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.
Biological: V-SARS
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
Inclusion Criteria:
- Confirmed cases of Covid-19 (all by RT-PCR from same laboratory)
- Mild to severe clinical presentation (identified at the time of admission to ward by
National Early Warning Score NEWS-2; mild 0-4; severe 5-6)
Exclusion Criteria:
- Unable to take oral medication,
- Immunocompromised
- Known comorbid condition like hypertension, cardiovascular disease, diabetes mellites,
asthma, COPD, cerebrovascular disorder, malignancy of any type, pregnancy,
- BMI less than 18
- Smoking history (more than one pack per day)
Immunitor Inc
Vancouver, BC - British Columbia, Canada
Aldar Bourinbayar
Ulaanbaatar, BZD, 3-khoroo, Mongolia
Aldar Bourinbayar, MD/PhD, Principal Investigator
Immunitor LLC