Human methamphetamine vaccine: Translational Avante Garde Award

人甲基苯丙胺疫苗：转化前卫奖

• 批准号: 8289239
• 负责人: THOMAS Richard KOSTEN
• 金额: $ 78.25万
• 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/8289239
• 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 Personnel; Self Administration; Squalene; Toxicology; Translations; Vaccination; Vaccine Adjuvant; Vaccines; aluminum sulfate; experience; programs; vaccine candidate; vaccine development

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: MA vaccines will provide practical and cost effective treatment options, as cocaine and ni

描述（由申请人提供）：四个因素使这种甲基苯丙胺（MA）疫苗准备好临床转化：1。我们的候选疫苗具有最佳的佐剂和抗体反应；2. 与我们合作的中国制造商获得了中国FDA对疫苗IND的支持和相应的临床研究资金；3. PI在中国有15年的药物开发经验，并成功开发了一种可卡因疫苗。我们可以加速MA疫苗的开发，远远超过美国可卡因所需的15年，因为制造商得到了中国政府的财政和FDA的支持，以及由于缺乏批准的MA治疗方法而产生的商业激励。我们的R01（DA023898）鉴定出了一种最佳载体蛋白- Keyhole帽贝血青素（KLH），该蛋白已被批准用于人用，以及一种被批准的中国角鲨烯脂类佐剂，该佐剂优于标准明矾，可优化疫苗接种后的抗ma抗体反应。最佳的klh -佐剂疫苗组合将在两年内确定，通过将诱导抗体的质量和数量与大鼠和灵长类动物的MA运动和自我给药行为的抑制联系起来。然后，我们迅速进入cGMP合成、动物毒理学、CMC、IND申请和第4 / 5年的1期和2a期临床试验。4. 在此中国人用疫苗的同时，我们计划更新R01-DA023898，与Sabin疫苗研究所合作开发类似的脂质佐剂疫苗，该研究所将于2011年7月迁至贝勒，其角鲨烯佐剂（Easai, E6020）已获得FDA批准。这两个相关项目将对美国和中国的MA发病率产生重大的实际影响，通过美国和中国研究人员和制造商之间的合作疫苗开发，生产第一代和潜在的第二代疫苗，迅速进入美国和亚洲的临床开发。