Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541093
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-06-21
Brief Title:
Study to Evaluate the Safety and Immunogenicity of an HIV-1 Vaccine Regimen of Adjuvanted UVAX-1107 Followed by Adjuvanted UVAX-1107 or Adjuvanted UVAX-1197 in Healthy Subjects Aged 25-55 Years
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 1 Proof-of-Concept Study to Evaluate the Safety and Immunogenicity of a Priming VaccinationRegimen of Uvax Bios Glycan Trimmed HIV-1 Vaccine UVAX-1107 With CpG 1018Aluminum HydroxideAdjuvant in Healthy Adults 25-55 Years Followed by Boosting Vaccination Regimen Using UVAX-1107 orWildtype Non-Glycan Trimmed HIV-1 Vaccine UVAX-1197 With CpG 1018Aluminum Hydroxide Adjuvant
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a first in human testing of novel HIV-1 protein nanoparticles vaccine candidates UVAX-1107 and UVAX-1197 mixed with Aluminum Hydroxide AH and CpG 1018 adjuvants After meeting all eligibility criteria approximately 34 participants will receive a 4-dose vaccination regimen of either 2 priming vaccinations of UVAX-1107 followed by 2 boosting vaccinations of UVAX-1197 or 4 doses of UVAX-1107 or placebo Subject participation is expected to last up to 374 days including up to a 30-day screening period and a 337-day study period during which subjects will be followed for safety and immunogenicity outcomes
Detailed Description:
This is a first in human testing of a novel HIV-1 vaccine candidate Both UVAX-1197 and UVAX-1107 are protein nanoparticle vaccines displaying an uncleaved prefusion-optimized UFO envelope Env glycoprotein from HIV-1 BG505 BG505-UFO The UVAX-1197 displays fully glycosylated UFO Env trimers with wildtype glycans WT UVAX-1107 is derived from UVAX-1197 by enzymatic glycan trimming GT of N-linked glycans in order to better expose major neutralizing epitopes on the surface of BG505-UFO Env to immune recognition The optimized vaccine immunogens will be mixed with Aluminum Hydroxide AH and CpG 1018 adjuvants to enhance the immune response Subject participation is expected to last up to 374 days including up to a 30-day screening period and a 337-day study period
Part 1 of the study will be a safety lead-in cohort in which 4 participants will receive 2 priming vaccinations of a half dose of adjuvanted UVAX-1107 administered in 05ml intramuscular injection on Days 1 and 57 followed by boosting vaccinations of a half dose of adjuvanted UVAX-1197 on Days 141 and 225 administered as intra-muscular IM injections Safety will be reviewed after subjects in Part 1 reach Day 8 prior to opening Part 2
A separate group of participants will be enrolled in Part 2 of the study Participants in Part 2 will be randomized to the following treatment arms to receive either
Priming vaccinations of adjuvanted UVAX-1107 full dose administered in 05ml intramuscular injection on Days 1 and 57 followed by boosting vaccinations of adjuvanted UVAX-1197 full dose administered in 05ml intramuscular injection on Days 141 and 225
Priming vaccinations of adjuvanted UVAX-1107 full dose on Days 1 and 57 followed by boosting vaccinations of adjuvated UVAX-1107 full dose on Days 141 and 225
When Part 2 of the study opens 5 sentinel participants 2 from each of the active treatment groups and 1 from the placebo group will be randomized Safety will be reviewed after these first 5 Part 2 participants reach Day 8 prior to opening randomization to the remaining participants in Part 2
Vaccinations will be administered by trained staff at the study sites according to sites SOPs Details regarding dosing including the dose administered arm and the date and time of dosing will be recorded in the subjects source notes and electronic case report form eCRF
Part 1 of the study will be a safety lead-in cohort in which 4 participants will receive 2 priming vaccinations of a half dose of adjuvanted UVAX-1107 administered in 05ml intramuscular injection on Days 1 and 57 followed by boosting vaccinations of a half dose of adjuvanted UVAX-1197 on Days 141 and 225 administered as intra-muscular IM injections Safety will be reviewed after subjects in Part 1 reach Day 8 prior to opening Part 2
A separate group of participants will be enrolled in Part 2 of the study Participants in Part 2 will be randomized to the following treatment arms to receive either
Priming vaccinations of adjuvanted UVAX-1107 full dose administered in 05ml intramuscular injection on Days 1 and 57 followed by boosting vaccinations of adjuvanted UVAX-1197 full dose administered in 05ml intramuscular injection on Days 141 and 225
Priming vaccinations of adjuvanted UVAX-1107 full dose on Days 1 and 57 followed by boosting vaccinations of adjuvated UVAX-1107 full dose on Days 141 and 225
When Part 2 of the study opens 5 sentinel participants 2 from each of the active treatment groups and 1 from the placebo group will be randomized Safety will be reviewed after these first 5 Part 2 participants reach Day 8 prior to opening randomization to the remaining participants in Part 2
Vaccinations will be administered by trained staff at the study sites according to sites SOPs Details regarding dosing including the dose administered arm and the date and time of dosing will be recorded in the subjects source notes and electronic case report form eCRF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None