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

NCT04788459 | Terminated Phase 1 DMC

• 2 other identifiers: COV-1/2-012020-003734-20
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (13)

• 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)

  Change from baseline at specific timepoints

  through 4 weeks post-each vaccination

• Red Blood Cell (RBC) levels (for Phase 1)

  Change from baseline at specific timepoints

  through 4 weeks post-each vaccination

• Platelets levels (for Phase 1)

  Change from baseline at specific timepoints

  through 4 weeks post-each vaccination

• Alanine Transaminase (ALT) levels (for Phase 1)

  Change from baseline at specific timepoints

  through 4 weeks post-each vaccination

• Aspartate Transaminase (AST) levels (for Phase 1)

  Change from baseline at specific timepoints

  through 4 weeks post-each vaccination

• Creatine Phosphokinase (CPK) levels (for Phase 1)

  Change from baseline at specific timepoints

  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

  through 4 weeks post-last vaccination

• SARS-CoV-2 neutralizing antibody titer (for Phase 2)

  GMT and GMFR from baseline

  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

  through 4 weeks post-last vaccination

• Percentage of subjects who seroconverted (for Phase 2)

  through 4 weeks post-last vaccination

Secondary Outcomes (15)

• Quantitative antibody titers, binding to the specific SARS-CoV-2 antigen (for Phase 1)

  through 4 weeks post-last vaccination

• SARS-CoV-2 neutralizing antibody titer (for Phase 1)

  through 4 weeks post-last vaccination

• Change from baseline in antigen-specific cellular immune responses to SARS-CoV-2 (for Phase 1)

  through 4 weeks post-last vaccination

• 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)

Study Arms (4)

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

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

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

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

Biological: COVID-eVax; Device: Cliniporator® and EPSGun

Interventions

COVID-eVax BIOLOGICAL

Plasmid DNA Vaccine for COVID-19

0.5 mg PB; 1 mg PB; 2 mg P; 2 mg PB

Cliniporator® and EPSGun DEVICE

IGEA Electroporation Device

0.5 mg PB; 1 mg PB; 2 mg P; 2 mg PB

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Diastolic BP ≥60 mmHg, ≤ 90 mmHg
• Systolic BP ≥ 90 mmHg, ≤ 140 mmHg
• Respiratory rate ≥ 12 breaths per minute, ≤ 16 breaths per minute

You may not qualify if:

• 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.
• 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
• frontline healthcare professionals working in Emergency departments, ICU and other higher risk healthcare areas
• Positive serological tests for:
• Hepatitis B surface antigen (HBsAg)

Sponsors & Collaborators

• Takis: lead
• Rottapharm Biotech: collaborator

Study Sites (4)

San Gerardo Hospital

Monza, Italy

Location

Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale

Naples, Italy

Location

INMI Lazzaro Spallanzani

Rome, Italy

Location

- CRC Centro Ricerche Cliniche di Verona

Verona, Italy

Location

MeSH Terms

Conditions

COVID-19; Virus Diseases; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 9, 2021
• Study Start: February 25, 2021
• Primary Completion: December 7, 2021
• Study Completion: December 7, 2021
• Last Updated: March 29, 2023

Record last verified: 2021-12

Locations

IT (4)