Clinical Data Ex-vivo immunologic recognition of E39 was assessed by clonal expansion of CTLs and in-vivo response by delayed-type hypersensitivity (DTH). Immunologic data was gathered at 1- and 6-months post-booster and was then analyzed. The 6-month post-PVS immunologic data was used to assess patients for SRI, defined as ≥2-fold increase from pre-PVS in E39-specific CD8+T-cells. Patients were sorted into two groups: those with SRI (SRI) and without (nSRI). Patients within each group were randomized to one booster of either E39’ or E39 resulting in four groups:

• SRI receiving E39 (SRI-E39)
• SRI receiving E39' (SRI-E39')
• nSRI receiving E39 (nSRI-E39)
• nSRI receiving E39' (nSRI-E39')

Sixteen patients were found to have SRI and 12 had nSRI; these patients were randomized to booster arms (SRI-E39:n=9; SRI-E39':n=7; nSRI-E39:n=7; nSRI-E39':n=5). There were no clinicopathologic differences between groups.  When comparing DTH pre-booster and at 1- and 6- months post-booster there were no significant differences between SRI vs nSRI (p=0.350, p=0.276, p=0.133, respectively), E39 vs. E39' (p=0.270, p=0.329, p=0.228), nor between all four groups (p=0.394, p=0.555, p=0.191). Comparing the change in CTL’s from pre- and 6-months post-booster, regardless of SRI, patients boosted with E39’ had increased CTL (+0.02) while those boosted with E39 had decreased CTL (-0.07, p=0.077). There was no difference comparing the change in DTH between groups (p=0.927).HLA-A2-positive breast or ovarian cancer patients were enrolled after completion of standard of care and without evidence of disease, regardless of FBP expression level. The PVS includes six inoculations, one every 3-4 weeks containing 250mcg GM-CSF plus 500mcg peptide in the first five patients per arm (n=14) and 250mcg GM-CSF + 1000mcg of peptide in the second five patients (n=16). Thirty-nine patients were randomized into three arms with 30 breast (n=27) or ovarian (n=3) cancer patients completing the PVS