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）：有四个因素使这种甲基苯丙胺（MA）疫苗可以进行临床转化： 1. 我们的候选疫苗具有最佳的佐剂和抗体反应； 2. 我们的候选疫苗具有最佳的佐剂和抗体反应； 2.我们合作的中国制造商拥有中国FDA对疫苗IND的支持和配套的临床研究资金； 3. PI拥有15年在中国开发药物和成功的可卡因疫苗的经验。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，因为制造商拥有中国政府和 FDA 的支持，以及由于缺乏经批准的 MA 治疗方法而获得的商业激励。我们的R01（DA023898）已经确定了一种最佳载体蛋白 - 匙孔血蓝蛋白（KLH），该蛋白已被批准用于人类，以及一种已批准的中国角鲨烯脂质佐剂，其优于标准明矾，以优化抗 MA 抗体对疫苗接种的反应。通过将诱导抗体的质量和数量与大鼠和灵长类动物中 MA 运动和自我给药行为的抑制相关联，将在两年内确定最佳的 KLH 佐剂疫苗组合。然后，我们在第四年/第五年迅速进入 cGMP 合成、动物毒理学、CMC、IND 备案以及 1 期和 2a 期临床试验。 4. 在这款中国人用疫苗的同时，我们计划更新R01-DA023898，与萨宾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，有角鲨烯佐剂（Easai，E6020）， FDA 批准。通过美国和中国研究人员和制造商之间的疫苗合作开发，生产第一代和可能的第二代疫苗，迅速进入美国和亚洲的临床开发，这两个相关项目将对美国和中国的麻疹发病率产生重大实际影响。 公共卫生相关性：MA 疫苗将提供实用且具有成本效益的治疗选择，如可卡因和尼古丁