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

December 21, 2021 updated by: Daiichi Sankyo Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Shinjuku-Ku, Tokyo, Japan, 160-0017
        • Medical Corporation Association Shinanokai Shinanozaka Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Reporting Treatment-emergent Adverse Events
Time Frame: From first administration through 28 days post second administration
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
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
From date of informed consent up to approximately 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2021

Primary Completion (Actual)

December 16, 2021

Study Completion (Actual)

December 16, 2021

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

May 31, 2021

First Posted (Actual)

June 4, 2021

Study Record Updates

Last Update Posted (Actual)

December 22, 2021

Last Update Submitted That Met QC Criteria

December 21, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VN0200-A-J101
  • jRCT2031210069 (Other Identifier: Japan Registry of Clinical Trials)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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