Study to Evaluate the Safety and Immunogenicity of an HIV-1 Vaccine Regimen of Adjuvanted UVAX-11… (NCT06541093) | Clinical Trial Compass
CompletedEarly Phase 1
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.
Australia34 participantsStarted 2024-01-30
Plain-language 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.
Who can participate
Age range
25 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess local and systemic reactogenicity following vaccination (Day 1 to Day 8, inclusive) following each vaccination.
Timeframe: Days 1 through Day 7 after each vaccination.
2
To determine if antibody responses are induced at 2 weeks after each vaccination using anti-HIV-1 protein IgG.
Timeframe: 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).
. 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.
Exclusion criteria
. 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.