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.
Phase 1 Proof-of-Concept Study to Evaluate the Safety and Immunogenicity of a Priming VaccinationRegimen of Uvax Bio's Glycan Trimmed HIV-1 Vaccine (UVAX-1107) With CpG 1018®/Aluminum 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 1018®/Aluminum Hydroxide Adjuvant
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 30, 2024
CompletedFirst Submitted
Initial submission to the registry
June 21, 2024
CompletedFirst Posted
Study publicly available on registry
August 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2025
CompletedMay 23, 2025
May 1, 2025
1.1 years
June 21, 2024
May 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
To assess serious adverse events (SAEs) or adverse events of special interest (AESI) attributed to 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).
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)
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.
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.
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.
- +2 more secondary outcomes
Study Arms (4)
UVAX-1107 half dose + UVAX-1197 half dose boost
EXPERIMENTALUVAX-1107 full dose + UVAX-1197 full dose boost
EXPERIMENTALUVAX-1107 full dose + UVAX-1107 full dose boost
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Novel HIV-1 protein nanoparticles vaccine candidate (WT) mixed with Aluminum Hydroxide (AH) and CpG 1018 adjuvants
Novel HIV-1 protein nanoparticles vaccine candidate (GT) mixed with Aluminum Hydroxide (AH) and CpG 1018 adjuvants
Eligibility Criteria
You may qualify if:
- Male or female, 25-55 years of age, inclusive, at screening.
- Stable health status, as established by physical examination and medical history.
- Capable of providing written informed consent.
- Female participants of reproductive potential must be non-pregnant and non lactating, and if of child-bearing potential must agree to be heterosexually inactive from at least 21 days prior to enrolment (Day 1)and through 90 days following last study vaccination or agrees to consistently use highly effective method of birth control and refrain from donating oocytes from at least 21 days prior to enrolment and through 90 days following last study vaccination.
- Male participants must:
- Agree not to donate sperm from the time of signing consent until at least 90 days after the last dose of study drug.
- If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception until at least 90 days after the last dose of study drug.
- If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, must agree to use a condom.
You may not qualify if:
- Chronic illness being treated actively and with evidence of recent adjustments in medications for worsening or fluctuating symptoms in the past 3 months, or hospitalizations / procedural interventions in the past 6 months.
- Body mass index (BMI) of less than 17 and greater than 32 kg/m2 at screening.
- Vital signs grading greater than 1 at screening
- Toxicity grading greater than 1 for screening laboratory test results.
- Any abnormal, clinically significant ECG result at screening.
- High risk of contracting HIV.
- History of cancer (malignancy) in the last 10 years.
- Use of narcotic/illicit drugs or a history of drug/alcohol abuse within the past 2 years.
- Has donated blood or suffered from blood loss of more than 450 mL (1 unit of blood) within 60 days prior to screening, or donated plasma within 14 days prior to screening.
- Receipt of immunoglobulin, blood-derived products, high dose systemic corticosteroids, or other immunosuppressant drugs within 90 days prior to Day 1 or who expect to receive immunoglobulin or another blood product during the study.
- Receipt of a licensed or emergency/provisional approval vaccine within the last 30 days prior to Day 1.
- Known hypersensitivity to any component of the study vaccines, including history of anaphylaxis or other significant allergy in the opinion of the Investigator.
- Any autoimmune or immunodeficiency disease/condition (inherited or iatrogenic) or chronic hematologic disorder (anemia, sickle cell, thalassemia).
- Evidence of HIV, positive hepatitis B surface antigen or core antibody or hepatitis C antibodies by screening test.
- Any chronic or degenerative neurological disease or history of significant neurological disorder.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uvax Bio LLClead
Study Sites (1)
Nucleus Network Melbourne
Melbourne, Victoria, 3004, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2024
First Posted
August 7, 2024
Study Start
January 30, 2024
Primary Completion
March 21, 2025
Study Completion
March 21, 2025
Last Updated
May 23, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share