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Clinical Cancer Research Vol. 6, 1347-1350, April 2000
© 2000 American Association for Cancer Research

Clinical Trials

Delayed-Type Hypersensitivity Response Is a Predictor of Peripheral Blood T-Cell Immunity after HER-2/neu Peptide Immunization1

Mary L. Disis2, Kathy Schiffman, Theodore A. Gooley, Douglas G. McNeel, Kristine Rinn and Keith L. Knutson

Division of Oncology, University of Washington, Seattle, Washington 98195 [M. L. D., K. S., D. G. M., K. R., K. L. K.], and Fred Hutchinson Cancer Research Center, Seattle, Washington 98104 [T. A. G.]

Many groups that immunize cancer patients with cancer vaccines use the generation of a delayed-type hypersensitivity (DTH) response as the primary measure of the ability to immunize a patient to a tumor cell or specific tumor antigen. This study examines whether the development of a tumor antigen-specific DTH response, measured after vaccination with peptide-based vaccines, correlates to in vitro assessment of peripheral blood antigen-specific T-cell responses. The HER-2/neu protein was used as a model tumor antigen. Thirty-two patients who completed a course of immunization with HER-2/neu peptide-based vaccines were analyzed. HER-2/neu peptide-specific DTH responses (n = 93) and peripheral blood T-cell responses (n = 93) were measured 30 days after the final immunization. Size of DTH induration was correlated with HER-2/neu-specific T-cell proliferative responses assessed from peripheral blood lymphocytes isolated concurrently with peptide skin test placement. HER-2/neu peptide-specific DTH responses >=10 mm2 correlated significantly to a measurable peptide-specific peripheral blood T-cell response defined as stimulation index >2.0 (P = 0.0006). However, antigen-specific DTH responses with magnitudes between 5 and 9 mm2 were not significantly associated with the development of systemic immunity. DTH responses between 5 and 9 mm2 carried an odds ratio of 1.3 (P = 0.61) in predicting a measurable systemic tumor antigen response. The findings presented here demonstrate that tumor antigen-specific DTH responses >=10 mm2 correlate with measurable in vitro antigen-specific lymphocytic proliferation and are, in this model system, a reflection of systemic immunization.




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