Evaluating a new plasmid DNA vaccine for COVID-19

Phase 1/2 Study to Evaluate Safety and Immunogenicity of a Prophylactic Plasmid DNA Booster Vaccine Against SARS-CoV-2 [Covigenix VAX-002] in Generally Healthy Adults 18 Years and Older

This study is testing a new COVID-19 vaccine to see how safe it is and how well it can help people build immunity against the virus.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Entos Pharmaceuticals Inc. (Industry-sponsored)
• Locations: 6 sites (Edmonton, Alberta and 5 other locations)
• Trial ID: NCT06436911 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and immunogenicity of the Covigenix VAX-002 vaccine, a plasmid DNA vaccine designed to prevent SARS-CoV-2 infections. The study is divided into two phases: Phase 1 involves a dose-finding approach with healthy adults receiving either low or high doses of the vaccine, while Phase 2 will evaluate the optimal dose determined from Phase 1 in a larger group of participants. Participants will receive intramuscular injections and will be monitored for safety and immune response over several follow-up visits. The trial seeks to contribute to the development of effective vaccines against COVID-19.

Who should consider this trial

Good fit: Ideal candidates for this study are generally healthy adults aged 18 years or older who have completed a prior COVID-19 vaccination course or have had a recent SARS-CoV-2 infection.

Not a fit: Patients who are not generally healthy or who have not completed a prior COVID-19 vaccination course or had a recent infection may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide an additional preventive option against COVID-19, potentially enhancing immunity in the population.

How similar studies have performed: Other studies have shown promise with similar plasmid DNA vaccine approaches, indicating potential for success in this area.

Eligibility criteria

Inclusion Criteria:

- 1. Generally healthy adults aged 18 years or older at the time of enrollment and with a body mass index (BMI) of ≤30 kg/m2

* Completion of a prior COVID-19 primary vaccination course or booster (any commercially available within the study country) at least 3 months prior to enrollment OR recent clinically documented SARS-CoV-2 infection (by polymerase chain reaction \[PCR\] or antibody test) in the past three months but not within one month from enrollment.
* Willing to refrain from receiving an authorized COVID-19 booster dose until at least 90 days post IP administration.
* Female participants of child-bearing potential must have practiced adequate contraception for 30 days before IP injection, have a negative pregnancy test on the day of IP injection, and agree to continue adequate contraception until 180 days after IP injection. (Please refer to Section 10.44 for the definition of childbearing potential and adequate contraception).
* Male participants must agree to continue adequate contraception until 180 days after IP injection.
* Able to consent to participate in the study and signed an Informed Consent Form (ICF).
* Able and willing to complete all the scheduled study procedures during the whole study period (approximately 6.5 months).
* Generally, in good health, as determined by a review of medical history and a physical examination within 14 days prior to IP injection.

Exclusion Criteria:

* 1. History of anaphylaxis to key ingredients within the vaccine. 2. History of seizure disorder, encephalopathy, or psychosis. 3. Female participant is pregnant (positive urine pregnancy test), lactating, or plans to become pregnant during the 180 days of enrollment. 4. Positive test result for human immunodeficiency virus (HIV) or hepatitis B and C at Screening (test to be performed at the discretion of the investigator based on medical history or physical examination). 5. Positive result of lateral flow test for SARS-COV-2 on Day 0. 6. Laboratory (hematological and biochemistry) examination that is out of normal range or greater than a Grade 2 abnormality. Grade 1 abnormalities will not be exclusionary if considered not clinically significant by the investigator. Laboratory tests include: complete blood count (CBC), prothrombin time (PT), partial thromboplastin time (PTT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin (T Bil), creatinine (CR), lipase, and blood glucose at screening. 7. Transient mild laboratory abnormalities may be rescreened once, and the participant will be excluded if the laboratory repeat test is abnormal as per local laboratory normal values and the investigator's assessment. 8. Presents with any acute febrile disease (oral temperature ≥37.5°C \[99.5oF\]) or active infectious disease within 48 hours prior to IP injection. 9. Unstable concomitant underlying conditions. Note: Stable condition defined as: the participant is appropriately managed on consistent disease management; for example, participants with well-controlled hypertension, adult-onset diabetes, benign prostate hypertrophy, or hypothyroid disease will be eligible for enrollment. The treatment regimen should be stable for at least 3 months prior to entering the study. Once IP treatment has started, the patient must be willing to maintain all aspects of the treatment regimen and forgo any elective changes in medication or management. Emergency changes in medication or management would be captured as an AE. 10. History of Guillain-Barre Syndrome or degenerative neurological disorders; a history of autoimmune, inflammatory disease or potential immune-mediated diseases (pIMD), or any condition that may put the participant at increased risk of safety events. 11. History of serious cardiovascular diseases, such as arrhythmia, conduction block, history of myocardial infarction, and severe hypertension not controlled with medication. 12. History of immunodeficiency, asplenia, or functional asplenia. 13. History of platelet disorder or other bleeding disorder that may cause contraindication for IM injection. 14. Heavy smoker (\>10 cigarettes per day), vaper (\>1 mL of e-liquid per day), or cannabis user (\[near\] daily use). Smokers have to agree to use the same cigarette brand throughout the study.

  15. History or diagnosis of coagulopathies. 16. Prior receipt of immunosuppressive medication, cytotoxic therapy, or systemic corticosteroids within 6 months before Day 0. 17. Recent receipt of blood products within 4 months before Day 0. 18. Administration of other investigational drugs within 3 months before Day 0 or planned use during the study period. 19. Currently has or a history of any condition that, in the opinion of the investigator, may interfere with the participant's compliance, evaluation of study objectives, or informed consent process (i.e., medical, psychological, social, or other conditions).

Where this trial is running

Edmonton, Alberta and 5 other locations

• University of Alberta — Edmonton, Alberta, Canada (Not_yet_recruiting)
• Centricity Research — Burlington, Ontario, Canada (Recruiting)
• Centricity Research — Toronto, Ontario, Canada (Recruiting)
• Centricity Research — Toronto, Ontario, Canada (Recruiting)
• Diex Recherche Quebec — Québec, Quebec, Canada (Recruiting)
• Diex Recherche — Sherbrooke, Quebec, Canada (Recruiting)

Study contacts

• Study coordinator: Yvonne Bessem, PhD

Conditions COVID-19