COVID-19Phase 1/2NCT04788459

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

A Phase 1/2 study testing COVID-eVax and Cliniporator® and EPSGun in people with COVID-19 and Protection Against COVID-19 and Infections With SARS-CoV- 2, run by Takis at 4 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19, Protection Against COVID-19 and Infections With SARS-CoV- 2, COVID-19 Immunisation
What is being tested?: COVID-eVax and Cliniporator® and EPSGun
Type of treatment: Vaccines, Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 4 sitesItaly
Study dates: 25 Feb 2021to 7 Dec 2021
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Show all 16Show fewer

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.

Who cannot join

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

Show all 35Show fewer

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.

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

San Gerardo Hospital
Monza
Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale
Naples
INMI Lazzaro Spallanzani
Rome
- CRC Centro Ricerche Cliniche di Verona
Verona

Other trials in Italy

About this study

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

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.

Conditions: COVID-19, Protection Against COVID-19 and Infections With SARS-CoV- 2, COVID-19 Immunisation
Being tested: COVID-eVax, Cliniporator® and EPSGun
Keywords: Infections Viral, Coronavirus Disease 2019, Respiratory Tract Infections, Vaccine, SARS-COV-2
Medical subject headings: COVID-19, Virus Diseases, Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

COVID-eVaxBiological
Plasmid DNA Vaccine for COVID-19
Cliniporator® and EPSGunDevice
IGEA Electroporation Device

Study groups in NCT04788459
Study group	Role	What they receive
0.5 mg PB	Experimental	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 Receives: Biological: COVID-eVax; Device: Cliniporator® and EPSGun
1 mg PB	Experimental	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 Receives: Biological: COVID-eVax; Device: Cliniporator® and EPSGun
2 mg PB	Experimental	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 Receives: Biological: COVID-eVax; Device: Cliniporator® and EPSGun
2 mg P	Experimental	2 mg P (Prime) - Total dose: 2 mg IM injection + electroporation by IGEA Cliniporator® and EPSGun, on Day 1 Receives: Biological: COVID-eVax; Device: Cliniporator® and EPSGun

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of solicited local Adverse events (AEs) at the injection site (for Phase 1)
Measured: Through 7 days post-each vaccination
Incidence of solicited systemic AEs (for Phase 1)
Measured: Through 7 days post-each vaccination
Incidence of unsolicited AEs (for Phase 1)
Measured: through 4 weeks post-each vaccination
White Blood Cell (WBC) levels (for Phase 1)
Change from baseline at specific timepoints
Measured: through 4 weeks post-each vaccination
Red Blood Cell (RBC) levels (for Phase 1)
Change from baseline at specific timepoints
Measured: through 4 weeks post-each vaccination
Platelets levels (for Phase 1)
Change from baseline at specific timepoints
Measured: through 4 weeks post-each vaccination
Alanine Transaminase (ALT) levels (for Phase 1)
Change from baseline at specific timepoints
Measured: through 4 weeks post-each vaccination
Aspartate Transaminase (AST) levels (for Phase 1)
Change from baseline at specific timepoints
Measured: through 4 weeks post-each vaccination
Creatine Phosphokinase (CPK) levels (for Phase 1)
Change from baseline at specific timepoints
Measured: through 4 weeks post-each vaccination
Quantitative antibody titers, binding to the specific SARS-CoV-2 antigen (for Phase 2)
Geometric Mean Titer (GMT) and Geometric Mean Fold Rise (GMFR) from baseline
Measured: through 4 weeks post-last vaccination
SARS-CoV-2 neutralizing antibody titer (for Phase 2)
GMT and GMFR from baseline
Measured: through 4 weeks post-last vaccination
Change from baseline in antigen-specific cellular immune responses to SARS-CoV-2 (for Phase 2)
Interferon-gamma (IFN-γ) ELISpot
Measured: through 4 weeks post-last vaccination
Percentage of subjects who seroconverted (for Phase 2)
Measured: through 4 weeks post-last vaccination

Secondary outcomes (15)

