This protocol tests the safety and efficacy of a novel universal vaccine concept called "allo-priming" which is designed to protect elderly adults from progression of any type of viral infection, including possible protection against progression of the current outbreak of COVID-19 infection, and any future variants, strains, mutations of the causative SARS-CoV-2 virus as well as protection from any future currently unknown newly emergent novel viruses.
The proposed Allo-Prime universal viral protection mechanism involves vaccination with a bioengineered living allogeneic cellular vaccine (AlloStim) derived from healthy blood donors. The vaccine is designed to create high titers of memory immune cells that are specific to the foreign antigens in the living cell vaccine. Upon encounter with any type of virus, these memory immune cells are activated and release cytokines including an immediate release of IFN-ϒ. This non-specific activation causes immune conditions similar to the conditions that occur in healthy younger patients that leads to rapid viral clearance and viral-specific memory immune response to clear infection and protect against recurrence.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
40
Living, activated allogeneic Th1-like memory immune cells
Delray Physician Care Center
Delray Beach, Florida, United States
Coral Research Clinic & Coral Diagnostic
Miami, Florida, United States
Model Research
Tampa, Florida, United States
Florida Medical Clinic, LLC
Zephyrhills, Florida, United States
frequency of vaccine events
vaccine events such as fever, rash, abnormal vital signs
Time frame: day 0 to day 28
Proportion of subjects with positive T-cell response
measurement of Th1/Th2 balance, allo-specific Th1/CTL response
Time frame: day 0 to 1 year
Proportion of subjects able to suppress viral propagation
ex-vivo challenge of blood samples with live virus including SARS-CoV-2, influenza A and B
Time frame: day 0 to 1 year
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