Development of a Micronized Needle-Free Nicotine Vaccine for Smoking Cessation an

描述(由申请人提供)：Aktiv-Dry LLC与Nabi生物制药公司合作，提议在动物模型中开发和评估精细干粉尼古丁疫苗的无针呼吸道递送。虽然注射器和针头一直是一种常见的疫苗给药机制，但国际当局认识到，对替代制剂和给药系统的需求日益增长，特别是因为针头污染、意外针刺、当前配方的热不稳定性以及对疫苗接种方案的遵从性造成的不慎疾病。尼古丁是吸烟的精神活性和成瘾效应的主要原因。免疫疗法已被证明在预防和/或治疗尼古丁成瘾和其他滥用药物方面是有用的。尼古丁特异性抗体可以结合和隔离血清中的尼古丁，从而阻止尼古丁到达大脑，因为抗体太大，无法越过血脑屏障。许多研究表明，在动物身上，尼古丁载体蛋白结合疫苗NicVax(Tm)可以减少尼古丁向大脑的分布，减弱尼古丁的运动和刺激特性，并防止尼古丁缓解尼古丁戒断综合征。在人类身上，这样的疫苗可能会有效地帮助戒烟，降低复发的几率/延长复发的时间。NABI已经证明了NICVAX(Tm)在人类中的安全性和免疫原性，并确定了它作为一种有效的治疗和预防药物的潜力，以帮助戒烟/戒烟和预防吸烟。Aktiv-Dry已经开发出一种技术，可以制造大小和稳定性适合吸入给药的具有药用活性的微粒。使用Aktiv-Dry技术通过无针途径将NicVax(Tm)输送到呼吸道，可能会促进患者的依从性，解决在全球范围内分配和使用的潜在问题，并可能增强尼古丁疫苗的效力。

DESCRIPTION (provided by applicant): Aktiv-Dry LLC, in collaboration with Nabi Biopharmaceuticals, proposes to develop and evaluate in animal models the needle-free respiratory delivery of fine dry powder nicotine vaccine. While syringe and needle have been a common vaccine administration mechanism, international authorities recognize a growing requirement for alternative formulations and delivery systems, especially because of inadvertent disease from needle contamination, accidental needle-sticks, thermal instability of current formulations, and compliance with vaccination regimens. Nicotine is primarily responsible for the psychoactive and addictive effects of smoking. Immunotherapy has already been shown to be useful in prevention and/or treatment of addiction to nicotine and other drugs of abuse. Nicotine-specific antibodies can bind and sequester nicotine in the serum, thus preventing nicotine from reaching the brain as antibodies are too large to cross the blood-brain barrier. A number of studies have shown that, in animals, NicVAX(tm), a nicotine-carrier protein conjugate vaccine, reduces the distribution of nicotine to the brain, attenuates the locomotor and stimulus properties of nicotine and prevents nicotine from relieving nicotine abstinence syndrome. In humans, such a vaccine may be an effective aid in smoking cessation and reduce the rate/extend the time to relapse. Nabi has already demonstrated the safety and immunogenicity of NicVAX(tm) in humans and established its potential as a useful therapeutic and preventative agent to assist in smoking cessation/abstinence and prophylaxis. Aktiv-Dry has developed a technology to manufacture pharmaceutically active microparticles suitable in size and stability for delivery by inhalation. Delivery of NicVAX(tm) by a needle-free approach to the respiratory tract using the Aktiv-Dry technology may facilitate patient compliance, address potential issues with distribution and use on a world-wide basis, and possibly enhance the efficacy of a nicotine vaccine.