Safety and Immunogenicity of COVID-eVax, a Candidate Plasmid DNA Vaccine for COVID-19, in Healthy Adult Volunteers
COVID-19, Protection Against COVID-19 and Infections With SARS-CoV- 2, COVID-19 Immunisation
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring Infections Viral, Coronavirus Disease 2019, Respiratory Tract Infections, Vaccine, SARS-COV-2
Eligibility Criteria
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:
- Body temperature ≤ 37,5 °C
- Pulse frequency ≥51 and ≤100 beats per minute
- Diastolic BP ≥60 mmHg, ≤ 90 mmHg
- Systolic BP ≥ 90 mmHg, ≤ 140 mmHg
- Respiratory rate ≥ 12 breaths per minute, ≤ 16 breaths per minute
- 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:
- subjects with any known exposure in the 4 weeks before enrolment
- close contacts of suspected or confirmed COVID-19 or SARS-CoV-2 infection cases
- subjects quarantined for any reason
- frontline healthcare professionals working in Emergency departments, ICU and other higher risk healthcare areas
Positive serological tests for:
- Hepatitis B surface antigen (HBsAg)
- Hepatitis C antibodies
- Human Immunodeficiency Virus (HIV) antibodies
Subjects with any of the following specific contraindications, even in medical history:
- Type 2 diabetes or glucose intolerance, even if controlled
- Hypertension, even if controlled
- chronic obstructive pulmonary disease (COPD)
- Any cardiac disease, even if not evident at ECG
- Pacemaker
- 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.
Sites / Locations
- San Gerardo Hospital
- Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale
- INMI Lazzaro Spallanzani
- - CRC Centro Ricerche Cliniche di Verona
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
0.5 mg PB
1 mg PB
2 mg PB
2 mg P
0.5 mg PB (Prime-Boost, 4 weeks apart) - Total dose: 1 mg IM injection + electroporation by IGEA Cliniporator® and EPSGun, on Day 1 and Day 29
1 mg PB (Prime-Boost, 4 weeks apart) - Total dose: 2 mg IM injection + electroporation by IGEA Cliniporator® and EPSGun, on Day 1 and Day 29
2 mg PB (Prime-Boost, 4 weeks apart) - Total dose: 4 mg IM injection + electroporation by IGEA Cliniporator® and EPSGun, on Day 1 and Day 29
2 mg P (Prime) - Total dose: 2 mg IM injection + electroporation by IGEA Cliniporator® and EPSGun, on Day 1