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.
- Conditions
- Prevention of COVID-19
- Registration Number
- JPRN-jRCT2071210081
- Lead Sponsor
- Shinmura Yasuhiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 2000
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method