Covigenix VAX-002 Vaccine for Coronavirus
(VAX-002-01 Trial)
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.12345Why 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-19.13467
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
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.
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:
- COVID-19 booster vaccine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Entos Pharmaceuticals Inc.
Lead Sponsor
PCI Pharma Services
Collaborator
Calian CRO
Collaborator
Q2 Solutions
Industry Sponsor
Citations
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-trialFirst 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.
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 ...
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 ...
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-dnaTo 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 ...
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 ...
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