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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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:

  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.
  2. 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

Other trials in Norway

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.

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 groups in NCT05069623
Study groupRoleWhat they receive
VB10.2129 Part 1 Dose escalatonExperimental0.3 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 escalationExperimental0.3 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 expansionExperimentalThe seleceted dose from Part 1 will be administered IM in a two-dose schedule.
Receives: Biological: VB10.2129
VB10.2210 Part 2 Dose expansionExperimentalThe 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.

  1. 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

  2. Incidence and frequency of local and systemic unsolicited AEs

    As elicited by investigator

    Measured: Day 0 to Day 49

  3. Incidence and frequency of serious AEs (SAEs)

    As elicited by investigator

    Measured: Day 0 to 1 year

Secondary outcomes (2)
  1. 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

  2. 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.

  1. First posted6 Oct 2021
  2. Study start1 Nov 2021
  3. Primary completion16 Dec 2022
  4. Study completion30 May 2023

Resources

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)
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.

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.

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