Phase 1a/1b Clinical Trials of Multivalent Opioid Vaccine Components

多价阿片类疫苗成分的 1a/1b 期临床试验

基本信息

批准号：
10782616
负责人：
SANDRA D COMER
金额：
$ 356.96万
依托单位：
NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-15 至 2027-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10782616
关键词：
Phase 1a 1b Clinical Trials

项目摘要

Project Summary Currently, abuse of prescription opioid analgesics and heroin is a pervasive problem in the U.S. Although several medications, including methadone, buprenorphine, and naltrexone, are available and effective in treating opioid use disorder (OUD), long-term relapse rates remain high. The current studies are designed to examine a novel approach to treating OUD, namely use of a vaccine (OXY-KLH) targeted against oxycodone, one of the most commonly abused prescription opioids, and a vaccine (M-KLH) targeted against heroin/morphine. Ultimately, a bivalent vaccine (OXY-KLH and M-KLH) will be developed that will target oxycodone and heroin. The long-term goal of this research is to develop a multivalent vaccine directed against oxycodone, heroin, and other relevant opioids. However, during our pre-IND meeting, the FDA/CBER asked that we study each vaccine separately before moving forward with development of the bivalent vaccine. The current application proposes a Phase 1a/1b study designed to evaluate the safety (Aim 1), immunogenicity (Aim 2), and preliminary efficacy (Aim 3) of OXY-KLH during the UG3 phase of the grant period (Study 1) and a similar Phase 1a/1b study of M-KLH during the UH3 phase of the grant period (Study 2). Transition to the UH3 phase will be determined after safety, immunogenicity, and preliminary efficacy analyses have been performed for the OXY-KLH vaccine. Overall, the proposed studies will provide a great deal of information about the safety and potential efficacy of the vaccines in reducing the abuse liability of opioids, which will be administered in a controlled laboratory setting. If the outcomes of the proposed studies with OXY-KLH and M- KLH are favorable, we will proceed with development of the bivalent vaccine (OXY-KLH plus M-KLH).

项目概要目前，处方阿片类镇痛药和海洛因的滥用在美国是一个普遍存在的问题。有几种药物可以有效治疗，包括美沙酮、丁丙诺啡和纳曲酮。治疗阿片类药物使用障碍（OUD）的长期复发率仍然很高。目前的研究旨在研究一种治疗 OUD 的新方法，即使用针对羟考酮的疫苗 (OXY-KLH)，最常滥用的处方阿片类药物之一，以及针对该药物的疫苗 (M-KLH) 海洛因/吗啡。最终，将开发出一种二价疫苗（OXY-KLH 和 M-KLH），其目标是羟考酮和海洛因。这项研究的长期目标是开发针对这种疾病的多价疫苗羟考酮、海洛因和其他相关的阿片类药物。然而，在我们的 IND 前会议期间，FDA/CBER 要求在继续开发二价疫苗之前，我们会单独研究每种疫苗。这目前的申请提出了一项 1a/1b 期研究，旨在评估安全性（目标 1）、免疫原性（目标 2），以及 OXY-KLH 在授予期 UG3 阶段的初步疗效（目标 3）（研究 1）和在资助期的 UH3 阶段对 M-KLH 进行类似的 1a/1b 期研究（研究 2）。过渡到 UH3期将在安全性、免疫原性和初步疗效分析完成后确定为 OXY-KLH 疫苗进行。总体而言，拟议的研究将提供大量信息关于疫苗在减少阿片类药物滥用倾向方面的安全性和潜在功效，这将是在受控实验室环境中进行。如果 OXY-KLH 和 M 的拟议研究结果 KLH 有利，我们将继续开发二价疫苗（OXY-KLH 加 M-KLH）。