A Clinical Trial of a Prophylactic Plasmid DNA Vaccine for COVID-19 [Covigenix VAX-001] in Adults

NCT04591184 | Completed Phase 1 DMC

• 1 other identifier: ENTVAX01-101
• Study Type: interventional
• Target: 268
• Locations: 4 countries
• Sites: 4

Brief Summary

This study is a Phase I/II clinical study in healthy adults designed to assess the safety, tolerability, and immunogenicity of receiving 2 IM injections of Covigenix VAX-001/-1b, 28 days apart. Covigenix VAX-001/-1b is a plasmid DNA vaccine that expresses key antigenic determinants from SARS-CoV-2 and uses Entos Pharmaceuticals' Fusogenix PLV platform. The phase I part of this study was completed in Canada. The phase II part of the study will be completed in Burkina Faso, Senegal and South Africa.

Conditions

SARS-CoV-2

Keywords

COVID-19; SARS-CoV-2; anti-infective; prophylaxis; healthy volunteer; prevention; Covigenix VAX-001

Outcome Measures

Primary Outcomes (3)

• Safety of a 2-dose regimen of VAX-001 when doses are given 14 days apart

  Frequency and Grade (mild, moderate, severe, potentially life-threatening; Gr. 1-4, respectively) of solicited injection site and systemic adverse events and unsolicited systemic adverse events

  Day 0 - 42

• Mean change from baseline in safety laboratory measures

  Adverse hematology /clinical chemistry parameter changes (mild, moderate, severe, or life-threatening; Gr. 1-4, respectively)

  Day 0 - 42

• Frequency of treatment-emergent Serious Adverse Events (SAE) throughout the study and up to 12 months post-second dose immunization (Day 379).

  Frequency of serious AEs

  Day 0 - 379

Secondary Outcomes (4)

• Percent seroconversion defined as a 4-fold or greater increase in IgG titers after one or two doses as measured by IgG ELISA

  Up to Day 379

• Geometric mean neutralizing antibody titers against pseudo-virion after one and two doses

  Up to Day 379

• Percent seroconversion defined as a 4-fold or greater increase in IgG titers after one or two doses as measured by pseudo-viral neutralization assay.

  up to Day 379

• Persistence of IgG antibody titers as measured by ELISA and neutralizing antibody titers measured by pseudo-virion neutralization assay, six months after the second vaccine dose

  Up to Day 379

Study Arms (2)

Active Covigenix VAX-001

EXPERIMENTAL

Dose-ranging, 2 dose levels. 24 subjects receiving active i.m. vaccine

Biological: Covigenix VAX-001

Placebo

PLACEBO COMPARATOR

Placebo injection. 12 subjects receiving placebo

Biological: Covigenix VAX-001 placebo

Interventions

Covigenix VAX-001 placebo BIOLOGICAL

Placebo vaccine

Placebo

Covigenix VAX-001 BIOLOGICAL

Active Covigenix VAX-001

Active Covigenix VAX-001

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each participant must meet all of the following criteria to be enrolled in the Phase 1 part of the study:
• The participant is a healthy adult from 18 \<55 years and with a BMI of ≤30 kg/m2 at the time of enrollment.
• If the participant is a WOCBP, she must have practiced adequate contraception for 30 days prior to IP Dose 1, have a negative pregnancy test on the day of IP Dose 1, and have agreed to continue adequate contraception until 90 days after IP Dose 2.
• If the participant is male, he must agree to continue adequate contraception until 90 days after IP Dose 2.
• The participant is able to provide consent to participate in the study and has signed an ICF.
• The participant is able and willing to complete all the scheduled study procedures during the whole study period (approximately 13 months).
• The participant is generally in good health, as determined by a review of medical history and a physical examination within 14 days prior to IP Dose 1.
• Each participant must meet all of the following criteria to be enrolled in Phase II part of the study:
• The participant is 18 years and older.
• If the participant is a WOCBP, she must have a negative pregnancy test on the day of IP Dose 1, and have agreed to adequate contraception until 90 days after IP Dose 2 administration.
• If the participant is male, he must agree to continue adequate contraception until 90 days after IP Dose 2
• The participant can provide consent to participate in and having signed an ICF.
• The participant is able and willing to complete all the scheduled study procedures during the whole study follow-up period (approximately 13 months).

You may not qualify if:

• Participants meeting any of the following criteria will be excluded from Phase I of the study:
• The participant has history of anaphylaxis to any allergen.
• The participant has history of seizure disorder, encephalopathy or psychosis.
• The female participant is pregnant (positive urine pregnancy test), lactating, or plans to become pregnant during the 3 months of enrollment.
• The participant has a positive test result for HIV or hepatitis B and C.
• The participant has a positive test results of IgG antibodies against SARS CoV 2 from RCT.
• The participant has a positive test result of real-time quantitative PCR screening of nasopharyngeal swab/sputum for SARS-CoV-2.
• The participant has a laboratory (hematological and biochemistry) examination that is out of normal range, or greater than a Grade 1 abnormality and clinically significant as assessed by the investigator including test results for: CBC, PT, PTT, ALT, AST, ALP, T Bil, Cr, lipase, and blood glucose;
• \- Transient mild laboratory abnormalities may be rescreened once, and the participant will be excluded if the laboratory repeat test is abnormal as per local laboratory normal values and the investigator's assessment.
• The participant presents with any acute febrile disease (oral temperature ≥38.0°C) or active infectious disease.
• The participant has a medical history of SARS-CoV-1.
• The participant has unstable concomitant underlying conditions.
• \- Note: Stable condition defined as: The participant is appropriately managed on consistent disease management, for example participants with well controlled hypertension, adult-onset diabetes, Benign Prostate Hypertrophy (BPH) or hypothyroid disease will be eligible for enrollment. The treatment regimen should be stable for at least 3 months prior to entering the study. Once IP treatment has started, must be willing to maintain all aspects of the treatment regimen and forgo any elective changes in medication or management. Emergency changes in medication or management would be captured as an adverse event.
• The participant has a history of Guillain-Barre Syndrome or degenerative neurological disorders; a history of autoimmune, inflammatory disease or potential immune-mediated medical conditions (PIMMCs), or any condition that may put the participant at increased risk of safety events
• The participant has serious cardiovascular diseases, such as arrhythmia, conduction block, history of myocardial infarction, severe hypertension not controlled with medication.

Sponsors & Collaborators

• Entos Pharmaceuticals Inc.: lead
• Aegis Life, Inc.: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Clinical Pharma Solutions Inc: collaborator
• Centre national de recherche et de formation sur le paludisme (CNRFP): collaborator

Study Sites (4)

National Center for Research and Training on Malaria

Ouagadougou, Burkina Faso

Location

Canadian Centre for Vaccinology, Dalhousie University

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Institute for Health Research, Epidemiological Surveillance and Training (IRESSEF)

Dakar, Senegal

Location

FARMOVS (PTY) Ltd.

Bloemfontein, 9301, South Africa

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Joakem Tazanu Fossung

  Clinical Pharma Solutions

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Unblinded study nurse with no other role in the trial administers VAX-001. Observer blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 19, 2020
• Study Start: April 7, 2021
• Primary Completion: December 6, 2023
• Study Completion: December 6, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1); CA (1); SE (1); ZA (1)