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.
NCT Number: NCT06541093
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: AIDS/HIV - RelatedDisease Associated With AIDS|Vaccine-Preventable Diseases|HIV Infections
Interventions: BIOLOGICAL: UVAX-1107|BIOLOGICAL: UVAX-1197|OTHER: Placebo
Sponsor: Uvax Bio LLC
Sex: ALL
Age: ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-01-30
Completion Date: 2025-02-28
Locations: Nucleus Network Melbourne, Melbourne, Victoria, 3004, Australia

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.

Primary Outcome Measures: To assess local and systemic reactogenicity following vaccination (Day 1 to Day 8, inclusive) following each vaccination., Reactogenicity (local and systemic) will be recorded by the subject using a daily diary after vaccination andfor 6 consecutive days thereafter., Days 1 through Day 7 after each vaccination.|To determine if antibody responses are induced at 2 weeks after each vaccination using anti-HIV-1 protein IgG., Serum samples will be collected at specified timepoints for HIV-1-specific IgG titers, Pre-vaccination timepoints (Day 1, Day 57, Day 141 and Day 225) and ~2 weeks after each vaccination (Day15, Day 71, Day 155 and Day 239) and Day 337 post enrolment/End of study (EOS).
Secondary Outcome Measures: To assess serious adverse events (SAEs) or adverse events of special interest (AESI) attributed to vaccination., As the proposed trial (UVAX-HIV-101) will be the first study of UVAX-1197 and -1107 in humans, there is currently no data regarding AEs associated with either UVAX-1197 or -1107 in humans. UVAX-1197 and -1107 have been administered in animals without significant adverse reactions being observed. Based on preclinical experience and AEs generally observed in other intramuscular administered vaccines using a similar development platform, the vaccinations are expected to result in mild to moderate local reactions and/or systemic reactions. These AEs will be assessed via clinical examination at the reference timepoints and via the use of a subject diary for the 7 days following each vaccination., At all visits, Day 1, Day 8, Day 15, Day 29, Day 57, Day 64, Day 71, Day 85, Day 141, Day 148, Day 156, Day 169,Day 225, Day 232, Day 239, Day 253 and Day 337 post enrolment/End of Study (EOS).|To describe occurrence of Medically Attended Adverse Events (MAAEs)., MAAEs (e.g. any AEs that are evaluated by a healthcare professional either at the site or within the community) will be reported from Day 1 through 28 days after the last vaccination was received. They will be assessed using study-specific questionnaire, clinical examination and data-linkage to medical records. These AEs will be assessed via clinical examination at the reference timepoints and via the use of a subject diary for the 7 days following each vaccination., On pre- and post-dose Day 1, Day 8, Day 15, Day 29, pre- and post-dose Day 57, Day 64, Day 71, Day 85,pre- and post-dose Day 141, Day 148, Day 156, Day 169, pre- and post-dose Day 225, Day 232, and Day 253|To describe occurrence of treatment emergent adverse events (TEAEs), TEAEs (e.g. any AEs that occur after the study product has been administered) will be reported throughout the study period until Day 253 (28 days following the last dose) .They will be assessed, using study-specific questionnaire, clinical examination and data-linkage to medical records. These AEs will be assessed via clinical examination at the reference timepoints and via the use of a subject diary for the 7 days following each vaccination, Endpoint will evaluate TEAEs reported until Day 29 following each vaccination (Day 1, Day 8, Day 15, Day 29,post-dose Day 57, Day 64, Day 71, Day 85, post-dose Day 141, Day 148, Day 156, Day 169, post-dose Day225, Day 232, and Day 253).|To describe occurrence of laboratory-related adverse events from pre-vaccination to 7 days following each vaccination., Clinically significant abnormal laboratory values for chemistry, hematology and bleeding indices will be graded according to the FDA toxicity scale, or CTCAE if not graded within the FDA scale, and recorded as an AE., Screening visit, Day 8, pre-dose Day 57, Day 64, pre-dose Day 141, day 148, pre-dose Day 225, Day 239 and Day 337 post-enrolment/End of Study (EOS)|To describe occurrence of adverse events from vital sign measurements following each vaccination., Vital signs assessments will include oral temperature (degrees C) using an oral/tympanic thermometer, respiratory rate (breaths per minute) using manual assessment of breaths, systolic and diastolic blood pressure (mmHg) and heart rate (bpm) using a digital blood pressure machine. Clinically significant abnormal vital sign measurements will be graded according to the FDA toxicity scale, or CTCAE if not graded within the FDA scale, and recorded as an AE., All study visits (Screening, pre- and post-dose Day 1, Day 8, Day 15, Day 29, pre- and post-dose Day 57, Day64, Day 71, Day 85, pre- and post-dose Day 141, Day 148, Day 156, Day 169, pre- and post-dose Day 225, Day232, Day 253 and Day 337.|To determine difference in autologous neutralizing antibody response across dose groups, Serum will be collected for assessment of occurrence and level of HIV-1-specifi c neutralization titers against vaccine neutralization titers against select Tier 2 panels, Pre-vaccinations timepoints (Day 1, Day 57, Day 141 and Day 225), and ~2 weeks after each vaccination (Day15, Day 71, Day 155, and Day 239) and at the EOS (Day 337 post-enrolment).|To determine difference in heterologous neutralizing antibody response across dose groups, Serum will be collected for assessment of occurrence and level of HIV-1-specific neutralization titers against select Tier 2 panels, Days 155 and 239. Conditional testing at timepoints (Day 1, Day 57, Day 141 and Day 225), and remaining post-vaccination timepoints (Day 15, Day 71) may be performed