COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCTs031210370

Hiroko Kumashiro

hiroko-kumashiro@lta-med.com

2021-10-08

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Prevention

1. Those who have provided the documented informed consent to participate in the research2. Male / female adults aged 20 or older

1. Those who clearly have a serious acute disease2. Those who have a history of severe hypersensitivity to ingredients in the investigational product3. Those who receive anticoagulation treatment or have thromboembolism, thrombocytopenia or clotting disorder4. Those who have previously diagnosed with immunodeficiency or have any close relatives with congenital immunodeficiency5. Those who have underlying disease such as cardiovascular disease, renal disease, hepatic disease, hematologic disease or developmental disability6. Those who have been vaccinated with the investigational product7. Those who have a history of capillary leak syndrome8. 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 product10. Those who are considered inappropriate for the research at PI's (or SI's) discretion other than the above

1

Tsuru Tomomi

20

100

Japan

Healthy volunteers

N/A

270

1. Safety:-Adverse Events-Assessment items in electronic health assessment diary2. 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)

Not reported

[{"arm_notes": "2nd dose;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.", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}]