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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004771
Receipt No. 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

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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
Email 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
Email rinshou@kitano-hp.or.jp

Sponsor
Institute Kitano hospital, The Tazuke Kofukai Medical Research Institute
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005680

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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