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

Daiichi Sankyo

Status and phase: Completed; Phase 2; Phase 1

Conditions: Covid19

Treatments: Biological: DS-5670a; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04821674

DS5670-A-J101

jRCT2071200110 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 142 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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142 participants in 10 patient groups, including a placebo group

Cohort A1: DS-5670a 10 µg

Experimental group

Description:

Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg.

Treatment:

Biological: DS-5670a

Cohort A2: DS-5670a 30 µg

Experimental group

Description:

Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg.

Treatment:

Biological: DS-5670a

Cohort A3: DS-5670a 60 µg

Experimental group

Description:

Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg.

Treatment:

Biological: DS-5670a

Cohort A4: DS-5670a 100 µg

Experimental group

Description:

Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg.

Treatment:

Biological: DS-5670a

Cohort A: Placebo

Placebo Comparator group

Description:

Healthy adults participants will be randomized to receive a intramuscular injection of placebo.

Treatment:

Biological: Placebo

Cohort B1: DS-5670a 10 µg

Experimental group

Description:

Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg.

Treatment:

Biological: DS-5670a

Cohort B2: DS-5670a 30 µg

Experimental group

Description:

Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg.

Treatment:

Biological: DS-5670a

Cohort B3: DS-5670a 60 µg

Experimental group

Description:

Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg.

Treatment:

Biological: DS-5670a

Cohort B4: DS-5670a 100 µg

Experimental group

Description:

Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg.

Treatment:

Biological: DS-5670a

Cohort B: Placebo

Placebo Comparator group

Description:

Healthy elderly participants will be randomized to receive a intramuscular injection of placebo.

Treatment:

Biological: Placebo