A Phase 1 Study to Assess the Safety, Tolerability, and Immunogenicity of VN-0200 After Intramuscular Injections in Japanese Healthy Adults and Elderly Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Number of Participants Reporting Treatment-emergent Adverse Events
Study Overview
Brief Summary
This study will assess the safety, tolerability, and immunogenicity of VN-0200 after intramuscular injections in Japanese healthy adults and elderly subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Arms & Interventions
Step 1: Placebo
Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo.
Intervention: Placebo (Biological)
Step 2: Placebo
Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo.
Intervention: Placebo (Biological)
Step 2: VN-0200 low dose
Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.
Intervention: VN-0200 (Biological)
Step 1: VN-0200 low dose
Healthy adults subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.
Intervention: VN-0200 (Biological)
Step 2: VN-0200 high dose
Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.
Intervention: VN-0200 (Biological)
Step 2: VN-0200 dose medium dose
Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.
Intervention: VN-0200 (Biological)
Step 1: VN-0200 high dose
Healthy adults subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.
Intervention: VN-0200 (Biological)
Step 1: VN-0200 medium dose
Healthy adults subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.
Intervention: VN-0200 (Biological)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)