Toxicity, dermal reactions, and immunity to AE37. A, maximum local and systemic toxicities observed during vaccinations (graded according to common terminology criteria). B, dermal reactions (orthogonal mean ± SEM) were recorded 48 hours postvaccination throughout the vaccination series. **, P = 0.0013; ***, P < 0.0001. IFN-γ ELISPOT responses to AE37 (C) *, P < 0.05; **, P < 0.01 or to AE36 (D) ***, P < 0.001 during vaccinations with AE37. Specific spots (mean ± SEM) are shown at baseline (R0) and 1 month after each vaccination (R1–R6). E, individual pre vac and maximal (max) ELISPOT IFN-γ responses obtained during vaccination. Horizontal bars, median values. F, percent AE37 and AE36 specific immunity after vaccination. Gray, increased; hatched, unchanged; black, decreased. G, pre vac and maximal ELISPOT IFN-γ responses in patients with preexistent immunity to AE36. H, durable immunity to AE36 induced by the AE37 vaccine: mean ± SEM. IFN-γ ELISPOT responses to AE36 at long term did not differ compared with maximal responses. ***, P < 0.0001.
Increased numbers of both CD4+ and CD8+ IFN-γ–producing T cells after vaccination. Individual responses to AE37 (A and D) and AE36 (B and E). Vaccine-induced AE36-specific CD4+IFN-γ+ (C) or CD8+IFN-γ+ (F) subsets during vaccinations (maximal responses) and at long term. *, P < 0.05; **, P < 0.01; ***, P < 0.0001.
Biological and immunologic parameters pre vac, post vac, and at long term. A, circulating Tregs. Serum levels of TGF-β (B) and HER-ECD (D). C, correlation between percent change in TGF-β and percent change in Treg frequency at long term compared with pre vac values. Horizontal bars, median values. *, P < 0.05; ***, P < 0.001.
Comparison of immune parameters in vaccinated patients classified according to staging (stage II-III versus stage IV), sensitivity, or resistance to testosterone lowering (castrate-sensitive versus castrate-resistant, respectively) and the levels of their tumors' HER-2/neu expression (HER1+2+ versus HER3+). A to C, results represent maximal-specific spots divided by pre vac–specific spots. D to F, results represent DTH post vac minus DTH pre vac. G to I, plasma TGF-β concentrations. J to L, % circulating Tregs. Where not indicated, intragroup comparisons were not statistically significant. Total, all patients. Bars, mean values ± SEM. **, P < 0.01.