NIPH Clinical Trials Search

Clinical trial of nasal HB vaccine for liver transplanted patients

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Liver transplantation due to HBV infection
Date of first enrollment	05/08/2025
Target sample size	5
Countries of recruitment
Study type	Interventional
Intervention(s)	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 lower than 200 mIU/mL in regular visits.

Outcome(s)

Primary Outcome	(1) anti-HBs induction and maintainace (2) total administrated dose of HBIG
Secondary Outcome	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

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 85age old
Gender	Both
Include 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
Exclude 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