A Phase 2 study to assess the safety, immunogenicity and recommended dose of DS-5670a in Japanese healthy adults

Phase 2

• Conditions: Prevention of infectious disease by Severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)

• Registration Number: JPRN-jRCT2071210086
• Lead Sponsor: Inoguchi Akihiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified