Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects

Phase 1

Completed

• Conditions: Covid19
• Interventions: Biological: DS-5670a; Biological: Placebo

• Registration Number: NCT04821674
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-15
• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-29
• Primary Completion: 2021-08-13
• Study Completion: 2022-07-14
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort B2: DS-5670a 30 µg	DS-5670a	Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg.
Cohort B: Placebo	Placebo	Healthy elderly participants will be randomized to receive a intramuscular injection of placebo.
Cohort A3: DS-5670a 60 µg	DS-5670a	Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg.
Cohort B3: DS-5670a 60 µg	DS-5670a	Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg.
Cohort A1: DS-5670a 10 µg	DS-5670a	Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg.
Cohort A: Placebo	Placebo	Healthy adults participants will be randomized to receive a intramuscular injection of placebo.
Cohort B1: DS-5670a 10 µg	DS-5670a	Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg.
Cohort A2: DS-5670a 30 µg	DS-5670a	Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg.
Cohort A4: DS-5670a 100 µg	DS-5670a	Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg.
Cohort B4: DS-5670a 100 µg	DS-5670a	Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg.

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting Local and Systemic Adverse Events	Day 1 up to Day 14 post-first and second dose
Seroconversion Rates of SARS-CoV-2 Specific Neutralizing Antibody	Days 15, 29, 43, and 57 post-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
Number of Participants Reporting Treatment-emergent Adverse Events	Day 1 up to Day 57 post-dose
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific Neutralizing Antibody	Days 15, 29, 43, and 57 post-dose

Secondary Outcome Measures

Name	Time	Method
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.
Seroconversion Rates of anti-IgG Antibody	Days 15, 29, 43, and 57 post-dose
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 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.
GMFR of anti-IgG Antibody	Days 15, 29, 43, and 57 post-dose
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.
GMT of anti-IgG Antibody	Days 15, 29, 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	Tmax of plasma MAFB-7566a and constituent lipids of LNP will be assessed.

Trial Locations

Locations (1)

SOUSEIKAI Hakata Clinic; 🇯🇵 Hakata, Fukuoka, Japan