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

NCT04914520 | Completed Phase 1

• 2 other identifiers: VN0200-A-J101jRCT2031210069
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Respiratory Syncytial Virus Infections

Keywords

Respiratory Syncytial Virus Infections; VN0200

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (8)

Step 1: VN-0200 low dose

EXPERIMENTAL

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

Step 1: VN-0200 medium dose

EXPERIMENTAL

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

Step 1: VN-0200 high dose

EXPERIMENTAL

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

Step 1: Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Step 2: VN-0200 low dose

EXPERIMENTAL

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

Step 2: VN-0200 dose medium dose

EXPERIMENTAL

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

Step 2: VN-0200 high dose

EXPERIMENTAL

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

Step 2: Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

VN-0200 BIOLOGICAL

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

Step 1: VN-0200 high dose; Step 1: VN-0200 low dose; Step 1: VN-0200 medium dose; Step 2: VN-0200 dose medium dose; Step 2: VN-0200 high dose; Step 2: VN-0200 low dose

Placebo BIOLOGICAL

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

Step 1: Placebo; Step 2: Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Participants with a history of anaphylaxis or severe allergies due to food, medicine, insect bites, cosmetics, or vaccination
• Having alcohol or drug dependence, etc.

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (1)

Medical Corporation Association Shinanokai Shinanozaka Clinic

Shinjuku-Ku, Tokyo, 160-0017, Japan

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Clinical Study Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: June 4, 2021
• Study Start: June 11, 2021
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2021
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)