Study of VN-0200 in Japanese Healthy Adults and Elderly Subjects

Study Overview
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Brief Summary
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This study will assess the safety, tolerability, and immunogenicity of VN-0200 after intramuscular injections in Japanese healthy adults and elderly subjects.

Official Title
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A Phase 1 Study to Assess the Safety, Tolerability, and Immunogenicity of VN-0200 After Intramuscular Injections in Japanese Healthy Adults and Elderly Subjects

Conditions
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Respiratory Syncytial Virus Infections

Intervention / Treatment
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* Biological: VN-0200
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Step 1: VN-0200 low dose<br>Healthy adults subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b. | Biological: VN-0200<br>* VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total<br>|
| Experimental: Step 1: VN-0200 medium dose<br>Healthy adults subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b. | Biological: VN-0200<br>* VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total<br>|
| Experimental: Step 1: VN-0200 high dose<br>Healthy adults subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b. | Biological: VN-0200<br>* VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total<br>|
| Placebo Comparator: Step 1: Placebo<br>Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo. | Biological: Placebo<br>* Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total<br>|
| Experimental: Step 2: VN-0200 low dose<br>Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b. | Biological: VN-0200<br>* VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total<br>|
| Experimental: Step 2: VN-0200 dose medium dose<br>Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b. | Biological: VN-0200<br>* VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total<br>|
| Experimental: Step 2: VN-0200 high dose<br>Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b. | Biological: VN-0200<br>* VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total<br>|
| Placebo Comparator: Step 2: Placebo<br>Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo. | Biological: Placebo<br>* Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Syncytial Virus Infections, VN0200