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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06541093




Registration number
NCT06541093
Ethics application status
Date submitted
21/06/2024
Date registered
7/08/2024
Date last updated
7/08/2024

Titles & IDs
Public 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.
Scientific title
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
Secondary ID [1] 0 0
UVAX-HIV-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
AIDS/HIV - RelatedDisease Associated With AIDS 0 0
Vaccine-Preventable Diseases 0 0
HIV Infections 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Normal development and function of the immune system
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - UVAX-1107
Treatment: Other - UVAX-1197
Other interventions - Placebo

Experimental: UVAX-1107 half dose + UVAX-1197 half dose boost -

Experimental: UVAX-1107 full dose + UVAX-1197 full dose boost -

Experimental: UVAX-1107 full dose + UVAX-1107 full dose boost -

Placebo comparator: Placebo -


Treatment: Other: UVAX-1107
Novel HIV-1 protein nanoparticles vaccine candidate (WT) mixed with Aluminum Hydroxide (AH) and CpG 1018 adjuvants

Treatment: Other: UVAX-1197
Novel HIV-1 protein nanoparticles vaccine candidate (GT) mixed with Aluminum Hydroxide (AH) and CpG 1018 adjuvants

Other interventions: Placebo
Saline injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess local and systemic reactogenicity following vaccination (Day 1 to Day 8, inclusive) following each vaccination.
Timepoint [1] 0 0
Days 1 through Day 7 after each vaccination.
Primary outcome [2] 0 0
To determine if antibody responses are induced at 2 weeks after each vaccination using anti-HIV-1 protein IgG.
Timepoint [2] 0 0
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 [1] 0 0
To assess serious adverse events (SAEs) or adverse events of special interest (AESI) attributed to vaccination.
Timepoint [1] 0 0
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).
Secondary outcome [2] 0 0
To describe occurrence of Medically Attended Adverse Events (MAAEs).
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
To describe occurrence of treatment emergent adverse events (TEAEs)
Timepoint [3] 0 0
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).
Secondary outcome [4] 0 0
To describe occurrence of laboratory-related adverse events from pre-vaccination to 7 days following each vaccination.
Timepoint [4] 0 0
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)
Secondary outcome [5] 0 0
To describe occurrence of adverse events from vital sign measurements following each vaccination.
Timepoint [5] 0 0
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.
Secondary outcome [6] 0 0
To determine difference in autologous neutralizing antibody response across dose groups
Timepoint [6] 0 0
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).
Secondary outcome [7] 0 0
To determine difference in heterologous neutralizing antibody response across dose groups
Timepoint [7] 0 0
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

Eligibility
Key inclusion criteria
1. Male or female, 25-55 years of age, inclusive, at screening.
2. Stable health status, as established by physical examination and medical history.
3. Capable of providing written informed consent.
4. 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.
5. Male participants must:

1. Agree not to donate sperm from the time of signing consent until at least 90 days after the last dose of study drug.
2. 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.
3. 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.
Minimum age
25 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. 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.
2. Body mass index (BMI) of less than 17 and greater than 32 kg/m2 at screening.
3. Vital signs grading greater than 1 at screening
4. Toxicity grading greater than 1 for screening laboratory test results.
5. Any abnormal, clinically significant ECG result at screening.
6. High risk of contracting HIV.
7. History of cancer (malignancy) in the last 10 years.
8. Use of narcotic/illicit drugs or a history of drug/alcohol abuse within the past 2 years.
9. 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.
10. 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.
11. Receipt of a licensed or emergency/provisional approval vaccine within the last 30 days prior to Day 1.
12. Known hypersensitivity to any component of the study vaccines, including history of anaphylaxis or other significant allergy in the opinion of the Investigator.
13. Any autoimmune or immunodeficiency disease/condition (inherited or iatrogenic) or chronic hematologic disorder (anemia, sickle cell, thalassemia).
14. Evidence of HIV, positive hepatitis B surface antigen or core antibody or hepatitis C antibodies by screening test.
15. Any chronic or degenerative neurological disease or history of significant neurological disorder.
16. Evidence of cardiovascular, pulmonary, renal, hepatobiliary disease or any other baseline condition (history and medication review) that has required active treatment or intervention.
17. Evidence of major depression disorder not well controlled in the past 2 years or history of suicidal ideation or attempt in the past 2 years.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Uvax Bio LLC
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT06541093
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06541093