This study will assess the safety, tolerability, and immunogenicity of VN-0200 after intramuscular injections in Japanese healthy adults and elderly subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
48
VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Medical Corporation Association Shinanokai Shinanozaka Clinic
Shinjuku-Ku, Tokyo, Japan
Number of Participants Reporting Treatment-emergent Adverse Events
Time frame: From first administration through 28 days post second administration
Number of Participants Reporting Local and Systemic Adverse Events
Time frame: From first administration up to 14 days after second administration
Number of Participants Reporting Serious Adverse Events
Time frame: From date of informed consent up to approximately 3 months
Geometric Mean Fold Rise (GMFR) of Anti-RSV Specific Neutralizing Activity
Time frame: Day 29 and Day 57 post-dose and at the time of discontinuation (whichever occurs first), up to approximately 2 months
Geometric Mean Titer (GMT) of Anti-VAGA-9001a IgG
Time frame: Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months
Geometric Mean Titer (GMT) of Anti-RSV IgG
Time frame: Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months
Number of IFN-γ spot-forming cells in PBMC Detected by ELISPOT
Time frame: Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months
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