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Completed

NCT Number: NCT04914520

Study of VN-0200 in Japanese Healthy Adults and Elderly Subjects

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

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medical Corporation Association Shinanokai Shinanozaka Clinic

Shinjuku-Ku, Tokyo, 160-0017, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Japanese
  • Healthy adults aged ≥20 and ≤50 years (Step 1) or healthy elderly aged ≥65 and ≤80 years (at the time of informed consent)
  • Body mass index (BMI) is ≥18.0 and <30.0 kg/m^2 (at screening)

Exclusion criteria

  • Participants with a history of anaphylaxis or severe allergies due to food, medicine, insect bites, cosmetics, or vaccination
  • Having alcohol or drug dependence, etc.

Treatment and study plan

VN-0200

Biological

VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) 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: From first administration through 28 days post second administration

  2. Number of Participants Reporting Local and Systemic Adverse Events

    Time frame: From first administration up to 14 days after second administration

  3. Number of Participants Reporting Serious Adverse Events

    Time frame: From date of informed consent up to approximately 3 months

Secondary outcomes

  1. Geometric Mean Fold Rise (GMFR) of Anti-RSV Specific Neutralizing Activity

    Time frame: Day 29 and Day 57 post-dose and at the time of discontinuation (whichever occurs first), up to approximately 2 months

  2. Geometric Mean Titer (GMT) of Anti-VAGA-9001a IgG

    Time frame: Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months

  3. Geometric Mean Titer (GMT) of Anti-RSV IgG

    Time frame: Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months

  4. Number of IFN-γ spot-forming cells in PBMC Detected by ELISPOT

    Time frame: Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

A Phase 1 Study to Assess the Safety, Tolerability, and Immunogenicity of VN-0200 After Intramuscular Injections in Japanese Healthy Adults and Elderly Subjects

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2021
Registry last updated
Dec 22, 2021

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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