Safety and immunogenicity one-month study in healthy individuals administered once-daily pill of therapeutic vaccine made from heat-inactivated plasma from donors with COVID-19. Healthy, at least 20, volunteers will be monitored for signs of adverse events. Their PBMC will be collected at baseline and one month later to analyze which type of immune response vaccine has induced.
Experimental batch of tableted thermostable vaccine obtained from pooled plasma of COVID-19 patients is produced. The goal of this trial is test safety and immunogenicity of once-per-day day administered orally to volunteers for 15 days. Baseline and post-treatment standard safety parameters will be compared. Blood samples from volunteers will be monitored and immunogenicity lab assays will be undertaken to characterize immune response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Therapeutic vaccine formulated as a pill derived from heat-inactivated plasma from COVID-19 patients administered once-per-day to at least 20 healthy volunters for at least one month
Immunitor Inc
Vancouver, BC - British Columbia, Canada
Aldar Bourinbayar
Ulaanbaatar, BZD, 3-khoroo, Mongolia
Effect on CBC as per CTCAE v4.0
Routine laboratory complete blood cell count at pre- and post-treatment periods by automated CBC counter Routine laboratory complete blood count Routine clinical laboratory CBC parameters at pre- and post-treatment periods
Time frame: 15 Days
Effect on biochemistry parameters as per CTCAE v4.0
Routine clinical laboratory blood biochemistry parameters at pre- and post-treatment periods by automated biochemistry analyzer
Time frame: 15 Days
Lack of adverse events as per CTCAE v4.0
Clinical well-being assessed by CTCAE v4.0
Time frame: 15 days
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