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Completed

NCT Number: NCT04821674

Study 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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

SOUSEIKAI Hakata Clinic

Hakata, Fukuoka, 812-0025, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DS-5670a

Biological

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

Biological

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

Primary outcomes

  1. Number of Participants Reporting Treatment-emergent Adverse Events

    Time frame: Day 1 up to Day 57 post-dose

  2. Number of Participants Reporting Local and Systemic Adverse Events

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

  3. Number of Participants Reporting Serious Events

    Time frame: Day 1 up to 12 months post-second dose

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

    Time frame: Days 15, 29, 43, and 57 post-dose

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

    Time frame: Days 15, 29, 43, and 57 post-dose

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

    Time frame: Days 15, 29, 43, and 57 post-dose

Secondary outcomes

  1. GMT of anti-IgG Antibody

    Time frame: Days 15, 29, 43, and 57 post-dose

  2. GMFR of anti-IgG Antibody

    Time frame: Days 15, 29, 43, and 57 post-dose

  3. Seroconversion Rates of anti-IgG Antibody

    Time frame: Days 15, 29, 43, and 57 post-dose

  4. Pharmacokinetic Parameter of Maximum (Peak) Observed Plasma Concentration (Cmax) Following Intramuscular Injection of DS-5670a

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 29, 2021
Registry last updated
Aug 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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