A Phase I, Multicenter, Randomized 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
- 20
- 试验地点
- 2
研究概览
简要总结
AMENDED 8/94: To expand the safety and immunogenicity profile of MN rgp160 vaccine (Immuno-AG) by administering a higher dose (800 mcg) at 0, 1, 6, and 12 months and 0, 2, 8 and 14 months (these two schedules were compared in VEU 013A using a dose of 200 mcg). To obtain plasma following the fourth immunization. To evaluate skin test reactivity.
ORIGINAL (replaced): To determine in healthy volunteers the safety and immunogenicity of two immunizations of MN rgp160 vaccine (Immuno-AG) in combination with a live recombinant vaccinia virus LAV HIV-1 gp160 vaccine (HIVAC-1e) versus DryVax (the standard smallpox vaccine that was used for many years) control in combination with placebo.
ORIGINAL (replaced): A gp160 vaccine derived from the MN strain, the most prevalent strain of HIV-1 in the United States, has been developed. A previous study showed that a combination vaccine strategy, consisting of priming with HIVAC-1e followed by boosting with a gp160 subunit vaccine, resulted in humoral and cellular immune responses of greater and longer duration than either vaccine alone. Thus, a live vector/subunit boost approach using the MN rgp160 vaccine merits investigation.
详细描述
ORIGINAL (replaced): A gp160 vaccine derived from the MN strain, the most prevalent strain of HIV-1 in the United States, has been developed. A previous study showed that a combination vaccine strategy, consisting of priming with HIVAC-1e followed by boosting with a gp160 subunit vaccine, resulted in humoral and cellular immune responses of greater and longer duration than either vaccine alone. Thus, a live vector/subunit boost approach using the MN rgp160 vaccine merits investigation.
AMENDED 8/94: Volunteers are randomized to receive 800 mcg MN rgp160 vaccine (Immuno-AG) or adjuvant control (placebo) on one of two dosing schedules. Sixteen volunteers receive candidate vaccine and four volunteers receive placebo.
ORIGINAL (replaced): Volunteers are randomized to receive either HIVAC-1e on days 0 and 56 followed by immunization with MN rgp160 vaccine on days 224 and 364, or DryVax control on days 0 and 56 followed by placebo on days 224 and 364. Ten volunteers are entered on the MN rgp160 vaccine arm and two volunteers on the placebo arm.
PER AMENDMENT 7/96: Two additional booster immunizations of 600 mcg of MN rgp 120/HIV-1 vaccine given at study months 22 and 24 to consenting St. Louis University volunteers.
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.
- •Negative test for HIV by Western blot.
- •CD4 count >= 400 cells/mm
- •No history of smallpox vaccination.
- •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).
- •Household contact with persons meeting any of the following criteria:
- •pregnancy, < 12 months of age, eczema, or immunodeficiency disease or use of immunosuppressive medications.
- •Subjects with the following prior conditions are excluded:
- •History of anaphylaxis or other serious adverse reactions to vaccines.
- •Eczema within the past year.
- •PER 8/94 AMENDMENT: History of cancer unless surgically excised with reasonable assurance of cure.
- •PER 8/94 AMENDMENT: History of serious allergic reaction requiring hospitalization or emergent medical care.
- •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.