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

描述（由申请方提供）：Aktiv-Dry LLC与Nabi Biopharmaceuticals合作，拟在动物模型中开发和评价无针呼吸递送细干粉尼古丁疫苗。虽然注射器和针头是一种常见的疫苗接种机制，但国际当局认识到对替代制剂和输送系统的需求日益增长，特别是因为针头污染、意外针刺、当前制剂的热不稳定性以及疫苗接种方案的依从性造成的意外疾病。尼古丁主要是造成吸烟的精神作用和成瘾作用的原因。免疫疗法已被证明可用于预防和/或治疗尼古丁和其他药物滥用成瘾。尼古丁特异性抗体可以结合并隔离血清中的尼古丁，从而防止尼古丁到达大脑，因为抗体太大而无法穿过血脑屏障。许多研究表明，在动物中，NicVAX（tm），一种尼古丁载体蛋白结合疫苗，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。在人类中，这种疫苗可能是戒烟的有效辅助手段，并降低复发率/延长复发时间。Nabi已经证明了NicVAX（tm）在人类中的安全性和免疫原性，并确定了其作为一种有用的治疗和预防剂的潜力，以帮助戒烟/戒烟和预防。Aktiv-Dry开发了一种技术，用于制造尺寸和稳定性适合于吸入递送的药物活性微粒。使用Aktiv-Dry技术通过无针途径向呼吸道输送NicVAX（TM）可促进患者依从性，解决全球范围内分销和使用的潜在问题，并可能提高尼古丁疫苗的功效。

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.