Respiratory Syncytial Virus Infections
Conditions
Keywords
Respiratory Syncytial Virus Infections, VN0200
Brief summary
This study will assess the safety, tolerability, and immunogenicity of VN-0200 after intramuscular injections in Japanese healthy adults and elderly subjects.
Interventions
BIOLOGICALVN-0200
VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
BIOLOGICALPlacebo
Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Sponsors
Daiichi Sankyo Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Japanese * Healthy adults aged ≥20 and ≤50 years (Step 1) or healthy elderly aged ≥65 and ≤80 years (at the time of informed consent) * Body mass index (BMI) is ≥18.0 and \<30.0 kg/m\^2 (at screening)
Exclusion criteria
* Participants with a history of anaphylaxis or severe allergies due to food, medicine, insect bites, cosmetics, or vaccination * Having alcohol or drug dependence, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Reporting Treatment-emergent Adverse Events | From first administration through 28 days post second administration |
| Number of Participants Reporting Local and Systemic Adverse Events | From first administration up to 14 days after second administration |
| Number of Participants Reporting Serious Adverse Events | From date of informed consent up to approximately 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Geometric Mean Fold Rise (GMFR) of Anti-RSV Specific Neutralizing Activity | 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 | 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-VAGA-9001a IgG | 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 | 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 |
Countries
Japan
Outcome results
None listed