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A Dose Finding Study of VN-0200

Phase 2
Completed
Conditions
Respiratory Syncytial Virus Infections
Interventions
Biological: VN-0200
Registration Number
NCT05547087
Lead Sponsor
Daiichi Sankyo
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
342
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group 4: VN-0200 low doseVN-0200Healthy 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 doseVN-0200Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a.
Group 7: VN-0200 high doseVN-0200Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a.
Group 8: VN-0200 high doseVN-0200Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.
Group 2: VN-0200 low doseVN-0200Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.
Group 1: VN-0200 low doseVN-0200Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a.
Group 3: VN-0200 low doseVN-0200Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.
Group 6: VN-0200 medium doseVN-0200Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.
Group 10: VN-0200 high doseVN-0200Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.
Group 9: VN-0200 high doseVN-0200Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.
Primary Outcome Measures
NameTimeMethod
Geometric Mean Titer (GMT) of anti-RSV Subgroup A (RSV/A) Neutralizing ActivityDay 57 (28 days after the second dosing of the investigational product)
Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing ActivityDay 57 (28 days after the second dosing of the investigational product)
Secondary Outcome Measures
NameTimeMethod
Geometric Mean Titer (GMT) of Anti-RSV/B Neutralizing ActivityDay 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)
Geometric Mean Fold Rise (GMFR) of Anti-RSV/B Neutralizing ActivityDay 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-RSV/A Neutralizing ActivityDay 29 (the second dosing of the investigational product)
Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing ActivityDay 29 (the second dosing of the investigational product)
Number of Participants Reporting Potential Immune-Mediated DiseaseDay 1 (the first dosing of the investigational product) up to the time of follow-up and discontinuation (up to approximately 12 months)
Number of Participants Reporting Solicited Adverse Events (Local and Systemic Adverse Reactions) and Side ReactionsDay 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 ReactionsDay 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
VAGA-9001a Specific IFN-Gamma Production ResponsesDay 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 Serious Adverse Events and Side ReactionsFrom date of informed consent up to approximately 12 months

Trial Locations

Locations (3)

SOUSEIKAI PS Clinic

🇯🇵

Hakata, Fukuoka, Japan

SOUSEIKAI Sumida Hopital

🇯🇵

Sumida, Tokyo, Japan

SOUSEIKAI Nishi-Kumamoto Hospital

🇯🇵

Kumamoto, Japan

SOUSEIKAI PS Clinic
🇯🇵Hakata, Fukuoka, Japan
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