Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects

Study Overview
=================
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.

Official Title
-----------------
A Phase 1/2 Study to Assess the Safety, Immunogenicity and Recommended Dose of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Biological: DS-5670a
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A1: DS-5670a 10 µg<br>Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg. | Biological: DS-5670a<br>* DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total<br>|
| Experimental: Cohort A2: DS-5670a 30 µg<br>Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg. | Biological: DS-5670a<br>* DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total<br>|
| Experimental: Cohort A3: DS-5670a 60 µg<br>Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg. | Biological: DS-5670a<br>* DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total<br>|
| Experimental: Cohort A4: DS-5670a 100 µg<br>Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg. | Biological: DS-5670a<br>* DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total<br>|
| Placebo Comparator: Cohort A: Placebo<br>Healthy adults participants will be randomized to receive a intramuscular injection of placebo. | Biological: Placebo<br>* Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total<br>|
| Experimental: Cohort B1: DS-5670a 10 µg<br>Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg. | Biological: DS-5670a<br>* DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total<br>|
| Experimental: Cohort B2: DS-5670a 30 µg<br>Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg. | Biological: DS-5670a<br>* DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total<br>|
| Experimental: Cohort B3: DS-5670a 60 µg<br>Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg. | Biological: DS-5670a<br>* DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total<br>|
| Experimental: Cohort B4: DS-5670a 100 µg<br>Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg. | Biological: DS-5670a<br>* DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total<br>|
| Placebo Comparator: Cohort B: Placebo<br>Healthy elderly participants will be randomized to receive a intramuscular injection of placebo. | Biological: Placebo<br>* Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMT of anti-IgG Antibody |  | Days 15, 29, 43, and 57 post-dose | 
| 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 | Cmax of plasma MAFB-7566a and constituent lipids of lipid nanoparticle (LNP) will be assessed. | Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose | 
| Pharmacokinetic Parameter of Time to Reach Maximum Concentration (Tmax) Following Intramuscular Injection of DS-5670a | Tmax of plasma MAFB-7566a and constituent lipids of LNP will be assessed. | Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose | 
| Pharmacokinetic Parameter of Area Under the Concentration-time Curve Following Intramuscular Injection of DS-5670a | 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. | Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose | 
| Pharmacokinetic Parameter of Apparent Total Body Clearance (CL/F) Following Intramuscular Injection of DS-5670a | CL/F of plasma MAFB-7566a and constituent lipids of LNP will be assessed. | Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose | 
| Pharmacokinetic Parameter of Terminal Elimination Half-life (t1/2) Following Intramuscular Injection of DS-5670a | Half-life (t1/2) of plasma MAFB-7566a and constituent lipids of LNP will be assessed. | Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose | 
| Pharmacokinetic Parameter of Apparent Volume of Distribution (Vz/F) Following Intramuscular Injection of DS-5670a | Vz/F of plasma MAFB-7566a and constituent lipids of LNP will be assessed. | Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19 Prevention, SARS CoV-2, Coronavirus Vaccine