CLINICAL TRIAL OF MELANOMA VACCINE AND IL-2 IN LIPOSOME

我们的长期目标是开发一种有效的疫苗来治疗，以及 可能是为了预防恶性黑色素瘤。作为这一进程的一部分，我们 寻求提高现有黑色素瘤疫苗的效力，该疫苗已经 在临床试验中显示了令人振奋的结果。 这项提议的目标是评估这一目标是否能够实现 通过将疫苗和IL-2一起封装到脂质体中。 我们的具体目标是：1)进行临床试验，以确定 多价黑色素瘤抗原疫苗的效力是否可以 通过将疫苗和IL-2一起封装到脂质体中而增加。 播散性黑色素瘤患者的序贯分组将得到治疗 用黑色素瘤疫苗单独或与 不同剂量的IL-2。在接种了4次疫苗后的一周， 抗黑色素瘤抗体与细胞免疫反应的不同 2)确定IL-2的最佳生物剂量 最大限度地增强疫苗诱导的免疫反应；3)评估 临床疗效；4)治疗的毒性。 这项工作的成功完成将提供基本的免疫学 合理提高黑色素瘤疗效所需的信息 疫苗，并可能导致改善对初级和 这种癌症的二级预防。更广泛地说，这些发现可能 为其他人提供增强疫苗免疫原性的方法 癌症和传染病。

Our long-term goal is to develop an effective vaccine to treat, and possibly to prevent, malignant melanoma. As part of this process, we seek to improve the potency of an existing melanoma vaccine which has shown promising results in clinical trials. The goal of this proposal is to evaluate whether this can be accomplished by encapsulating the vaccine together with IL-2 into liposomes. Our specific aims are: 1) To conduct a clinical trial to determine whether the potency of a polyvalent melanoma antigen vaccine can be increased by encapsulating the vaccine together with IL-2 into liposomes. Sequential groups of patients with disseminated melanoma will be treated with melanoma vaccine encapsulated into liposomes alone or together with different doses of IL-2. One week following 4 vaccine immunizations, antimelanoma antibody and cellular immune responses in the different groups will be compared; 2) determine the optimal biologic dose of IL-2 that maximally potentiates vaccine-induced immune responses; 3) evaluate the clinical effectiveness and; 4) the toxicity of this treatment. Successful completion of this work will provide basic immunological information necessary to rationally improve the effectiveness of melanoma vaccines, and may lead to improved treatments for the primary and secondary prevention of this cancer. More generally, the findings may provide means of augmenting the immunogenicity of vaccines for other cancers and for infectious diseases.