ONCO VAX CL IN COLORECTAL CANCER

这是一项小的I期研究，主要目的是确定疫苗的安全性和转移性KSA阳性癌症患者对由包裹脂质A的明矾沉淀脂质体和重组KSA抗原组成的疫苗的免疫应答。免疫应答测定的重点是细胞毒性T细胞对免疫的应答。临床反应也将进行评估。所有接受至少一次免疫接种的患者都将接受评估和报告。目标是评估六(6)名完成了完整系列四(4)次免疫接种并完成了所有必要研究的患者。如果任何患者不符合这一标准，他将被另一名患者取代。如果确定了安全性，我们计划利用这项研究的数据来设计一项更大的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.