A Dose Finding Study of VN-0200

Respiratory Syncytial Virus Infections Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05547087
• Other study ID #: VN0200-091
• Status: Completed
• Phase: Phase 2
• Start date: October 13, 2022
• Est. completion date: February 15, 2024

Study information

• Verified date: February 2024
• Source: Daiichi Sankyo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: February 15, 2024
• Est. primary completion date: April 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
Japan	SOUSEIKAI PS Clinic	Hakata	Fukuoka
Japan	SOUSEIKAI Nishi-Kumamoto Hospital	Kumamoto
Japan	SOUSEIKAI Sumida Hopital	Sumida	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titer (GMT) of anti-RSV Subgroup A (RSV/A) Neutralizing Activity		Day 57 (28 days after the second dosing of the investigational product)
Primary	Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity		Day 57 (28 days after the second dosing of the investigational product)
Secondary	Geometric Mean Titer (GMT) of Anti-RSV/A Neutralizing Activity		Day 29 (the second dosing of the investigational product)
Secondary	Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity		Day 29 (the second dosing of the investigational product)
Secondary	Geometric Mean Titer (GMT) of Anti-RSV/B Neutralizing Activity		Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
Secondary	Geometric Mean Fold Rise (GMFR) of Anti-RSV/B Neutralizing Activity		Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
Secondary	Geometric Mean Titer (GMT) of Anti-VAGA-9001a Immunoglobulin G (IgG)		Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
Secondary	Geometric Mean Fold Rise (GMFR) of Anti-VAGA-9001a Immunoglobulin G (IgG)		Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
Secondary	VAGA-9001a Specific IFN-Gamma Production Responses		Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
Secondary	Number of Participants Reporting Solicited Adverse Events (Local and Systemic Adverse Reactions) and Side Reactions		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
Secondary	Number of Participants Reporting Non-Solicited Adverse Events and Side Reactions		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
Secondary	Number of Participants Reporting Serious Adverse Events and Side Reactions		From date of informed consent up to approximately 12 months
Secondary	Number of Participants Reporting Potential Immune-Mediated Disease		Day 1 (the first dosing of the investigational product) up to the time of follow-up and discontinuation (up to approximately 12 months)