UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of Varicella Zoster Virus specific immune response assessed by IFN-g releasing assay
Acronym	Varicella Zoster Virus specific immune response assessed by IFN-g releasing assay
Scientific Title	Evaluation of Varicella Zoster Virus specific immune response assessed by IFN-g releasing assay
Scientific Title:Acronym	Varicella Zoster Virus specific immune response assessed by IFN-g releasing assay
Region	Japan

Condition
Condition	healthy adult, 20 to 75 years of age
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish methods for evaluating changes IFN-g releasing from mononuclear cells of subjects with immunization of Varicella zoster vaccine.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	rate of change of IFN-g after vaccination of varicella vaccine
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Vaccine
Interventions/Control_1	varicella vaccine live attenuated "BIKEN"
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	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	healthy adults, male or female
Key exclusion criteria	Vaccination inappropriate person : A person under any of the following condition is not able to be vaccinated. 1. A person who has a fever 2. A person appear suffering severe acute illness 3. A person who previously exhibited anaphylaxis by components of this varicella vaccine 4. A pregnant woman 5. In addition to the persons listed above, a person who is in an inappropriate state for vaccination
Target sample size	17

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	06-6131-2889
Homepage URL
Email	infe@kitano-hp.or.jp

Sponsor
Institute	The Tazuke Kofukai Medical Research Institute
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research
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	The Tazuke Kofukai Medical Research Institute Ethics Committee
Address	2-4-20 Ohgimachi Kitaku Osaka 530-8480 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 08 Month 17 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 07 Month 31 Day
Date of IRB	2015 Year 06 Month 23 Day
Anticipated trial start date	2015 Year 08 Month 17 Day
Last follow-up date	2019 Year 03 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 08 Month 17 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=R000021482