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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new COVID-19 booster, COVIGENIX VAX-002, designed to target the omicron variants. The main goal is to assess the safety and effectiveness of this booster for individuals who received a COVID-19 vaccine or booster at least three months prior. The trial consists of two parts: the first determines the optimal dose, and the second evaluates the chosen dose. Individuals who are generally healthy, have received a COVID-19 vaccine or booster, and have no history of severe allergies or certain medical conditions may qualify. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that Covigenix VAX-002 is likely to be safe for humans?

Research has shown that the Covigenix VAX-001 vaccine and its variant, VAX-001-1b, have been safe in ongoing studies. In one study, adults received either low or high doses of VAX-001, and the results indicated safety at both levels. Participants mostly experienced only minor side effects, such as mild soreness or tiredness, with no serious side effects reported.

For VAX-001-1b, an early review of participants who received a 100 microgram dose demonstrated it was generally safe. Like VAX-001, only minor side effects were noted, and importantly, no serious side effects occurred. Based on these findings, the safety committee recommended continuing with the second dose in the trial.

VAX-002, the vaccine currently under study, builds on this previous work. While specific data on VAX-002 is not yet available, it is developed using a similar method to VAX-001 and VAX-001-1b, which have been well-tolerated so far. This background offers some confidence in its safety as the trial explores its use as a booster. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the Covigenix VAX-002 vaccine because it offers a new approach to COVID-19 prevention. Unlike traditional vaccines that often rely on inactivated viruses or protein subunits, VAX-002 uses a novel, potentially more effective method that could enhance immune response. Additionally, its administration as a single intramuscular injection may simplify the vaccination process compared to multidoses required by some other vaccines. This streamlined delivery, along with its novel formulation, could make VAX-002 a promising addition to our arsenal against coronavirus.

What evidence suggests that Covigenix VAX-002 might be an effective booster for COVID-19?

Studies have shown that Covigenix VAX-001 and VAX-001-1b, the earlier versions of VAX-002, were generally safe in early trials, with no serious side effects reported. These vaccines use plasmid DNA, which instructs cells to produce a part of the virus, aiding the immune system in recognizing and combating it. Initial findings suggest that VAX-002, the investigational vaccine in this trial, targets the omicron variants of COVID-19, which are currently widespread. Animal studies have demonstrated promising immune responses against these variants. Researchers hope that VAX-002 will be effective as a booster, enhancing protection against COVID-19. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06436911

Study Details | NCT06436911 | To Evaluate Safety and ... 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 ...

2. entospharma.com entospharma.com/news-%26-media/f/entos-first-participant-dosed-in-covid-19-vaccine-booster-trial

First Participant Dosed in COVID-19 Vaccine Booster Trial The first participant has been dosed in the phase 1/2 clinical trial (NCT06436911) evaluating Covigenix VAX-002 as a COVID-19 booster vaccine.

3. biotech.ca biotech.ca/news/aegis-life-and-entos-complete-phase-1-enrollment-of-clinical-trial-for-covid-19-vaccine-booster/

Aegis Life and Entos Complete Phase 1 Enrollment of ... Covigenix VAX-002 shows significant promise as a novel DNA vaccine to stimulate immunity against circulating strains of SARS-CoV-2 in animal ...

4. withpower.com withpower.com/trial/phase-2-covid-19-6-2024-65a21

Covigenix VAX-002 Vaccine for Coronavirus 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 ...

5. firstwordpharma.com firstwordpharma.com/story/5865520

Entos Pharmaceuticals Receives Approval from Health ... The Covigenix VAX-002 COVID-19 vaccine booster clinical study is a phase 1/2 design. The phase 1 component of the trial has a target enrollment ...

6. ctv.veeva.com ctv.veeva.com/study/to-evaluate-safety-and-immunogenicity-of-a-prophylactic-plasmid-dna

To Evaluate Safety and Immunogenicity of a Prophylactic ... The present study investigates the safety and immunogenicity of VAX-002 when given as a booster dose to generally healthy adults aged 18 years ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04591184

A Clinical Trial of a Prophylactic Plasmid DNA Vaccine for ... The primary objective is to evaluate the safety of a 2-dose vaccination schedule of the Covigenix VAX-001 vaccine, given 14 days apart. The secondary objectives ...