HBsAb Response After HBV Vaccination in Chronic Hepatitis B Patients Who Have Lost HBsAg

Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine Clinical Trial

Official title:

HBsAb Response After HBV Vaccination in Chronic Hepatitis B Patients Who Have Lost HBsAg

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03405597
• Other study ID #: 13/2560(EC1)
• Status: Recruiting
• Phase: Phase 3
• First received: January 4, 2018
• Last updated: January 12, 2018
• Start date: March 30, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: January 2018
• Source: Mahidol University
• Contact: Suppawat Jiraphairot
• Phone: +66 877116517
• Email: suppawat_tu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic HBV infection is major problem in Asian countries. Years after chronic infection, in some cases serum HBsAg level declines to unmeasurable level. Some of patients develop anti-HBsAb but there is no standard treatment to accelerate HBsAg seroconversion.

There is a study to determine efficacy and safety of HBV vaccine in who is Chronic HBV infection and lost their HBsAg without seroconversion to anti-HBsAb.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 97
• Est. completion date: June 30, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Chronic Hepatitis B infection group

• 18-80 year-old

• Compensated liver disease

• Chronic HBV infection with or without NUCs treatment

• History of HBsAg positive > 6 months

• HBsAg negative with qualitative Elecsys (Roche) twice at least 6 months apart

• HBsAb negative

• HBV DNA < 20 IU/mL

Healthy group

• Healthy person without history of HBV vaccination (HBsAg, anti-HBc and HBsAb negative)

Exclusion Criteria:

• History of previous HBV vaccination

• Anti-HCV and/or anti-HIV positive

• Decompensated cirrhosis

• History of previous malignancies

• History or currently receive immunotherapy, cytotoxic or immunosuppressive agents

• Patient with immunodeficiency disease

• Creatinine > 1.5 mg/dL

• Pregnancy or lactating woman

• Unable to consent

Related Conditions & MeSH terms

• Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Commercial Hepatitis B vaccine
Commercial Hepatitis B vaccine (Engerix B) 20 microgram subcutaneous injection at month 0, 1, 6

Other:
• Standard Treatment
HBsAg, HBsAb test Ultrasound upper abdomen every 6 months

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Taheri H, Hasanjani Roushan MR, Soleimani Amiri MJ, Pouralijan M, Bijani A. Efficacy of Hepatitis B vaccine in those who lost Hepatitis B surface antigen during follow-up: Efficacy of HBV vaccine in those who lost HBsAg. Hepat Mon. 2011 Feb;11(2):119-22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBsAb level at 4 weeks after complete vaccine injection	HBsAb level more than 10 mIU/ml at 7 months	an average of 7 months
Secondary	HBsAb level at 6 months after complete vaccine injection	HBsAb level more than 10 mIU/ml at 6 months	an average of 1 year
Secondary	Adverse event from HBV vaccine	Any adverse event from HBV vaccine by CTCAE v4.0	an average of 1 year
Secondary	Factors associated with HBV vaccine response	Factors associated with HBV vaccine response at 12 months	an average of 1 year