Back to resultsStudy of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects
Primary Purpose
Covid19
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
DS-5670a
Placebo
Sponsored by
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
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
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
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Participants Reporting Treatment-emergent Adverse Events
Number of Participants Reporting Local and Systemic Adverse Events
Number of Participants Reporting Serious Events
Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific Neutralizing Antibody
Seroconversion Rates of SARS-CoV-2 Specific Neutralizing Antibody
Secondary Outcome Measures
GMT of anti-IgG Antibody
GMFR of anti-IgG Antibody
Seroconversion Rates of anti-IgG Antibody
Pharmacokinetic Parameter of Maximum (Peak) Observed Plasma Concentration (Cmax) Following Intramuscular Injection of DS-5670a
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
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
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
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
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
Vz/F of plasma MAFB-7566a and constituent lipids of LNP will be assessed.
Full Information
NCT ID
NCT04821674
First Posted
March 25, 2021
Last Updated
August 29, 2022
Sponsor
Daiichi Sankyo Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04821674
Brief Title
Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects
Official Title
A Phase 1/2 Study to Assess the Safety, Immunogenicity and Recommended Dose of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
August 13, 2021 (Actual)
Study Completion Date
July 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID-19 Prevention, SARS CoV-2, Coronavirus Vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort A1: DS-5670a 10 µg
Arm Type
Experimental
Arm Description
Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg.
Arm Title
Cohort A2: DS-5670a 30 µg
Arm Type
Experimental
Arm Description
Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg.
Arm Title
Cohort A3: DS-5670a 60 µg
Arm Type
Experimental
Arm Description
Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg.
Arm Title
Cohort A4: DS-5670a 100 µg
Arm Type
Experimental
Arm Description
Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg.
Arm Title
Cohort A: Placebo
Arm Type
Placebo Comparator
Arm Description
Healthy adults participants will be randomized to receive a intramuscular injection of placebo.
Arm Title
Cohort B1: DS-5670a 10 µg
Arm Type
Experimental
Arm Description
Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg.
Arm Title
Cohort B2: DS-5670a 30 µg
Arm Type
Experimental
Arm Description
Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg.
Arm Title
Cohort B3: DS-5670a 60 µg
Arm Type
Experimental
Arm Description
Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg.
Arm Title
Cohort B4: DS-5670a 100 µg
Arm Type
Experimental
Arm Description
Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg.
Arm Title
Cohort B: Placebo
Arm Type
Placebo Comparator
Arm Description
Healthy elderly participants will be randomized to receive a intramuscular injection of placebo.
Intervention Type
Biological
Intervention Name(s)
DS-5670a
Intervention Description
DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Primary Outcome Measure Information:
Title
Number of Participants Reporting Treatment-emergent Adverse Events
Time Frame
Day 1 up to Day 57 post-dose
Title
Number of Participants Reporting Local and Systemic Adverse Events
Time Frame
Day 1 up to Day 14 post-first and second dose
Title
Number of Participants Reporting Serious Events
Time Frame
Day 1 up to 12 months post-second dose
Title
Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody
Time Frame
Days 15, 29, 43, and 57 post-dose
Title
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific Neutralizing Antibody
Time Frame
Days 15, 29, 43, and 57 post-dose
Title
Seroconversion Rates of SARS-CoV-2 Specific Neutralizing Antibody
Time Frame
Days 15, 29, 43, and 57 post-dose
Secondary Outcome Measure Information:
Title
GMT of anti-IgG Antibody
Time Frame
Days 15, 29, 43, and 57 post-dose
Title
GMFR of anti-IgG Antibody
Time Frame
Days 15, 29, 43, and 57 post-dose
Title
Seroconversion Rates of anti-IgG Antibody
Time Frame
Days 15, 29, 43, and 57 post-dose
Title
Pharmacokinetic Parameter of Maximum (Peak) Observed Plasma Concentration (Cmax) Following Intramuscular Injection of DS-5670a
Description
Cmax of plasma MAFB-7566a and constituent lipids of lipid nanoparticle (LNP) will be assessed.
Time Frame
Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose
Title
Pharmacokinetic Parameter of Time to Reach Maximum Concentration (Tmax) Following Intramuscular Injection of DS-5670a
Description
Tmax of plasma MAFB-7566a and constituent lipids of LNP will be assessed.
Time Frame
Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose
Title
Pharmacokinetic Parameter of Area Under the Concentration-time Curve Following Intramuscular Injection of DS-5670a
Description
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.
Time Frame
Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose
Title
Pharmacokinetic Parameter of Apparent Total Body Clearance (CL/F) Following Intramuscular Injection of DS-5670a
Description
CL/F of plasma MAFB-7566a and constituent lipids of LNP will be assessed.
Time Frame
Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose
Title
Pharmacokinetic Parameter of Terminal Elimination Half-life (t1/2) Following Intramuscular Injection of DS-5670a
Description
Half-life (t1/2) of plasma MAFB-7566a and constituent lipids of LNP will be assessed.
Time Frame
Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose
Title
Pharmacokinetic Parameter of Apparent Volume of Distribution (Vz/F) Following Intramuscular Injection of DS-5670a
Description
Vz/F of plasma MAFB-7566a and constituent lipids of LNP will be assessed.
Time Frame
Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
SOUSEIKAI Hakata Clinic
City
Hakata
State/Province
Fukuoka
ZIP/Postal Code
812-0025
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
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Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects
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