A Phase I/II Safety and Immunogenicity Trial of UBI Microparticulate Monovalent (HIV-1 MN) Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
To evaluate the safety and immunogenicity of a combination of microparticulate monovalent HIV-1 MN synthetic branched peptide candidate vaccine for oral administration and monovalent HIV-1 MN synthetic branched peptide vaccine in alum for intramuscular administration in intermediate or higher risk HIV-negative volunteers.
详细描述
Volunteers receive one of two schedules of vaccines or placebo administered at days 0, 28, and 168. Specifically, group 1 receives oral microparticulate monovalent vaccine over 3 consecutive days on days 0, 1, and 2, and 28, 29, and 30, with the intramuscular monovalent vaccine given on day 168. Group 2 receives the intramuscular vaccine first, on day 0, followed by the oral form given on days 28, 29, and 30 and 168, 169, and 170. Volunteers are followed for 1 year.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers must have:
- •Normal history and physical exam.
- •HIV negativity.
- •CD4 count >= 400 cells/mm
- •Intermediate or high risk sexual behavior or a history of injection drug use within 12 months prior to study entry.
- •Normal urine dipstick with esterase and nitrite.
排除标准
- •Co-existing Condition:
- •Volunteers with the following symptoms or conditions are excluded:
- •Active tuberculosis.
- •Occupational or other responsibilities that would prevent completion of study.
- •Volunteers with the following prior conditions are excluded:
- •History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
- •Psychiatric, medical, or substance abuse problems within the past 6 months that would affect ability to participate in study.
- •History of anaphylaxis or other serious adverse reactions to vaccines.
- •History of inflammatory gastrointestinal disease, celiac disease, or intestinal malignancy.
- •Acute gastroenteritis or gastrointestinal surgery within the past 12 months.
- •Prior Medication:
- •Live or attenuated vaccine within the past 60 days.
- •Illicit or experimental agents within the past 30 days. Intermediate or high risk sexual behavior. Injection drug use within the past 12 months.