A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
To evaluate the safety and tolerability of the Chiron vaccine human immunodeficiency virus (HIV) p24(25 or 50 micrograms)/MF59 in healthy HIV-1 seronegative adults. To evaluate the immunogenicity of the HIV p24(50 micrograms)/MF59 vaccine.
详细描述
This study evaluates the safety and immunogenicity of the Chiron vaccine HIV p24/MF59. In Part A, 15 volunteers are randomly assigned to receive either HIV p24/MF59 or a placebo at 0, 1, and 6 months. 10 volunteers receive the vaccine and 5 volunteers receive the placebo. If no serious adverse events are observed within 1 week after the first injection in these first 15 patients, Part B is initiated. In Part B, 25 volunteers are randomly assigned to receive HIV p24/MF59 or a placebo at 0, 1, and 6 months. 20 volunteers receive the vaccine and 5 volunteers receive the placebo.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Prevention
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers must have:
- •Good health as determined by medical history, physical examination, and clinical judgment.
- •Negative serology for HIV infection as determined by licensed HIV ELISA test performed within 6 weeks prior to first immunization.
- •In vitro Epstein-Barr virus-immortalized cell line from peripheral blood can be established (required for selected Part B volunteers only).
排除标准
- •Co-existing Condition:
- •Volunteers with the following symptoms or conditions are excluded:
- •Significant acute systemic infection.
- •Occupational or other responsibilities that would prevent completion of participation in the study.
- •Any condition that might interfere with the evaluation of the study objectives.
- •Volunteers with the following prior conditions are excluded:
- •History of immunodeficiency, autoimmune disease, or any serious chronic illness.
- •Evidence of psychiatric or medical history or substance abuse that would adversely affect the volunteer's ability to participate in the trial.
- •History of anaphylaxis or other serious adverse reactions to vaccines or vaccine components.
- •1. Immunosuppressive medications.
- •Live, attenuated vaccine within 60 days of study entry.
- •Medically indicated subunit or killed vaccines (e.g., influenza or pneumococcal) are not exclusionary but should be given at least 4 weeks before or after HIV immunizations to avoid potential confusion of adverse reactions.
- •Experimental agents within 30 days of study entry.
- •HIV vaccine or MF59 adjuvant. Blood products or immunoglobulins in the past 3 months.
- •Engaging in high-risk behavior within 6 months of study entry, i.e.:
- •injection drug use, sexual intercourse without a condom with 4 or more partners or with known iv drug user or HIV+ partner, or newly acquired sexually-transmitted disease.