Study of VN-0200 in Japanese Healthy Adults and Elderly Subjects
Status and phase
Completed
Phase 1
Conditions
Respiratory Syncytial Virus Infections
Treatments
Biological: VN-0200
Biological: Placebo
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
This study will assess the safety, tolerability, and immunogenicity of VN-0200 after intramuscular injections in Japanese healthy adults and elderly subjects.
Enrollment
48 patients
Sex
All
Ages
20 to 80 years old
Volunteers
Accepts Healthy Volunteers
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.
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Triple Blind
48 participants in 8 patient groups, including a placebo group
Step 1: VN-0200 low dose
Experimental group
Description:
Healthy adults subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.
Treatment:
Biological: VN-0200
Step 1: VN-0200 medium dose
Experimental group
Description:
Healthy adults subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.
Treatment:
Biological: VN-0200
Step 1: VN-0200 high dose
Experimental group
Description:
Healthy adults subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.
Treatment:
Biological: VN-0200
Step 1: Placebo
Placebo Comparator group
Description:
Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo.
Treatment:
Biological: Placebo
Step 2: VN-0200 low dose
Experimental group
Description:
Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.
Treatment:
Biological: VN-0200
Step 2: VN-0200 dose medium dose
Experimental group
Description:
Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.
Treatment:
Biological: VN-0200
Step 2: VN-0200 high dose
Experimental group
Description:
Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.
Treatment:
Biological: VN-0200
Step 2: Placebo
Placebo Comparator group
Description:
Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo.
Treatment:
Biological: Placebo
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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