Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects
Covid19
About this trial
This is an interventional prevention trial for Covid19 focused on measuring COVID-19 Prevention, SARS CoV-2, Coronavirus Vaccine
Eligibility Criteria
Inclusion Criteria:
- Japanese citizen
- Healthy adults aged ≥20 and <65 years, or healthy elderly aged ≥65 and <75 years (at the time of informed consent)
- Body Mass Index (BMI) is ≥17.5 and <30.0 kg/m^2 (at screening)
- Participants who can follow the compliance requirements during clinical trials, undergo medical examinations and tests specified by the protocol, and report symptoms, etc.
Exclusion Criteria:
- Have a history of immunodeficiency or having a close relative with congenital immunodeficiency.
- Have a history of SARS-CoV-2 infection.
- Have previously participated in an investigational study of SARS-Cov-2 vaccine or involving LNPs.
- Have a history of anaphylaxis or severe allergies due to food, cosmetics, medicines, or vaccination
- Have alcohol or drug dependence.
- Have a fever of ≥39.0°C or symptoms of suspected allergies such as systemic rash within 2 days after past vaccination, etc.
Sites / Locations
- SOUSEIKAI Hakata Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Cohort A1: DS-5670a 10 µg
Cohort A2: DS-5670a 30 µg
Cohort A3: DS-5670a 60 µg
Cohort A4: DS-5670a 100 µg
Cohort A: Placebo
Cohort B1: DS-5670a 10 µg
Cohort B2: DS-5670a 30 µg
Cohort B3: DS-5670a 60 µg
Cohort B4: DS-5670a 100 µg
Cohort B: Placebo
Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg.
Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg.
Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg.
Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg.
Healthy adults participants will be randomized to receive a intramuscular injection of placebo.
Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg.
Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg.
Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg.
Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg.
Healthy elderly participants will be randomized to receive a intramuscular injection of placebo.