A Phase 1 study to assess the safety, tolerability, and immunogenicity of VN-0200 after intramuscular injection in Japanese healthy adults and elderly subjects

JRCT ID: jRCT2031210069

Registered date:07/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prevention of respiratory syncytial virus
• Date of first enrollment: 11/06/2021
• Target sample size: 48
• Study type: Interventional
• Intervention(s): VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) or placebo 0.5 mL is administered twice on Day 1 and Day 29.

Outcome(s)

• Primary Outcome: Safety:Adverse events, specific adverse events, Potential Immune-Mediated Disease, laboratory data, body weight, vital signs and 12-lead ECGs,
• Secondary Outcome: Geometric Mean Fold Rise (GMFR) of Anti-RSV Specific Neutralizing activity, Geometric Mean Titer (GMT) of anti-VAGA-9001a IgG, GMT of anti-RSV G IgG, VAGA-9001a-specific IFN-gamma production

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1. Japanese healthy subjects.
2. Age >=20 and <=50 years upon providing informed consent at step1 or Age >=65 and <=80 years upon providing informed consent at step2.
3. Body mass index (BMI) >=18.0 and <30.0 kg/m2 at screening.

Exclude criteria

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

Related Information

• Primary Sponsor: Inoguchi Akihiro
• Source(s) of Monetary Support: Japan Science and Technology Agency