A Dose Finding Study of VN-0200

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

Official Title
-----------------
A Phase 2, Randomized, Double-Blind, Dose Finding Study to Describe the Immunogenicity, Safety and Tolerability of VN-0200 in Japanese Adults Aged 60-80 Years

Conditions
-----------------
Respiratory Syncytial Virus Infections

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese healthy elderly aged >=60 and =<80 years (at the time of informed consent). Subjects who can follow the compliance requirements during clinical trials, undergo medical examinations and tests specified by the protocol, and report symptoms, etc. Exclusion Criteria: Serious cardiovascular, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disorders. Serious acute illness. Has been diagnosed with congenital or acquired immunodeficiency. Previous vaccination with an RSV vaccine (including the investigational drugs). Having a history of anaphylaxis or severe allergies due to medicines, or vaccination. Administration of gamma globulins, systemic immunosuppressants (including drugs for the treatment of autoimmune diseases), hematopoietics (excluding iron and vitamins), and corticosteroids (excluding topical preparations, inhalants, and small-dose short-term oral administration*) or planned administration of them in the period starting 28 days prior to informed consent and ending 28 days after the second vaccination. * <14 days, 20 mg/day on a prednisolone basis. Planned or actual administration of other vaccine in the period starting 14 days prior to informed consent and ending 14 days after the second vaccination.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: VN-0200 low dose<br>Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a. | Biological: VN-0200<br>* VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.<br>|
| Experimental: Group 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; 2 shots in 4 weeks.<br>|
| Experimental: Group 3: VN-0200 low dose<br>Healthy elderly subjects will be randomized to receive intramuscular injection of low 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; 2 shots in 4 weeks.<br>|
| Experimental: Group 4: VN-0200 low dose<br>Healthy elderly subjects will be randomized to receive intramuscular injection of low 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; 2 shots in 4 weeks.<br>|
| Experimental: Group 5: VN-0200 medium dose<br>Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a. | Biological: VN-0200<br>* VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.<br>|
| Experimental: Group 6: VN-0200 medium dose<br>Healthy elderly subjects will be randomized to receive intramuscular injection of medium 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; 2 shots in 4 weeks.<br>|
| Active Comparator: Group 7: VN-0200 high dose<br>Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a. | Biological: VN-0200<br>* VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.<br>|
| Experimental: Group 8: VN-0200 high dose<br>Healthy elderly subjects will be randomized to receive intramuscular injection of high 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; 2 shots in 4 weeks.<br>|
| Experimental: Group 9: VN-0200 high dose<br>Healthy elderly subjects will be randomized to receive intramuscular injection of high 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; 2 shots in 4 weeks.<br>|
| Experimental: Group 10: 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; 2 shots in 4 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer (GMT) of anti-RSV Subgroup A (RSV/A) Neutralizing Activity |  | Day 57 (28 days after the second dosing of the investigational product) | 
| Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity |  | Day 57 (28 days after the second dosing of the investigational product) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer (GMT) of Anti-RSV/A Neutralizing Activity |  | Day 29 (the second dosing of the investigational product) | 
| Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity |  | Day 29 (the second dosing of the investigational product) | 
| Geometric Mean Titer (GMT) of Anti-RSV/B Neutralizing Activity |  | Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product) | 
| Geometric Mean Fold Rise (GMFR) of Anti-RSV/B Neutralizing Activity |  | Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product) | 
| Geometric Mean Titer (GMT) of Anti-VAGA-9001a Immunoglobulin G (IgG) |  | Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product) | 
| Geometric Mean Fold Rise (GMFR) of Anti-VAGA-9001a Immunoglobulin G (IgG) |  | Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product) | 
| VAGA-9001a Specific IFN-Gamma Production Responses |  | Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product) | 
| Number of Participants Reporting Solicited Adverse Events (Local and Systemic Adverse Reactions) and Side Reactions |  | Day 1 (the first dosing of the investigational product) up to Day 8, Day 29 (the second dosing of the investigational product) up to Day 36 and at time of discontinuation (whichever comes first), up to approximately 1 month | 
| Number of Participants Reporting Non-Solicited Adverse Events and Side Reactions |  | Day 1 (the first dosing of the investigational product) up to Day 57 (28 days after second dosing of the investigational product) and at time of discontinuation (whichever comes first), up to approximately 2 months | 
| Number of Participants Reporting Serious Adverse Events and Side Reactions |  | From date of informed consent up to approximately 12 months | 
| Number of Participants Reporting Potential Immune-Mediated Disease |  | Day 1 (the first dosing of the investigational product) up to the time of follow-up and discontinuation (up to approximately 12 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory Syncytial Virus Infections