UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040526 |
|---|---|
| Receipt number | R000046155 |
| Scientific Title | Long-term immunity after Yellow fever vaccination |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2026/07/19 22:37:11 |
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Basic information
Public title
Long-term immunity after Yellow fever vaccination
Acronym
Long-term immunity after Yellow fever vaccination
Scientific Title
Long-term immunity after Yellow fever vaccination
Scientific Title:Acronym
Long-term immunity after Yellow fever vaccination
Region
| Japan |
Condition
Condition
Yellow fever
Classification by specialty
| Medicine in general | Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the Long term immunity after Yellow fever vaccination.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
seropositivity rate of neutralizing antibody titers against yellow fever virus
Key secondary outcomes
geometric mean titer of neutralizing antibody titers against yellow fever virus
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Japanese people who received yellow fever vaccine more than 5 years ago
Key exclusion criteria
no restriction
Target sample size
50
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, Shinjuku, Tokyo, Japan
TEL
+81-3-5339-3726
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, Shinjuku, Tokyo, Japan
TEL
+81-3-5339-3726
Homepage URL
fuku789@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Hospital
Travellers' Medical Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University, Institutional Review Board
Address
6-7-1 Nishishinjuku, Shinjuku, Tokyo, Japan
Tel
03-3342-6111
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）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2076-393X/13/7/675
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2076-393X/13/7/675
Number of participants that the trial has enrolled
65
Results
The 65 participants comprised 35 males and 30 females, with a median age at vaccination of 34 years.
The time between YF vaccination and registration was between 5 and 26 years.
All participants remained seropositive even after a long time.
Statistical analysis showed no correlation between the time elapsed since YF vaccination and PRNT50.
Results date posted
| 2026 | Year | 07 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 06 | Month | 25 | Day |
Baseline Characteristics
This observational study enrolled Japanese adults who received a single YF vaccination >5 years previously.
The 65 participants comprised 35 males and 30 females, with a median age at vaccination of 34 years.
Participant flow
This observational study enrolled Japanese adults who received a single YF vaccination >5 years previously.
Blood samples were collected after confirming eligibility for the study.
The serum levels of anti-yellow fever virus (YFV)-neutralizing antibodies were measured using the 50% plaque reduction neutralization test (PRNT50).
Seropositivity was defined as the proportion of participants with neutralizing antibody titers more than 1:10.
Adverse events
None
Outcome measures
The serum levels of anti-yellow fever virus (YFV)-neutralizing antibodies were measured using the 50% plaque reduction neutralization test (PRNT50).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Descriptive study
Management information
Registered date
| 2020 | Year | 05 | Month | 26 | Day |
Last modified on
| 2026 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046155
