Covigenix VAX-002 Vaccine for Coronavirus

(VAX-002-01 Trial)

Recruiting at 4 trial locations

Overseen By Yvonne Bessem, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Entos Pharmaceuticals Inc.

Must not be taking: Immunosuppressants, Cytotoxic, Corticosteroids, others

Disqualifiers: Seizure disorder, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have a stable condition, you must maintain your treatment regimen without elective changes once the trial starts.

What is the purpose of this trial?

Currently, several vaccines are available to combat the COVID-19 pandemic. The persistence of SARS-CoV-2 globally requires the development of additional vaccines to aid in preventing further SARS-CoV-2 infections. Covigenix VAX-002 is a vaccine based off its predecessors VAX-001 and VAX-001-1b. All three are plasmid DNA vaccines that express key antigenic determinants from SARS-CoV-2 and use the Entos Pharmaceuticals' Fusogenix proteo-lipid vehicle (PLV) platform. Currently, the safety and tolerability of VAX-001 and VAX-001-1b for primary vaccination following 1 or 2 doses are being investigated in a Phase 1/2 study (ENTVAX01-101). In Phase 1, VAX-001 was administered to healthy adults on Day 0 and Day 14, as either 2 low doses (100 μg/dose) or 2 high doses (250 μg/dose). Overall, data suggest that VAX-001 is safe at both the low and high dose levels. The Phase 2 part evaluates VAX-001-1b in adults at a 100 μg dose level on a 1-dose and a 2-dose schedule (Days 0 and 28). An interim analysis conducted on data from 18 participants in the sentinel group who had received their first dose of 100 μg showed that VAX-001-1b was overall safe with minor adverse events (AEs) registered. No serious adverse events (SAEs) were reported. After a review of the data, the Data Safety Monitoring Committee (DSMC) provided their recommendations for the participants in the 100 μg dose sentinel group to receive a second dose. The present study investigates the safety and immunogenicity of VAX-002 when given as a booster dose to generally healthy adults aged 18 years or older who have received a primary vaccination course or a booster dose of an authorized COVID-19 vaccine at least 3 months prior to Day 0. VAX-002 was specifically designed to address the new circulating omicron variants of SARS-CoV-2. The study consists of 2 parts: a dose-finding/safety evaluation part (Phase 1) to determine the dose of VAX-002 for booster vaccination (100 μg or 250 μg) followed by an adaptive Phase

Eligibility Criteria

This trial is for generally healthy adults aged 18 or older who have already received a full initial COVID-19 vaccination series or booster at least 3 months before the study. Details on specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

I am over 18 and my BMI is 30 or less.

Generally in good health, as determined by a review of medical history and a physical examination within 14 days prior to IP injection

I am a male and will use contraception for 6 months after treatment.

Exclusion Criteria

I have no conditions that would affect my study participation or understanding of consent.

I haven't taken immunosuppressants, chemotherapy, or steroids in the last 6 months.

I have a bleeding or platelet disorder that may affect getting shots in the muscle.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Dose-Finding/Safety Evaluation

Participants receive a single 0.5 mL IM injection of VAX-002 (100 μg or 250 μg) on Day 0. Follow-up visits occur on Days 7, 14, 17 (phone call visit), 21, 28, 42, and 180.

6 months

7 visits (in-person), 1 visit (phone call)

Phase 2 Adaptive Evaluation

Participants receive a single 0.5 mL IM injection of the optimal VAX-002 dose on Day 0. Follow-up visits occur on Days 7, 14, 17 (phone call visit), 21, 28, 42, and 180.

6 months

7 visits (in-person), 1 visit (phone call)

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 months

Treatment Details

Interventions

• COVIGENIX VAX-002

Trial Overview The trial tests COVIGENIX VAX-002, a plasmid DNA vaccine designed to boost immunity against new omicron variants of SARS-CoV-2. It follows previous studies on similar vaccines (VAX-001 and VAX-001-1b) and aims to find the right dose for boosting.

Participant Groups

Group I: Phase 2 Experimental Treatment 1 Intervention

In Phase 2 approximately 250 participants will be enrolled and will receive a single 0.5 mL IM injection of the optimal VAX-002 dose (determined in the Phase 1 interim analysis) on Day 0. Follow- up visits will occur on Days 7, 14, 17 (phone call visit), 21, 28, 42, and 180.

Group II: Phase 1 Experimental Treatment 1 Intervention

In Phase 1 up to 50 participants are planned to be randomized 1:1 into one of two groups: either 100 μg intramuscular (IM) injection or 250 μg IM injection. Participants are to receive a single 0.5 mL IM injection of VAX-002 100 μg or 250 μg on Day 0. Follow-up visits will occur on Days 7, 14, 17 (phone call visit), 21, 28, 42, and 180. An interim analysis is planned once all participants in Phase 1 have completed their

COVIGENIX VAX-002 is already approved in Canada for the following indications:

Approved in Canada as Covigenix VAX-002 for:

• COVID-19 booster vaccine

Who Is Running the Clinical Trial?

Entos Pharmaceuticals Inc.

Lead Sponsor

Trials

2

Recruited

570+

PCI Pharma Services

Collaborator

Trials

1

Recruited

300+

Calian CRO

Collaborator

Trials

1

Recruited

300+

Q2 Solutions

Industry Sponsor

Trials

15

Recruited

1,600+