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

NCT03405597 — Phase 3, Unknown, 97 participants, Mahidol University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT03405597
Status	Unknown
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	97 (Estimated)
Sponsor	Mahidol University (Other)
Conditions	Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine
Interventions	Commercial Hepatitis B vaccine, Standard Treatment (Drug, other)
Dates	start 2017-03-30, primary completion 2018-02-28 (estimated), completion 2018-06-30 (estimated), first posted 2018-01-23, last updated 2018-01-23
Locations	1 site in Thailand

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Healthy control	Experimental	Drug: Commercial Hepatitis B vaccine	Commercial Hepatitis B vaccine
Chronic hepatitis B with vaccination	Experimental	Drug: Commercial Hepatitis B vaccine; Other: Standard Treatment	Commercial Hepatitis B vaccine
Chronic hepatitis B without vaccination	Active comparator	Other: Standard Treatment	Standard treatment

Commercial Hepatitis B vaccine (Drug), also known as Engerix B: Commercial Hepatitis B vaccine (Engerix B) 20 microgram subcutaneous injection at month 0, 1, 6
Standard Treatment (Other): HBsAg, HBsAb test Ultrasound upper abdomen every 6 months

+Outcome measures

Primary outcomes

HBsAb level at 4 weeks after complete vaccine injection [an average of 7 months]: HBsAb level more than 10 mIU/ml at 7 months

Secondary outcomes

HBsAb level at 6 months after complete vaccine injection [an average of 1 year]: HBsAb level more than 10 mIU/ml at 6 months
Adverse event from HBV vaccine [an average of 1 year]: Any adverse event from HBV vaccine by CTCAE v4.0
Factors associated with HBV vaccine response [an average of 1 year]: Factors associated with HBV vaccine response at 12 months

+Eligibility

Sex: All, ages: 18 Years to 80 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Faculty of Medicine Siriraj Hospital	Bangkoknoi, Bangkok	Thailand	Recruiting

+Publications

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. PMID 22087128

+Investigators

Tawesak Tanwandee, Principal investigator, Department of Medicine, Faculty of medicine Siriraj Hospital, Mahidol University

My Notes

Public

To Read Reading Read