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

NCT05069623 | Completed Phase 1

• 1 other identifier: VB-D-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19; Infection Viral; Infections

Keywords

COVID-19; Coronavirus; DNA vaccine; Vaccine

Outcome Measures

Primary Outcomes (3)

• Incidence and frequency of local and systemic solicited adverse events (AEs)

  As self reported in eDiary

  Day 0 to Day 7 days after each vaccination

• Incidence and frequency of local and systemic unsolicited AEs

  As elicited by investigator

  Day 0 to Day 49

• Incidence and frequency of serious AEs (SAEs)

  As elicited by investigator

  Day 0 to 1 year

Secondary Outcomes (2)

• Humoral responses against SARS-CoV-2

  Day 0 (before Dose 1) up to 1 year

• Cellular responses (T-cell responses) to SARS-CoV-2 RBD epitopes by ELISpot

  Day 0 (before Dose 1) up to 1 year

Study Arms (4)

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.

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.

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.

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.

Biological: VB10.2210

Interventions

VB10.2129 BIOLOGICAL

0.3 mg, 1 mg or 3 mg on Day 0 and Day 21 or 3 mg on Day 0

VB10.2129 Part 1 Dose escalaton; VB10.2129 Part 2 Dose expansion

VB10.2210 BIOLOGICAL

3 doses (dose to be determined) on Day 0 and Day 21 or highest dose (TBD) on Day 0

VB10.2210 Part 1 Dose escalation; VB10.2210 Part 2 Dose expansion

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nykode Therapeutics ASA: lead
• Vaccibody AS: collaborator

Study Sites (2)

Haukeland University Hospital, Klinisk Forskningspost

Bergen, 5020, Norway

Location

Oslo University Hospital Ullevål Sykehus, Dept. Infection Diseases

Oslo, Norway

Location

MeSH Terms

Conditions

COVID-19; Virus Diseases; Infections; Coronavirus Infections

Interventions

VB10.COV-2 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two vaccine candidates are investigated in parallell.

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 6, 2021
• Study Start: November 1, 2021
• Primary Completion: December 16, 2022
• Study Completion: May 30, 2023
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

NO (2)