A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Volunteers to Evaluate Accelerated Vaccine Schedules
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 3
研究概览
简要总结
To evaluate the safety and immunogenicity of an accelerated schedule of recombinant canarypox vaccine ALVAC-HIV MN120TMG (vCP205) versus control followed by boost with rgp120/HIV-1 SF2 vaccine in HIV-negative volunteers.
Frequent injections of ALVAC-HIV vCP205 may result in more rapid induction of cytotoxic T-lymphocytes. This trial will evaluate whether an accelerated vaccination schedule can produce immunological responses comparable to those obtained in other trials of ALVAC-HIV vCP205.
详细描述
Frequent injections of ALVAC-HIV vCP205 may result in more rapid induction of cytotoxic T-lymphocytes. This trial will evaluate whether an accelerated vaccination schedule can produce immunological responses comparable to those obtained in other trials of ALVAC-HIV vCP205.
Volunteers are randomized to receive immunization with either ALVAC-HIV vCP205 or ALVAC-RG rabies glycoprotein (vCP65) at days 0, 7, 14, and 21, followed by boost with rgp120/HIV-1 SF2 at days 28 and 84. A third cohort receives ALVAC-HIV vCP65 on the same schedule followed by boost with placebo.
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.
- •Negative ELISA and Western blot for HIV.
- •CD4 count >= 400 cells/mm
- •Normal urine dipstick with esterase and nitrite.
- •Lower-risk sexual behavior.
排除标准
- •Co-existing Condition:
- •Volunteers 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.
- •Occupational responsibilities that preclude 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.
- •Allergy to egg products or neomycin.
- •Occupational exposure to birds.
- •Volunteers 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.
- •Prior immunization against rabies.
- •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 rabies immunization.
- •Prior Treatment:
- •Blood products or immunoglobulin within 6 months prior to study entry. Identifiable high-risk behavior for HIV infection, such as
- •injection drug use within past 12 months.
- •higher- or intermediate-risk sexual behavior.