ask 3: Conduct Immunogenicity study of Ii-Key-Epit
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Posted On: 11/18/2020 2:27:36 PM
Quote:
ask 3: Conduct Immunogenicity study of Ii-Key-Epitope Peptides in the DR4 humanized transgenic mouse model with Human HLA (complete by US and China team)
NOTE: Because the Ii-Key is specific for human HLA complexes to activate human CD-4 responses, animals will not respond the same as humans to Ii-Key Peptide Vaccines. Human Ii-Key does not bind to animal MHC complexes to activate animal CD-4 responses. Therefore, transgenic animal models with human immune cells are needed for immunogenicity trials in animals. Party B has plans to evaluate the U.S. formulation of the Ii-Key-SARS-CoV-2 vaccine in mouse immunogenicity studies using the DR4-Transgenic mouse model. Party B will provide the study report to Party C for filing with the NMPA. If the pre clinical study reports are not sufficient for the NMPA, Party C agree to conduct any and all pre-clinical and immunogenicity studies required by the NMPA to enable human clinical trials in China.
I thought we don't need animal studies, so what's the point of going backwards? Probably not reading this right.
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