Liver transplantation due to HBV infection
Conditions
Interventions
CVP-NASVAC is administrated via nose total 3 times in every 2 weeks. Additional dose of CVP-NASVAC is administrated in regular medical visits. HBIG injection will be skipped, if anti-HBs titer is lowe
Sponsors
Hiasa Yoichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Liver transplanted patients who fulfill the inclusion criteria below (1) 20-85 years old (2) Liver transplantation was conducted previously (3) HBIG was regulary administrated for mainitaining serum anit-HBs level (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 abnormality in ECG 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) if participation in the study is not in the best interest of the research subject (e.g., may compromise the subject's well-being), or if it is determined that participation would interfere with, restrict, or confound the specific assessments outlined in the clinical research protocol (7) Individuals who, under the direction of the principal investigator or the study site, are directly involved in this study or other clinical studies, including employees of the principal investigator or the study site, as well as family members of such employees or of the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) anti-HBs induction and maintainace (2) total administrated dose of HBIG | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) number of AEs, frequency of AE more than grade 3 2) induction of IgA type HBs 3) induction of anti-HBc (IgG and IgA) 4) induction of HBV specific CTL 5) HBV neutralizing capacity 6) frequency of HBV reactivation | — |
Contacts
Public ContactOsamu Yoshida
Ehime University
Outcome results
None listed