Advance to Human Clinical Trials Task 1: Manufa
Post# of 36537
Quote:
Advance to Human Clinical Trials
Task 1: Manufacture 33 Laboratory Grade Ii-Key Peptide Vaccines
(The number of epitopes to be determined-see below) (Completed in US)
Party B has produced 33 laboratory-grade Ii-Key peptides for use in screening blood samples of people in the United States. According to the needs of the cooperative research team, Party B will produce more laboratory-grade Ii Key peptides (each small-scale production of about 20 mg) for screening the convalescent blood and serum samples of the entire population
Task 2: Screen Ii-Key-Epitope Peptides against convalescent serum from the all populations (All the population, in US, has completed)
Party B is currently screening the 33 Ii-Key-SARS-CoV-2 peptides against convalescent blood samples from COVID-19 recovered patients at a commercial laboratory and at an academic research institute in the U.S. to evaluate T-Cell activity and ability to bind neutralizing antibodies. The final Ii-Key polypeptide vaccine formulation will be grouped by HLA type.
NOTE: Because the Ii-Key is specific for human HLA complexes and HLA varies across ethnic populations, the Ii-Key-SARS-CoV-2 epitope peptides that work in the U.S. population may not be optimal for the East Asian population. Therefore, following the U.S. blood screening program, analyzing the T-Cell response data, and evaluating the HLA interactions of the Ii-Key-SARS-CoV-2 peptides, the cooperative research team will mutually determine which Ii-Key epitope peptides are optimal for the Chinese population, and conduct additional in-vitro T-Cell assays using convalescent blood samples from patients who have recovered from COVID-19 to develop vaccines to be used in China. Party B will provide technical solutions for T cell detection to the cooperative research team.
So what works in the US, may not work in China, therefore possibly new combinations will be needed, or maybe just a different one of the 33 will work better. So we may have the Chinese design done already.
BTW, didn't Joe say the peptides are being tested ex-vitro since it is blood outside the body. So should that point above be ex-vitro?