臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 29, 2021
Last modified on	Aug. 05, 2023
Trial ID	jRCT2071210086

Scientific Title	A Phase 2 study to assess the safety, immunogenicity and recommended dose of DS-5670a (COVID-19 vaccine) in Japanese healthy adults
Public Title	A Phase 2 study to assess the safety, immunogenicity and recommended dose of DS-5670a in Japanese healthy adults

Contact for Scientific Queries	Name	Inoguchi Akihiro
	Affiliation	DAIICHI SANKYO Co.,Ltd.
	Address	1-2-58, Hiromachi, Shinagawa-ku, Tokyo
	Telephone	+81-3-6225-1111
	E-mail	dsclinicaltrial@daiichisankyo.co.jp
Contact for Public Queries	Name	Contact for Clinical Trial Information
	Affiliation	DAIICHI SANKYO Co.,Ltd.
	Address	1-2-58, Hiromachi, Shinagawa-ku, Tokyo
	Telephone	+81-3-6225-1111
	E-mail	dsclinicaltrial@daiichisankyo.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Nov. 06, 2021
Actual date of first enrollment		Nov. 08, 2021
Target sample size		80
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	uncontrolled control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Japanese 2) Healthy adults aged >=20 and <65 years at the time of informed consent (Part 1 and Part 2) 3) Body Mass Index (BMI) is >=17.5 and <30.0 kg/m^2 (at screening ) 4) Subjects who can follow the compliance requirements during clinical trials, undergo medical examinations and tests specified by the protocol, and report symptoms, etc 5) Subjects who received DS-5670a 60 ug twice intramuscularly in Part 1 or Part 2 of this study and 6 months have passed (3rd administration part)
	Exclusion Criteria	1) Having a history of anaphylaxis or severe allergies due to food, cosmetics, medicines, or vaccination. 2) Having alcohol or drug dependence. 3) Having a history of immunodeficiency or having a close relative with congenital immunodeficiency. 4) Having a history of SARS-CoV-2 infection. 5) Having fever of >=39.0 C or symptoms of suspected anaphylaxis such as systemic rash within 2 days after past vaccination. etc.
	Age Minimum	20age old over
	Age Maximum	65age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Prevention of infectious disease by Severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)
Intervention(s)		Part 1 and Part 2: Administer 30 or 60 ug of DS-5670a intramuscularly twice. 3rd administration part: Administer 60 ug of DS-5670a intramuscularly once.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Safety: Adverse events, specific adverse events, laboratory data, weight, vital signs and 12-lead ECGs
Secondary Outcome(s)		Immunogenicity: Neutralizing antibodies against SARS-CoV-2 levels in blood, Anti-IgG levels in blood Pharmacokinetics: Plasma concentration of MAFB-7566a and constituent lipids of LNP

Primary Sponsor	DAIICHI SANKYO Co.,Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Japan Agency for Medical Research and Development
Secondary Sponsor	Not applicable

Name of Certified Review Board	Hakata Clinic Institutional Review Board
Address	6-18, Tenyamachi, Hakata-ku, Fukuoka-shi, Fukuoka
Telephone	+81-92-283-7701
E-Mail
Approval Status	Approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	Aug. 05, 2023	(this page)	Changes
4	July. 07, 2022	Detail	Changes
3	Jan. 08, 2022	Detail	Changes
2	Nov. 27, 2021	Detail	Changes
1	Oct. 29, 2021	Detail

List of change history