Prophylaxis of an infectious disease caused by SARS-CoV-2
Conditions
Interventions
Against the three variant strains of COVID-19, each combination of the same vaccines and different vaccines is to be dosed twice with 4-week interval. The combination makes 9 arms in the trial.
Sponsors
Tsuru Tomomi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Those who have provided the documented informed consent to participate in the research 2. Male / female adults aged 20 or older
Exclusion criteria
Exclusion criteria: 1. Those who clearly have a serious acute disease 2. Those who have a history of severe hypersensitivity to ingredients in the investigational product 3. Those who receive anticoagulation treatment or have thromboembolism, thrombocytopenia or clotting disorder 4. Those who have previously diagnosed with immunodeficiency or have any close relatives with congenital immunodeficiency 5. Those who have underlying disease such as cardiovascular disease, renal disease, hepatic disease, hematologic disease or developmental disability 6. Those who have been vaccinated with the investigational product 7. Those who have a history of capillary leak syndrome 8. Those who have been vaccinated with non-investigational product in 14 days prior to investigational product 9. Those who have received immunosuppressant (except for topical steroid, and low dose steroid used for less than 14 days) in 6 months prior to investigational product 10. Those who are considered inappropriate for the research at PI's (or SI's) discretion other than the above
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety: -Adverse Events -Assessment items in electronic health assessment diary 2. Antibody durability and Immunogenicity -SARS-CoV-2 serum neutralizing antibody -SARS-CoV-2 S binding antibody -SARS-CoV-2 N binding antibody -Cell-mediated immunity assessment (Confirming whether or not there are antigen-specific T cells / antigen-specific B cells) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Safety: -Weight and Vital signs 2) Antibody durability and Immunogenicity - Serum neutralizing antibody titer to a variant strain | — |
Contacts
Public ContactHiroko Kumashiro
SOUSEIKAI
Outcome results
None listed