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.

7号物品项目概要/摘要： 研究计划 项目总结/摘要 四个因素使这种甲基苯丙胺（MA）疫苗准备好临床翻译：1。我们的候选人 疫苗具有最佳的佐剂和抗体应答; 2.我们的合作伙伴中国制造商有中文 FDA对疫苗IND的支持及配套的临床研究经费; 3. PI有15年的经验 在中国开发药物和成功的可卡因疫苗。我们可以加速MA疫苗 发展远远超过了美国可卡因所需的15年，因为制造商有中国人， 政府财政和FDA的支持以及缺乏批准的治疗方法的商业激励， MA.我们的R 01（DA 023898）已经鉴定了最佳载体蛋白-钥孔血蓝蛋白（KLH）， 其已经被批准用于人类使用，以及被批准的中国角鲨烯脂质佐剂，其优于 标准明矾以优化抗MA抗体对疫苗接种的应答。最佳KLH佐剂疫苗 组合将在两年内确定相关的质量和数量的诱导 抑制大鼠和灵长类动物MA运动和自我给药行为的抗体。然后我们 快速进入cGMP合成、动物毒理学、CMC、IND备案以及1期和2a期临床试验， 四、五年。4.与此同时，我们计划更新R 01-DA 023898以开发 与萨宾疫苗研究所合作开发了一种类似的脂质佐剂疫苗， 2011年7月获得FDA批准的角鲨烯佐剂（Easai，E6020）。这两个项目将有 通过合作疫苗对MA在美国和中国的严重发病率产生了重大的实际影响 美国和中国的研究人员和制造商之间的发展，以产生第一个和潜在的 第二代疫苗在美国和亚洲迅速进入临床开发阶段。