Study of VN-0200 in Japanese Healthy Adults and Elderly Subjects
Phase 1
Completed
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Biological: VN-0200Biological: Placebo
- Registration Number
- NCT04914520
- Lead Sponsor
- Daiichi Sankyo Co., Ltd.
- Brief Summary
This study will assess the safety, tolerability, and immunogenicity of VN-0200 after intramuscular injections in Japanese healthy adults and elderly subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Step 1: VN-0200 medium dose VN-0200 Healthy adults subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b. Step 2: VN-0200 high dose VN-0200 Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b. Step 1: Placebo Placebo Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo. Step 2: VN-0200 low dose VN-0200 Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b. Step 1: VN-0200 low dose VN-0200 Healthy adults subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b. Step 1: VN-0200 high dose VN-0200 Healthy adults subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b. Step 2: Placebo Placebo Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo. Step 2: VN-0200 dose medium dose VN-0200 Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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
Trial Locations
- Locations (1)
Medical Corporation Association Shinanokai Shinanozaka Clinic
🇯🇵Shinjuku-Ku, Tokyo, Japan