosuppressant's, oral corticosteroids or other immune-modifying drugs, within the 12 months prior to Screening
- Received any vaccination within the 28 days prior to Screening
- Received any prescription medicines (except hormonal contraception for WOCBP) within 14 days prior to Visit 0 (Screening) or over the counter medicines (except paracetamol and acetaminophen at a dose of (≤2 grams/day)) within 48 hours of Visit 0.
- Have a known history or a positive test of HIV 1 or 2, Hep B, or Hep C
- Have a positive rtPCR test for SARS-CoV-2 within 2 days of Screening
- Documented history of previous infection with SARS-CoV-2 and/or who have the presence of serum Ab indicative of a previous SARS-CoV-2 infection
- Have a history of hypersensitivity or have had a serious reaction to a previous vaccination
- Have any abnormality or permanent body art (eg, tattoo) that, would obstruct the ability to observe local reactions at the injection site.
- Have a condition known to put them at high risk for severe COVID-19, including those with any of the following risk factors: Hypertension, diabetes mellitus, chronic pulmonary disease, asthma, chronic liver disease, known stage 3 or worse chronic kidney disease
- Anticipating the need for immunosuppressive treatment within the next 6 months.
Other inclusion or exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Haukeland University Hospital, Klinisk Forskningspost
Bergen, 5020
Oslo University Hospital Ullevål Sykehus, Dept. Infection Diseases
Oslo
About this study
Official title: 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
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.
Read the 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
- Being tested
- VB10.2129, VB10.2210
- Keywords
- COVID-19, Coronavirus, DNA vaccine, Vaccine
- Medical subject headings
- COVID-19, Virus Diseases, Infections, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VB10.2129Biological
0.3 mg, 1 mg or 3 mg on Day 0 and Day 21 or 3 mg on Day 0
VB10.2210Biological
3 doses (dose to be determined) on Day 0 and Day 21 or highest dose (TBD) on Day 0
| Study group | Role | What they receive |
|---|---|---|
| VB10.2129 Part 1 Dose escalaton | Experimental | 0.3 mg, 1 mg or 3 mg will be administered by two IM injections 21 days apart. Receives: Biological: VB10.2129 |
| VB10.2210 Part 1 Dose escalation | Experimental | 0.3 mg, 1 mg or 3 mg will be administered by two IM injections 21 days apart. Receives: Biological: VB10.2210 |
| VB10.2129 Part 2 Dose expansion | Experimental | The seleceted dose from Part 1 will be administered IM in a two-dose schedule. Receives: Biological: VB10.2129 |
| VB10.2210 Part 2 Dose expansion | Experimental | The seleceted dose from Part 1 will be administed IM in a two-dose schedule. Receives: Biological: VB10.2210 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and frequency of local and systemic solicited adverse events (AEs)
As self reported in eDiary
Measured: Day 0 to Day 7 days after each vaccination
Incidence and frequency of local and systemic unsolicited AEs
As elicited by investigator
Measured: Day 0 to Day 49
Incidence and frequency of serious AEs (SAEs)
As elicited by investigator
Measured: Day 0 to 1 year
Secondary outcomes (2)
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)
Measured: 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
Measured: Day 0 (before Dose 1) up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Nov 2021
- Primary completion16 Dec 2022
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two vaccine candidates are investigated in parallell.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nykode Therapeutics ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vaccibody AS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069623
- Sponsor's protocol ID
- VB-D-01
- Status last verified
- Apr 2024
- First submitted
- 4 Oct 2021
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05069623
- Acronym / sponsor ID
- VB-D-01
- Conditions
- COVID-19, Infection Viral, Infections
- Keywords
- COVID-19, Coronavirus, DNA vaccine, Vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Nykode Therapeutics ASAIndustry (pharma, biotech, devices)
- Collaborators
- Vaccibody AS
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Two vaccine candidates are investigated in parallell.
| Arm | Type | Receives |
|---|---|---|
| VB10.2129 Part 1 Dose escalaton | Experimental | Biological: VB10.21290.3 mg, 1 mg or 3 mg will be administered by two IM injections 21 days apart. |
| VB10.2210 Part 1 Dose escalation | Experimental | Biological: VB10.22100.3 mg, 1 mg or 3 mg will be administered by two IM injections 21 days apart. |
| VB10.2129 Part 2 Dose expansion | Experimental | Biological: VB10.2129The seleceted dose from Part 1 will be administered IM in a two-dose schedule. |
| VB10.2210 Part 2 Dose expansion | Experimental | Biological: VB10.2210The seleceted dose from Part 1 will be administed IM in a two-dose schedule. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VB10.21290.3 mg, 1 mg or 3 mg on Day 0 and Day 21 or 3 mg on Day 0 | Biological | VB10.2129 Part 1 Dose escalaton, VB10.2129 Part 2 Dose expansion |
| VB10.22103 doses (dose to be determined) on Day 0 and Day 21 or highest dose (TBD) on Day 0 | Biological | VB10.2210 Part 1 Dose escalation, VB10.2210 Part 2 Dose expansion |
Primary outcome
Incidence and frequency of local and systemic solicited adverse events (AEs)
Time frame: Day 0 to Day 7 days after each vaccination
As self reported in eDiary
Incidence and frequency of local and systemic unsolicited AEs
Time frame: Day 0 to Day 49
As elicited by investigator
Incidence and frequency of serious AEs (SAEs)
Time frame: Day 0 to 1 year
As elicited by investigator
2 secondary outcomes
Humoral responses against SARS-CoV-2
Time frame: Day 0 (before Dose 1) up to 1 year
Cellular responses (T-cell responses) to SARS-CoV-2 RBD epitopes by ELISpot
Time frame: Day 0 (before Dose 1) up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: Yes. Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VB10.2129 and VB10.2210 in people with COVID-19 and Infection Viral, run by Nykode Therapeutics ASA at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and frequency of local and systemic solicited adverse events (AEs) (time frame: Day 0 to Day 7 days after each vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024; AzTrials last refreshed its copy on 31 Oct 2026.