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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04821674
• Other study ID #: DS5670-A-J101
• Secondary ID: jRCT2071200110
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 15, 2021
• Est. completion date: July 14, 2022

Study information

• Verified date: August 2022
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: July 14, 2022
• Est. primary completion date: August 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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
Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total

Locations

Country	Name	City	State
Japan	SOUSEIKAI Hakata Clinic	Hakata	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Reporting Treatment-emergent Adverse Events		Day 1 up to Day 57 post-dose
Primary	Number of Participants Reporting Local and Systemic Adverse Events		Day 1 up to Day 14 post-first and second dose
Primary	Number of Participants Reporting Serious Events		Day 1 up to 12 months post-second dose
Primary	Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody		Days 15, 29, 43, and 57 post-dose
Primary	Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific Neutralizing Antibody		Days 15, 29, 43, and 57 post-dose
Primary	Seroconversion Rates of SARS-CoV-2 Specific Neutralizing Antibody		Days 15, 29, 43, and 57 post-dose
Secondary	GMT of anti-IgG Antibody		Days 15, 29, 43, and 57 post-dose
Secondary	GMFR of anti-IgG Antibody		Days 15, 29, 43, and 57 post-dose
Secondary	Seroconversion Rates of anti-IgG Antibody		Days 15, 29, 43, and 57 post-dose
Secondary	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.	Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose
Secondary	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.	Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose
Secondary	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.	Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose
Secondary	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.	Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose
Secondary	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.	Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose
Secondary	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.	Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose