ACTG218--RECOMBINANT ENVELOPE PROTEIN TRIAL IN HIV+ CHILDREN

ACTG218——HIV儿童中的重组包膜蛋白试验

• 批准号: 5224087
• 负责人: MARILYN G DOYLE
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/5224087
• 关键词: AIDS therapy; AIDS vaccines; HIV envelope protein; HIV envelope protein gp120; HIV envelope protein gp160; HIV infections; antiAIDS agent; child (0-11); clinical research; clinical trial phase I; drug screening /evaluation; human subject; human therapy evaluation; immunotherapy; pediatric AIDS; recombinant proteins

This is a Phase I trial to evaluate the safety and immunogenicity of 2 doses of 3 candidate AIDS vaccines in asymptomatic HIV+ children >1 month to 12 years of age. Patients were randomized to vaccine (HIV gp 160 & gp 120) or their adjuvants in one of three treatment arms. This study closed to accrual for children in April, 1994. Patients who were enrolled at the time of closure continued to receive booster immunizations as outlined in the protocol and were followed until they reached their final scheduled study visit. In December 1994 the Genetech adult therapeutic vaccine trial was closed. The Genentech vaccine was the same vaccine used in one arm of ACTG 218 (Genetech MN gp120). To summarize the results of the Genentech-sponsored therapeutic trial, 573 adults with CD4 counts greater than or equal to 600 were immunized with 600 mcg of MN gp120 once a month for the first six months, and then once every other month. The planned duration of the study was three years. At 15 months, the Genentech Data Safety and Monitoring Board voted to terminate the study based on no effect seen in vaccine vs placebo as measured by CD4 decline, change in viral burden, and minor clinical endpoints. It was not believed that the termination of the Genentech trial would have an impact on the completion of ACTG 218, but this information was shared with patients participating in the trial.

这是一项I期试验，旨在评估2-甲氧基苯丙氨酸的安全性和免疫原性。 无症状HIV+儿童接种3种候选艾滋病疫苗1个月 至12岁。患者被随机分配接种疫苗(HIV GP 160& GP 120)或其佐剂在三个治疗臂中的一个中。本研究 1994年4月对儿童停止计提。曾经的病人 在关闭时注册的继续接受助学金 方案中概述的免疫接种，并一直遵循，直到他们 完成了他们最后一次预定的学习访问。 1994年12月，Genetech成人治疗性疫苗试验结束。 基因泰克疫苗与ACTG 218的一只手臂使用的疫苗相同 (Genetech MN Gp120)。总结基因泰克主办的 治疗试验，573名CD4计数大于或等于的成年人 600人用600微克的MN gp120每月免疫一次，第一次 六个月，然后每隔一个月一次。计划的持续时间 研究时间为三年。15个月后，基因泰克数据安全和 监督委员会投票决定终止这项研究，因为在#年没有看到任何影响 疫苗与安慰剂相比，通过CD4下降，病毒负荷变化， 和次要的临床终点。人们不相信这一终止 基因泰克试验的完成将对ACTG的完成产生影响 218，但这一信息是与参与 审判。