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

Daiichi Sankyo Co., Ltd.142 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

142

Conditions

Covid19

Interventions

DS-5670aBIOLOGICAL

DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total

PlaceboBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 74 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

SOUSEIKAI Hakata Clinic

Hakata, Fukuoka, Japan

Outcomes

Primary Outcomes

Number of Participants Reporting Treatment-emergent Adverse Events

Time frame: Day 1 up to Day 57 post-dose

Number of Participants Reporting Local and Systemic Adverse Events

Time frame: Day 1 up to Day 14 post-first and second dose

Number of Participants Reporting Serious Events

Time frame: Day 1 up to 12 months post-second dose

Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody