Transcutaneous Immunization for Tetanus Booster

描述：(申请人提供)基于广泛的动物试验和有限的人体研究，经皮免疫似乎是对传统疫苗接种的一种可行和有价值的技术改进。拟议研究计划的目的是通过进一步临床开发铅破伤风增强剂产品，通过简单的皮肤贴片给药，继续将该技术商业化。 该计划中的关键活动包括： 进一步证明安全性和免疫原性的I期人体临床研究 在较低的佐剂/抗原比率下。 在配方、分析方法和 补丁设计以产生稳定的、商业上可行的产品设计。 一项随后的I期人体研究，以评估该药物的安全性和有效性 建议处方(S)和贴片设计(S)，在适当的剂量 佐剂和抗原。 这项工作的具体成果将是一种产品设计，可以进入监管许可所需的第二阶段/第三阶段人体研究。 已经研究和确定了破伤风增强剂产品的商业机会，主要包括旨在消除产妇和新生儿破伤风的发展中国家方案，以及发达国家的高危人群，包括50岁以上的人和其他特定的高危人群。 拟议的商业应用：经皮破伤风增强剂针对两个市场：1.主要在发展中国家消除孕产妇和新生儿破伤风；2.成人破伤风增强剂和高危人群，包括50岁以上人群和其他特定高危群体，如农业工人。通过补丁提供的破伤风疫苗的商业引入预计将增加两个重点市场获得疫苗的机会和对免疫方案的遵守，从而促进这两个市场的增长。此外，经皮推进器将降低针刺和相关疾病的风险，并减少与破伤风免疫相关的人员和设备需求。

DESCRIPTION: (Provided by Applicant) Based on extensive animal testing and limited human studies, transcutaneous immunization appears to be a viable and valuable technological improvement to traditional administration of vaccines. The aim of the proposed research plan is to continue commercialization of the technology through further clinical development of the lead tetanus booster product, administered by means of a simple skin patch. The critical activities in this program include: A Phase I human clinical study to further demonstrate safety and immunogenicity at lower adjuvant/antigen ratios. Product development in the area of formulation, analytical methodology, and patch design to yield a stable, commercially viable product design. A subsequent Phase I human study to evaluate the safety and efficacy of the proposed formulation(s) and patch design(s), at the appropriate dose of adjuvant and antigen. Specific outcomes of the work will be a product design that can advance to Phase II/III human studies required for regulatory licensure. Commercial opportunities for a tetanus booster product have been researched and identified, consisting primarily of developing world programs aimed at eliminating maternal and neonatal tetanus, and at-risk populations in developed countries, including those over 50 years of age and other specific at-risk groups. PROPOSED COMMERCIAL APPLICATION: The Transcutaneous tetanus booster is directed to 2 markets: 1. Maternal and neonatal tetanus elimination, primarily in developing countries; and, 2. Adult booster & at-risk population, including the over-50 population and other specific at-risk groups, such as agricultural workers. The commercial introduction of a tetanus vaccine delivered through a patch is expected to increase access to the vaccine and compliance with immunization protocols for the 2 focus markets, thus growing both markets. Additionally, the Transcutaneous booster will decrease the risk of needle-sticks and related disease, and reduce personnel and equipment requirements related to tetanus immunization.