Evaluation of Alpha Gal in Vaccines and Medications using a Human Monoclonal IgE Antibody

Abstract

Galactose-alpha-1,3-galactose (alpha-gal) sensitivity has emerged as a causal agent of red meat allergy and drug allergy. We aim to use the first panel of naturally-occurring alpha gal-specific human IgE mAbs from subjects with red meat allergy to develop a sensitive and specific assay to evaluate for the presence of alpha-gal in medications, blood samples, and foods. Full-length naturally-occurring human IgE mAb were generated from a subject with anaphylaxis to alpha-gal allergy using human B cell hybridoma technology. Using this IgE mAb the presence of alpha-gal antigen in medications and vaccinations will be evaluated using enzyme linked immunosorbent assay (ELISA), and Western blot. Human FcεRI transgenic alpha-gal knock out mice will be sensitized using the IgE mAb and exposed to cetuximab and other alpha-gal containing medications to demonstrate anaphylaxis. Human IgE mAbs specific for alpha gal from a subject with anaphylaxis were able to qualitatively detect the presence of alpha-gal allergen using ELISA assay in cetuximab. Standardization curves using dilutions to determine the quantity of alpha-gal in cetuximab will be performed. Once standardizations are complete, our assay can be used to evaluate and quantify alpha-gal in medications and vaccinations. We anticipate that Human FcεRI transgenic alpha-gal knock out mice will demonstrate anaphylaxis to cetuximab and other alpha-gal containing products when our IgE mAb is administered prior to drug challenge in an in vivo model. Alpha gal-specific human IgE mAbs from subjects with red meat allergy have the potential for use to evaluate and quantify alpha-gal antigen in current and novel therapeutics.