UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004771 |
|---|---|
| Receipt number | R000005680 |
| Scientific Title | Evaluation of varicella zoster virus specific immune response after varicella vaccine immunization in elderly patients with diabetes mellitus. |
| Date of disclosure of the study information | 2010/12/21 |
| Last modified on | 2015/03/09 15:23:18 |
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Basic information
Public title
Evaluation of varicella zoster virus specific immune response after varicella vaccine immunization in elderly patients with diabetes mellitus.
Acronym
Varicella zoster virus specific immune response induced by varicella vaccine immunization in old patients with diabetes mellitus.
Scientific Title
Evaluation of varicella zoster virus specific immune response after varicella vaccine immunization in elderly patients with diabetes mellitus.
Scientific Title:Acronym
Varicella zoster virus specific immune response induced by varicella vaccine immunization in old patients with diabetes mellitus.
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether live varicella vaccines increase specific immune response to varicella-zoster virus in patients with diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
cell-mediated immunity(skin test reaction)
Key secondary outcomes
1. cell-mediated immunity; interferon-gamma (IFN-g) enzyme-linked immunospot (ELISPOT)
2.immunogenicity; immune adherence hemagglutination (IAHA)
3.Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
Interventions:Immunization with 0.5ml of saline and 1 dose of pneumococcal vaccine (Pneumovax) to 25 patients with diabetes.
Interventions/Control_2
Interventions:Immunization with 1 dose of live attenuated Varicella vaccine (BIKEN) and 1 dose of pneumococcal vaccine (Pneumovax)to 25 patients with diabetes.
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
| 60 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
60 to 75 years of 50 patients with diabetes in HBA1c levels from 6 to 9.5
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 and patients within 5 years of primary 23-valent pneumococcal polysaccharides vaccine(PPSV23).
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hata Atsuko |
Organization
Kitano hospital, The Tazuke Kofukai Medical
Division name
4th Division
Zip code
Address
2-4-20 Ohgimachi Kitaku Osaka
TEL
06-6312-8824
ahata@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taku Satomi |
Organization
Kitano hospital, The Tazuke Kofukai Medical Research Institute
Division name
Clinical Research
Zip code
Address
2-4-20 Ohgimachi Kitaku Osaka
TEL
06-6312-1221
Homepage URL
rinshou@kitano-hp.or.jp
Sponsor or person
Institute
Kitano hospital, The Tazuke Kofukai Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National institute of Biomedical Innovation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
田附興風会医学研究所 北野病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 21 | 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
Completed
Date of protocol fixation
| 2010 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 21 | Day |
Last modified on
| 2015 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005680
