Clinical trial of therapeutic vaccine against chronic hepatitis B patients under NAs treatment

phase 2 clinical trial of a therapeutic vaccine containing HBs/HBc antigen for chronic hepatitis B patients under nucleos(t)ide analogue treatment: a multicentered, placebo control, double blind, randomized clinical trial - HepVac-P2NAs

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs061210086

Enrollment

140

Registered

2022-03-22

Start date

2022-07-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic hepatitis B

Interventions

Participants will be assigned to CVP-NASVAC group or placebo group. CVP-NASVAC or placebo will be given total 10 doses every 2 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Chronic hepatitis B patients who fulfill the inclusion criteria below (1) 20-85 years old (2) Positive fo HBsAg or HBV-DNA (3) Taking nucleos(t)ide analogue (4) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS: 0-2) (5) No evidence of organ dysfunction Liver: Child-Pugh Score less than 9 Kidney: eGFR more than 30 Heart: No severe heart failure by interview Lung: SpO2 above 90% in room air

Exclusion criteria

Exclusion criteria: 1) Allergic history of 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, interferon prior 90 days (8) Inappropriate to participate in this trial

Design outcomes

Primary

Measure	Time frame
amount of HBsAg reduction HBsAg loss (below 0.005 IU/mL) rate	—

Secondary

Measure	Time frame
amount of HBV-DNA reduction amount of HBcrAg reduction HBeAg seroconversion rate anti-HBs induction (more than 1.0 mIU/mL) rate HBcAg specific CTL induction	—

Contacts

Public ContactOsamu Yoshida

Ehime University

yoshidao@m.ehime-u.ac.jp+81-89-960-5308

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026