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
COVID-19, Infection Viral, Infections
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, Coronavirus, DNA vaccine, Vaccine
Eligibility Criteria
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.
Sites / Locations
- Haukeland University Hospital, Klinisk Forskningspost
- Oslo University Hospital Ullevål Sykehus, Dept. Infection Diseases
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
VB10.2129 Part 1 Dose escalaton
VB10.2210 Part 1 Dose escalation
VB10.2129 Part 2 Dose expansion
VB10.2210 Part 2 Dose expansion
0.3 mg, 1 mg or 3 mg will be administered by two IM injections 21 days apart.
0.3 mg, 1 mg or 3 mg will be administered by two IM injections 21 days apart.
The seleceted dose from Part 1 will be administered IM in a two-dose schedule.
The seleceted dose from Part 1 will be administed IM in a two-dose schedule.