UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of live varicella vaccine in patients with diabetes mellitus associated with decreased cell-mediated immunity: a Randomized, Double-blind, Placebo-controlled Trial
Acronym	Efficacy and safety of live varicella vaccine in patients with diabetes: a Randomized, Double-blind, Placebo-controlled Trial
Scientific Title	Efficacy and safety of live varicella vaccine in patients with diabetes mellitus associated with decreased cell-mediated immunity: a Randomized, Double-blind, Placebo-controlled Trial
Scientific Title:Acronym	Efficacy and safety of live varicella vaccine in patients with diabetes: a Randomized, Double-blind, Placebo-controlled Trial
Region	Japan

Condition
Condition	diabetes mellitus
Classification by specialty	Endocrinology and Metabolism Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate varicella zoster virus (VZV)-specific cell-mediated immunity live attenuated Oka varicella zoster vaccine
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	varicella zoster virus-specific cell-mediated immunity by using an interferon-g enzyme-linked immunosorbent assay at 3, 6 and 12 months after primary administration of vaccine or placebo.
Key secondary outcomes	immunogenicity of varicella vaccine at 3, 6 and 12 months after primary administration of vaccine or placebo. safety of varicella vaccine for 12 months after after primary administration of vaccine or placebo.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Vaccine
Interventions/Control_1	A: saline+saline
Interventions/Control_2	B: varicella vaccine+saline
Interventions/Control_3	C: varicella vaccine+varicella vaccine
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	diabetic patients with HbA1c(JDS) 6-9.5% Diabetic patients diagnosed by a physician based on the Report of the Committee on the Classification and Diagnostic Criteria of Diabetes Mellitus(J Diabetes Investig.1:212-28. 2010).
Key exclusion criteria	Excluded were users of steroids or other immunosuppressive drugs, those with heart disease treated by antiplatelet drugs, immunocompromised patients with any potential malignant disease, autoimmune disease, renal failure, patients with immunization of varicella vaccine within 5 years, HZ patients, andsmokers,
Target sample size	80

Research contact person
Last name of lead principal investigator	1st name Atsuko Middle name Last name Hata
Organization	Kitano hospital, The Tazuke Kofukai Medical Research Institute
Division name	Department of Infectious Diseases
Zip code	5308480
Address	2-4-20 Ohgimachi Kitaku Osaka
TEL	06-6312-8824
Email	ahata@kitano-hp.or.jp

Public contact
1st name of contact person	1st name Atsuko Middle name Last name Hata
Organization	The Tazuke Kofukai Medical Research Institute
Division name	department of infectious diseases
Zip code	5308480
Address	2-4-20 Ohgimachi Kitaku Osaka
TEL	06-6312-1221
Homepage URL
Email	infe@kitano-hp.or.jp

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

Funding Source
Organization	Japan Society for the Promotion of Science
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	Kitano hospital, The Tazuke Kofukai Medical Research Institute
Address	2-4-20 Ohgimachi Kitaku Osaka Japan
Tel	06-6312-1221
Email	rinshou@kitano-hp.or.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	2015 Year 09 Month 01 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	2015 Year 08 Month 05 Day
Date of IRB	2015 Year 07 Month 08 Day
Anticipated trial start date	2015 Year 09 Month 07 Day
Last follow-up date	2018 Year 10 Month 24 Day
Date of closure to data entry	2018 Year 12 Month 12 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 09 Month 01 Day
Last modified on	2019 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021834