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
1 other identifier
interventional
342
1 country
3
Brief Summary
This study will assess the immunogenicity, safety and tolerability of VN-0200 after intramuscular injections in Japanese healthy elderly subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2022
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2022
CompletedFirst Posted
Study publicly available on registry
September 21, 2022
CompletedStudy Start
First participant enrolled
October 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2024
CompletedFebruary 29, 2024
February 1, 2024
6 months
September 15, 2022
February 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (11)
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)
- +6 more secondary outcomes
Study Arms (10)
Group 1: VN-0200 low dose
EXPERIMENTALHealthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a.
Group 2: VN-0200 low dose
EXPERIMENTALHealthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.
Group 3: VN-0200 low dose
EXPERIMENTALHealthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.
Group 4: VN-0200 low dose
EXPERIMENTALHealthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.
Group 5: VN-0200 medium dose
EXPERIMENTALHealthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a.
Group 6: VN-0200 medium dose
EXPERIMENTALHealthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.
Group 7: VN-0200 high dose
ACTIVE COMPARATORHealthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a.
Group 8: VN-0200 high dose
EXPERIMENTALHealthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.
Group 9: VN-0200 high dose
EXPERIMENTALHealthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.
Group 10: VN-0200 high dose
EXPERIMENTALHealthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.
Interventions
VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (3)
SOUSEIKAI PS Clinic
Hakata, Fukuoka, 812-0025, Japan
SOUSEIKAI Sumida Hopital
Sumida City, Tokyo, 130-0004, Japan
SOUSEIKAI Nishi-Kumamoto Hospital
Kumamoto, 861-4157, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Study Leader
Daiichi Sankyo
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2022
First Posted
September 21, 2022
Study Start
October 13, 2022
Primary Completion
April 11, 2023
Study Completion
February 15, 2024
Last Updated
February 29, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
- 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.
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/