Prevention of infectious disease by Severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)
Conditions
Interventions
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.
Sponsors
Inoguchi Akihiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese 2) Healthy adults aged >=20 and =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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Adverse events, specific adverse events, laboratory data, weight, vital signs and 12-lead ECGs | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactContact for Clinical Trial Information
DAIICHI SANKYO Co.,Ltd.
Outcome results
None listed