Herpes Murine Model as a Biological Assay to Test Dialyzable Leukocyte Extracts Activity

Abstract EN

Human dialyzable leukocyte extracts (DLEs) are heterogeneous mixtures of low-molecular-weight peptides that are released on disruption of peripheral blood leukocytes from healthy donors.

DLEs improve clinical responses in infections, allergies, cancer, and immunodeficiencies.

Transferon is a human DLE that has been registered as a hemoderivate by Mexican health authorities and commercialized nationally.

To develop an animal model that could be used routinely as a quality control assay for Transferon, we standardized and validated a murine model of cutaneous HSV-1 infection.

Using this model, we evaluated the activity of 27 Transferon batches.

All batches improved the survival of HSV-1-infected mice, wherein average survival rose from 20.9% in control mice to 59.6% in Transferon-treated mice.

The activity of Transferon correlated with increased serum levels of IFN- γ and reduced IL-6 and TNF- α concentrations.

Our results demonstrate that (i) this mouse model of cutaneous herpes can be used to examine the activity of DLEs, such as Transferon; (ii) the assay can be used as a routine test for batch release; (iii) Transferon is produced with high homogeneity between batches; (iv) Transferon does not have direct virucidal, cytoprotective, or antireplicative effects; and (v) the protective effect of Transferon in vivo correlates with changes in serum cytokines.