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 Blood, 17 September 2009, Vol. 114, No. 12, pp. 2417-2426.
Prepublished online as a Blood First Edition Paper on July 15, 2009; DOI 10.1182/blood-2008-12-189266.

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IMMUNOBIOLOGY

Safety and immunologic effects of IL-15 administration in nonhuman primates

Carolina Berger1,2, Michael Berger1, Robert C. Hackman1,3, Michael Gough4, Carole Elliott4, Michael C. Jensen5, and Stanley R. Riddell1,2

1 Fred Hutchinson Cancer Research Center (FHCRC), Seattle, WA; Departments of 2 Medicine, and 3 Pathology, University of Washington, Seattle; 4 University of Washington National Primate Research Center, Seattle; and 5 City of Hope National Medical Center, Duarte, CA

The administration of cytokines that modulate endogenous or transferred T-cell immunity could improve current approaches to clinical immunotherapy. Interleukin-2 (IL-2) is used most commonly for this purpose, but causes systemic toxicity and preferentially drives the expansion of CD4+CD25+Foxp3+ regulatory T cells, which can inhibit antitumor immunity. IL-15 belongs to the {gamma}c cytokine family and possesses similar properties to IL-2, including the ability to induce T-cell proliferation. Whereas IL-2 promotes apoptosis and limits the survival of CD8+ memory T cells, IL-15 is required for the establishment and maintenance of CD8+ T-cell memory. However, limited data are available to guide the clinical use of IL-15. Here, we demonstrate in nonhuman primates that IL-15 administration expands memory CD8+ and CD4+ T cells, and natural killer (NK) cells in the peripheral blood, with minimal increases in CD4+CD25+Foxp3+ regulatory T cells. Daily administration of IL-15 resulted in persistently elevated plasma IL-15 levels and transient toxicity. Intermittent administration of IL-15 allowed clearance of IL-15 between doses and was safe for more than 3 weeks. These findings demonstrate that IL-15 has profound immunomodulatory properties distinct from those described for IL-2, and suggest that intermittent administration of IL-15 should be considered in clinical studies.


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