Human methamphetamine vaccine: Translational Avante Garde Award

人甲基苯丙胺疫苗：转化前卫奖

• 批准号: 8540992
• 负责人: THOMAS Richard KOSTEN
• 金额: $ 75.12万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-30 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8540992
• 关键词: Adjuvant; Animals; Antibodies; Antibody Formation; Asia; Award; Behavior; Carrier Proteins; China; Chinese American; Chinese People; Clinical; Clinical Research; Clinical Trials; Cocaine; Collaborations; Combined Vaccines; Cyclic GMP; Development; Funding; Generations; Government; Human; Incentives; Institutes; Keyhole Limpet Hemocyanin; Link; Lipids; Locomotion; Manufacturer Name; Methamphetamine; Morbidity - disease rate; Oral Poliovirus Vaccine; Pharmaceutical Preparations; Phase; Primates; Rattus; Research; Research Personnel; Self Administration; Squalene; Toxicology; Translations; Vaccination; Vaccine Adjuvant; Vaccines; abstracting; aluminum sulfate; experience; programs; vaccine candidate; vaccine development

Item Number 7. Project Summary/Abstract: Research Plan PROJECT SUMMARY/ABSTRACT Four factors make this methamphetamine (MA) vaccine ready for clinical translation: 1. Our candidate vaccine has optimal adjuvant and antibody responses; 2. Our partnering Chinese manufacturer has Chinese FDA support for the vaccine IND and matching clinical study funds; 3. The PI has 15 years experience developing medications in China and a successful cocaine vaccine. We can accelerate MA vaccine development well beyond the 15 years needed for cocaine in the USA, because the manufacturer has Chinese government financial and FDA support and commercial incentives from the lack of approved treatments for MA. Our R01(DA023898) has identified an optimal carrier protein - Keyhole Limpet Hemocyanin (KLH), which is already approved for human use, and an approved Chinese squalene lipid adjuvant that is better than standard alum to optimize the anti-MA antibody response to vaccination. The optimal KLH-adjuvant vaccine combination will be determined within two years by correlating the quality and quantity of the induced antibodies with inhibition of MA locomotion and self-administration behavior in rats and primates. We then rapidly moved into cGMP synthesis, animal toxicology, CMC, IND filing and phase 1 and 2a clinical trials in years four/five. 4. Concurrently with this Chinese human vaccine, we plan to renew R01-DA023898 to develop a similar lipid adjuvant vaccine in collaboration with the Sabin Vaccine Institute, which is moving to Baylor in July 2011 and has a squalene adjuvant (Easai, E6020) with FDA approval. These two linked programs will have major practical impacts on MA's profound morbidity in the USA and China through collaborative vaccine development between American and Chinese investigators and manufacturers to produce a first and potentially a second generation vaccine quickly into clinical development in the USA and Asia.

项目编号 7. 项目摘要/摘要： 研究计划 项目概要/摘要 有四个因素使这种甲基苯丙胺 (MA) 疫苗做好了临床转化的准备： 1. 我们的候选疫苗 疫苗具有最佳的佐剂和抗体反应； 2. 我们的合作中国制造商有中文 FDA对疫苗IND和配套临床研究资金的支持； 3. PI拥有15年经验 在中国开发药物并成功开发可卡因疫苗。我们可以加速 MA 疫苗的研发 其发展远远超出了美国可卡因所需的 15 年，因为制造商有中国 由于缺乏批准的治疗方法而受到政府财政和 FDA 的支持以及商业激励 马。我们的R01（DA023898）已经鉴定出最佳的载体蛋白——匙孔血蓝蛋白（KLH）， 已获批准用于人类，并且是经批准的中国角鲨烯脂质佐剂，其效果优于 标准明矾可优化抗 MA 抗体对疫苗接种的反应。最佳 KLH 佐剂疫苗 组合将在两年内通过关联诱导的质量和数量来确定 抑制大鼠和灵长类动物 MA 运动和自我给药行为的抗体。我们然后 迅速进入 cGMP 合成、动物毒理学、CMC、IND 备案以及 1 期和 2a 期临床试验 第四/五年级。 4. 与这款中国人用疫苗同步，我们计划更新R01-DA023898来开发 与萨宾疫苗研究所合作开发了一种类似的脂质佐剂疫苗，该研究所将于 2017 年迁至贝勒 2011年7月，角鲨烯佐剂（Easai，E6020）获得FDA批准。这两个链接的程序将具有 通过合作疫苗对美国和中国的麻疹发病率产生重大实际影响 美国和中国研究人员和制造商之间的发展，以生产第一个和潜在的 第二代疫苗迅速在美国和亚洲进入临床开发。