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phase II clinical trial of a therapeutic vaccine containing HBs/HBcAg for HBV carriers without ongoing anti-HBV treatment (HepBVac-P2ASC)

Clinical trial of therapeutic vaccine against HBV carriers without anti-HBV treatment (HepBVac-P2C)

Hiasa Yoichi

Ehime University

454 Shitsukawa, Toon, Ehime

hiasa@m.ehime-u.ac.jp

Yoshida Osamu

Ehime University

454 Shitsukawa, Toon, Ehime

+81-89-960-5308

yoshidao@m.ehime-u.ac.jp

Recruiting

Mar. 22, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

HBV carriers who fulfill the inclusion criteria below
(1) 20-85 years old
(2) Positive for HBsAg or HBV-DNA
(3) Not under nucleos(t)ide analogue or interferon treatment
(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

(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) Taking nucleos(t)ide analogues
(9) Inappropriate to participate in this trial

Both

chronic hepatitis B

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

D019694

amount of HBsAg reduction
HBsAg loss (below 0.005 IU/mL by CLEIA) rate

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

+81-89-960-5172

Jan. 24, 2022

none