UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013624 |
|---|---|
| Receipt number | R000015906 |
| Scientific Title | Antibody response after vaccination with Japanese Hepatitis A Vaccine and evaluation of the booster program |
| Date of disclosure of the study information | 2014/04/03 |
| Last modified on | 2025/04/13 14:15:08 |
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Basic information
Public title
Antibody response after vaccination with Japanese Hepatitis A Vaccine and evaluation of the booster program
Acronym
Antibody response after vaccination with Japanese Hepatitis A Vaccine and evaluation of the booster program
Scientific Title
Antibody response after vaccination with Japanese Hepatitis A Vaccine and evaluation of the booster program
Scientific Title:Acronym
Antibody response after vaccination with Japanese Hepatitis A Vaccine and evaluation of the booster program
Region
| Japan |
Condition
Condition
Hepatitis A
Classification by specialty
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to evaluate immunogenicity and safety of single booster dose of Japanese Hepatitis A Vaccine in adults
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Anti-HAV antibody
Key secondary outcomes
Adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
Single dose of Aimmugen
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy adult
Key exclusion criteria
acute febrile illness
immunodeficiency
allergy against vaccine contents
pregnancy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | SHINJI |
| Middle name | |
| Last name | FUKUSHIMA |
Organization
Tokyo Medical University Hospital
Division name
Travellers' Medical Center
Zip code
160-0023
Address
6-7-1 Nishishinjuku shinjukuku, Tokyo
TEL
03-3342-6111
fuku789@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | SHINJI |
| Middle name | |
| Last name | FUKUSHIMA |
Organization
Tokyo Medical University Hospital
Division name
Travellers' Medical Center
Zip code
160-0023
Address
6-7-1 Nishishinjuku shinjukuku, Tokyo
TEL
03-3342-6111
Homepage URL
http://hospinfo.tokyo-med.ac.jp/shinryo/tokou/
fuku789@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Institute of Infectious Diseases
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University
Address
6-1-1 Nishishinjuku, Shinjuku-ku, Tokyo
Tel
03-3351-6141
adm_IRB@tokyo-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京医科大学病院(東京都)、国立感染症研究所(東京都)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 03 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/abs/pii/S0264410X23007235?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S0264410X23007235?via%3Dihub
Number of participants that the trial has enrolled
30
Results
Seroprotection rates (95%CI) for HAV were 96.6% (82.2-99.9) at prevaccination and 100%(88.1-100) at postvaccination.
The GMC(95% CI) increased from 105mIU/mL (55.1-200) at prevaccination to 4,013mIU/mL (2,993-5,768) at postvaccination.
Results date posted
| 2025 | Year | 04 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 06 | Month | 21 | Day |
Baseline Characteristics
Thirty participants were enrolled, and all participants completed the study. However, one participant was excluded because a nonspecific reaction prevented antibody titer measurement.
The 29 evaluable participants comprised 14 men and 15 women with a mean age of 36.2 years (range: 24-53).
Participant flow
At the first visit (prevaccination), informed consent for study enrollment was obtained from all participants. Blood was collected
from each participant before the third dose of Aimmugen ; the participant then received Aimmugen through intramuscular injection in the deltoid region.
The study protocol allowed for coadministration of other travel vaccines. The second visit (postvaccination) was conducted for blood collection between 28 and 42 days after the third dose.
Serum samples were stored at 20 C or below until analysis.
For each participant, two consecutive serum samples were tested in parallel to measure anti-HAV antibodies
Adverse events
No immediate allergic reactions, including anaphylaxis, were observed.
Local reactions at the injection site were reported in four cases: pain at the injection site was observed in four cases, all of which were mild (Grade 1); swelling was observed in two cases, and redness in one case.
Systemic reactions were observed in three cases: two cases reported mild (Grade 1) general fatigue, and one case reported headache and nausea, both classified as mild. No cases of muscle pain were reported.
There were no reports of adverse events affecting daily life, and no cases of serious adverse events resulting in hospitalization or long-term complications during the observation period.
Outcome measures
Seroprotection rates (SPR) and geometric mean titers (GMT) against hepatitis A virus (HAV) before and after the third dose of the hepatitis A vaccine
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 03 | Day |
Last modified on
| 2025 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015906