Quantitative antibody titers, binding to the specific SARS-CoV-2 antigen (for Phase 1)
GMT and GMFR from baseline
Measured: through 4 weeks post-last vaccination
SARS-CoV-2 neutralizing antibody titer (for Phase 1)
GMT and GMFR from baseline
Measured: through 4 weeks post-last vaccination
Change from baseline in antigen-specific cellular immune responses to SARS-CoV-2 (for Phase 1)
Interferon-gamma (IFN-γ) ELISpot
Measured: through 4 weeks post-last vaccination
Percentage of subjects who seroconverted (for Phase 1)
Measured: through 4 weeks post-last vaccination
Incidence of unsolicited AEs (for Phase 1)
Measured: through study completion (6 months)
Incidence of solicited local AEs at the injection site (for Phase 2)
Measured: Through 7 days post-each vaccination
Incidence of solicited systemic AEs (for Phase 2)
Measured: Through 7 days post-each vaccination
Incidence of unsolicited AEs (for Phase 2)
Measured: through 4 weeks post-each vaccination
White Blood Cell (WBC) levels (for Phase 2)
Change from baseline at specific timepoints
Measured: through 4 weeks post-each vaccination
Red Blood Cell (RBC) levels (for Phase 2)
Change from baseline at specific timepoints
Measured: through 4 weeks post-each vaccination
Platelets levels (for Phase 2)
Change from baseline at specific timepoints
Measured: through 4 weeks post-each vaccination
Alanine Transaminase (ALT) levels (for Phase 2)
Change from baseline at specific timepoints
Measured: through 4 weeks post-each vaccination
Aspartate Transaminase (AST) levels (for Phase 2)
Change from baseline at specific timepoints
Measured: through 4 weeks post-each vaccination
Creatine Phosphokinase (CPK) levels (for Phase 2)
Change from baseline at specific timepoints
Measured: through 4 weeks post-each vaccination
Incidence of unsolicited AEs (for Phase 2)
Measured: through study completion (6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Feb 20217 Dec 2021

First posted9 Mar 2021
Study start25 Feb 2021
Primary completion7 Dec 2021
Study completion7 Dec 2021

Why it stopped: The good progress of the Italian national vaccination campaign against COVID-19 made impossible to complete the study as planned.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04788459
Sponsor's protocol ID: COV-1/2-01
Other IDs: 2020-003734-20
Status last verified: Dec 2021
First submitted: 1 Mar 2021
Last updated: 29 Mar 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04788459
Acronym / sponsor ID: COV-1/2-01
Conditions: COVID-19, Protection Against COVID-19 and Infections With SARS-CoV- 2, COVID-19 Immunisation
Keywords: Infections Viral, Coronavirus Disease 2019, Respiratory Tract Infections, Vaccine, SARS-COV-2
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The good progress of the Italian national vaccination campaign against COVID-19 made impossible to complete the study as planned.
Enrolment: 68 participants (actual)
Lead sponsor: TakisIndustry (pharma, biotech, devices)
Collaborators: Rottapharm Biotech
Study start: 25 Feb 2021 (actual)
Primary completion: 7 Dec 2021 (actual)
Study completion: 7 Dec 2021 (actual)
First posted: 9 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

In animal models COVID-eVax was safe and induced high immunological humoral and cellular response.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
0.5 mg PB	Experimental	Biological: COVID-eVax, Device: Cliniporator® and EPSGun0.5 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	Experimental	Biological: COVID-eVax, Device: Cliniporator® and EPSGun1 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	Experimental	Biological: COVID-eVax, Device: Cliniporator® and EPSGun2 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	Experimental	Biological: COVID-eVax, Device: Cliniporator® and EPSGun2 mg P (Prime) - Total dose: 2 mg IM injection + electroporation by IGEA Cliniporator® and EPSGun, on Day 1

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

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:
ECG at screening normal or with no clinically significant findings (pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome are absolute exclusion criteria)

Key exclusion criteria (35 listed)

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:
Positive serological tests for:
Subjects with any of the following specific contraindications, even in medical history:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
COVID-eVaxPlasmid DNA Vaccine for COVID-19	Biological	0.5 mg PB, 1 mg PB, 2 mg P, 2 mg PB
Cliniporator® and EPSGunIGEA Electroporation Device	Device	0.5 mg PB, 1 mg PB, 2 mg P, 2 mg PB

Primary outcome

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

15 secondary outcomes

Quantitative antibody titers, binding to the specific SARS-CoV-2 antigen (for Phase 1)
Time frame: through 4 weeks post-last vaccination
SARS-CoV-2 neutralizing antibody titer (for Phase 1)
Time frame: through 4 weeks post-last vaccination
Change from baseline in antigen-specific cellular immune responses to SARS-CoV-2 (for Phase 1)
Time frame: through 4 weeks post-last vaccination
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
Red Blood Cell (RBC) levels (for Phase 2)
Time frame: through 4 weeks post-each vaccination
Platelets levels (for Phase 2)
Time frame: through 4 weeks post-each vaccination
Alanine Transaminase (ALT) levels (for Phase 2)
Time frame: through 4 weeks post-each vaccination
Aspartate Transaminase (AST) levels (for Phase 2)
Time frame: through 4 weeks post-each vaccination
Creatine Phosphokinase (CPK) levels (for Phase 2)
Time frame: through 4 weeks post-each vaccination
Incidence of unsolicited AEs (for Phase 2)
Time frame: through study completion (6 months)

Results and safety

The study was stopped early (reason given: The good progress of the Italian national vaccination campaign against COVID-19 made impossible to complete the study as planned.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing COVID-eVax and Cliniporator® and EPSGun in people with COVID-19 and Protection Against COVID-19 and Infections With SARS-CoV- 2, run by Takis at 4 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of solicited local Adverse events (AEs) at the injection site (for Phase 1) (time frame: Through 7 days post-each vaccination). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04788459.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.