UMIN-CTR Clinical Trial

Basic information
Public title	The Efficacy of Hepatitis B Virus (HBV) Vaccination in Patients with Previously Resolved HBV Infection Receiving Immunosuppressive Therapy to Prevent HBV Reactivation through Increase of Serum Levels of Anti-HBs (Pilot Study)
Acronym	Hepatitis B Virus Vaccination to Prevent HBV Reactivation
Scientific Title	The Efficacy of Hepatitis B Virus (HBV) Vaccination in Patients with Previously Resolved HBV Infection Receiving Immunosuppressive Therapy to Prevent HBV Reactivation through Increase of Serum Levels of Anti-HBs (Pilot Study)
Scientific Title:Acronym	Hepatitis B Virus Vaccination to Prevent HBV Reactivation
Region	Japan

Condition
Condition	Collagen disease, collagen disease related disease, ulcerative colitis, Crohn's disease, intestinal Behcet's disease (simple ulcers included), psoriasis, and diseases that require other immunosuppressive therapies.
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the efficacy of HBV vaccination as a prophylactic procedure for HBV reactivation in patients with previously resolved HBV infection receiving immunosuppressive therapies, serum levels of anti-HBs were evaluated in relation to serum HBV-DNA levels during the therapies after the vaccination.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The percentages of patients showing anti-HBs titer rises above the baseline and 10 mIU / ml or more at 4-8 weeks after vaccination among the patients received the vaccination during immunosuppressive therapy.
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Vaccine
Interventions/Control_1	HBV vaccines at a volume of 0.5 mL are administrated by intramuscular injection for 3 times at baseline and 4 and 20 weeks later. If anti-HBs titer is less than 10 mIU /mL after vaccinations, HBV vaccines are administrated for 3 times additionally in the same way.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients tested positive for serum anti-HBs and/or anti-HBc despite of a negative serum HBs-antigen status. Patients receiving immunosuppressive therapy.
Key exclusion criteria	Patients after HB vaccination. Patients who have had allergic symptoms due to vaccination. Patients with serious infections. Pregnant and lactating women. Patients judged by the attending physician to be ineligible.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Mochida
Organization	Saitama Medical University
Division name	Department of Gastroenterology and Hepatology
Zip code	350-0495
Address	Morohongo 38, Moroyama-Machi, Iruma-Gun, Saitama, 350-0495, Japan
TEL	049-276-1198
Email	smochida@saitama-med.ac.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Mochida
Organization	Saitama Medical University
Division name	Department of Gastroenterology and Hepatology
Zip code	350-0495
Address	Morohongo 38, Moroyama-Machi, Iruma-Gun, Saitama, 350-0495, Japan
TEL	049-276-1198
Homepage URL
Email	smochida@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
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	IRB, Saitama Medical University
Address	Morohongo 38, Moroyama-Machi, Iruma-Gun, Saitama, 350-0495, Japan
Tel	049-276-1354
Email	hirb@saitama-med.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	2020 Year 10 Month 30 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	13
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	No longer recruiting
Date of protocol fixation	2020 Year 03 Month 01 Day
Date of IRB	2020 Year 04 Month 06 Day
Anticipated trial start date	2020 Year 10 Month 30 Day
Last follow-up date	2024 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	2020 Year 10 Month 29 Day
Last modified on	2022 Year 05 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044149