UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018230 |
|---|---|
| Receipt number | R000021102 |
| Scientific Title | Immunological persistence after booster doses of the inactivated polio vaccine |
| Date of disclosure of the study information | 2015/07/07 |
| Last modified on | 2025/04/24 13:49:24 |
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Basic information
Public title
Immunological persistence after booster doses of the inactivated polio vaccine
Acronym
Immunological persistence after booster doses of the inactivated polio vaccine
Scientific Title
Immunological persistence after booster doses of the inactivated polio vaccine
Scientific Title:Acronym
Immunological persistence after booster doses of the inactivated polio vaccine
Region
| Japan |
Condition
Condition
Polio
Classification by specialty
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is evaluate immunological persistence of booster dose of eIPV in Japanese adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Neutralizing antibody titer of poliovirus
Key secondary outcomes
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
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
Other
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
6-7-1 Nishishinjuku, Shinjuku, Tokyo, Japan
Tel
0333426111
fuku789@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
| 2015 | Year | 07 | Month | 07 | Day |
Related information
URL releasing protocol
https://crai.tokyo-med.ac.jp/
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2076-393X/13/5/447
Number of participants that the trial has enrolled
10
Results
The results indicate that, even 10 years after the booster vaccination, antibodies against poliovirus types 1 and 2 remained at high levels, exceeding the detection limits of neutralization tests. However, some participants showed decreased antibody levels against poliovirus type 3.
Results date posted
| 2025 | Year | 04 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The ten participants comprised four men and six women with a median age of 35.5 years (range: 28 - 56). Five participants had maternal and child health handbooks documenting that they had received two doses of OPV.
Participant flow
We contacted Japanese adults who participated in the previous short-term study by email approximately 3 years after the two-dose booster was administered.
Of the participants in the prior short-term study, 10 were successfully contacted.
These 10 partici-pants were included in this long-term study.
They visited Tokyo Medical University Hos-pital and underwent blood sampling at 3, 5 and 10 years after receiving the two-dose IPV booster vaccination.
Adverse events
None
Outcome measures
The seropositivity rates and the geometric mean titers (GMT) of anti-poliovirus titers at 3, 5, and 10 years after 2-dose IPV booster vaccination
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
We evaluate immunological persistence against polio virus.
(Serum neutralizing antibody titer against polio virus)
Management information
Registered date
| 2015 | Year | 07 | Month | 07 | Day |
Last modified on
| 2025 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021102
