NCT00000845已完成1 期
A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects
National Institute of Allergy and Infectious Diseases (NIAID)3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2001年8月31日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
研究概览
简要总结
To evaluate an HIV synthetic lipopeptide candidate vaccine component, P3C541b, at two dose levels, administered subcutaneously (s.c.) in a randomized, double-blind, placebo controlled study.
详细描述
The prospective volunteers will be screened and HLA typed for Class I MHC haplotypes. Only volunteers possessing HLA alleles A33, B8, B27, B35 or Bw62 or any combination thereof will be enrolled in the study. Subjects will be allocated to 1 of 2 study groups. Group 1 will receive 70 mcg of P3C541b or the placebo and Group II will receive 350 mcg of P3C541b or the placebo. NOTE: Enrollment for Group II wil not begin until at least 5 Group I participants have reached day 14 without serious adverse events.
研究设计
- 研究类型
- Interventional
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must have or be:
- •Negative ELISA for HIV.
- •One or more HLA alleles:
- •A33, B8, B27, B35, or Bw
- •Negative for Hepatitis B surface antigen.
- •Normal urine dipstick.
- •Normal history and physical examination.
- •Availability for follow-up planned duration of the study (12 months).
- •Viable EBV line prior to enrollment.
- •Risk behavior: Required:
- •Lower risk sexual behavior as defined by AVEG.
排除标准
- •Co-existing Condition:
- •Patients with any of the following symptoms or conditions are excluded:
- •Medical or psychiatric condition or occupational responsibilities, which preclude subject compliance with the protocol (e.g., recent suicidal ideation or present psychosis).
- •Active syphilis. NOTE: If the serology is documented to be false positive due to a remote (> 6 months) treated infection, the volunteer is eligible.
- •Hepatitis B surface antigenemia.
- •Active tuberculosis. NOTE: Volunteers with a positive PPD and a normal chest X-Ray showing no evidence of TB and not requiring INH therapy are eligible.
- •Patients with any of the following prior conditions are excluded:
- •History of immunodeficiency, chronic illness, malignancy, autoimmune disease.
- •History of cancer, unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of a cure.
- •History of anaphylaxis or history of other serious adverse reactions to vaccines.
- •History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care.
- •History of suicide attempts or past psychosis.
- •Prior Medication:
- •History of use of immunosuppressive medication.
- •Live attenuated vaccines within 60 days of study.
- •Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary but should be given at least 2 weeks away from HIV immunizations.
- •Use of experimental agents within 30 days prior to study.
- •Prior Treatment:
- •Receipt of blood products or immunoglobulin in the past 6 months.
- •Risk Behavior:
- •Subjects with identifiable higher risk behavior for HIV infection as determined by screening questionnaire designed to identify risk factors for HIV infection.
- •History of injection drug use within the last 12 months prior to enrollment.
- •Higher or intermediate risk sexual behavior as defined by AVEG.
研究者
研究点 (3)
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