Phase I clinical trial of the vaccination for the patients with metastatic melanoma using gp100-derived epitope peptide restricted to HLA-A*2402

Table 3 The results of immunological monitoring

Patients	Times of vaccination (Course)	Follow-up	ELISPOT assay (IFN-γ)	Dextramer assay (The frequency of peptide specific CTLs)
P1	12 (3)	13 months	++	+
P2	8 (2)	8 months	++	++
P3	8 (2)	7 months	+	++
P4	4 (1)	2 months	++	+
P5	2 (1)	1 month	-	++
P6	4 (1)	4 months	-	+

The characteristics of patients exhibiting objective immunological responses. In ELISPOT assay, the responses of the patients were evaluated as ++ (strongly positive), if the numbers of IFN-γ positive spots after the vaccinations increased more than two fold when compared with the numbers at pre-vaccination. If the increase was in between one to two fold, they were evaluated as + (marginally positive). These assays were performed at least three times to confirm reproducibility.

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