臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 25, 2019
Last modified on	Dec. 01, 2022
Trial ID	jRCTs061180100

Scientific Title	Phase I/II clinical trial of therapeutic vaccine containing HBsAg and HBcAg against HBV carrier (HepBVac-J1)
Public Title	Clinical trial for therapeutic vaccine against HBV (HepBVac-J1)

Completion date	Sept. 30, 2021
Result actual enrolment	71
Baseline Characteristics	N=29 CHB patients (median age=56, male: female= 21:8, NAs for HBV treatment: ETV(14), TDF(6), TAF(5), LAM+TAF(4)) and N=42 HBV carriers without NAs treatment (median age=54, male: female=19:23, NAs for HBV treatment: none(42))
Participant flow	Participants enrollment was conducted smoothly, however CVP-NASVAC displayed better outcome than expected in terms of HBsAg reduction and HBsAg loss. Participants enrollment was ended at n=71 patients, because clinical trial will move to the phase II clinical trial (placebo controlled, double blinded, multi-centered).
Adverse events	Slight AEs were observed in n=28 participants (total 64 times). No severe AEs including death were observed in this trial. Lip herpes was observed in one CHB patient with NAs treatment. Although the relation between CVP-NASVAC treatment and lip herpes was uncertain, we reported lip herpes as TRD.
Outcome measures	HBsAg reduction was observed after CVP-NASVAC treatment regardless of NAs treatment (CHB with NAs: -0.1003 LogIU/mL (p<0/05 by paired ttest), HBV carriers without NAs: -0.1930 LogIU/mL (p<0/05 by paired ttest)). 4 participants lost HBsAg in this clinical trial.
Brief summary	CVP-NASVAC reduced HBsAg in chronic hepatitis B patients in both under NAs treatment and without NAs treatment. Furthermore, 4 patients lost HBsAg after CVP-NASVAC treatment. No severe AEs were observed by CVP-NASVAC treatment. CVP-NASVAC might be a new curable immune therapy against chronic HBV infection.
Date of posting of results summaries	Dec. 01, 2022
Date of the first journal publication of results	Dec. 01, 2022
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	n/a
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs061180100

Contact for Scientific Queries	Name	Hiasa Yoichi
	Affiliation	Ehime University
	Address	454 Shitsukawa, Toon, Ehime
	Telephone	+81-89-960-5308
	E-mail	hiasa@m.ehime-u.ac.jp
Contact for Public Queries	Name	Yoshihda Osamu
	Affiliation	Ehime University
	Address	454 Shitsukawa, Toon, Ehime
	Telephone	+81-89-960-5308
	E-mail	yoshidao@m.ehime-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Oct. 01, 2016
Actual date of first enrollment		Jan. 05, 2017
Target sample size		120
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	HBV asymptomatic carrier or chronic hepatitis B patients under nucleotide analogue treatment after obtaining written informed consent (1) Positive for HBsAg or HBV-DNA (2) Eastern Cooperative Oncology Group (EOCG) Perforrmance Status (PS) 0-2 (3) No evidence of organ dysfunction Liver: Child Pugh Score <9 Kidney: eGFR >30 ml/min Heart: No abnormality in ECG Lung: Sp2 >92%
	Exclusion Criteria	(1) Allergic history against past vaccination (2) Pregnant, unwilling to practice contraception during the study or lactating female (3) Severe complication (malignant hypertension, severe congestive heart failure, severe liver failure, poorly controlled diabetes mellitus, severe pulmonary fibrosis, active interstitial pneumonia) (4) Bearing malignant carcinoma including HCC (5) Severe mental disability (6) Positive for HCV-RNA (7) Taking immunosuppressive drugs, steroid and interferons (8) Inappropriate to participate in this trial
	Age Minimum	20age old over
	Age Maximum	85age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		chronic hepatitis B
Intervention(s)		NASVAC (HBsAg 80 microgram, HBcAg 80 microgram) given every 2 weeks for 10 times via nasal route to HBV carrier (HBV asymptomatic carrier and CHB patient treating with NUCs)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		HBsAg reduction
Secondary Outcome(s)		Anti-HBs induction, HBV-DNA reduction, HBeAg seroconversion

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Japan Agency for Medical Research and Development
Secondary Sponsor	Not applicable

Name of Certified Review Board	Certificated Review Board, Ehime University
Address	454 Shitsukawa, Toon, Ehime, Ehime
Telephone	+81-89-960-5172
E-Mail	rinri@m.ehime-u.ac.jp
Approval Status	Approval
Date of approval	Jan. 28, 2019

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Dec. 01, 2022	(this page)	Changes
3	Mar. 07, 2022	Detail	Changes
2	Feb. 01, 2021	Detail	Changes
1	Mar. 25, 2019	Detail

List of change history