To Evaluate Safety and Immunogenicity of a Prophylactic Plasmid DNA

Last updated: August 26, 2024
Sponsor: Entos Pharmaceuticals Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Covid-19

Treatment

COVIGENIX VAX- 002

Clinical Study ID

NCT06436911
ENTVAX-002-01
  • Ages 18-65
  • All Genders

Study Summary

Currently, several vaccines are available to combat the COVID-19 pandemic. The persistence of SARS-CoV-2 globally requires the development of additional vaccines to aid in preventing further SARS-CoV-2 infections. Covigenix VAX-002 is a vaccine based off its predecessors VAX-001 and VAX-001-1b. All three are plasmid DNA vaccines that express key antigenic determinants from SARS-CoV-2 and use the Entos Pharmaceuticals' Fusogenix proteo-lipid vehicle (PLV) platform. Currently, the safety and tolerability of VAX-001 and VAX-001-1b for primary vaccination following 1 or 2 doses are being investigated in a Phase 1/2 study (ENTVAX01-101). In Phase 1, VAX-001 was administered to healthy adults on Day 0 and Day 14, as either 2 low doses (100 μg/dose) or 2 high doses (250 μg/dose). Overall, data suggest that VAX-001 is safe at both the low and high dose levels. The Phase 2 part evaluates VAX-001-1b in adults at a 100 μg dose level on a 1-dose and a 2-dose schedule (Days 0 and 28). An interim analysis conducted on data from 18 participants in the sentinel group who had received their first dose of 100 μg showed that VAX-001-1b was overall safe with minor adverse events (AEs) registered. No serious adverse events (SAEs) were reported. After a review of the data, the Data Safety Monitoring Committee (DSMC) provided their recommendations for the participants in the 100 μg dose sentinel group to receive a second dose.

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 received a primary vaccination course or a booster dose of an authorized COVID-19 vaccine at least 3 months prior to Day 0.

VAX-002 was specifically designed to address the new circulating omicron variants of SARS-CoV-2.

The study consists of 2 parts: a dose-finding/safety evaluation part (Phase 1) to determine the dose of VAX-002 for booster vaccination (100 μg or 250 μg) followed by an adaptive Phase

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Generally healthy adults aged 18 years or older at the time of enrollment andwith a body mass index (BMI) of ≤30 kg/m2
  • Completion of a prior COVID-19 primary vaccination course or booster (anycommercially available within the study country) at least 3 months prior toenrollment OR recent clinically documented SARS-CoV-2 infection (by polymerase chainreaction [PCR] or antibody test) in the past three months but not within one monthfrom 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 adequatecontraception for 30 days before IP injection, have a negative pregnancy test on theday of IP injection, and agree to continue adequate contraception until 180 daysafter IP injection. (Please refer to Section 10.44 for the definition ofchildbearing potential and adequate contraception).

  • Male participants must agree to continue adequate contraception until 180 days afterIP 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 wholestudy period (approximately 6.5 months).

  • Generally, in good health, as determined by a review of medical history and aphysical examination within 14 days prior to IP injection.

Exclusion

Exclusion Criteria:

  1. History of anaphylaxis to key ingredients within the vaccine. 2. History ofseizure disorder, encephalopathy, or psychosis. 3. Female participant ispregnant (positive urine pregnancy test), lactating, or plans to becomepregnant during the 180 days of enrollment. 4. Positive test result for humanimmunodeficiency virus (HIV) or hepatitis B and C at Screening (test to beperformed at the discretion of the investigator based on medical history orphysical examination). 5. Positive result of lateral flow test for SARS-COV-2on Day 0. 6. Laboratory (hematological and biochemistry) examination that isout of normal range or greater than a Grade 2 abnormality. Grade 1abnormalities will not be exclusionary if considered not clinically significantby the investigator. Laboratory tests include: complete blood count (CBC),prothrombin time (PT), partial thromboplastin time (PTT), alanineaminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin (T Bil), creatinine (CR), lipase, and blood glucose atscreening. 7. Transient mild laboratory abnormalities may be rescreened once,and the participant will be excluded if the laboratory repeat test is abnormalas per local laboratory normal values and the investigator's assessment. 8.Presents with any acute febrile disease (oral temperature ≥37.5°C [99.5oF]) oractive infectious disease within 48 hours prior to IP injection. 9. Unstableconcomitant underlying conditions. Note: Stable condition defined as: theparticipant is appropriately managed on consistent disease management; forexample, participants with well-controlled hypertension, adult-onset diabetes,benign prostate hypertrophy, or hypothyroid disease will be eligible forenrollment. The treatment regimen should be stable for at least 3 months priorto entering the study. Once IP treatment has started, the patient must bewilling to maintain all aspects of the treatment regimen and forgo any electivechanges in medication or management. Emergency changes in medication ormanagement would be captured as an AE. 10. History of Guillain-Barre Syndromeor degenerative neurological disorders; a history of autoimmune, inflammatorydisease or potential immune-mediated diseases (pIMD), or any condition that mayput the participant at increased risk of safety events. 11. History of seriouscardiovascular diseases, such as arrhythmia, conduction block, history ofmyocardial infarction, and severe hypertension not controlled with medication.

  2. History of immunodeficiency, asplenia, or functional asplenia. 13. Historyof platelet disorder or other bleeding disorder that may cause contraindicationfor IM injection. 14. Heavy smoker (>10 cigarettes per day), vaper (>1 mL ofe-liquid per day), or cannabis user ([near] daily use). Smokers have to agreeto use the same cigarette brand throughout the study.

  3. History or diagnosis of coagulopathies. 16. Prior receipt of immunosuppressivemedication, cytotoxic therapy, or systemic corticosteroids within 6 monthsbefore Day 0. 17. Recent receipt of blood products within 4 months before Day

    1. 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 anycondition that, in the opinion of the investigator, may interfere with theparticipant's compliance, evaluation of study objectives, or informed consentprocess (i.e., medical, psychological, social, or other conditions).

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: COVIGENIX VAX- 002
Phase: 1/2
Study Start date:
August 01, 2024
Estimated Completion Date:
July 31, 2026

Study Description

Phase 1 is the randomized, observer-blinded, multi-center, dose-finding part of the study, followed by an adaptive Phase 2 in which the optimal dose, determined from Phase 1, will be evaluated for safety and efficacy. 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 Day 28 visit to evaluate dose-response and safety to support optimal dose selection for Phase 2.

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.

Connect with a study center

  • University of Alberta

    Edmonton, Alberta
    Canada

    Site Not Available

  • Centricity Research

    Burlington, Ontario L7M4Y1
    Canada

    Active - Recruiting

  • Centricity Research

    Toronto, Ontario M9W4L6
    Canada

    Active - Recruiting

  • Diex Recherche Quebec

    Québec, Quebec G1V4T3
    Canada

    Active - Recruiting

  • Diex Recherche

    Sherbrooke, Quebec J1L0H8
    Canada

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.