TRANSCUTANEOUS IMMUNIZATION FOR TETANUS BOOSTER

描述：(改编自申请者摘要)经皮免疫 (TCI)，使用应用于完整皮肤的抗原引入，是一种 新技术可以减少与使用 针头和改善接种疫苗的机会。我们已经证明了 霍乱毒素(CT)在皮肤上的应用可诱导强烈的免疫反应 没有全身毒性的证据。CT在皮肤上的应用 也会导致经典的抗体增强动力学，血清和 联合注射抗原的粘膜抗体和保护性反应。 儿童和新生儿破伤风和白喉在世界范围内仍然很严重 有问题。发展中国家破伤风的发病率反映了 不遵守免疫接种规定。一种使用TCI的更简单的免疫技术 可以降低免疫门槛，提高免疫接种率。我们的 目的是使用一种相对简单的模型疫苗，如破伤风增强剂 发展TCI的基本原则。剂量和剂量的优化研究 佐剂(CT)和抗原(TT和DT)的浓度将被引导到 最大限度地提高免疫反应；挑战研究(破伤风)和中和 化验(白喉)将评估TCI的功能反应。数据 这些研究为临床设计提供了合理的依据 导致经皮破伤风增强剂的试验 建议的商业应用：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