Covid19
Conditions
Keywords
COVID-19 Prevention, SARS CoV-2, Coronavirus Vaccine
Brief summary
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.
Interventions
BIOLOGICALDS-5670a
DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
BIOLOGICALPlacebo
Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Sponsors
Daiichi Sankyo Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Reporting Treatment-emergent Adverse Events | Day 1 up to Day 57 post-dose |
| Number of Participants Reporting Local and Systemic Adverse Events | Day 1 up to Day 14 post-first and second dose |
| Number of Participants Reporting Serious Events | Day 1 up to 12 months post-second dose |
| Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody | Days 15, 29, 43, and 57 post-dose |
| Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific Neutralizing Antibody | Days 15, 29, 43, and 57 post-dose |
| Seroconversion Rates of SARS-CoV-2 Specific Neutralizing Antibody | Days 15, 29, 43, and 57 post-dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Parameter of Apparent Total Body Clearance (CL/F) Following Intramuscular Injection of DS-5670a | Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose | CL/F of plasma MAFB-7566a and constituent lipids of LNP will be assessed. |
| GMT of anti-IgG Antibody | Days 15, 29, 43, and 57 post-dose | — |
| Pharmacokinetic Parameter of Apparent Volume of Distribution (Vz/F) Following Intramuscular Injection of DS-5670a | Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose | Vz/F of plasma MAFB-7566a and constituent lipids of LNP will be assessed. |
| Pharmacokinetic Parameter of Terminal Elimination Half-life (t1/2) Following Intramuscular Injection of DS-5670a | Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose | Half-life (t1/2) of plasma MAFB-7566a and constituent lipids of LNP will be assessed. |
| GMFR of anti-IgG Antibody | Days 15, 29, 43, and 57 post-dose | — |
| Seroconversion Rates of anti-IgG Antibody | Days 15, 29, 43, and 57 post-dose | — |
| Pharmacokinetic Parameter of Maximum (Peak) Observed Plasma Concentration (Cmax) Following Intramuscular Injection of DS-5670a | Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose | Cmax of plasma MAFB-7566a and constituent lipids of lipid nanoparticle (LNP) will be assessed. |
| Pharmacokinetic Parameter of Time to Reach Maximum Concentration (Tmax) Following Intramuscular Injection of DS-5670a | Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose | Tmax of plasma MAFB-7566a and constituent lipids of LNP will be assessed. |
| Pharmacokinetic Parameter of Area Under the Concentration-time Curve Following Intramuscular Injection of DS-5670a | Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose | Area under the concentration-time curve from time 0 to last measurable time point (AUClast) and time 0 to infinity (AUCinf) of plasma MAFB-7566a and constituent lipids of LNP will be assessed. |
Countries
Japan
Outcome results
None listed