Clinical trial NCT05547087: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory Syncytial Virus Infections
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2022-09-21
Enrollment: 342
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: Geometric Mean Titer (GMT) of anti-RSV Subgroup A (RSV/A) Neutralizing Activity
timeFrame: Day 57 (28 days after the second dosing of the investigational product)
measure: Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity
timeFrame: Day 57 (28 days after the second dosing of the investigational product)
Secondary outcomes:
measure: Geometric Mean Titer (GMT) of Anti-RSV/A Neutralizing Activity
timeFrame: Day 29 (the second dosing of the investigational product)
measure: Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity
timeFrame: Day 29 (the second dosing of the investigational product)
measure: Geometric Mean Titer (GMT) of Anti-RSV/B Neutralizing Activity
timeFrame: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
measure: Geometric Mean Fold Rise (GMFR) of Anti-RSV/B Neutralizing Activity
timeFrame: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
measure: Geometric Mean Titer (GMT) of Anti-VAGA-9001a Immunoglobulin G (IgG)
timeFrame: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
measure: Geometric Mean Fold Rise (GMFR) of Anti-VAGA-9001a Immunoglobulin G (IgG)
timeFrame: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
measure: VAGA-9001a Specific IFN-Gamma Production Responses
timeFrame: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
measure: Number of Participants Reporting Solicited Adverse Events (Local and Systemic Adverse Reactions) and Side Reactions
timeFrame: 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
measure: Number of Participants Reporting Non-Solicited Adverse Events and Side Reactions
timeFrame: 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
measure: Number of Participants Reporting Serious Adverse Events and Side Reactions
timeFrame: From date of informed consent up to approximately 12 months
measure: Number of Participants Reporting Potential Immune-Mediated Disease
timeFrame: Day 1 (the first dosing of the investigational product) up to the time of follow-up and discontinuation (up to approximately 12 months)
Other outcomes:
Locations:
city: Hakata
country: Japan
facility: SOUSEIKAI PS Clinic
state: Fukuoka
city: Sumida
country: Japan
facility: SOUSEIKAI Sumida Hopital
state: Tokyo
city: Kumamoto
country: Japan
facility: SOUSEIKAI Nishi-Kumamoto Hospital
Study officials:
affiliation: Daiichi Sankyo
name: Clinical Study Leader
role: STUDY_DIRECTOR
References: