UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045026 |
|---|---|
| Receipt number | R000051429 |
| Scientific Title | A retrospective survey on the prevention of herpes zoster through the VARICELLA VACCINE LIVE ATTENUATED "BIKEN" |
| Date of disclosure of the study information | 2021/08/02 |
| Last modified on | 2023/06/24 07:39:38 |
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Basic information
Public title
A retrospective survey on herpes zoster prevention with varicella vaccine
Acronym
A retrospective survey on herpes zoster prevention with varicella vaccine
Scientific Title
A retrospective survey on the prevention of herpes zoster through the VARICELLA VACCINE LIVE ATTENUATED "BIKEN"
Scientific Title:Acronym
A retrospective survey on the prevention of herpes zoster through the VARICELLA VACCINE LIVE ATTENUATED "BIKEN"
Region
| Japan |
Condition
Condition
Herpes Zoster
Classification by specialty
| Medicine in general | Infectious disease | Dermatology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The onset of herpes zoster will be investigated and compared in the two groups of adults over 50 years old; A vaccination group: subjects inoculated with the VARICELLA VACCINE LIVE ATTENUATED "BIKEN"
A comparative group: those with similar lifestyles with the subjects in a vaccination group such as their spouses
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effectiveness of the varicella vaccine against herpes zoster will be evaluated by analyzing statistically the frequency of herpes zoster onsets between each group and the background of the study subjects.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Those who are over 50 years old
2) Those who have provided the written consent to participate in this study
Key exclusion criteria
Those who have been vaccinated with a freeze-dried recombinant herpes zoster vaccine.
Target sample size
1830
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Irie |
Organization
SOUSEIKAI
Division name
Executive Director
Zip code
812-0025
Address
6-18 Tenyamachi Hakataku Fukuoka-City Fukuoka
TEL
092-283-7810
junko-manabe@lta-med.com
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Kumashiro |
Organization
SOUSEIKAI
Division name
Department of strategy & business development
Zip code
812-0025
Address
6-18 Tenyamachi Hakataku Fukuoka-City Fukuoka
TEL
092-409-1914
Homepage URL
Hiroko-kumashiro@lta-med.com
Sponsor or person
Institute
SOUSEIKAI
Institute
Department
Personal name
Funding Source
Organization
The Research Foundation for Microbial Diseases of Osaka University
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka City University Graduate School of Medicine Department of Public Health
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hakata Clinic Institutional Review Board
Address
6-18 Tenyamachi, Hakata-ku, Fukuoka, Fukuoka
Tel
0922837701
miyako-koga@lta-med.com
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
医療法人相生会（福岡県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 02 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2076-393X/11/2/259
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2076-393X/11/2/259
Number of participants that the trial has enrolled
1616
Results
1098 vaccinated and 518 unvaccinated subjects were analyzed. 26 vaccinated(2.4%) and 22 unvaccinated(4.2%) subjects reported herpes zoster diagnosis, and 3vaccinated(0.3%) and 2unvaccinated(0.4%) subjects reported postherpetic neuralgia. Adjusted vaccine effectiveness against a clinical diagnosis was 41% for herpes zoster [-6% to 67%], with marginal significance, and 16% [-408% to 86%] for postherpetic neuralgia.
Results date posted
| 2023 | Year | 06 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1098 vaccinated
518 unvaccinated
Participant flow
Vaccinated between 2021 and 2022 and compared with unvaccinated family members.
Self-administered questionnaires determined retrospective experiences of herpes zoster and postherpetic neuralgia diagnosis.
Adverse events
None
Outcome measures
vaccine effectiveness
-retrospective experiences of HZ
-retrospective experiences of PHN
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The onset of herpes zoster will be investigated and compared in the two groups of adults over 50 years old; A vaccination group: subjects inoculated with the VARICELLA VACCINE LIVE ATTENUATED "BIKEN" from 2016 to 2017.
A comparative group: those with similar lifestyles with the subjects in a vaccination group such as their spouses
Management information
Registered date
| 2021 | Year | 07 | Month | 31 | Day |
Last modified on
| 2023 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051429
