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Completed

NCT Number: NCT05547087

A Dose Finding Study of VN-0200

This study will assess the immunogenicity, safety and tolerability of VN-0200 after intramuscular injections in Japanese healthy elderly subjects.

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Key information

Conditions

Respiratory Syncytial Virus Infections Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Virus Diseases

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

SOUSEIKAI PS Clinic, Hakata, Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Japanese healthy elderly aged >=60 and =<80 years (at the time of informed consent).
  • Subjects who can follow the compliance requirements during clinical trials, undergo medical examinations and tests specified by the protocol, and report symptoms, etc.

Exclusion criteria

  • Serious cardiovascular, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disorders.
  • Serious acute illness.
  • Has been diagnosed with congenital or acquired immunodeficiency.
  • Previous vaccination with an RSV vaccine (including the investigational drugs).
  • Having a history of anaphylaxis or severe allergies due to medicines, or vaccination.
  • Administration of gamma globulins, systemic immunosuppressants (including drugs for the treatment of autoimmune diseases), hematopoietics (excluding iron and vitamins), and corticosteroids (excluding topical preparations, inhalants, and small-dose short-term oral administration*) or planned administration of them in the period starting 28 days prior to informed consent and ending 28 days after the second vaccination. * <14 days, 20 mg/day on a prednisolone basis.
  • Planned or actual administration of other vaccine in the period starting 14 days prior to informed consent and ending 14 days after the second vaccination.

Treatment and study plan

VN-0200

Biological

VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.

Primary outcomes

  1. Geometric Mean Titer (GMT) of anti-RSV Subgroup A (RSV/A) Neutralizing Activity

    Time frame: Day 57 (28 days after the second dosing of the investigational product)

  2. Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity

    Time frame: Day 57 (28 days after the second dosing of the investigational product)

Secondary outcomes

  1. Geometric Mean Titer (GMT) of Anti-RSV/A Neutralizing Activity

    Time frame: Day 29 (the second dosing of the investigational product)

  2. Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity

    Time frame: Day 29 (the second dosing of the investigational product)

  3. Geometric Mean Titer (GMT) of Anti-RSV/B Neutralizing Activity

    Time frame: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)

  4. Geometric Mean Fold Rise (GMFR) of Anti-RSV/B Neutralizing Activity

    Time frame: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)

  5. Geometric Mean Titer (GMT) of Anti-VAGA-9001a Immunoglobulin G (IgG)

    Time frame: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)

  6. Geometric Mean Fold Rise (GMFR) of Anti-VAGA-9001a Immunoglobulin G (IgG)

    Time frame: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)

  7. VAGA-9001a Specific IFN-Gamma Production Responses

    Time frame: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)

  8. Number of Participants Reporting Solicited Adverse Events (Local and Systemic Adverse Reactions) and Side Reactions

    Time frame: Day 1 (the first dosing of the investigational product) up to Day 8, Day 29 (the second dosing of the investigational product) up to Day 36 and at time of discontinuation (whichever comes first), up to approximately 1 month

  9. Number of Participants Reporting Non-Solicited Adverse Events and Side Reactions

    Time frame: Day 1 (the first dosing of the investigational product) up to Day 57 (28 days after second dosing of the investigational product) and at time of discontinuation (whichever comes first), up to approximately 2 months

  10. Number of Participants Reporting Serious Adverse Events and Side Reactions

    Time frame: From date of informed consent up to approximately 12 months

  11. Number of Participants Reporting Potential Immune-Mediated Disease

    Time frame: Day 1 (the first dosing of the investigational product) up to the time of follow-up and discontinuation (up to approximately 12 months)

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Dose Finding Study to Describe the Immunogenicity, Safety and Tolerability of VN-0200 in Japanese Adults Aged 60-80 Years

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 21, 2022
Registry last updated
Feb 29, 2024

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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