Generex Biotechnology Corporation announced that the company has completed the mouse immunogenicity study with transgenic mice that have been genetically engineered with a gene from the human immune system called the DR4 human leukocyte antigen (HLA) allele, which is one of hundreds of alleles in the human immune system. HLAs are proteins - or markers -found on most cells in your body. Your immune system uses these markers to recognize which cells belong in your body and which do not. So, for example, HLA is used to match patients and donors for bone marrow or organ transplants. The Ii-Key is specific for human HLA, so therefore does not work in other species, making it difficult to evaluate vaccine efficacy in animal models. The DR4 transgenic mouse provides an opportunity to evaluate the ability of Ii-Key vaccines to generate immune responses in an animal model, recognizing that the DR4 allele is only one of dozens of human HLA epitopes contained in the Ii-Key-SARS-CoV-2 vaccine. The results of the mouse immunogenicity study demonstrated that the Ii-Key vaccine in combination with the adjuvant produced antibodies that are directed against the Ii-Key-SARS-CoV-2 epitopes as measured by ELISA assay. T cells from the mice reacted strongly to stimulation by the Ii-Key vaccine in ex vivo studies of the mouse spleen cells which contain T and B cells, dendritic cells and macrophages, which have different immune functions. These results in a mouse model of the human immune system indicate the potential for Ii-Key-SARS-CoV-2 to be a Complete Vaccine™, though the true potential can only be determined in human clinical trials. A Complete Vaccine is designed to regulate the immune system to provide a targeted, neutralizing antibody response without generating off-target, non-neutralizing antibodies that can lead to antibody dependent enhancement of disease (ADE); further a complete vaccine should activate the appropriate T cell responses to yield long-term immune memory without activating detrimental Th2 responses that have been associated with immune-related complications of COVID-19 disease.