Clinical Safety and Immunogenicity of Tumor-Targeted, Plant-Made Id-KLH Conjugate Vaccines for Follicular Lymphoma

Table 4

Humoral and cellular responses to vaccination in the eleven evaluable FL patients on study.

Patient UPIN^1	Tumor class	Number of vaccinations^2	Immune status (lymphocyte number)	Humoral				Cellular response^8
				ELISA			Flow Cytometry^7	T-cell proliferation	ELISpot
				KLH^4	Plant Id^5	Hybridoma Id^6
U001	IgM-lambda	12 of 12	Normal total lymphocyte count; Low CD4+ T-cell count	+	+	+	+	+	−
T003	IgM-kappa	12 of 12	Lymphopenic (all subsets)	+	−	−	ND	−	−
T006	IgG-lambda	12 of 12	Normal total lymphocyte count; Low CD4+ T-cell count	+	−	ND	ND	+	+
T008	IgM-kappa	7 of 12	Lymphopenic; Normal CD8+ T-cell count	+	−	−	ND	−	−
T010	IgG-kappa	9 of 12	Normal total lymphocyte count; Low CD4+ T-cell count	−	−	−	ND	+	+
U011	IgM-kappa	12 of 12	Lymphopenic (all T-cell subsets)	+	+	+	+	+	+
U016	IgM-lambda	12 of 12	Lymphopenic (all T-cell subsets)	+	−	−	ND	+	−
U017	IgM-kappa; IgG-kappa	12 of 12	Normal total lymphocyte count; Low CD4+ T-cell count	+	−	ND	ND	+	+
T021	IgG-lambda	9 of 11	Normal total lymphocyte count; Low CD4+ T-cell count; Borderline CD19+ B-cell count	−	+	−	−	+	−
T022	IgG-kappa	12 of 12	Normal total lymphocyte count; Low CD4+ T-cell count; Low CD19+ B-cell count	−	−	−	ND	+	−
U026	IgM-lambda	12 of 12	Lymphopenic (all subsets)	+	−	ND	ND	+	−

+ = Positive response; − = Negative response; ND = Not determined. 1 = Unique Patient Identification Number. 2 = Number of vaccines administered of the maximum 12 vaccines scheduled. 3 = Humoral responses were measured by ELISA and by flow cytometry. 4 = Specific response to KLH by ELISA was included to assess patients’ overall immune responsiveness. 5 = Plant-made idiotype administered in the clinical study. 6 = Equivalent Id made in hybridoma to cross-check immune response to plant-made Id. 7 = Flow cytometry was used only as a confirmatory assay for humoral response when positive ELISA responses were measured. 8 = Cellular immune responses were measured by T-cell proliferation and by ELISpot.