Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects
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
2 other identifiers
interventional
142
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 covid19
Started Mar 2021
Typical duration for phase_1 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2021
CompletedFirst Submitted
Initial submission to the registry
March 25, 2021
CompletedFirst Posted
Study publicly available on registry
March 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2022
CompletedAugust 30, 2022
August 1, 2022
5 months
March 25, 2021
August 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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 Outcomes (9)
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
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
- +4 more secondary outcomes
Study Arms (10)
Cohort A1: DS-5670a 10 µg
EXPERIMENTALHealthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg.
Cohort A2: DS-5670a 30 µg
EXPERIMENTALHealthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg.
Cohort A3: DS-5670a 60 µg
EXPERIMENTALHealthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg.
Cohort A4: DS-5670a 100 µg
EXPERIMENTALHealthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg.
Cohort A: Placebo
PLACEBO COMPARATORHealthy adults participants will be randomized to receive a intramuscular injection of placebo.
Cohort B1: DS-5670a 10 µg
EXPERIMENTALHealthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg.
Cohort B2: DS-5670a 30 µg
EXPERIMENTALHealthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg.
Cohort B3: DS-5670a 60 µg
EXPERIMENTALHealthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg.
Cohort B4: DS-5670a 100 µg
EXPERIMENTALHealthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg.
Cohort B: Placebo
PLACEBO COMPARATORHealthy elderly participants will be randomized to receive a intramuscular injection of placebo.
Interventions
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 administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SOUSEIKAI Hakata Clinic
Hakata, Fukuoka, 812-0025, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Daiichi Sankyo
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2021
First Posted
March 29, 2021
Study Start
March 15, 2021
Primary Completion
August 13, 2021
Study Completion
July 14, 2022
Last Updated
August 30, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share