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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05069623
Recruitment Status : Active, not recruiting
First Posted : October 6, 2021
Last Update Posted : October 26, 2022
Sponsor:
Collaborator:
Vaccibody AS
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
COVID-19 Infection Viral Infections Biological: VB10.2129 Biological: VB10.2210 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two vaccine candidates are investigated in parallell.
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : October 27, 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VB10.2129 Part 1 Dose escalaton
0.3 mg, 1 mg or 3 mg will be administered by two IM injections 21 days apart.
Biological: VB10.2129
0.3 mg, 1 mg or 3 mg on Day 0 and Day 21 or 3 mg on Day 0

Experimental: VB10.2210 Part 1 Dose escalation
0.3 mg, 1 mg or 3 mg will be administered by two IM injections 21 days apart.
Biological: VB10.2210
3 doses (dose to be determined) on Day 0 and Day 21 or highest dose (TBD) on Day 0

Experimental: VB10.2129 Part 2 Dose expansion
The seleceted dose from Part 1 will be administered IM in a two-dose schedule.
Biological: VB10.2129
0.3 mg, 1 mg or 3 mg on Day 0 and Day 21 or 3 mg on Day 0

Experimental: VB10.2210 Part 2 Dose expansion
The seleceted dose from Part 1 will be administed IM in a two-dose schedule.
Biological: VB10.2210
3 doses (dose to be determined) on Day 0 and Day 21 or highest dose (TBD) on Day 0




Primary Outcome Measures :
  1. 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

  2. Incidence and frequency of local and systemic unsolicited AEs [ Time Frame: Day 0 to Day 49 ]
    As elicited by investigator

  3. Incidence and frequency of serious AEs (SAEs) [ Time Frame: Day 0 to 1 year ]
    As elicited by investigator


Secondary Outcome Measures :
  1. Humoral responses against SARS-CoV-2 [ Time Frame: 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)

  2. Cellular responses (T-cell responses) to SARS-CoV-2 RBD epitopes by ELISpot [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05069623


Locations
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Norway
Haukeland University Hospital, Klinisk Forskningspost
Bergen, Norway, 5020
Oslo University Hospital Ullevål Sykehus, Dept. Infection Diseases
Oslo, Norway
Sponsors and Collaborators
Nykode Therapeutics ASA
Vaccibody AS
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Responsible Party: Nykode Therapeutics ASA
ClinicalTrials.gov Identifier: NCT05069623    
Other Study ID Numbers: VB-D-01
First Posted: October 6, 2021    Key Record Dates
Last Update Posted: October 26, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Anonymous IPD may be shared following or during the publication of summary data. Archival data may be accessed for up to 25 years following the end of the study.
Access Criteria: Those who request the anonymous IPD must provide a plan of study explaining how the data will be used. Requests may be sent to the Central Contact Person. Requests will be reviewed based on the potential for the planned use of the IPD for advancing scientific knowledge and theory.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nykode Therapeutics ASA:
COVID-19
Coronavirus
DNA vaccine
Vaccine
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Virus Diseases
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases