A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination With Soluble Recombinant Envelope Vaccine (VaxSyn)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
研究概览
简要总结
Primary: To determine whether additional boosting with soluble recombinant gp160 vaccine (VaxSyn) after priming with a vaccinia-HIV envelope recombinant (HIVAC-1e) provides a significant advantage in the degree and duration of immunogenicity. Secondary: To learn more about the safety of the combination use of the two HIV envelope vaccines in the study (VaxSyn and HIVAC-1e).
Recent Phase I trials conducted at the AIDS Vaccine Units have shown that antibodies have persisted in most recipients for 6 months after boosting, and responses seem significantly higher and more persistent than responses achieved by just two doses of soluble protein vaccine alone or two doses of HIVAC-1e alone. This study tests in a previously recruited cohort of volunteers whether additional boosting with soluble recombinant gp160 results in increased immunogenicity of longer duration.
详细描述
Recent Phase I trials conducted at the AIDS Vaccine Units have shown that antibodies have persisted in most recipients for 6 months after boosting, and responses seem significantly higher and more persistent than responses achieved by just two doses of soluble protein vaccine alone or two doses of HIVAC-1e alone. This study tests in a previously recruited cohort of volunteers whether additional boosting with soluble recombinant gp160 results in increased immunogenicity of longer duration.
Twelve volunteers who have previously received two doses of HIVAC-1e (or DryVax) and two doses of gp160 receive an additional boost of gp160 at 12-20 months after the last boost and an additional dose of HIVAC-1e at least 9 months after the final gp160 boost.
研究设计
- 研究类型
- Interventional
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients must have:
- •Normal history and physical exam.
- •Negative ELISA for HIV.
- •Negative HIV p24 antigen test.
- •Normal urinalysis.
- •Prior Medication: Required:
- •Two prior doses of HIVAC-1e (or DryVax) and two prior doses of gp160 vaccine.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms and conditions are excluded:
- •Risk factors for HIV infection including active intravenous drug use and more than 2 sexual partners.
- •History of immunodeficiency or chronic illness.
- •Hypersensitivity to insects.
- •Medical or psychiatric condition that makes it unlikely the patient will comply with the protocol.
- •Patients with the following prior conditions are excluded:
- •History of immunodeficiency or chronic illness.
- •Prior Medication:
- •Immunosuppressive medications.
- •Prior Treatment:
- •Blood or blood product transfusion within the past 6 months.
- •Risk Behavior: Excluded:
- •Intravenous drug use.
- •More than 2 sexual partners.