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应答; 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.该PI在中国拥有15年的药物开发经验，并成功开发了可卡因疫苗。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，因为制造商拥有中国政府的财政和FDA的支持，以及缺乏获得批准的MA治疗方法的商业激励。我们的R 01（DA 023898）已经确定了一种最佳的载体蛋白-钥孔血蓝蛋白（KLH），已被批准用于人类使用，以及一种批准的中国角鲨烯脂质佐剂，其优于标准明矾，可优化抗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KLH-佐剂疫苗组合。然后，我们在第四/五年迅速进入cGMP合成，动物毒理学，CMC，IND申请以及1期和2a期临床试验。4.与此同时，我们计划更新R 01-DA 023898，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月搬到贝勒，并拥有FDA批准的角鲨烯佐剂（Easai，E6020）。这两个相互关联的项目将对MA在美国和中国的严重发病率产生重大的实际影响，通过美国和中国研究者和制造商之间的合作疫苗开发，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。 公共卫生相关性：MA疫苗将提供实用和成本效益高的治疗选择，如可卡因和镍