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A Dose Finding Study of VN-0200

Primary Purpose

Respiratory Syncytial Virus Infections

Status
Active
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
VN-0200
Sponsored by
Daiichi Sankyo Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Syncytial Virus Infections focused on measuring Respiratory Syncytial Virus Infections

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • SOUSEIKAI PS Clinic
  • SOUSEIKAI Sumida Hopital
  • SOUSEIKAI Nishi-Kumamoto Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Group 1: VN-0200 low dose

Group 2: VN-0200 low dose

Group 3: VN-0200 low dose

Group 4: VN-0200 low dose

Group 5: VN-0200 medium dose

Group 6: VN-0200 medium dose

Group 7: VN-0200 high dose

Group 8: VN-0200 high dose

Group 9: VN-0200 high dose

Group 10: VN-0200 high dose

Arm Description

Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a.

Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.

Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.

Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.

Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a.

Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.

Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a.

Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.

Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.

Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.

Outcomes

Primary Outcome Measures

Geometric Mean Titer (GMT) of anti-RSV Subgroup A (RSV/A) Neutralizing Activity
Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity

Secondary Outcome Measures

Geometric Mean Titer (GMT) of Anti-RSV/A Neutralizing Activity
Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity
Geometric Mean Titer (GMT) of Anti-RSV/B Neutralizing Activity
Geometric Mean Fold Rise (GMFR) of Anti-RSV/B Neutralizing Activity
Geometric Mean Titer (GMT) of Anti-VAGA-9001a Immunoglobulin G (IgG)
Geometric Mean Fold Rise (GMFR) of Anti-VAGA-9001a Immunoglobulin G (IgG)
VAGA-9001a Specific IFN-Gamma Production Responses
Number of Participants Reporting Solicited Adverse Events (Local and Systemic Adverse Reactions) and Side Reactions
Number of Participants Reporting Non-Solicited Adverse Events and Side Reactions
Number of Participants Reporting Serious Adverse Events and Side Reactions
Number of Participants Reporting Potential Immune-Mediated Disease

Full Information

First Posted
September 15, 2022
Last Updated
February 20, 2023
Sponsor
Daiichi Sankyo Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05547087
Brief Title
A Dose Finding Study of VN-0200
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 13, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
Keywords
Respiratory Syncytial Virus Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: VN-0200 low dose
Arm Type
Experimental
Arm Description
Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a.
Arm Title
Group 2: VN-0200 low dose
Arm Type
Experimental
Arm Description
Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.
Arm Title
Group 3: VN-0200 low dose
Arm Type
Experimental
Arm Description
Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.
Arm Title
Group 4: VN-0200 low dose
Arm Type
Experimental
Arm Description
Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.
Arm Title
Group 5: VN-0200 medium dose
Arm Type
Experimental
Arm Description
Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a.
Arm Title
Group 6: VN-0200 medium dose
Arm Type
Experimental
Arm Description
Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.
Arm Title
Group 7: VN-0200 high dose
Arm Type
Active Comparator
Arm Description
Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a.
Arm Title
Group 8: VN-0200 high dose
Arm Type
Experimental
Arm Description
Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.
Arm Title
Group 9: VN-0200 high dose
Arm Type
Experimental
Arm Description
Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.
Arm Title
Group 10: VN-0200 high dose
Arm Type
Experimental
Arm Description
Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.
Intervention Type
Biological
Intervention Name(s)
VN-0200
Intervention Description
VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
Primary Outcome Measure Information:
Title
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)
Title
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 Outcome Measure Information:
Title
Geometric Mean Titer (GMT) of Anti-RSV/A Neutralizing Activity
Time Frame
Day 29 (the second dosing of the investigational product)
Title
Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity
Time Frame
Day 29 (the second dosing of the investigational product)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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
Title
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
Title
Number of Participants Reporting Serious Adverse Events and Side Reactions
Time Frame
From date of informed consent up to approximately 12 months
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Study Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
SOUSEIKAI PS Clinic
City
Hakata
State/Province
Fukuoka
ZIP/Postal Code
812-0025
Country
Japan
Facility Name
SOUSEIKAI Sumida Hopital
City
Sumida
State/Province
Tokyo
ZIP/Postal Code
130-0004
Country
Japan
Facility Name
SOUSEIKAI Nishi-Kumamoto Hospital
City
Kumamoto
ZIP/Postal Code
861-4157
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/daiichi-sankyo/

Learn more about this trial

A Dose Finding Study of VN-0200

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