Study of VN-0200 in Japanese Healthy Adults and Elderly Subjects
NCT ID: NCT04914520
Last Updated: 2021-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2021-06-11
2021-12-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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.
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
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.
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
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.
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
Step 1: Placebo
Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo.
Placebo
Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
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.
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
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.
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
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.
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
Step 2: Placebo
Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo.
Placebo
Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* Having alcohol or drug dependence, etc.
20 Years
80 Years
ALL
Yes
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Study Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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Medical Corporation Association Shinanokai Shinanozaka Clinic
Shinjuku-Ku, Tokyo, Japan
Countries
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Other Identifiers
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jRCT2031210069
Identifier Type: OTHER
Identifier Source: secondary_id
VN0200-A-J101
Identifier Type: -
Identifier Source: org_study_id