臨床研究等提出・公開システム

Japanese

Date of registration	Aug. 23, 2021
Last modified on	Jan. 30, 2022
Trial ID	jRCT2031210269

Scientific Title	A Double blind Phase 1/2 study of S-268019 (COVID-19)
Public Title	A Phase 1/2 study of S-268019 (COVID-19)

Contact for Scientific Queries	Name	Nagata Tsutae
	Affiliation	Shionogi & Co., Ltd.
	Address	1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka
	Telephone	+81-6-6209-7885
	E-mail	shionogiclintrials-admin@shionogi.co.jp
Contact for Public Queries	Name	Corporate Communications Department
	Affiliation	Shionogi & Co., Ltd.
	Address	1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka
	Telephone	+81-6-6209-7885
	E-mail	shionogiclintrials-admin@shionogi.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Aug. 11, 2021
Actual date of first enrollment
Target sample size		60
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	A person with Japanese parents. Apparently healthy as determined by medical assessment. Participant must be 20 to 64 years of age inclusive, at the time of signing the informed consent form (ICF).
	Exclusion Criteria	Positive SARS-CoV-2 antigen test result at Screening or before the first vaccination on Visit 1 (Day 1) . Presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders that, in the opinion of the investigator/subinvestigator, will lead to a safety issue or interfere with the assessment of efficacy Body temperature higher than 37.5 degree Celsius on Day 1 before the vaccination. Positive SARS-CoV-2 antibody test result at Screening or a known history of SARS-CoV-2 infection by medical consultation on Day 1 before the vaccination Past use of vaccines approved or under development related to SARS-CoV-2 prior to the first vaccination. Past use of immunosuppressive drug within 6 months prior to the first vaccination. Hypersensitivity to any of the study drugs, or components thereof, or drug or other allergy that, in the opinion of the investigator/subinvestigator, contraindicates participation in the study (except pollinosis and atopic dermatitis).
	Age Minimum	20age 0month 0week old over
	Age Maximum	64age 0month 0week old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Prevention of infectious disease caused by SARS-CoV-2
Intervention(s)		S-268019 0.5 mL or Placebo, intramuscular injection in the upper arm for a total of two doses. Of the participants assigned to the S-268019 group, S-268019 0.5 mL is injected intramuscularly once to the participants who wish to receive the third vaccination.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		The incidence of adverse events (AEs), adverse reactions, serious AEs (SAEs), solicited AEs, vital signs, laboratory tests, ECG
Secondary Outcome(s)

Primary Sponsor	Shionogi & 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	P-One Clinic, Keikokai Medical Corporation IRB
Address	View Tower Hachioji 4F, 8-1 Yokamachi Hachioji City, Tokyo
Telephone	+81-42-625-5216
E-Mail	irbjimukyoku@p1-clinic.or.jp
Approval Status	Approval
Date of approval	Aug. 02, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Jan. 30, 2022	(this page)	Changes
2	Sept. 06, 2021	Detail	Changes
1	Aug. 23, 2021	Detail

List of change history