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About
This is a multicentre, open-label Phase 1/2 study, with a first-in-human (FIH) dose escalation part (Phase 1 study) followed by an open-label single arm (or two-arms, randomized) dose expansion part (Phase 2 study). The vaccine will be administered by intramuscular (IM) injection followed by electroporation (EP) applied to the injection site.
The study is aimed at assessing the safety and immunogenicity of COVID-eVax, a DNA plasmid-based vaccine whose target antigen is a portion of the S protein of SARS-CoV-2 virus (the Receptor Binding Domain located in the CTD1 of the S1 region of the S protein).
In animal models COVID-eVax was safe and induced high immunological humoral and cellular response.
Enrollment
Sex
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Volunteers
Inclusion criteria
Signed and dated informed consent obtained before undergoing any study-specific procedure
Healthy male or female aged ≥18 and ≤ 65 years
Body Mass Index >18.5 and ≤30 kg/m2
Vital signs within the following values or ranges:
ECG at screening normal or with no clinically significant findings (pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome are absolute exclusion criteria)
Laboratory examinations within normal reference range or with no clinically significant abnormalities
Absence of any respiratory and flu-like symptoms
Non-pregnant women of childbearing potential, willing to practice a highly effective method of contraception from enrolment up to study completion or at least 90 days after the last vaccination in case of withdrawal
For sexually active men with a female partner of childbearing potential, willingness to use a condom and to refrain from donating sperm from enrolment up to study completion or at least 90 days after the last vaccination in case of withdrawal
Agreement to refrain from blood donation during the course of the study
Able and willing to comply with all study procedures.
Exclusion criteria
History of confirmed infection with SARS-CoV-2, by positive nasopharyngeal swab or by positive serological test for SARS-CoV-2 antibodies
Positive serological test for SARS-CoV-2 antibodies at screening
Subjects at high risk of SARS-CoV-2 infection prior or during the trial, including:
Positive serological tests for:
Subjects with any of the following specific contraindications, even in medical history:
Use of any investigational drugs/treatments, or enrolment in a clinical trial during the 6 months preceding screening
Prior administration of any vaccine in the 2 weeks preceding screening
Administration of any monoclonal or polyclonal antibody product within 4 weeks preceding screening
Administration of any blood product within 3 months of screening
Current or prior administration, within the 6 months preceding screening, of immunosuppressants (inhaled, topical skin and/or eye drop-containing corticosteroids; a short course of corticosteroids, defined as ≤20 mg/day prednisone or equivalent for 10 days, and low-dose methotrexate are allowed until 4 weeks prior to screening)
Any prior major surgery or any chemo- or radiation therapy within 5 years of screening
Current or suspected immunosuppressive or immunodeficient state, including HIV infection, asplenia, recurrent severe infections
Active, known, or suspected autoimmune disease (except mild psoriasis, well-controlled autoimmune thyroid disease, vitiligo or stable coeliac disease not requiring immunosuppressive or immunomodulatory therapy)
Bleeding disorders (e.g. coagulopathy or platelet disorder or coagulation factor deficiency) or prior history of significant bleeding or bruising following IM injections or venipuncture
History of seizures or mental illness
History of allergy to vaccines or of severe allergic reaction of any kind
Metal implants within 20 cm of the planned site(s) of injection
Presence of keloid scar formation or hypertrophic scar, or other clinically significant medical condition at the planned site(s) of injection
Any abnormality or permanent body art (e.g. tattoos) that would interfere with the ability to observe local reactions at the injection site in the deltoid area
History of alcohol or drug abuse during the 12 months preceding the screening
Pregnancy (i.e. positive pregnancy test) or willingness/intention to become pregnant during the study
Breastfeeding
Any other clinically relevant disease and condition that, in the opinion of the Investigator, may jeopardize efficacy or safety assessments or may compromise the subject's safety during trial participation.
Primary purpose
Allocation
Interventional model
Masking
68 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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