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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 主要终点
- Immunogenicity
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •(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.)
排除标准
- •(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.
结局指标
主要结局
Immunogenicity
时间窗: 28 days after the second, third, and fourth doses of the investigational product
Geometric mean of neutralizing antibody titers against SARS-CoV-2
Safety - Adverse Events (First to Third Dose)
时间窗: 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
Safety - Unsolicited 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
Safety - Serious Adverse Events (Post Third Dose)
时间窗: 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
Safety - Serious Adverse Events (Post Fourth Dose)
时间窗: after the post fourth 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
Safety - 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 local adverse events
Safety - 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 solicited systemic adverse events
Safety - Adverse Events (Fourth Dose)
时间窗: after the fourth dose of the investigational product to the post fourth 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
Safety - Highest Body Temperature
时间窗: between each administration of the investigational product and 6 days post-injection
- The highest body temperature
次要结局
- Neutralizing antibody conversion rate against SARS-CoV-2(28 days after the first, second, third, and fourth doses)
- Summary statistics of neutralizing antibody titers against SARS-CoV-2(13, 26, and 52 weeks after the third dose; 13 and 26 weeks after the fourth dose)
- Geometric mean of neutralizing antibody titers against SARS-CoV-2 and changes by subject
- Seroprotection rate of neutralizing antibody against SARS-CoV-2(28 days after the first, second, and third doses; 13, 26, and 52 weeks after the third dose; 28 days after the fourth dose; 13 and 26 weeks after the fourth dose)
- Seroprotection rate of neutralizing antibody against SARS-CoV-2 in seroconverted subjects(13 and 26 weeks after the fourth dose)
- Geometric mean of neutralizing antibody titers against SARS-CoV-2(13, 26, and 52 weeks after the third dose; 13 and 26 weeks after the fourth dose)
- Geometric mean fold rise of neutralizing antibody titers against SARS-CoV-2(28 days after the fourth dose)