A Dose Finding Study of VN-0200

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

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

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Biological: VN-0200

• Study Type: Interventional
• Enrollment (Actual): 342
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Kumamoto, Japan, 861-4157
    • SOUSEIKAI Nishi-Kumamoto Hospital
  • Fukuoka
    • Hakata, Fukuoka, Japan, 812-0025
      • SOUSEIKAI PS Clinic
  • Tokyo
    • Sumida, Tokyo, Japan, 130-0004
      • SOUSEIKAI Sumida Hopital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: VN-0200 low dose; Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a.	Biological: VN-0200; VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
Experimental: Group 2: VN-0200 low dose; Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.	Biological: VN-0200; VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
Experimental: Group 3: VN-0200 low dose; Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.	Biological: VN-0200; VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
Experimental: Group 4: VN-0200 low dose; Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.	Biological: VN-0200; VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
Experimental: Group 5: VN-0200 medium dose; Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a.	Biological: VN-0200; VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
Experimental: Group 6: VN-0200 medium dose; Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.	Biological: VN-0200; VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
Active Comparator: Group 7: VN-0200 high dose; Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a.	Biological: VN-0200; VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
Experimental: Group 8: VN-0200 high dose; Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.	Biological: VN-0200; VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
Experimental: Group 9: VN-0200 high dose; Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.	Biological: VN-0200; VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
Experimental: Group 10: VN-0200 high dose; Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.	Biological: VN-0200; VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)
Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity	Day 57 (28 days after the second dosing of the investigational product)

Secondary Outcome Measures

Outcome Measure	Time Frame
Geometric Mean Titer (GMT) of Anti-RSV/A Neutralizing Activity	Day 29 (the second dosing of the investigational product)
Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity	Day 29 (the second dosing of the investigational product)
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)
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)
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)
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)
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)
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
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
Number of Participants Reporting Serious Adverse Events and Side Reactions	From date of informed consent up to approximately 12 months
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)

Collaborators and Investigators

• Sponsor: Daiichi Sankyo
• Investigators: Study Director: Clinical Study Leader, Daiichi Sankyo

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2022
• Primary Completion (Actual): April 11, 2023
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Respiratory Syncytial Virus Infections
• Additional Relevant MeSH Terms: RNA Virus Infections; Infections; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Virus Diseases; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: VN0200-091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• IPD Sharing Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No