Clinical trial NCT04821674: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Covid19
Keywords: COVID-19 Prevention
SARS CoV-2
Coronavirus Vaccine
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2021-03-29
Enrollment: 142
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Number of Participants Reporting Treatment-emergent Adverse Events
timeFrame: Day 1 up to Day 57 post-dose
measure: Number of Participants Reporting Local and Systemic Adverse Events
timeFrame: Day 1 up to Day 14 post-first and second dose
measure: Number of Participants Reporting Serious Events
timeFrame: Day 1 up to 12 months post-second dose
measure: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody
timeFrame: Days 15, 29, 43, and 57 post-dose
measure: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific Neutralizing Antibody
timeFrame: Days 15, 29, 43, and 57 post-dose
measure: Seroconversion Rates of SARS-CoV-2 Specific Neutralizing Antibody
timeFrame: Days 15, 29, 43, and 57 post-dose
Secondary outcomes:
measure: GMT of anti-IgG Antibody
timeFrame: Days 15, 29, 43, and 57 post-dose
measure: GMFR of anti-IgG Antibody
timeFrame: Days 15, 29, 43, and 57 post-dose
measure: Seroconversion Rates of anti-IgG Antibody
timeFrame: Days 15, 29, 43, and 57 post-dose
measure: Pharmacokinetic Parameter of Maximum (Peak) Observed Plasma Concentration (Cmax) Following Intramuscular Injection of DS-5670a
timeFrame: Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose
measure: Pharmacokinetic Parameter of Time to Reach Maximum Concentration (Tmax) Following Intramuscular Injection of DS-5670a
timeFrame: Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose
measure: Pharmacokinetic Parameter of Area Under the Concentration-time Curve Following Intramuscular Injection of DS-5670a
timeFrame: Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose
measure: Pharmacokinetic Parameter of Apparent Total Body Clearance (CL/F) Following Intramuscular Injection of DS-5670a
timeFrame: Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose
measure: Pharmacokinetic Parameter of Terminal Elimination Half-life (t1/2) Following Intramuscular Injection of DS-5670a
timeFrame: Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose
measure: Pharmacokinetic Parameter of Apparent Volume of Distribution (Vz/F) Following Intramuscular Injection of DS-5670a
timeFrame: Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose
Other outcomes:
Locations:
city: Hakata
country: Japan
facility: SOUSEIKAI Hakata Clinic
state: Fukuoka
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: