Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects
NCT ID: NCT04821674
Last Updated: 2022-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
142 participants
INTERVENTIONAL
2021-03-15
2022-07-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Cohort A1: DS-5670a 10 µg
Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg.
DS-5670a
DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Cohort A2: DS-5670a 30 µg
Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg.
DS-5670a
DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Cohort A3: DS-5670a 60 µg
Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg.
DS-5670a
DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Cohort A4: DS-5670a 100 µg
Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg.
DS-5670a
DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Cohort A: Placebo
Healthy adults participants will be randomized to receive a intramuscular injection of placebo.
Placebo
Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Cohort B1: DS-5670a 10 µg
Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg.
DS-5670a
DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Cohort B2: DS-5670a 30 µg
Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg.
DS-5670a
DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Cohort B3: DS-5670a 60 µg
Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg.
DS-5670a
DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Cohort B4: DS-5670a 100 µg
Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg.
DS-5670a
DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Cohort B: Placebo
Healthy elderly participants will be randomized to receive a intramuscular injection of placebo.
Placebo
Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Interventions
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DS-5670a
DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Placebo
Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Eligibility Criteria
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Inclusion Criteria
* 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 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.
20 Years
74 Years
ALL
Yes
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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SOUSEIKAI Hakata Clinic
Hakata, Fukuoka, Japan
Countries
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Other Identifiers
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jRCT2071200110
Identifier Type: OTHER
Identifier Source: secondary_id
DS5670-A-J101
Identifier Type: -
Identifier Source: org_study_id
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