UMIN-CTR Clinical Trial

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
Email	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
Email	yukin@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023478