ACTRN12624000064505进行中（未招募）1 期
Phase 1 Proof-of-Concept Study to Evaluate the Safety and Immunogenicity of a Priming Vaccination Regimen of Uvax Bio’s Glycan Trimmed HIV-1 Vaccine (UVAX-1107) with CpG 1018®/Aluminum Hydroxide Adjuvant in Healthy Adults (25-55 years), Followed by Boosting Vaccination Regimen Using UVAX-1107 or Wildtype Non-Glycan Trimmed HIV-1 Vaccine (UVAX-1197) with CpG 1018®/Aluminum Hydroxide Adjuvant
vax Bio Australia, Pty, Ltd, a wholly owned subsidiary of Uvax Bio, LLC0 个研究点目标入组 34 人开始时间: 2024年1月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 25 Years 至 55 Years（—）
- 性别
- All
入选标准
- •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 highlyle 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:
- •a. Agree not to donate sperm from the time of signing consent until at least 90 days after the last dose of study drug.
- •b. 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.
- •c. 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.
排除标准
- •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.
研究者
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