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Covigenix VAX-001 for COVID-19
Study Summary
This trial will assess the safety, tolerability and immunogenicity of receiving 2 doses of Covigenix VAX-001/-1b, given 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.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- You have a condition that affects your blood platelets or causes bleeding, which makes it unsafe for you to receive an injection.You have previously taken part in other studies that involved a medication with lipid nanoparticles.You have chronic obstructive pulmonary disease (COPD) or currently smoke or use e-cigarettes.You have had a severe allergic reaction called anaphylaxis in the past.You have a history of seizures, brain disorder, or mental illness.You have a weakened immune system or your spleen is not functioning properly.You have a history of certain neurological disorders, autoimmune diseases, or other medical conditions that could make you more likely to experience safety issues during the study.You have a serious long-term illness like asthma, diabetes, or thyroid problems.You have received any other COVID-19 vaccine before the start of this study.You have a weakened immune system or have had your spleen removed.
Frequently Asked Questions
Are there still openings for those wanting to participate in this project?
"As of the most recent update on July 23rd, 2022, this clinical trial is actively recruiting participants. It was first posted to clinicaltrials.gov on April 7th 2021."
What results is the research team hoping to achieve from this investigation?
"The primary goal of the trial, which will be assessed from Day 0-42, is to evaluate Frequency of Serious Adverse Events (SAE) during and after treatment. Secondary objectives include: determining Persistence of IgG antibody titers through ELISA testing as well as neutralizing antibody titers by pseudo-virion neutralization assay; assessing Maintenance of Antibody Titres up to 12 months post second dose; measuring Geometric Mean Neutralizing Antibody against Pseudo-Virions after one and two doses; and gauging Percent Seroconversion following either single or double dosing via IgG ELISA test."
Is this research open to elderly volunteers?
"This trial is open to applicants aged 18-95. Participants younger than 18 years old and seniors over 65 have the option of enrolling in 135 or 896 studies, respectively."
What qualifications must a potential participant possess to join this trial?
"This clinical trial is recruiting 36 individuals with COVID-19 between the ages of 18 and 95. The applicants must also meet a number of criteria, such as providing written consent to participate in the study, being physically healthy upon enrolment and within 14 days prior to dose 1, having BMI's under 30kg/m2 (unless aged over 55), and if female - proving adequate contraception for at least 30 days before dose 1 plus 90 days after dose 2. Furthermore, the duration of this medical experiment will be approximately 13 months."
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