Multicenter, open-label, uncontrolled study to evaluate the safety and immunogenicity of KD-414, a vaccine against COVID-19, in healthy Japanese subjects aged 18 years or older.
Multicenter, open-label, uncontrolled study to evaluate the safety and immunogenicity of KD-414, a vaccine against COVID-19, in healthy Japanese subjects aged 18 years or older.
Shinmura Yasuhiko
KM Biologics Co., Ltd.
1314-1 Kyokushi Kawabe, Kikuchi-shi, Kumamoto, Japan
+81-968-37-4073
rinkai-jrct@kmbiologics.com
Fujita Yoichi
KM Biologics Co., Ltd.
1-6-1 Okubo, Kita-ku, Kumamoto-shi,Kumamoto, Japan
+81-96-344-1385
kmb-otoiawase@kmbiologics.com
Complete
Oct. 22, 2021
Oct. 22, 2021
2000
Interventional
single arm study
open(masking not used)
uncontrolled control
single assignment
prevention purpose
(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) Female subjects who are pregnant, may be pregnant, are desiring to become pregnant before completion of the test 28 days after the last dose of the study drug as specified, or are breast-feeding
(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.
18age old over
No limit
Both
Prevention of COVID-19
Intramuscularly administer 2 doses of 0.5 mL at an interval of 28 days, and a dose of 0.5 mL is administered intramuscularly at 13 weeks after the second dose. In addition, a dose of 0.5 mL is administered intramuscularly at least 26 weeks after the third dose.
[Immunogenicity]
Geometric mean of neutralizing antibody titers against SARS-CoV-2 at 28 days after the second, third, and fourth 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 third vaccination test
-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 fourth dose of the investigational product to the post fourth vaccination test
-The incidence and causal relationship to the investigational product of adverse events resulting in death and serious adverse events other than death occurring after the post third vaccination test to the completion of follow-up
-The incidence and causal relationship to the investigational product of adverse events resulting in death and serious adverse events other than death occurring after the post fourth vaccination test to the completion of follow-up
-The incidence, severity, number of days to onset, duration, incidence by the first/second/third/fourth 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/fourth 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/fourth 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
-Neutralizing antibody conversion rate against SARS-CoV-2 at 28 days after the first, second, third, and fourth doses of the investigational product
-Geometric mean of neutralizing antibody titers against SARS-CoV-2 at 28 days after the first dose of the investigational product
-Summary statistics of neutralizing antibody titers against SARS-CoV-2 at 28 days after the first, second, third, and fourth doses of the investigational product
-Geometric mean of neutralizing antibody titers against SARS-CoV-2 and changes by subject
-Geometric mean of neutralizing antibody titers against SARS-CoV-2 at 13, 26, and 52 weeks after the third dose, and at 13 and 26 weeks after the fourth dose of the investigational product
-Summary statistics of neutralizing antibody titers against SARS-CoV-2 at 13, 26, and 52 weeks after the third dose, and at 13 and 26 weeks after the fourth dose of the investigational product
-Seroprotection rate of neutralizing antibody against SARS-CoV-2 at 28 days after the first, second, and third doses, and at 13, 26, and 52 weeks after the third dose, and at 28 days after the fourth dose, and at 13 and 26 weeks after the fourth dose of investigational product
-Seroprotection rate of neutralizing antibody against SARS-CoV-2 at 13, 26, and 52 weeks after the third dose, and at 28 days after the fourth dose, and at 13 and 26 weeks after the fourth dose of the investigational product in seroconverted subjects at 28 days after the third dose of the investigational product
-Seroprotection rate of neutralizing antibody against SARS-CoV-2 at 13 and 26 weeks after the fourth dose of the investigational product in seroconverted subjects at 28 days after the fourth dose of the investigational product
-Geometric mean fold rise of neutralizing antibody titers against SARS-CoV-2 at 28 days after the first, second, and third doses of the investigational product, compared to the titer before the first vaccination
-Geometric mean fold rise of neutralizing antibody titers against SARS-CoV-2 at 28 days after the third dose of the investigational product, compared to the titer before the third vaccination
-Geometric mean fold rise of neutralizing antibody titers against SARS-CoV-2 at 28 days after the fourth dose of the investigational product, compared to the titer before the fourth vaccination
