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

Sponsor
Vaccibody AS (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05069623
Collaborator
(none)
160
Enrollment
2
Locations
4
Arms
23.7
Anticipated Duration (Months)
80
Patients Per Site
3.4
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • 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 in will receive two vaccinations 21 days apart (Day 0 and Day 21).

There will also be one group of 10 subjects previously vaccinated with an mRNA vaccine who will receive only one vaccination on Day 0 at the highest dose reached.

In Part 2 bis a dose expansion phase with one arm for each candidate; VB10.2129 and VB01.2210, in previousl vaccinated healthy adult 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

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two vaccine candidates are investigated in parallell.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
Anticipated Study Start Date :
Oct 11, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: VB10.2129 Part 1 Dose escalaton

0.3 mg, 1 mg or 3 mg will be administered by one or two IM injections 21 days apart. One group will recive one IM administration at D0 at the highest dose level reached.

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

3 dose levels (TBD) will be administered by one or two IM injections 21 days apart. One group will recive one IM administration at D0 at the highest dose level reached.

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 one or 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 one or 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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Incidence and frequency of local and systemic unsolicited AEs [Day 0 to Day 49]

    As elicited by investigator

  3. Incidence and frequency of serious AEs (SAEs) [Day 0 to 1 year]

    As elicited by investigator

Secondary Outcome Measures

  1. 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)

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Main inclusion criteria:
  • Give informed consent by signing the Informed Consent Form (ICF)

  • Part 1: have received 2 doses of an mRNA SARS-CoV-2 vaccine, minimum 6 months prior to Visit 1.

  • Part 2: have received full vaccination schedule of an approved SARS-CoV-2 vaccine, minimum 6 months prior to Visit 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Haukeland University Hospital, Klinisk ForskningspostBergenNorway5020
2Oslo University Hospital Ullevål Sykehus, Dept. Infection DiseasesOsloNorway

Sponsors and Collaborators

  • Vaccibody AS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vaccibody AS
ClinicalTrials.gov Identifier:
NCT05069623
Other Study ID Numbers:
  • VB-D-01
First Posted:
Oct 6, 2021
Last Update Posted:
Oct 11, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Vaccibody AS
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2021