Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects
Study Details
Study Description
Brief Summary
This study will assess the safety, tolerability and immunogenicity of DS-5670a (COVID-19 Vaccine) and determine the recommended dose in Japanese healthy adults and elderly participants.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cohort A1: DS-5670a 10 µg Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg. |
Biological: 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
|
Experimental: Cohort A2: DS-5670a 30 µg Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg. |
Biological: 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
|
Experimental: Cohort A3: DS-5670a 60 µg Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg. |
Biological: 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
|
Experimental: Cohort A4: DS-5670a 100 µg Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg. |
Biological: 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 Comparator: Cohort A: Placebo Healthy adults participants will be randomized to receive a intramuscular injection of placebo. |
Biological: Placebo
Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
|
Experimental: Cohort B1: DS-5670a 10 µg Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg. |
Biological: 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
|
Experimental: Cohort B2: DS-5670a 30 µg Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg. |
Biological: 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
|
Experimental: Cohort B3: DS-5670a 60 µg Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg. |
Biological: 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
|
Experimental: Cohort B4: DS-5670a 100 µg Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg. |
Biological: 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 Comparator: Cohort B: Placebo Healthy elderly participants will be randomized to receive a intramuscular injection of placebo. |
Biological: Placebo
Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Reporting Treatment-emergent Adverse Events [Day 1 up to Day 57 post-dose]
- Number of Participants Reporting Local and Systemic Adverse Events [Day 1 up to Day 14 post-first and second dose]
- Number of Participants Reporting Serious Events [Day 1 up to 12 months post-second dose]
- Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody [Days 15, 29, 43, and 57 post-dose]
- Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific Neutralizing Antibody [Days 15, 29, 43, and 57 post-dose]
- Seroconversion Rates of SARS-CoV-2 Specific Neutralizing Antibody [Days 15, 29, 43, and 57 post-dose]
Secondary Outcome Measures
- GMT of anti-IgG Antibody [Days 15, 29, 43, and 57 post-dose]
- GMFR of anti-IgG Antibody [Days 15, 29, 43, and 57 post-dose]
- Seroconversion Rates of anti-IgG Antibody [Days 15, 29, 43, and 57 post-dose]
- Pharmacokinetic Parameter of Maximum (Peak) Observed Plasma Concentration (Cmax) Following Intramuscular Injection of DS-5670a [Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose]
Cmax of plasma MAFB-7566a and constituent lipids of lipid nanoparticle (LNP) will be assessed.
- Pharmacokinetic Parameter of Time to Reach Maximum Concentration (Tmax) Following Intramuscular Injection of DS-5670a [Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose]
Tmax of plasma MAFB-7566a and constituent lipids of LNP will be assessed.
- Pharmacokinetic Parameter of Area Under the Concentration-time Curve Following Intramuscular Injection of DS-5670a [Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose]
Area under the concentration-time curve from time 0 to last measurable time point (AUClast) and time 0 to infinity (AUCinf) of plasma MAFB-7566a and constituent lipids of LNP will be assessed.
- Pharmacokinetic Parameter of Apparent Total Body Clearance (CL/F) Following Intramuscular Injection of DS-5670a [Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose]
CL/F of plasma MAFB-7566a and constituent lipids of LNP will be assessed.
- Pharmacokinetic Parameter of Terminal Elimination Half-life (t1/2) Following Intramuscular Injection of DS-5670a [Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose]
Half-life (t1/2) of plasma MAFB-7566a and constituent lipids of LNP will be assessed.
- Pharmacokinetic Parameter of Apparent Volume of Distribution (Vz/F) Following Intramuscular Injection of DS-5670a [Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose]
Vz/F of plasma MAFB-7566a and constituent lipids of LNP will be assessed.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Japanese citizen
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Healthy adults aged ≥20 and <65 years, or healthy elderly aged ≥65 and <75 years (at the time of informed consent)
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Body Mass Index (BMI) is ≥17.5 and <30.0 kg/m^2 (at screening)
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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:
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Have a history of immunodeficiency or having a close relative with congenital immunodeficiency.
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Have a history of SARS-CoV-2 infection.
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Have previously participated in an investigational study of SARS-Cov-2 vaccine or involving LNPs.
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Have a history of anaphylaxis or severe allergies due to food, cosmetics, medicines, or vaccination
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Have alcohol or drug dependence.
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Have a fever of ≥39.0°C or symptoms of suspected allergies such as systemic rash within 2 days after past vaccination, etc.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | SOUSEIKAI Hakata Clinic | Hakata | Fukuoka | Japan | 812-0025 |
Sponsors and Collaborators
- Daiichi Sankyo Co., Ltd.
Investigators
- Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DS5670-A-J101
- jRCT2071200110