To Evaluate Safety and Immunogenicity of a Prophylactic Plasmid DNA

NCT06436911 | Completed Phase 1 DMC

• 1 other identifier: ENTVAX-002-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 6

Brief 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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  To evaluate the safety of VAX-002; Frequency and grade of each solicited local (injection site) and systemic reactogenicity AE from Day 0 through Day 28 Phase 2: Frequency and grade of each solicited local (injection site) and systemic reactogenicity AE at Day 0 through Day 28 Phase 1 only: Frequency and grade of unsolicited AEs, SAEs, and medically- attended AEs (MAAEs) from administration of investigational product (IP) through Day 28 Phase 2: Frequency and grade of unsolicited AEs, SAEs, and MAAEs from IP administration through Day 28 Phase 1/2: Frequency, type, and grade of SAEs related to IP administration, MAAEs related to IP administration, adverse events of special interest (AESI), or COVID-19 illness from IP administration through end-of-study (EOS)

  13 months

Secondary Outcomes (1)

• Secondary Outcome

  13 months

Other Outcomes (1)

• Exploratory Outcome

  13 months

Study Arms (2)

Phase 1

EXPERIMENTAL

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

Drug: COVIGENIX VAX- 002

Phase 2

EXPERIMENTAL

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.

Drug: COVIGENIX VAX- 002

Interventions

COVIGENIX VAX- 002 DRUG

ENTVAX-001-01

Phase 1; Phase 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \. 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).

Sponsors & Collaborators

• PCI Pharma Services: collaborator
• Entos Pharmaceuticals Inc.: lead
• Calian CRO: collaborator
• Q2 Solutions: collaborator

Study Sites (6)

University of Alberta

Edmonton, Alberta, Canada

Location

Centricity Research

Burlington, Ontario, L7M4Y1, Canada

Location

Centricity Research

Toronto, Ontario, M4G3E8, Canada

Location

Centricity Research

Toronto, Ontario, M9W4L6, Canada

Location

Diex Recherche Quebec

Québec, Quebec, G1V4T3, Canada

Location

Diex Recherche

Sherbrooke, Quebec, J1L0H8, Canada

Location

Related Links

• Related Info

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 31, 2024
• Study Start: July 22, 2024
• Primary Completion: October 3, 2025
• Study Completion: October 3, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)