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Cancer Vaccine

Covigenix VAX-002 Vaccine for Coronavirus (VAX-002-01 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Entos Pharmaceuticals Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Prior receipt of immunosuppressive medication, cytotoxic therapy, or systemic corticosteroids within 6 months before Day 0

History of platelet disorder or other bleeding disorder that may cause contraindication for IM injection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 13 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new COVID-19 vaccine called Covigenix VAX-002, which is based on previous vaccines VAX-001 and VAX-001-1b. The study

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Previous related vaccines showed minor adverse events with no serious side effects reported in earlier phases. Side effects may include typical reactions seen with other COVID-19 vaccines like soreness at injection site, fatigue, headache.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have a history of immune system problems or missing spleen.

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I have a history of blood clotting disorders.

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I have not received blood products in the last 4 months.

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I have a history of seizures, brain disorders, or severe mental illness.

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I am not pregnant, breastfeeding, nor planning to become pregnant in the next 6 months.

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I have not had a fever or infection in the last 48 hours.

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I have a history of Guillain-Barre Syndrome or similar conditions.

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I have a history of serious heart diseases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 13 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~13 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Secondary study objectives

Other study objectives

Exploratory Outcome

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2Experimental Treatment1 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 1Experimental Treatment1 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

0 / 10Eligibility criteria met