JRCT ID: jRCT2031210069
Registered date:07/05/2021
A Phase 1 study to assess the safety, tolerability, and immunogenicity of VN-0200 after intramuscular injection in Japanese healthy adults and elderly subjects
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Prevention of respiratory syncytial virus |
Date of first enrollment | 11/06/2021 |
Target sample size | 48 |
Countries of recruitment | |
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, |
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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 |
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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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | Japan Science and Technology Agency |
Secondary ID(s) |
Contact
Public contact | |
Name | Contact for Clinical Trial Information |
Address | 1-2-58, Hiromachi, Shinagawa-ku, Tokyo Tokyo Japan 140-8710 |
Telephone | +81-3-6225-1111 |
dsclinicaltrial@daiichisankyo.co.jp | |
Affiliation | DAIICHI SANKYO Co.,Ltd. |
Scientific contact | |
Name | Akihiro Inoguchi |
Address | 1-2-58, Hiromachi, Shinagawa-ku, Tokyo Tokyo Japan 140-8710 |
Telephone | +81-3-6225-1111 |
dsclinicaltrial@daiichisankyo.co.jp | |
Affiliation | DAIICHI SANKYO Co.,Ltd. |