Generex President & CEO Joseph Moscato said, “My team and I are in discussions with the U.S. government about funding our vaccine development program, and we are speaking with people at Health Canada this week to discuss the Canadian regulatory path for approval in Canada. Our current plan is to conduct a clinical trial of our Ii-Key multivalent peptide vaccine to evaluate safety and immunogenicity as defined by activation of the cellular and humoral response. The 3-arm study design will compare the Ii-Key-SARS-CoV-2 vaccine alone and with immune adjuvant versus adjuvant alone. In the first stage of this immunogenicity trial, 20 healthy subjects will be enrolled in each arm, and will be vaccinated at day 0, given a booster vaccination on day 21, and have blood drawn for evaluation of immune response on day 31. A data safety monitoring board will review the interim results for safety and immune response before providing a go/no go decision to complete enrollment in the extension stage of the trial, which will enroll a total of an estimated 120 subjects. If approved by the FDA, this protocol will establish the data foundation for a large scale, mass vaccination protocol under an EUA.
hmmm.
