UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050169 |
|---|---|
| Receipt number | R000056918 |
| Scientific Title | An observational study to investigate the efficacy and safety of smallpox vaccine for prophylaxis in mpox |
| Date of disclosure of the study information | 2023/01/29 |
| Last modified on | 2024/04/12 14:50:01 |
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Basic information
Public title
An observational study to investigate the efficacy and safety of smallpox vaccine for prophylaxis in mpox
Acronym
post-mkp
Scientific Title
An observational study to investigate the efficacy and safety of smallpox vaccine for prophylaxis in mpox
Scientific Title:Acronym
post-mkp
Region
| Japan |
Condition
Condition
mpox
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the smallpox vaccine in preventing the onset and severity of mpox in persons who have close contact with mpox patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of participants developed mpox within 28 days after innoculation among close contacts who received smallpox vaccine (LC16 KMB) within 14 days after exposure
Key secondary outcomes
The proportion of participants developed major skin reactions up to 14 days after innoculation
The proportion of participants developed severe mpox up to 28 days after innoculation
Safety up to 28 days after innoculation
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
| 1 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Subjects who have obtained written consent from the person himself/herself or his/her agent regarding participation in the research
2) Men and women aged 1 year or older at the time of obtaining consent
3) Subjects who plan to receive or have received the dry cell culture smallpox vaccine LC16 "KMB" for the purpose of preventing mpox within 14 days after exposure to mpox patients.
Key exclusion criteria
1) Subjects who have developed mpox at the time of smallpox vaccine innoculation
2) Subjects whose smallpox vaccine innoculation site and timing are unknown
3) Subjects who are judged inappropriate for inclusion in the study by the principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Mugen |
| Middle name | |
| Last name | Ujiie |
Organization
National Center for Global Health and Medicine
Division name
Disease control and prevention center
Zip code
162-8655
Address
1-21-1,Toyama,Shinjuku-ku,Tokyo
TEL
03-3202-7181
post-mkp-office@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Mugen |
| Middle name | |
| Last name | Ujiie |
Organization
Disease control and prevention center
Division name
Disease control and prevention center
Zip code
162-8655
Address
1-21-1,Toyama,Shinjuku-ku,Tokyo
TEL
03-3202-7181
Homepage URL
post-mkp-office@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour Standards
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine
Address
1-21-1,Toyama,Shinjuku-ku,Tokyo
Tel
03-3202-7181
post-mkp-office@hosp.ncgm.go.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
国立研究開発法人 国立国際医療研究センター（東京都）
市立札幌病院（北海道）
藤田医科大学病院（愛知県）
地方独立行政法人 りんくう総合医療センター（大阪府）
独立行政法人 国立病院機構 福岡東医療センター（福岡県）
琉球大学病院（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 01 | Month | 29 | Day |
Last modified on
| 2024 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056918
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
