UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy and safety of live attenuated vaccine in patients treated with steroid and immunosuppresive drugs: A prospective study
Acronym	The prospective study of live attenuated vaccine for patients treated with steroids and immunosuppresive drugs
Scientific Title	The efficacy and safety of live attenuated vaccine in patients treated with steroid and immunosuppresive drugs: A prospective study
Scientific Title:Acronym	The prospective study of live attenuated vaccine for patients treated with steroids and immunosuppresive drugs
Region	Japan

Condition
Condition	collagen diseases, kidney diseases, digestive diaseases, liver diaseases, neurological diseases, kidney transplant patients
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of live attenuated vaccine in patients treated with steroid and immunosuppresive drugs
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1) Assessment of antibody acquisition after vaccination classified by each virus. 2) Analysis of long maintenance of acquired immunity. 3) Analysis of incididence of adverse events.
Key secondary outcomes	1) Analysis of causes of vaccine failure. 2) Analysis of causes of adverse events. 3) Analysis of effect for prevention of virus infection.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Vaccine
Interventions/Control_1	Live attenuated vaccine
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	1 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Equal or more than one years old. 2. Patients under treatment with immunosuppressants(tacrolimus, cyclosporine, mizoribine, azathioprine, methotrexate mycophenolate mofetil) 3. Normal cellular immunity (CD4 counts>500/mm3, PHA lymphocyte stimulatory test-stimulation index>101.6). 4. Serum IgG level>300mg/dl 5. Negative or borderline antibody titer of one or more of the following viruses: measles, rubella, varicella, or mumps. 6. Patients under treatment with prednisolone <1mg/kg/day or <2mg/kg every alternate day. 7. tacrolimus trough level<10ng/ml or cyclosporine trough level<100ng/ml. 8. Patients with low activity of underlying disease. 9. Patients who cannot discontinue immunosuppressants because of primary disease.
Key exclusion criteria	1. Steroid use of more than 1mg/kg/d. 2. For renal transplant recipients, <1 year since transplantation or acute rejection within the previous 6 months.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Kenichi Middle name Last name Nishimura
Organization	Yokohama City University
Division name	Department of Pediatrics
Zip code	2360004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan
TEL	+81-45-787-2800
Email	k_nsm@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Kenichi Middle name Last name Nishimura
Organization	Yokohama City University
Division name	Department of Pediatrics
Zip code	2360004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan
TEL	+81-45-787-2671
Homepage URL
Email	k_nsm@yokohama-cu.ac.jp

Sponsor
Institute	Department of Pediatrics, Yokohama City University
Institute
Department

Funding Source
Organization	Department of Pediatrics, Yokohama City University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University
Address	3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan
Tel	+81-45-787-2800
Email	k_nsm@yokohama-cu.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	横浜市立大学附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 10 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	Terminated
Date of protocol fixation	2015 Year 07 Month 09 Day
Date of IRB	2015 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry	2021 Year 07 Month 31 Day
Date trial data considered complete	2021 Year 08 Month 31 Day
Date analysis concluded	2021 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2015 Year 08 Month 10 Day
Last modified on	2020 Year 08 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021555