objectives
GAPVAC is among the first clinical projects in the direction of fully active personalized medicine, where patients are treated based on specific characteristics of their individual disease. For design and manufacturing of APVACs very sophisticated methods, have to be applied with the long-term objectives:
- to extend patients’ lives in a meaningful fashion
- to increase the proportion of patients responding to therapy
Since a fully personalized approach has never been tested in clinical development before, the primary objectives for the GAPVAC phase I clinical trial were:
- to demonstrate the feasibility of the approach and the capability of the consortium to design and to manufacture APVACs on-demand within a short period of time
- to show that actively personalized vaccines are well tolerated
- to demonstrate the biological activity of APVAC vaccinations
Further goals of the GAPVAC project
Apart from the primary objectives mentioned above, the GAPVAC project bears the potential to answer important scientific questions:
- Establish biomarkers associated with induction of immune responses and clinical endpoints
- Compare the immunogenicity of mutated and non-mutated antigenic peptides
- Discover and validate tumor-associated peptides presente d by soluble HLA molecules as an additional antigen source and as markers for tumor burden and relapse
- Investigate and compare immune responses to vaccinated antigens in the periphery but also in the tumor before and after vaccination