NCT00000832已完成1 期
A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined With MF59 in HIV-1 Uninfected Adult Volunteers
National Institute of Allergy and Infectious Diseases (NIAID)4 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
- 4
研究概览
简要总结
To determine the safety and immunogenicity of rgp120/HIV-1SF2 combined with MF59 adjuvant emulsion versus MF59 alone in HIV-negative volunteers.
One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant.
详细描述
One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant.
Healthy volunteers receive intramuscular injections of rgp120/HIV-1SF2 with MF59 adjuvant emulsion or MF59 alone at months 0, 1, 6, 9, 10 and 12 (was months 0, 1, 6 and 10, amended 12/19/96).
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
- •Volunteers must have:
- •Normal history and physical exam.
- •HIV negativity.
- •Absolute CD4 count >= 400 cells/mm
- •Normal urine dipstick with esterase and nitrite.
- •Lower risk sexual behavior.
排除标准
- •Co-existing Condition:
- •Subjects with the following symptoms or conditions are excluded:
- •Positive hepatitis B surface antigen.
- •Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.
- •Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (> 6 months) treated infection are eligible.
- •Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
- •Subjects with the following prior conditions are excluded:
- •History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
- •History of anaphylaxis or other serious adverse reactions to vaccines.
- •History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
- •Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance.
- •History of cancer unless there has been surgical excision that is considered to have achieved cure.
- •Prior Medication:
- •Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations.
- •Experimental agents within 30 days prior to study entry.
- •Prior HIV vaccines.
- •Prior Treatment:
- •Blood products or immunoglobulin within the past 6 months.
- •Identifiable high-risk behavior for HIV infection, including:
- •History of injection drug use within past 12 months.
- •Higher risk sexual behavior.
研究者
研究点 (4)
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