COVID-19 prevention. MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: COVID-eVax Solution for Injection
Product Code: [COVID-eVax]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: COVID-eVax
Current Sponsor code: COVID-eVax
Concentration un
Sponsors
Takis S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent obtained before undergoing any study-specific procedure 2. Healthy male or female aged =18 and = 65 years 3. Body Mass Index >18.5 and =30 kg/m2 4. Vital signs within the following values or ranges: a. Body temperature = 37,5 °C b. Pulse frequency =51 and =100 beats per minute c. Diastolic BP =60 mmHg, = 90 mmHg d. Systolic BP = 90 mmHg, = 140 mmHg e. Respiratory rate = 12 breaths per minute, = 16 breaths per minute 5. ECG at screening normal or with no clinically significant findings (pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome are absolute exclusion criteria) 6. Laboratory examinations within normal reference range or with no clinically significant abnormalities 7. Absence of any respiratory and flu-like symptoms 8. 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 9. 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 10. Agreement to refrain from blood donation during the course of the study 11. Able and willing to comply with all study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 152 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 1. History of confirmed infection with SARS-CoV-2, by positive nasopharingeal swab or by positive serological test for SARS-CoV-2 antibodies 2. Positive serological test for SARS-CoV-2 antibodies at screening 3. Subjects at high risk of SARS-CoV-2 infection prior or during the trial, including: a. subjects with any known exposure in the 4 weeks before enrolment b. close contacts of suspected or confirmed COVID-19 or SARS-CoV-2 infection cases c. subjects quarantined for any reason d. frontline healthcare professionals working in Emergency departments, ICU and other higher risk healthcare areas 4. Positive serological tests for: a. Hepatitis B surface antigen (HBsAg) b. Hepatitis C antibodies c. Human Immunodeficiency Virus (HIV) antibodies 5. Subjects with any of the following specific contraindications, even in medical history: a. Type 2 diabetes or glucose intolerance, even if controlled b. Hypertension, even if controlled c. COPD d. Any cardiac disease, even if not evident at ECG e. Pacemaker 6. Use of any investigational drugs/treatments, or enrolment in a clinical trial during the 6 months preceding screening 7. Prior administration of any vaccine in the 2 weeks preceding screening 8. Administration of any monoclonal or polyclonal antibody product within 4 weeks preceding screening 9. Administration of any blood product within 3 months of screening 10. 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) 11. Any prior major surgery or any chemio- or radiation therapy within 5 years of screening 12. Current or suspected immunosuppressive or immunodeficient state, including HIV infection, asplenia, recurrent severe infections 13. Active, known, or suspected autoimmune disease (except mild psoriasis, wellcontrolled autoimmune thyroid disease, vitiligo or stable coeliac disease not requiring immunosuppressive or immunomodulatory therapy) 14. 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 15. History of seizures or mental illness 16. History of allergy to vaccines or of severe allergic reaction of any kind 17. Metal implants within 20 cm of the planned site(s) of injection 18. Presence of keloid scar formation or hypertrophic scar, or other clinically significant medical condition at the planned site(s) of injection 19. 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 20. History of alcohol or drug abuse during the 12 months preceding the screening 21. Pregnancy (i.e. positive pregnancy test) or willingness/intention to become pregnant during the study 22. Breastfeeding 23. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I (Dose Escalation): - To assess the safety and reactogenicity of the candidate vaccine COVID-eVax in healthy adult volunteers - To identify the dose(s)/schedule(s) to be used in the Phase II (Dose Expansion) Phase II (Dose Expansion): - To assess the immunogenicity of the selected dose(s)/schedule(s) of the candidate vaccine COVID-eVax in healthy adult volunteers;Secondary Objective: Phase I (Dose Escalation): - To preliminarily assess the immunogenicity of the candidate vaccine COVIDeVax in healthy adult volunteers Phase II (Dose Expansion): - To assess the duration of the immune response of the selected dose(s)/schedule(s) of the candidate vaccine COVID-eVax in healthy adult volunteers - To assess the (long-term post-administration) safety of the candidate vaccine COVID-eVax in healthy adult volunteers;Primary end point(s): Phase I (Dose Escalation): - Incidence of solicited local AEs at the injection site and solicited systemic AEs. - Incidence of unsolicited AEs and changes in safety laboratory parameters. Phase II (Dose Expansion): - See secondary immunogenicity endpoints evaluated through 4 weeks post-last vaccination described for Phase I. In both study Phases, all primary and secondary endpoints will also be assessed in the time frame through study completion (6 months).;Timepoint(s) of evaluation of this end point: Phase I (Dose Escalation): - Through 7 days post-each vaccination - Through 4 weeks post-each vaccination Phase II (Dose Expansion): - Through 4 weeks post-each vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Phase I (Dose Escalation): 1. Through 4 weeks post-each vaccination 2. Through 4 weeks post-each vaccination 3. Through 4 weeks post-each vaccination 4. Through study completion (6 months) 5. Through study completion (6 months) Phase II (Dose Expansion): 1. Through study completion (6 months) 2. Through study completion (6 months);Secondary end point(s): Phase I (Dose Escalation): 1. Quantitative antibody titers, binding to the specific SARS-CoV-2 antigen and SARS-CoV-2 neutralizing antibody titer (Geometric Mean Titer (GMT) and Geometric Mean Fold Rise (GMFR). 2. Change in antigen-specific cellular immune responses to SARSCoV-2. 3. Percentage of subjects who seroconverted. 4. Duration of the immune response on all criteria and parameters. 5. Incidence of unsolicited AEs. Phase II (Dose Expansion): See primary endpoints described for Phase I. 1. Duration of the immune response on all criteria and parameters. 2. Incidence of unsolicited AEs. | — |
Countries
Italy
Contacts
Public ContactDipartimento Medico
OPIS s.r.l.
Outcome results
None listed