UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020913 |
|---|---|
| Receipt number | R000023478 |
| Scientific Title | Study of VZV-specific immune response induced by intradermal injection of Varicella vaccine |
| Date of disclosure of the study information | 2016/02/08 |
| Last modified on | 2022/03/25 15:56:21 |
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Basic information
Public title
Study of VZV-specific immune response induced by intradermal injection of Varicella vaccine
Acronym
Study of intradermal injection of Varicella vaccine
Scientific Title
Study of VZV-specific immune response induced by intradermal injection of Varicella vaccine
Scientific Title:Acronym
Study of intradermal injection of Varicella vaccine
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effects of intradermal injection of VZV vaccine on the inducton of immune response
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
enhancement of CMI
VZV-skin test reaction
6W,1Y,2Y 3Y after injection
Key secondary outcomes
antibody titer
safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
SC injection of VZV vaccine
Interventions/Control_2
ID injection of VZV vaccine
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
criteria of live vactine
Key exclusion criteria
excluding criteria:
patients with acute conditions; patients with underlying diseases, malignant disease, autoimmune diseases, and renal failure with serum creatinine greater than 2; smoker; treated with steroid, immunosuppressant drugs or antiplatelet drugs; with allergic reaction against varicella vaccine or pneumococcal vaccine;
dermatological disorder unable to judge if skin test reaction or not; herpes zoster patients.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Asada |
| Middle name | |
| Last name | Hideo |
Organization
Nara Medical Univ
Division name
Dept of Dermatology
Zip code
634-8522
Address
840 Shijyo-cho Kashihara
TEL
0744-22-3051
asadah@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Nishimura |
| Middle name | |
| Last name | Yuki |
Organization
Nara Medical Univ
Division name
Dept of Dermatology
Zip code
634-8522
Address
840 Shijyo-cho Kashihara
TEL
0744-22-3051
Homepage URL
yukin@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Biken Center for Innovative Vaccine Research and Development, The Research Foundation for Microbial Diseases of Osaka University (BIKEN)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical Univ
Address
840 Shijyo-cho Kashihara
Tel
0744-22-3051
asadah@naramed-u.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 08 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
66
Results
Intradermal injection with one-fifth dose VZV vaccine showed a similar or greater effect on VZV-specific cellular immunostimulation
than conventional subcutaneous injection.
Results date posted
| 2022 | Year | 03 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy adults aged 50-75
Participant flow
We compared the immunogenicity of subcutaneous and intradermal VZV vaccination. Immunogenicity to VZV was determined via the VZV skin test reaction, VZV-specific memory T cell proliferation, VZV-specific serum antibody levels, and cytokine production from peripheral blood cells. The VZV skin test was performed before and 6-8 weeks after vaccination. Blood samples were obtained before and 6-8 weeks after vaccination and used for measurement of VZV-specific serum antibody titer, cytokine production analysis, and flow cytometry.
Adverse events
None
Outcome measures
We compared the immunogenicity and safety of intradermal VZV vaccination with that of conventional subcutaneous vaccination.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 07 | Day |
Last modified on
| 2022 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023478
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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