NCT00000846已完成1 期
A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers.
National Institute of Allergy and Infectious Diseases (NIAID)3 个研究点 分布在 1 个国家目标入组 36 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
- 36
- 试验地点
- 3
研究概览
简要总结
To evaluate safety and immunogenicity of 2 different HIV-1 peptide candidate vaccines, the UBI HIV-1 MN PND peptide immunogen and the UBI microparticulate monovalent HIV-1 MN branched peptide when administered sequentially by 2 different routes of immunization, parental priming followed by oral boosting.
详细描述
After the prescreening, volunteers will be randomized into Group I or Group II. Each group will contain 16 volunteers. At least 5 volunteers in each group must be women. At month 0 all volunteers will receive multivalent HIV-1 peptide immunogen or the placebo. Group I will receive the injection in the deltoid and Group II will receive it in the anterior thigh. At months 1, 2 and 8 all patients will receive microparticulate monovalent HIV-1 peptide or the placebo. Follow up will be conducted.
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
- •Patients must have or be:
- •Negative ELISA for HIV.
- •Negative for Hepatitis B surface antigen.
- •Normal urine dipstick.
- •Normal history and physical exam.
- •Availability for follow-up for planned duration of the study (60 weeks).
- •Risk Behavior: Required:
- •Lower or intermediate risk sexual behavior as defined by AVEG.
排除标准
- •Co-existing Condition:
- •Patients with any of the following symptoms or conditions are excluded:
- •Medical or psychiatric condition or occupational responsibilities which preclude subject compliance with the protocol.
- •Active syphilis. NOTE: If the serology is documented to be a false positive or due to a remote (> 6 months) treated infection, the volunteer is eligible.
- •Active tuberculosis. NOTE: Volunteers with a positive PPD and a normal chest X-ray showing no evidence of TB and not requiring INH therapy are eligible.
- •Patients with any of the following prior conditions are excluded:
- •History of immunodeficiency, chronic illness, malignancy or autoimmune disease.
- •History of anaphylaxis or other serious adverse reactions to vaccines.
- •History of inflammatory gastrointestinal disease, celiac disease or intestinal malignancy.
- •History of acute gastroenteritis within the past month or gastrointestinal surgery within the past 12 months.
- •Prior Medication:
- •History of use of immunosuppressive medication.
- •Live attenuated vaccines within 60 days of study. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary but should be given at least 2 weeks away from HIV immunizations.
- •Use of experimental agents within 30 days prior to study.
- •Receipt of blood products or immunoglobulin in the past 6 months.
- •Prior receipt of HIV vaccines or a placebo recipient in an HIV vaccine trial.
- •Risk Behavior:
- •Subjects with identifiable higher risk behavior for HIV infection as determined by screening questionnaire designed to identify risk factors for HIV infection.
- •History of injection drug use within the last 12 months to enrollment.
- •Higher risk sexual behavior as defined by AVEG.
研究者
研究点 (3)
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