Preventative anti-cancer vaccination strategies have long been hampered by the challenge of targeting the diverse array of potential tumor antigens, with successes to date limited to cancers with viral etiologies. Identification and vaccination against frameshift neoantigens conserved across multiple species and tumor histologies is a potential cancer preventative strategy currently being investigated. Companion dogs spontaneously develop cancers at a similar incidence to those in people and are a complementary comparative patient population for the development of novel anti-cancer therapeutics. In addition to an intact immune system with tumors that arise in an autochthonous tumor microenvironment, dogs also have a shorter lifespan and temporally compressed tumor natural history as compared to humans, which allows for more rapid evaluation of safety, immunogenicity, and efficacy of cancer vaccination strategies. Here we describe the study protocol for the Vaccination Against Canine Cancer Study (VACCS), the largest interventional cancer clinical trial conducted in companion dogs to date. In addition to safety and immunogenicity, the primary endpoint of VACCS is the cumulative incidence (CI) of dogs developing malignant neoplasia of any type at the end of the study period. Secondary endpoints include changes in incidence of specific tumor types, survival times following neoplasia diagnosis, and all-cause mortality.

预防性抗癌疫苗接种策略长期以来一直受到针对多种潜在肿瘤抗原的挑战的阻碍，迄今为止的成功仅限于病毒病因的癌症。针对跨多个物种和肿瘤组织学保守的移码新抗原的鉴定和疫苗接种是目前正在研究的一种潜在的癌症预防策略。伴侣犬自发患癌症的几率与人类相似，是开发新型抗癌疗法的补充比较患者群体。除了具有在原生肿瘤微环境中产生的肿瘤的完整免疫系统之外，与人类相比，狗的寿命更短，肿瘤自然史也更短，这使得可以更快速地评估癌症疫苗接种的安全性、免疫原性和有效性策略。在这里，我们描述了犬癌症疫苗接种研究 (VACCS) 的研究方案，这是迄今为止在伴侣犬中进行的最大的介入性癌症临床试验。除了安全性和免疫原性之外，VACCS 的主要终点是在研究期结束时犬患任何类型恶性肿瘤的累积发病率 (CI)。次要终点包括特定肿瘤类型发生率的变化、肿瘤诊断后的生存时间以及全因死亡率。