Impact of Hepatitis B Vaccination on HBs Antigenemia
|ClinicalTrials.gov Identifier: NCT03193775|
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : June 21, 2017
- HBV is not curable with persistent HBsAg even after the disappearance of HBV DNA.
- HBsAg > 1000 IU/ml is associated with the risk of virological recurrence and HCC.
- There is an impaired immune response to HBsAg and HBV vaccine is an easily available, cost-effective, non-harmful method of stimulating immunity.
|Condition or disease||Intervention/treatment||Phase|
|HBV||Biological: HBV vaccine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Group I: inactive carriers (n=100). Group II: CHB exposed to nucleos(t)ides (n=120) till 6 months after HBe seroconversion and HBV DNA disappearance in HBeAg positive (n=60) or DNA disappearance in HBeAg negative patients (n=60). All showed persistent HBs antigenemia.
-A control group (n=100) did not receive HBV vaccine
|Masking:||None (Open Label)|
|Masking Description:||open label|
|Official Title:||Impact of Hepatitis B Vaccination on HBsAg Kinetics, Interferon-inducible Protein 10 Level and Recurrence of Viremia|
|Actual Study Start Date :||August 1, 2011|
|Actual Primary Completion Date :||October 1, 2015|
|Actual Study Completion Date :||October 1, 2015|
Active Comparator: chronic HBV with persistent HBsAg
inactive carriers (n=100). Group II: CHB exposed to nucleos(t)ides (n=120) till 6 months after HBe seroconversion and HBV DNA disappearance in HBeAg positive (n=60) or DNA disappearance in HBeAg negative patients (n=60). All showed persistent HBs antigenemia.
they were given 30 µg of HBV vaccine initiated 6 months after HBe seroconversion and disappearance of HBV DNA.
Biological: HBV vaccine
HBV vaccine which contains Purified HBsAg produced by recombinant DNA technology (Euvax-B, LG Life sciences, Korea) intramuscularly in deltoid region at three different time intervals (0, 1, 6 months).
No Intervention: control group
A control group (n=100) did not receive HBV vaccine
- production of protective HBsAb [ Time Frame: three months after the last dose of vaccine ]Current treatment by NAs may suppress HBV replication but cannot completely eradicate the virus due to the systemic immune tolerance or exhaustion. HBV vaccine may enhance the immunity against HBsAg and may be an efficient immunotherapy in chronic HBV.
- impact on Insulin resistance, fibrosis regression [ Time Frame: 3 month after the last dose of vaccination ]study of the possibility of improving insulin resistance and degree of fibrosis