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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
46
ENTVAX-001-01
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
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)
Time frame: 13 months
Secondary Outcome
To assess SARS-CoV-2 neutralizing antibody response: Phase 1 only : Antibody responses at specified timepoints from baseline (Day 0) through Day 28 - Geometric mean neutralizing antibody titers, as measured by SARS-CoV-2 neutralization assay Phase 1/2: Antibody responses at specified timepoints from baseline (Day 0) through EOS \- Geometric mean neutralizing antibody titers, as measured by SARSCoV2 neutralization assay Phase 1 only: Seroconversion rate (% of participants who seroconvert), defined as a 4-fold or greater increase in neutralizing antibody titers, as measured by SARSCoV-2 neutralization assay from baseline (Day 0) through Day 28 Phase 1/2: Seroconversion rate (% of participants who seroconvert), defined as a 4-fold or greater increase in neutralizing antibody titers, as measured by SARS-CoV-2 neutralization assay at specified timepoints from baseline (Day 0) through EOS
Time frame: 13 months
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