COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCT2071210081

Yoichi Fujita

kmb-otoiawase@kmbiologics.com

2021-10-22

Not recruiting

RCT

Randomized

Single group assignment

Open label

single-center

Prevention

(1) Japanese subjects aged 18 years or older at the time of informed consent (regardless of sex)(2) Subjects with written consent (in the case of a minor subject, whose legally acceptable representatives have provided written informed consent.)

(1) Subjects infect with the novel coronavirus (SARS-CoV-2), or previously infected with SARS-CoV-2 (based on the interview with subject),(2) Close contacts with patients with infected with SARS-CoV-2 (except those denied infection by testing) (based on the interview with subject),(3) Subjects who have been received any vaccines against the novel coronavirus (including unapproved drugs),(4) Subjects who have experienced documented anaphylaxis caused by an ingredient of the investigational product (thimerosal),(5) Pregnant or possibly pregnant women, women desiring to become pregnant before the end of the post vaccination test, and breastfeeding women,(6) Patients with progressive ossifying fibrodysplasia,(7) Subjects with a history of Guillain-Barre syndrome or other demyelinating disease,(8) Subjects with a history of capillary leak syndrome(9) Subjects with clinically significant bleeding or a history of serious bleeding or internal bleeding after intramuscular or intravenous injection,(10) Subjects with previous thrombocytopenia or venous or arterial thrombosis associated with thrombocytopenia,(11) Subjects who are immunosuppressed or immunocompromised, including subjects with asplenic syndrome, or suspected of having such conditions(12) Subjects who participated in another clinical trial and have received another investigational product (excluding placebo) within 4 months (120 days) prior to the date of the first dose of the investigational product in this study, those who plan to participate in another clinical trial during their participation in this study, or those who are scheduled to receive the novel corona vaccine,(13) Subjects who have received transfusion or a gamma globulin preparation within 3 months (90 days), or a bolus therapy (>=200 mg/kg) with a gamma globulin preparation within 6 months (180 days), prior to the date of the first dose of the investigational product,(14) Subject who have received any treatments that may affect the immune function* within 6 months (180 days) prior to the date of the first dose of the investigational product, radiotherapy, immunosuppressants (except for external use), immunosuppressive therapy, antirheumatics, adrenocorticotropic hormones, or corticosteroids (treatment at prednisolone equivalent doses >=2 mg/kg/day for >=14 days, except for external use.).(15) Subjects having an underlying disease, such as cardiovascular diseases, renal diseases, hepatic diseases, hematological diseases, developmental disorders, respiratory diseases, diabetes mellitus, etc., whose symptoms are unstable and for whom the principal investigator or the subinvestigator judged that there are difficulties in participating in the study,(16) Subject being otherwise ineligible for this study in the principal investigator's or subinvestigator's opinion.

3

Oda Yoshiaki

18

100

Japan

Healthy volunteers

N/A

2000

[Immunogenicity]Geometric mean of neutralizing antibody titers against SARS-CoV-2 at 28 days after the second and third doses of the investigational product[Safety]-The incidence and causal relationship to the investigational product of all adverse events; adverse events resulting in death; serious adverse events other than death; important adverse events; and severe (Grade 3 or higher) adverse events occurring after the first dose of the investigational product to the post vaccination test-The incidence and causal relationship to the investigational product of adverse events resulting in death; serious adverse events other than death; and severe (Grade 3 or higher) adverse events occurring after the post vaccination test to the completion of follow-up-The incidence; severity; number of days to onset; duration; incidence by the first/second/third dose; and causal relationship to the investigational product of solicited local adverse events-The incidence; severity; number of days to onset; duration; incidence by the first/second/third dose; and causal relationship to the investigational product of solicited systemic adverse events-The incidence; severity; number of days to onset; duration; incidence by the first/second/third dose; and causal relationship to the investigational product of unsolicited adverse events-The highest body temperature between each administration of the investigational product and 6 days post-injection

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 703, "treatment_name": "Kd-414", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]