Official Title
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
Brief Summary

Currently, several vaccines are available to combat the COVID-19 pandemic. Thepersistence of SARS-CoV-2 globally requires the development of additional vaccines to aidin preventing further SARS-CoV-2 infections. Covigenix VAX-002 is a vaccine based off itspredecessors VAX-001 and VAX-001-1b. All three are plasmid DNA vaccines that express keyantigenic determinants from SARS-CoV-2 and use the Entos Pharmaceuticals' Fusogenixproteo-lipid vehicle (PLV) platform. Currently, the safety and tolerability of VAX-001and VAX-001-1b for primary vaccination following 1 or 2 doses are being investigated in aPhase 1/2 study (ENTVAX01-101). In Phase 1, VAX-001 was administered to healthy adults onDay 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. ThePhase 2 part evaluates VAX-001-1b in adults at a 100 μg dose level on a 1-dose and a2-dose schedule (Days 0 and 28). An interim analysis conducted on data from 18participants in the sentinel group who had received their first dose of 100 μg showedthat VAX-001-1b was overall safe with minor adverse events (AEs) registered. No seriousadverse events (SAEs) were reported. After a review of the data, the Data SafetyMonitoring Committee (DSMC) provided their recommendations for the participants in the100 μg dose sentinel group to receive a second dose.The present study investigates the safety and immunogenicity of VAX-002 when given as abooster dose to generally healthy adults aged 18 years or older who have received aprimary vaccination course or a booster dose of an authorized COVID-19 vaccine at least 3months prior to Day 0.VAX-002 was specifically designed to address the new circulating omicron variants ofSARS-CoV-2.The study consists of 2 parts: a dose-finding/safety evaluation part (Phase 1) todetermine the dose of VAX-002 for booster vaccination (100 μg or 250 μg) followed by anadaptive Phase

Detailed 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.

Recruiting
COVID-19

Drug: COVIGENIX VAX- 002

ENTVAX-001-01

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).

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Countries
Canada
Locations

University of Alberta
Edmonton, Alberta, Canada

Centricity Research
Burlington, Ontario, Canada

Centricity Research
Toronto, Ontario, Canada

Centricity Research
Toronto, Ontario, Canada

Diex Recherche Quebec
Québec, Quebec, Canada

Diex Recherche
Sherbrooke, Quebec, Canada

Contacts

Yvonne Bessem, PhD
4164606574
yvonne.bessem@entospharma.com

Catalina Vasquez
7804995396
Catalina.Vasquez@entospharma.com

Not Provided

Entos Pharmaceuticals Inc.
NCT Number