UMIN-CTR Clinical Trial

Basic information
Public title	Phase I/II clinical trial for therapeutic HB vaccine containing HBsAg and HBcAg
Acronym	Clinical trial for therapeutic HB vaccine
Scientific Title	Phase I/II clinical trial for therapeutic HB vaccine containing HBsAg and HBcAg
Scientific Title:Acronym	Clinical trial for therapeutic HB vaccine
Region	Japan

Condition
Condition	Chronic hepatitis B
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To ensure the safety and efficacy of therapetutic vaccine in Japanese patients
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety: frequency and degree of adverse events
Key secondary outcomes	Efficacy: HBV-DNA reduction

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	Medicine
Interventions/Control_1	HBV patients with inactive carrier or under nucleotide analogues treatment will receive therapeutic vaccine 10 times every two weeks intranasally.
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	HBV inactive carrier chronic hepatitis B patients treating with nucleotide analogue
Key exclusion criteria	severe complication malignancy taking immunosuppresive agents
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Yoichi Middle name Last name Hiasa
Organization	Ehime University Graduate School of Medicine
Division name	Department of Gastroenterology and Metabology
Zip code	791-0295
Address	454 Shitsukawa, Toon, Ehime
TEL	089-960-5308
Email	hiasa@m.ehime-u.ac.jp

Public contact
Name of contact person	1st name Osamu Middle name Last name Yoshida
Organization	Ehime University Graduate School of Medicine
Division name	Department of Gastroenterology and Metabology
Zip code	791-0295
Address	454 Shitsukawa, Toon, Ehime
TEL	089-960-5308
Homepage URL
Email	yoshidao@m.ehime-u.ac.jp

Sponsor
Institute	Ehime University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Ehime University Graduate School of Medicine
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	Certified Review Board,Ehime University
Address	454 Shitsukawa, Toon, Ehime
Tel	089-960-5172
Email	rinri@m.ehime-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	2017 Year 05 Month 22 Day

Related information
URL releasing protocol	NA
Publication of results	Unpublished

Result
URL related to results and publications	https://onlinelibrary.wiley.com/doi/10.1111/hepr.13851
Number of participants that the trial has enrolled	71
Results	The safety of HBsAg/HBcAg containing nasal administrative therapeutic vaccine. Anti-HBs induction and HBsAg reduction were confirmed after administration of the therapeutic vaccine.
Results date posted	2022 Year 11 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Positive for either HBsAg or HBV-DNA
Participant flow	N=72 participants provided written consent. N=1 excluded due to mismatch with the criteria. N=71 completed 6 months follow-up
Adverse events	Mild AEs were temporally observed in some participants. All the AEs were cured without any medications.
Outcome measures	HBsAg reduction, anti-HBs induction
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 01 Day
Date of IRB	2016 Year 09 Month 26 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 22 Day
Last modified on	2022 Year 11 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031442