A Phase I, Multicenter, Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
研究概览
简要总结
To determine the safety and immunogenicity of 200 mcg MN rgp160 vaccine (Immuno-AG) versus placebo, administered on two immunization schedules to healthy volunteers. Per 06/15/94 amendment, to determine the safety and immunogenicity of 800 versus 200 mcg given as a fourth immunization at 9 or 11 months after the third injection (i.e., at month 17).
A gp160 vaccine developed from the IIIB strain of HIV-1 has been found to be safe and immunogenic in healthy adults. Since the MN strain of HIV-1 is representative of a larger proportion of HIV-1 isolates in the United States than is the IIIB strain, evaluation of a gp160 vaccine derived from the MN strain is important.
详细描述
A gp160 vaccine developed from the IIIB strain of HIV-1 has been found to be safe and immunogenic in healthy adults. Since the MN strain of HIV-1 is representative of a larger proportion of HIV-1 isolates in the United States than is the IIIB strain, evaluation of a gp160 vaccine derived from the MN strain is important.
Volunteers are randomized to receive 200 mcg MN rgp160 or placebo at months 0, 1, and 6 or at months 0, 2, and 8. For each immunization schedule, ten volunteers receive vaccine and two volunteers receive placebo. Per amendment, volunteers receive a fourth immunization of 800 or 200 mcg (or placebo) at 9 or 11 months after the third injection (i.e., at month 17) and are followed for 6 months afterward.
研究设计
- 研究类型
- Interventional
- 主要目的
- Prevention
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
- •Subjects must have:
- •Normal history and physical exam.
- •Negative test for HIV by ELISA within 6 weeks prior to immunization.
- •CD4 count >= 400 cells/mm
- •Normal urine dipstick with esterase and nitrate.
- •No history of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppresssive medications.
排除标准
- •Co-existing Condition:
- •Subjects with the following conditions are excluded:
- •Positive for hepatitis B surface antigen.
- •Medical or psychiatric condition or occupational responsibilities that preclude compliance.
- •Active syphilis (NOTE: If serology is documented to be a false positive or due to a remote (> 6 months) infection, subject is eligible).
- •Active tuberculosis (NOTE: Subjects with a positive PPD and normal x-ray showing no evidence of TB and who do not require INH therapy are eligible).
- •Subjects with the following prior conditions are excluded:
- •History of anaphylaxis or other serious adverse reactions to vaccines.
- •Prior Medication:
- •Prior HIV vaccines.
- •Live attenuated vaccines within the past 60 days. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) do not exclude but should be administered at least 2 weeks prior to HIV immunizations.
- •Experimental agents within the past 30 days.
- •Prior Treatment:
- •Blood products or immunoglobulin within the past 6 months.
- •Higher risk behavior for HIV infection as determined by screening questionnaire, including:
- •History of injection drug use within 12 months prior to study entry.
- •Higher or intermediate risk sexual behavior.