Btw - looks like the plan is have 2 phases instead
Post# of 36533
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Posted On: 05/02/2020 2:02:34 PM
Re: Paul Jackson #15740
Btw - looks like the plan is have 2 phases instead of the usual 3 phases for the clinical trial....phase 1 - 20 subjects, phase 2 - 120 subjects
We are at pre-clinical stage -
Per 4/27 PR - this is where are at now - manufacturing peptides...so obviously they have identified possible peptides.
We are manufacturing these peptides with the Ii-Key and will be screening them against blood samples from patients who have recovered from COVID-19. The blood from previously infected individuals contains T-Cells and antibodies that have actually worked to neutralize the coronavirus infection so the patients could recover from COVID-19.
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I wrote -
Per gnbt’s 4/14 PR, looks like phase I and II, each take 31 days to complete.
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.
Read More: https://investorshangout.com/post/newpost/622...z6LJ8844gB
We are at pre-clinical stage -
Per 4/27 PR - this is where are at now - manufacturing peptides...so obviously they have identified possible peptides.
We are manufacturing these peptides with the Ii-Key and will be screening them against blood samples from patients who have recovered from COVID-19. The blood from previously infected individuals contains T-Cells and antibodies that have actually worked to neutralize the coronavirus infection so the patients could recover from COVID-19.
______
I wrote -
Per gnbt’s 4/14 PR, looks like phase I and II, each take 31 days to complete.
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.
Read More: https://investorshangout.com/post/newpost/622...z6LJ8844gB
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