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Safety and Immunogenicity of COVID-eVax, a Candidate Plasmid DNA Vaccine for COVID-19, in Healthy Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04788459
Recruitment Status : Active, not recruiting
First Posted : March 9, 2021
Last Update Posted : December 21, 2021
Sponsor:
Collaborator:
Rottapharm Biotech
Information provided by (Responsible Party):
Takis

Tracking Information
First Submitted Date  ICMJE March 1, 2021
First Posted Date  ICMJE March 9, 2021
Last Update Posted Date December 21, 2021
Actual Study Start Date  ICMJE February 25, 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2021)
  • Incidence of solicited local Adverse events (AEs) at the injection site (for Phase 1) [ Time Frame: Through 7 days post-each vaccination ]
  • Incidence of solicited systemic AEs (for Phase 1) [ Time Frame: Through 7 days post-each vaccination ]
  • Incidence of unsolicited AEs (for Phase 1) [ Time Frame: through 4 weeks post-each vaccination ]
  • White Blood Cell (WBC) levels (for Phase 1) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints
  • Red Blood Cell (RBC) levels (for Phase 1) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints
  • Platelets levels (for Phase 1) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints
  • Alanine Transaminase (ALT) levels (for Phase 1) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints
  • Aspartate Transaminase (AST) levels (for Phase 1) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints
  • Creatine Phosphokinase (CPK) levels (for Phase 1) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: through 4 weeks post-last vaccination ]
    Interferon-gamma (IFN-γ) ELISpot
  • Percentage of subjects who seroconverted (for Phase 2) [ Time Frame: through 4 weeks post-last vaccination ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2021)
  • Quantitative antibody titers, binding to the specific SARS-CoV-2 antigen (for Phase 1) [ Time Frame: through 4 weeks post-last vaccination ]
    GMT and GMFR from baseline
  • SARS-CoV-2 neutralizing antibody titer (for Phase 1) [ Time Frame: 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) [ Time Frame: through 4 weeks post-last vaccination ]
    Interferon-gamma (IFN-γ) ELISpot
  • Percentage of subjects who seroconverted (for Phase 1) [ Time Frame: through 4 weeks post-last vaccination ]
  • Incidence of unsolicited AEs (for Phase 1) [ Time Frame: through study completion (6 months) ]
  • Incidence of solicited local AEs at the injection site (for Phase 2) [ Time Frame: Through 7 days post-each vaccination ]
  • Incidence of solicited systemic AEs (for Phase 2) [ Time Frame: Through 7 days post-each vaccination ]
  • Incidence of unsolicited AEs (for Phase 2) [ Time Frame: through 4 weeks post-each vaccination ]
  • White Blood Cell (WBC) levels (for Phase 2) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints
  • Red Blood Cell (RBC) levels (for Phase 2) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints
  • Platelets levels (for Phase 2) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints
  • Alanine Transaminase (ALT) levels (for Phase 2) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints
  • Aspartate Transaminase (AST) levels (for Phase 2) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints
  • Creatine Phosphokinase (CPK) levels (for Phase 2) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints
  • Incidence of unsolicited AEs (for Phase 2) [ Time Frame: through study completion (6 months) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity of COVID-eVax, a Candidate Plasmid DNA Vaccine for COVID-19, in Healthy Adult Volunteers
Official Title  ICMJE A Phase I/II Study to Assess the Safety and Immunogenicity of COVID-eVax, a Candidate Plasmid DNA Vaccine for COVID-19, in Healthy Adult Volunteers
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • COVID-19
  • Protection Against COVID-19 and Infections With SARS-CoV- 2
  • COVID-19 Immunisation
Intervention  ICMJE
  • Biological: COVID-eVax
    Plasmid DNA Vaccine for COVID-19
  • Device: Cliniporator® and EPSGun
    IGEA Electroporation Device
Study Arms  ICMJE
  • Experimental: 0.5 mg PB

    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

    Interventions:
    • Biological: COVID-eVax
    • Device: Cliniporator® and EPSGun
  • Experimental: 1 mg PB

    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

    Interventions:
    • Biological: COVID-eVax
    • Device: Cliniporator® and EPSGun
  • Experimental: 2 mg PB

    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

    Interventions:
    • Biological: COVID-eVax
    • Device: Cliniporator® and EPSGun
  • Experimental: 2 mg P

    2 mg P (Prime) - Total dose: 2 mg

    IM injection + electroporation by IGEA Cliniporator® and EPSGun, on Day 1

    Interventions:
    • Biological: COVID-eVax
    • Device: Cliniporator® and EPSGun
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 5, 2021)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Exclusion Criteria:

  1. History of confirmed infection with SARS-CoV-2, by positive nasopharyngeal 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:

    1. subjects with any known exposure in the 4 weeks before enrolment
    2. close contacts of suspected or confirmed COVID-19 or SARS-CoV-2 infection cases
    3. subjects quarantined for any reason
    4. frontline healthcare professionals working in Emergency departments, ICU and other higher risk healthcare areas
  4. Positive serological tests for:

    1. Hepatitis B surface antigen (HBsAg)
    2. Hepatitis C antibodies
    3. Human Immunodeficiency Virus (HIV) antibodies
  5. Subjects with any of the following specific contraindications, even in medical history:

    1. Type 2 diabetes or glucose intolerance, even if controlled
    2. Hypertension, even if controlled
    3. chronic obstructive pulmonary disease (COPD)
    4. Any cardiac disease, even if not evident at ECG
    5. 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 chemo- 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, well-controlled 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04788459
Other Study ID Numbers  ICMJE COV-1/2-01
2020-003734-20 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Takis
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Takis
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Rottapharm Biotech
Investigators  ICMJE Not Provided
PRS Account Takis
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP