臨床研究等提出・公開システム

Phase I/II clinical trial of HB vaccine containing HBsAg and HBcAg for prophylaxis (HepBVac-J2)

Clinical trial of HB vaccine against HBV infection (HepBVac-J2)

81

Healthy individuals agreed to participate in this trial after providing written informed consent HB vaccine naive; no past history of HB vaccination HB vaccine resnponder; anti-HBs >10 mIU/mL after HB vaccination HB vaccine non-responder; anti-HBs <10 mIu/mL after HB vaccination

N=81 healthy individuals were enrolled in this clinical trial after providing a written consent. Participants were consisted with HB vaccine naive (n=11), HB vaccine responder (n=28) and HB vaccine non-responder (n=42). All the participants were injected total 3 doses of CVP-NASVAC every two weeks and followed up to 6 months after the final injection.

N=60 (74.1%) participants experienced AEs. No severe AEs were observed. AEs are listed below; discomfort (6.2%), CRP elevation (6.2%), nasal discharge (4.9%), sneeze (3.7%), fatigue (3.7%), pain (1.2%), fever (1.2%), WBC elevation (1.2%), ALT elevation (1.2%), itching (1.2%).

CVP-NASVAC induced anti-HBs and anti-HBc in72.7% (n=8/11) HB vaccine naive individuals. CVP-NASVAC displayed anti-HBs boost in HB vaccine responders and developed anti-HBc in 89.3% (n=25/28) of HB vaccine responders. 87.8% (n=36/41) HB vaccine non-responders developed anti-HBs after CVP-NASVAC administration.

The safety of CVP-NASVAC was confirmed. CVP-NASVAC induced anti-HBs in HB vaccine non-responders and HBV vaccine naive individuals. CVP-NASVAC displayed anti-HBs boost in HB vaccine responders. CVP-NASVAC could be a stronger prophylactic vaccine compared with conventional HB vaccine.

June. 01, 2024

Sept. 12, 2023

https://pubmed.ncbi.nlm.nih.gov/37766155/

No

n/a

https://jrct.mhlw.go.jp/latest-detail/jRCTs061180101

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

Complete

Oct. 01, 2016

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

prevention purpose

Healthy individuals agreed to participate in this trial after obtaining writen informed consent
a) HB vaccine naive: No pasthistory of HB vaccination
b) HB vaccine responder: Anti-HBs > 10mIU/mL after HB vaccination
c) HB vaccine non-responder: Anti-HBs < 10mIU/mL after HB vaccination
(1) Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
(2) No evidence of organ dysfunction
Liver: Child-Pugh Score < 9
Kidney: eGFR > 30ml/min
Heart: No abnormality in ECG
Lung: SpO2 >92%

(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

Both

HBV infection

NASVAC (HBsAG 80 microgram, HBcAg 80 microgram) given every 2 weeks for 3 times via nasal route to healthy individuals (HB vaccine naive, HB vaccine responder, HB vaccine non-responder). Additional 1 dose will be administrated, if anti-HBs is under 10 mIU/mL at 28 week.

Anti-HBs induction

Anti-HBc and HBcAg specific CTL induction

+81-89-960-5172

Jan. 28, 2019

none