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

Sponsor
Daiichi Sankyo Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04821674
Collaborator
(none)
152
1
10
21.6
7.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: DS-5670a
  • Biological: Placebo
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
152 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Mar 15, 2021
Actual Primary Completion Date :
Aug 13, 2021
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort A1: DS-5670a 10 µg

Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg.

Biological: DS-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

Experimental: Cohort A2: DS-5670a 30 µg

Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg.

Biological: DS-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

Experimental: Cohort A3: DS-5670a 60 µg

Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg.

Biological: DS-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

Experimental: Cohort A4: DS-5670a 100 µg

Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg.

Biological: DS-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

Placebo Comparator: Cohort A: Placebo

Healthy adults participants will be randomized to receive a intramuscular injection of placebo.

Biological: Placebo
Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total

Experimental: Cohort B1: DS-5670a 10 µg

Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg.

Biological: DS-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

Experimental: Cohort B2: DS-5670a 30 µg

Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg.

Biological: DS-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

Experimental: Cohort B3: DS-5670a 60 µg

Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg.

Biological: DS-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

Experimental: Cohort B4: DS-5670a 100 µg

Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg.

Biological: DS-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

Placebo Comparator: Cohort B: Placebo

Healthy elderly participants will be randomized to receive a intramuscular injection of placebo.

Biological: Placebo
Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total

Outcome Measures

Primary Outcome Measures

  1. Number of Participants Reporting Treatment-emergent Adverse Events [Day 1 up to Day 57 post-dose]

  2. Number of Participants Reporting Local and Systemic Adverse Events [Day 1 up to Day 14 post-first and second dose]

  3. Number of Participants Reporting Serious Events [Day 1 up to 12 months post-second dose]

  4. Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody [Days 15, 29, 43, and 57 post-dose]

  5. Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific Neutralizing Antibody [Days 15, 29, 43, and 57 post-dose]

  6. Seroconversion Rates of SARS-CoV-2 Specific Neutralizing Antibody [Days 15, 29, 43, and 57 post-dose]

Secondary Outcome Measures

  1. GMT of anti-IgG Antibody [Days 15, 29, 43, and 57 post-dose]

  2. GMFR of anti-IgG Antibody [Days 15, 29, 43, and 57 post-dose]

  3. Seroconversion Rates of anti-IgG Antibody [Days 15, 29, 43, and 57 post-dose]

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 74 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 SOUSEIKAI Hakata Clinic Hakata Fukuoka Japan 812-0025

Sponsors and Collaborators

  • Daiichi Sankyo Co., Ltd.

Investigators

  • Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04821674
Other Study ID Numbers:
  • DS5670-A-J101
  • jRCT2071200110
First Posted:
Mar 29, 2021
Last Update Posted:
Dec 3, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Daiichi Sankyo Co., Ltd.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2021