Transferon™, a peptide mixture with immunomodulatory properties is not immunogenic when administered with various adjuvants

Sandra Avila, Leslie Muñoz-García, Said Vázquez-Leyva, Nohemí Salinas-Jazmín, Emilio Medina-Rivero, Lenin Pavón, Gabriela Mellado-Sánchez, Rommel Chacón-Salinas, Sergio Estrada-Parra, Luis Vallejo-Castillo, Sonia Mayra Pérez-Tapia

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3 Scopus citations

Abstract

Transferon, a human dialyzable leukocyte extract (hDLE), is a biotherapeutic that comprises a complex mixture of low-molecular-weight peptides (<10 kDa) and is used to treat diseases with an inflammatory component. Some biotherapeutics, including those composed of peptides, can induce anti-drug antibodies (ADA) that block or diminish their therapeutic effect. Nevertheless, few studies have evaluated peptidederived drug immunogenicity. In this study, the immunogenicity of Transferon was examined in a murine model during an immunization scheme using the following adjuvants: Al(OH)3, incomplete Freund's adjuvant (IFA), or Titermax Gold. The inoculation scheme entailed three routes of administration (intraperitoneal, Day 1; subcutaneous, Day 7; and intramuscular, Day 14) using 200 lg Transferon/inoculation. Serum samples were collected on Day 21. Total IgG levels were quantitated by affinity chromatography, and specific antibodies against components of Transferon were analyzed by dot-blot and ELISA. Ovalbumin (OVA, 44 kDa) and peptides from hydrolyzed collagen (PFHC,<17 kDa) were used as positive and negative controls, respectively, in the same inoculation scheme and analyses for Transferon. OVA, PFHC, and Transferon increased total IgG concentrations in mice. However, only IgG antibodies against OVA were detected. Based on the results, it is concluded that Transferon does not induce generation of specific antibodies against its components in this model, regardless of adjuvant and route of administration. These results support the safety of Transferon by confirming its inability to induce ADA in this animal model.

Original languageEnglish
Pages (from-to)169-177
Number of pages9
JournalJournal of Immunotoxicology
Volume14
Issue number1
DOIs
StatePublished - 1 Jan 2017

Keywords

  • ADA
  • Adjuvants
  • Immunogenicity
  • Transferon™
  • hDLE

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