TRANSCUTANEOUS IMMUNIZATION FOR TETANUS BOOSTER

描述：（改编自申请人的摘要）经皮免疫 (TCI)使用应用程序将抗原引入完整皮肤，是一种 新技术，可以减少与使用相关的并发症 注射器，并改善疫苗接种。我们已经证明 将霍乱毒素（CT）应用于皮肤诱导强有力的免疫应答 没有全身毒性的证据。使用CT作为皮肤上的辅助剂 也导致经典的抗体加强动力学，血清的存在， 粘膜抗体共同给予抗原和保护性反应。 儿童和新生儿破伤风和白喉在全世界仍然很严重 问题发展中国家的破伤风发病率反映了 不遵守免疫规定。使用TCI的更简单的免疫技术 可以减少免疫障碍，提高免疫率。我们 目的是使用一种相对简单的疫苗模型，如破伤风加强剂， 发展TCI的基本原则。剂量优化研究， 将进行佐剂（CT）和抗原（TT和DT）的浓度测定， 最大限度地提高免疫反应;激发研究（破伤风）和中和 检测（白喉）将评估对TCI的功能反应。数据 这些研究中产生的结果为临床设计提供了合理的依据。 经皮破伤风加强剂试验 拟定商业应用：不可用

DESCRIPTION: (Adapted from Applicant's Abstract) Transcutaneous immunization (TCI), the introduction of antigens using an application to intact skin, is a new technology that could decrease the complications associated with the use of needles and improve access to vaccination. We have demonstrated that application of cholera toxin (CT) to the skin induces potent immune responses without evidence of systemic toxicity. The use of CT as an adjuvant on the skin also results in classic antibody boosting kinetics, the presence of serum and mucosal antibodies to co-administered antigens and protective responses. Childhood and neonatal tetanus and diphtheria remain significant worldwide problems. The incidence of tetanus in the developing world reflects non-compliance with immunization. A simpler immunization technique using TCI could decrease the barriers to immunization and improve immunization rates. Our aim is to use a relatively simple model vaccine such as the tetanus booster to develop the fundamental principals of TCI. Optimization studies on the dose and concentration of adjuvant (CT) and antigens (TT and DT) will be conducted to maximize the immune response; challenge studies (tetanus) and neutralization assays (diphtheria) will assess the functional response to TCI. The data generated in these studies provide a rational basis for the design of clinical trials leading towards a transcutaneous tetanus booster PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE