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Covid19Phase 1/2NCT04821674

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

A Phase 1/2 study testing DS-5670a in people with Covid19, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 74 yearsHealthy volunteers can take part
Conditions the study is for
Covid19
What is being tested?
DS-5670a
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
142 participants
Where
1 siteJapan
Study dates
15 Mar 2021to 14 Jul 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 74 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • SOUSEIKAI Hakata Clinic

    Hakata, Fukuoka, 812-0025

Other trials in Japan

About this study

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

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.

Conditions
Covid19
Being tested
DS-5670a, Placebo
Keywords
COVID-19 Prevention, SARS CoV-2, Coronavirus Vaccine
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DS-5670aBiological

    DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total

  • PlaceboBiological

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

Study groups in NCT04821674
Study groupRoleWhat they receive
Cohort A1: DS-5670a 10 µgExperimentalHealthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg.
Receives: Biological: DS-5670a
Cohort A2: DS-5670a 30 µgExperimentalHealthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg.
Receives: Biological: DS-5670a
Cohort A3: DS-5670a 60 µgExperimentalHealthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg.
Receives: Biological: DS-5670a
Cohort A4: DS-5670a 100 µgExperimentalHealthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg.
Receives: Biological: DS-5670a
Cohort A: PlaceboPlacebo comparatorHealthy adults participants will be randomized to receive a intramuscular injection of placebo.
Receives: Biological: Placebo
Cohort B1: DS-5670a 10 µgExperimentalHealthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg.
Receives: Biological: DS-5670a
Cohort B2: DS-5670a 30 µgExperimentalHealthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg.
Receives: Biological: DS-5670a
Cohort B3: DS-5670a 60 µgExperimentalHealthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg.
Receives: Biological: DS-5670a
Cohort B4: DS-5670a 100 µgExperimentalHealthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg.
Receives: Biological: DS-5670a
Cohort B: PlaceboPlacebo comparatorHealthy elderly participants will be randomized to receive a intramuscular injection of placebo.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Reporting Treatment-emergent Adverse Events

    Measured: Day 1 up to Day 57 post-dose

  2. Number of Participants Reporting Local and Systemic Adverse Events

    Measured: Day 1 up to Day 14 post-first and second dose

  3. Number of Participants Reporting Serious Events

    Measured: Day 1 up to 12 months post-second dose

  4. Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody

    Measured: Days 15, 29, 43, and 57 post-dose

  5. Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific Neutralizing Antibody

    Measured: Days 15, 29, 43, and 57 post-dose

  6. Seroconversion Rates of SARS-CoV-2 Specific Neutralizing Antibody

    Measured: Days 15, 29, 43, and 57 post-dose

Secondary outcomes (9)

  1. GMT of anti-IgG Antibody

    Measured: Days 15, 29, 43, and 57 post-dose

  2. GMFR of anti-IgG Antibody

    Measured: Days 15, 29, 43, and 57 post-dose

  3. Seroconversion Rates of anti-IgG Antibody

    Measured: Days 15, 29, 43, and 57 post-dose

  4. 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.

    Measured: Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose

  5. 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.

    Measured: Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose

  6. 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.

    Measured: Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose

  7. 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.

    Measured: Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose

  8. 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.

    Measured: Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose

  9. 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.

    Measured: Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2021
  2. Study start15 Mar 2021
  3. Primary completion13 Aug 2021
  4. Study completion14 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04821674
Sponsor's protocol ID
DS5670-A-J101
Other IDs
jRCT2071200110
Status last verified
Aug 2022
First submitted
25 Mar 2021
Last updated
30 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DS-5670a in people with Covid19, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting Treatment-emergent Adverse Events (time frame: Day 1 up to Day 57 post-dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04821674.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.

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