Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06436911
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-15
Brief Title:
To Evaluate Safety and Immunogenicity of a Prophylactic Plasmid DNA
Sponsor:
Entos Pharmaceuticals Inc
Organization:
Entos Pharmaceuticals Inc
Study Overview
Official Title:
Phase 12 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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VAX-002-01
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 12 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 μgdose or 2 high doses 250 μgdose 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-findingsafety evaluation part Phase 1 to determine the dose of VAX-002 for booster vaccination 100 μg or 250 μg followed by an adaptive Phase
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-findingsafety evaluation part Phase 1 to determine the dose of VAX-002 for booster vaccination 100 μg or 250 μg followed by an adaptive 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 11 into one of two groups either 100 μg intramuscular IM injection or 250 μg IM injection Participants are to receive a single 05 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 05 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
In Phase 2 approximately 250 participants will be enrolled and will receive a single 05 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None