COVID-19, COVID-19 Immunisation, Protection Against COVID-19 and Infections With SARS-CoV- 2
Conditions
Keywords
Infections Viral, Coronavirus Disease 2019, Respiratory Tract Infections, Vaccine, SARS-COV-2
Brief summary
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.
Interventions
BIOLOGICALCOVID-eVax
Plasmid DNA Vaccine for COVID-19
DEVICECliniporator® and EPSGun
IGEA Electroporation Device
Sponsors
Rottapharm Biotech
Takis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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: 1. Body temperature ≤ 37,5 °C 2. Pulse frequency ≥51 and ≤100 beats per minute 3. Diastolic BP ≥60 mmHg, ≤ 90 mmHg 4. Systolic BP ≥ 90 mmHg, ≤ 140 mmHg 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of solicited local Adverse events (AEs) at the injection site (for Phase 1) | Through 7 days post-each vaccination | — |
| Incidence of solicited systemic AEs (for Phase 1) | Through 7 days post-each vaccination | — |
| Incidence of unsolicited AEs (for Phase 1) | through 4 weeks post-each vaccination | — |
| White Blood Cell (WBC) levels (for Phase 1) | through 4 weeks post-each vaccination | Change from baseline at specific timepoints |
| Red Blood Cell (RBC) levels (for Phase 1) | through 4 weeks post-each vaccination | Change from baseline at specific timepoints |
| Platelets levels (for Phase 1) | through 4 weeks post-each vaccination | Change from baseline at specific timepoints |
| Alanine Transaminase (ALT) levels (for Phase 1) | through 4 weeks post-each vaccination | Change from baseline at specific timepoints |
| Aspartate Transaminase (AST) levels (for Phase 1) | through 4 weeks post-each vaccination | Change from baseline at specific timepoints |
| Creatine Phosphokinase (CPK) levels (for Phase 1) | through 4 weeks post-each vaccination | Change from baseline at specific timepoints |
| Quantitative antibody titers, binding to the specific SARS-CoV-2 antigen (for Phase 2) | through 4 weeks post-last vaccination | Geometric Mean Titer (GMT) and Geometric Mean Fold Rise (GMFR) from baseline |
| SARS-CoV-2 neutralizing antibody titer (for Phase 2) | through 4 weeks post-last vaccination | GMT and GMFR from baseline |
| Change from baseline in antigen-specific cellular immune responses to SARS-CoV-2 (for Phase 2) | through 4 weeks post-last vaccination | Interferon-gamma (IFN-γ) ELISpot |
| Percentage of subjects who seroconverted (for Phase 2) | through 4 weeks post-last vaccination | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative antibody titers, binding to the specific SARS-CoV-2 antigen (for Phase 1) | through 4 weeks post-last vaccination | GMT and GMFR from baseline |
| Creatine Phosphokinase (CPK) levels (for Phase 2) | through 4 weeks post-each vaccination | Change from baseline at specific timepoints |
| SARS-CoV-2 neutralizing antibody titer (for Phase 1) | through 4 weeks post-last vaccination | GMT and GMFR from baseline |
| Change from baseline in antigen-specific cellular immune responses to SARS-CoV-2 (for Phase 1) | through 4 weeks post-last vaccination | Interferon-gamma (IFN-γ) ELISpot |
| Percentage of subjects who seroconverted (for Phase 1) | through 4 weeks post-last vaccination | — |
| Incidence of unsolicited AEs (for Phase 1) | through study completion (6 months) | — |
| Incidence of solicited local AEs at the injection site (for Phase 2) | Through 7 days post-each vaccination | — |
| Incidence of solicited systemic AEs (for Phase 2) | Through 7 days post-each vaccination | — |
| Incidence of unsolicited AEs (for Phase 2) | through 4 weeks post-each vaccination | — |
| White Blood Cell (WBC) levels (for Phase 2) | through 4 weeks post-each vaccination | Change from baseline at specific timepoints |
| Red Blood Cell (RBC) levels (for Phase 2) | through 4 weeks post-each vaccination | Change from baseline at specific timepoints |
| Platelets levels (for Phase 2) | through 4 weeks post-each vaccination | Change from baseline at specific timepoints |
| Alanine Transaminase (ALT) levels (for Phase 2) | through 4 weeks post-each vaccination | Change from baseline at specific timepoints |
| Aspartate Transaminase (AST) levels (for Phase 2) | through 4 weeks post-each vaccination | Change from baseline at specific timepoints |
Countries
Italy
Outcome results
None listed