DEVELOPMENT OF A LEISHMANIA VACCINE USING INTERLEUKIN-12 AS AN ADJUVANT

使用 IL-12 作为佐剂开发利什曼原虫疫苗

• 批准号: 6161173
• 负责人: R T KENNEY
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6161173
• 关键词: Leishmania; Primates; biomaterial development /preparation; clinical research; clinical trial phase I; disease /disorder model; drug screening /evaluation; human subject; immunologic skin test; immunomodulators; interleukin 12; laboratory mouse; microorganism culture; protozoal vaccine; vaccine development; vector vaccine

Cutaneious leishmaniasis still affects about 10 million people a year, despite numerous attempts at vector control, parasite eradication, and creation of various vaccine formulations. With the cooperation of the Genetics Institute (Cambridge, MA), which makes recombinant human and murine IL-12 and Biobras (Montes Claros, Brazil), which makes a leishmania vaccine and skin test antigen, we are developing a product for use in a human Phase I/II trial . We have just completed a series of experiments using mice to test the safety, potency, efficacy and stability of several preparations. The vaccine antigen is made from cultures of parasites that are washed then frozen and thawed several times to break the cells. These crude preps were shown to work well despite autoclaving and the autoclaved preparation remains stable-after 1 month at 37. Monkey experiments are in progress to evaluate the safety immunogenicity, and efficacy of the autoclaved preparation with rHuIL-12 as an adjuvant. We plan to submit an IND for the combination of the products and begin the clinical trials at NIH by the end of the year.

皮肤利什曼病每年仍影响约1000万人， 尽管在病媒控制、寄生虫根除和 生产各种疫苗。 合作下 遗传学研究所（剑桥，MA），该研究所制造重组人和 鼠IL-12和Biobras（Montes Claros，Brazil），其产生利什曼原虫 疫苗和皮肤测试抗原，我们正在开发一种产品，用于 人类I/II期试验。 我们刚刚完成了一系列的实验 使用小鼠测试几种化合物的安全性、效力、功效和稳定性， 准备工作。疫苗抗原是由寄生虫培养物制成的， 洗涤，然后冷冻和解冻数次以破碎细胞。这些 尽管进行了高压灭菌，但粗制备物显示出良好的效果， 制剂在37 ℃下1个月后保持稳定。猴子实验在 评估安全性、免疫原性和有效性的进展 使用rHuIL-12作为佐剂的高压灭菌制剂。 我们计划提交一份 产品组合的IND，并开始临床试验， 国家卫生研究院年底前