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

Primary Purpose

Respiratory Syncytial Virus Infections

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

VN-0200

Placebo

About this trial

This is an interventional prevention trial for Respiratory Syncytial Virus Infections focused on measuring Respiratory Syncytial Virus Infections, VN0200

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Medical Corporation Association Shinanokai Shinanozaka Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Step 1: VN-0200 low dose

Step 1: VN-0200 medium dose

Step 1: VN-0200 high dose

Step 1: Placebo

Step 2: VN-0200 low dose

Step 2: VN-0200 dose medium dose

Step 2: VN-0200 high dose

Step 2: Placebo

Arm Description

Healthy adults subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.

Healthy adults subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.

Healthy adults subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.

Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo.

Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.

Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.

Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.

Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo.

Outcomes

Primary Outcome Measures

Number of Participants Reporting Treatment-emergent Adverse Events

Number of Participants Reporting Local and Systemic Adverse Events

Number of Participants Reporting Serious Adverse Events

Secondary Outcome Measures

Geometric Mean Fold Rise (GMFR) of Anti-RSV Specific Neutralizing Activity

Geometric Mean Titer (GMT) of Anti-VAGA-9001a IgG

Geometric Mean Titer (GMT) of Anti-RSV IgG

Number of IFN-γ spot-forming cells in PBMC Detected by ELISPOT

Full Information

NCT ID

NCT04914520

First Posted

May 19, 2021

Last Updated

December 21, 2021

Sponsor

Daiichi Sankyo Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04914520

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

June 11, 2021 (Actual)

Primary Completion Date

December 16, 2021 (Actual)

Study Completion Date

December 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Daiichi Sankyo Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Syncytial Virus Infections

Keywords

Respiratory Syncytial Virus Infections, VN0200

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Step 1: VN-0200 low dose

Arm Type

Experimental

Arm Description

Healthy adults subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.

Arm Title

Step 1: VN-0200 medium dose

Arm Type

Experimental

Arm Description

Healthy adults subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.

Arm Title

Step 1: VN-0200 high dose

Arm Type

Experimental

Arm Description

Healthy adults subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.

Arm Title

Step 1: Placebo

Arm Type

Placebo Comparator

Arm Description

Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo.

Arm Title

Step 2: VN-0200 low dose

Arm Type

Experimental

Arm Description

Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.

Arm Title

Step 2: VN-0200 dose medium dose

Arm Type

Experimental

Arm Description

Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.

Arm Title

Step 2: VN-0200 high dose

Arm Type

Experimental

Arm Description

Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.

Arm Title

Step 2: Placebo

Arm Type

Placebo Comparator

Arm Description

Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo.

Intervention Type

Biological

Intervention Name(s)

VN-0200

Intervention Description

VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total

Primary Outcome Measure Information:

Title

Number of Participants Reporting Treatment-emergent Adverse Events

Time Frame

From first administration through 28 days post second administration

Title

Number of Participants Reporting Local and Systemic Adverse Events

Time Frame

From first administration up to 14 days after second administration

Title

Number of Participants Reporting Serious Adverse Events

Time Frame

From date of informed consent up to approximately 3 months

Secondary Outcome Measure Information:

Title

Geometric Mean Fold Rise (GMFR) of Anti-RSV Specific Neutralizing Activity

Time Frame

Day 29 and Day 57 post-dose and at the time of discontinuation (whichever occurs first), up to approximately 2 months

Title

Geometric Mean Titer (GMT) of Anti-VAGA-9001a IgG

Time Frame

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

Title

Geometric Mean Titer (GMT) of Anti-RSV IgG

Time Frame

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

Title

Number of IFN-γ spot-forming cells in PBMC Detected by ELISPOT

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Study Leader

Organizational Affiliation

Daiichi Sankyo, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Medical Corporation Association Shinanokai Shinanozaka Clinic

City

Shinjuku-Ku

State/Province

Tokyo

ZIP/Postal Code

160-0017

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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