Optimized phase I-II trial design for vaccination with epidermal growth factor (EGF): Effect on immunogenicity and safety

2610 Background: We have previously studied immunogenicity and safety of vaccination with EGF on advanced NSCLC patients. More than 70 patients were immunized in several pilot clinical trials. Here we present the preliminary results from a Phase I-II clinical trial in which we optimized the immunization protocol to improve vaccination effects. Methods: Immediately after diagnosis, 16 stages IIIb and IV NSCLC patients were enrolled in the trial. Each vaccination comprised a total dose of 200 ug (EGF) divided in 4 immunization sites. Vaccinations were administered on days 0 and 14. Chemotherapy (4–6 cycles of cisplatin-based regime) was initiated 14 days after the 2nd vaccine dose. Vaccinations continued on day 32 after the completion of chemotherapy and then monthly. The vaccine was composed of human recombinant EGF conjugated to P64K as carrier protein and emulsified in Montanide ISA51 (adjuvant). Sera anti-EGF antibody (Ab) titers as well as plasma EGF concentration ([EGF]) were measured monthly. Results...