Placebo-controlled, multicenter, double-blind, randomized, parallel-group, comparative study to evaluate the safety and immunogenicity of KD-414, a vaccine against COVID-19, in healthy adults aged >=20 years to <65 years, and healthy elderly subjects aged >=65 years.
Placebo-controlled, multicenter, double-blind, randomized, parallel-group, comparative study to evaluate the safety and immunogenicity of KD-414, a vaccine against COVID-19, in healthy adults aged >=20 years to <65 years, and healthy elderly subjects aged >=65 years.
Matsumoto Takayuki
KM Biologics Co., Ltd.
1314-1 Kyokushi Kawabe, Kikuchi-shi, Kumamoto, Japan
+81-968-37-4081
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
Mar. 02, 2021
Mar. 02, 2021
210
Interventional
randomized controlled trial
double blind
placebo control
parallel assignment
prevention purpose
<Adult>
1) Healthy adults aged >=20 years to <65 years at the informed consent and at the first dose of study product (regardless of sex), and
2) Those who have provided a written informed consent.
<Elderly>
1) Healthy elderly subjects aged >=65 years at the first dose of study product (regardless of sex), and
2) Those who have provided a written informed consent.
1) Subjects who tested positive for COVID-19 by a PCR test at screening,
2) Subjects with COVID-19, or have a history of COVID-19 (based on the interview with subject),
3) Close contacts with patients with COVID-19 (based on the interview with subject),
4) Subjects with a history of overseas travel in and after January 2020 (based on the interview with subject),
5) Subjects who have been received any vaccines against COVID-19 (including unapproved drugs),
6) Subjects who have experienced documented anaphylaxis caused by an ingredient of the study product,
7) Pregnant or possibly pregnant women, women desiring to become pregnant before the end of the examination 28 days after the second dose, and breastfeeding women,
8) Patients with progressive ossifying fibrodysplasia,
9) Patients having an underlying disease, such as serious cardiovascular diseases, serious renal diseases, serious hepatic diseases, serious hematological diseases, serious developmental disorders, serious respiratory diseases, serious diabetes mellitus, etc.,
10) Subjects having experienced pyrexia or symptoms suggesting allergy, such as generalized exanthema, within 2 days after immunization (not applicable if the causative ingredient is confirmed not included in the study product),
11) Subjects with a history of convulsions,
12) Subjects having been diagnosed with immunodeficiency or having a close relative with congenital immunodeficiency,
13) Subjects possibly being allergic to any ingredient of the study product,
14) 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 study product in this study, or those who plan to participate in another clinical trial during their participation in this study,
15) 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 study product,
16) 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 study product, including 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.),
17) Subjects who are judged by the principal investigator or the subinvestigator as ineligible for the study as a result of the screening test, or
18) Subject being otherwise ineligible for this study in the principal investigator's or subinvestigator's opinion.
20age old over
No limit
Both
COVID-19
Inoculate KD-414 or placebo intramuscularly 2 doses of 0.5 mL at intervals of 27 days.
At 26 weeks after the second dose of the investigational product, 0.5 mL will be inoculated intramuscularly.
<Immunogenicity>
Neutralizing antibody conversion rate against SARS-CoV-2 at 28 days after the second dose of study product in each group
<Safety>
The incidence and causal relationship to the study products 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 study product to the examination 28 days after the second dose in each group
The incidence and causal relationship to the study products of adverse events resulting in death, serious adverse events other than death, and severe (Grade 3 or higher) adverse events occurring after the examination 28 days after the second dose to the completion of follow-up in each group
The incidence, severity, number of days to onset, duration, incidence by the first/second dose, and causal relationship to the study products of solicited local adverse events in each group
The incidence, severity, number of days to onset, duration, incidence by the first/second dose, and causal relationship to the study products of solicited systemic adverse events in each group
The incidence, severity, number of days to onset, duration, incidence by the first/second dose, and causal relationship to the study products of unsolicited adverse events in each group
The highest body temperature between each administration of the study product and 6 days post-injection in each group
< Immunogenicity Secondary endpoint>
Neutralizing antibody conversion rate against SARS-CoV-2 after the first dose and at 14 days after the second dose of study product in each group
Geometric mean of neutralizing antibody titers against SARS-CoV-2 after the first dose, and at 14 and 28 days after the second dose of study product in each group
Summary statistics of neutralizing antibody titers against SARS-CoV-2 after the first dose, and at 14 and 28 days after the second dose of study product in each group
Geometric mean of neutralizing antibody titers against SARS-CoV-2 in each group and changes by subject
Geometric mean of neutralizing antibody titers against SARS-CoV-2 at 13, 26, and 52 weeks after the second dose of study product in each group
Summary statistics of neutralizing antibody titers against SARS-CoV-2 at 13, 26, and 52 weeks after the second dose of study product in each group
Seroprotection rate of neutralizing antibody titers against SARS-CoV-2 after the first dose, at 14 and 28 days after the second dose, and at 13, 26, and 52 weeks after the second dose of study product in each group
Seroprotection rate of neutralizing antibody titers against SARS-CoV-2 at 13, 26, and 52 weeks after the second dose of study product in seroconverted subjects at 28 days after the second dose of study product in each group
Geometric mean fold rise of neutralizing antibody titers against SARS-CoV-2 after the first dose, and at 14 and 28 days after the second dose of study product in each group, compared to the titer before the first vaccination
< Immunogenicity Exploratory endpoint>
ELISA antibody titers against the S protein of SARS-CoV-2
