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

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ClinicalTrials.gov Identifier: NCT04788459
Recruitment Status : Recruiting
First Posted : March 9, 2021
Last Update Posted : October 5, 2021
Sponsor:
Collaborator:
Rottapharm Biotech
Information provided by (Responsible Party):
Takis

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.


Condition or disease Intervention/treatment Phase
COVID-19 Protection Against COVID-19 and Infections With SARS-CoV- 2 COVID-19 Immunisation Biological: COVID-eVax Device: Cliniporator® and EPSGun Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : February 25, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : September 2022

Arm Intervention/treatment
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

Biological: COVID-eVax
Plasmid DNA Vaccine for COVID-19

Device: Cliniporator® and EPSGun
IGEA Electroporation Device

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

Biological: COVID-eVax
Plasmid DNA Vaccine for COVID-19

Device: Cliniporator® and EPSGun
IGEA Electroporation Device

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

Biological: COVID-eVax
Plasmid DNA Vaccine for COVID-19

Device: Cliniporator® and EPSGun
IGEA Electroporation Device

Experimental: 2 mg P

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

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

Biological: COVID-eVax
Plasmid DNA Vaccine for COVID-19

Device: Cliniporator® and EPSGun
IGEA Electroporation Device




Primary Outcome Measures :
  1. Incidence of solicited local Adverse events (AEs) at the injection site (for Phase 1) [ Time Frame: Through 7 days post-each vaccination ]
  2. Incidence of solicited systemic AEs (for Phase 1) [ Time Frame: Through 7 days post-each vaccination ]
  3. Incidence of unsolicited AEs (for Phase 1) [ Time Frame: through 4 weeks post-each vaccination ]
  4. White Blood Cell (WBC) levels (for Phase 1) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints

  5. Red Blood Cell (RBC) levels (for Phase 1) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints

  6. Platelets levels (for Phase 1) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints

  7. Alanine Transaminase (ALT) levels (for Phase 1) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints

  8. Aspartate Transaminase (AST) levels (for Phase 1) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints

  9. Creatine Phosphokinase (CPK) levels (for Phase 1) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints

  10. 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

  11. SARS-CoV-2 neutralizing antibody titer (for Phase 2) [ Time Frame: through 4 weeks post-last vaccination ]
    GMT and GMFR from baseline

  12. 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

  13. Percentage of subjects who seroconverted (for Phase 2) [ Time Frame: through 4 weeks post-last vaccination ]

Secondary Outcome Measures :
  1. 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

  2. SARS-CoV-2 neutralizing antibody titer (for Phase 1) [ Time Frame: through 4 weeks post-last vaccination ]
    GMT and GMFR from baseline

  3. 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

  4. Percentage of subjects who seroconverted (for Phase 1) [ Time Frame: through 4 weeks post-last vaccination ]
  5. Incidence of unsolicited AEs (for Phase 1) [ Time Frame: through study completion (6 months) ]
  6. Incidence of solicited local AEs at the injection site (for Phase 2) [ Time Frame: Through 7 days post-each vaccination ]
  7. Incidence of solicited systemic AEs (for Phase 2) [ Time Frame: Through 7 days post-each vaccination ]
  8. Incidence of unsolicited AEs (for Phase 2) [ Time Frame: through 4 weeks post-each vaccination ]
  9. White Blood Cell (WBC) levels (for Phase 2) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints

  10. Red Blood Cell (RBC) levels (for Phase 2) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints

  11. Platelets levels (for Phase 2) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints

  12. Alanine Transaminase (ALT) levels (for Phase 2) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints

  13. Aspartate Transaminase (AST) levels (for Phase 2) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints

  14. Creatine Phosphokinase (CPK) levels (for Phase 2) [ Time Frame: through 4 weeks post-each vaccination ]
    Change from baseline at specific timepoints

  15. Incidence of unsolicited AEs (for Phase 2) [ Time Frame: through study completion (6 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04788459


Contacts
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Contact: Luigi Aurisicchio +39 06 50576077 aurisicchio@takisbiotech.it
Contact: Nadia Brambilla +390399066055 nadia.brambilla@rottapharmbiotech.com

Locations
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Italy
San Gerardo Hospital Recruiting
Monza, Italy
Contact: Paolo Bonfanti, MD         
Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale Recruiting
Naples, Italy
Contact: Paolo A Ascierto, MD         
INMI Lazzaro Spallanzani Not yet recruiting
Rome, Italy
Contact: Simone Lanini, MD         
Sponsors and Collaborators
Takis
Rottapharm Biotech
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Responsible Party: Takis
ClinicalTrials.gov Identifier: NCT04788459    
Other Study ID Numbers: COV-1/2-01
2020-003734-20 ( EudraCT Number )
First Posted: March 9, 2021    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takis:
Infections Viral
Coronavirus Disease 2019
Respiratory Tract Infections
Vaccine
SARS-COV-2
Additional relevant MeSH terms:
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Infections
COVID-19
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases