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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.

NCT06541093 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-05-23

No results posted yet for this study

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.

Conditions

  • AIDS/HIV - RelatedDisease Associated With AIDS
  • Vaccine-Preventable Diseases
  • HIV Infections

Interventions

BIOLOGICAL

UVAX-1107

Novel HIV-1 protein nanoparticles vaccine candidate (WT) mixed with Aluminum Hydroxide (AH) and CpG 1018 adjuvants

BIOLOGICAL

UVAX-1197

Novel HIV-1 protein nanoparticles vaccine candidate (GT) mixed with Aluminum Hydroxide (AH) and CpG 1018 adjuvants

OTHER

Placebo

Saline injection

Sponsors & Collaborators

  • Uvax Bio LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-30
Primary Completion
2025-03-21
Completion
2025-03-21

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06541093 on ClinicalTrials.gov