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

Respiratory Syncytial Virus Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04914520
• Other study ID #: VN0200-A-J101
• Secondary ID: jRCT2031210069
• Status: Completed
• Phase: Phase 1
• Start date: June 11, 2021
• Est. completion date: December 16, 2021

Study information

• Verified date: December 2021
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 16, 2021
• Est. primary completion date: December 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
Japan	Medical Corporation Association Shinanokai Shinanozaka Clinic	Shinjuku-Ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Reporting Treatment-emergent Adverse Events		From first administration through 28 days post second administration
Primary	Number of Participants Reporting Local and Systemic Adverse Events		From first administration up to 14 days after second administration
Primary	Number of Participants Reporting Serious Adverse Events		From date of informed consent up to approximately 3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of IFN-? 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