ONCO VAX CL IN COLORECTAL CANCER

这是一项小型I期研究，其主要目的是确定疫苗的安全性以及转移性KSA阳性癌症患者对疫苗免疫的免疫应答，该疫苗由包封脂质A的明矾沉淀脂质体和重组KSA抗原组成。 免疫应答测定的重点是对免疫的细胞毒性T细胞应答。 还将评价临床反应。 将对所有接受至少一次免疫接种的患者进行评价和报告。目标是评价完成完整系列4次免疫接种并完成所有要求研究的6例患者。 如果任何患者不符合此标准，将由另一名患者替换。 如果确定了安全性，我们计划使用本研究的数据设计一项更大规模的I/II期研究，以获得有关疫苗安全性和免疫原性的更多信息。

This is a small phase I study, the main purpose of which is to determine the safety of the vaccine and the immunologic responses of patients with metastatic KSA positive cancer to immunization with a vaccine consisting of alum precipitated liposomes with encapsulated lipid A and recombinant KSA antigen. The focus of the determination of immunologic responses is on the cytotoxic T-cell response to immunization. Clinical responses will also be evaluated. All patients receiving at least one immunization will be evaluated and reported. The goal is to evaluate six (6) patients who complete the full series of four (4) immunizations and have all of the required studies completed. If any patient does not meet this criteria, he will be replaced by an additional patient. If safety is established, we plan to use the data from this study to design a larger phase I/II study to gain additional information regarding safety and immunogenicity of the vaccine.