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

Primary Purpose

Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine

Status

Unknown status

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

Commercial Hepatitis B vaccine

Standard Treatment

About this trial

This is an interventional treatment trial for Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Faculty of Medicine Siriraj HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Healthy control

Chronic hepatitis B with vaccination

Chronic hepatitis B without vaccination

Arm Description

Commercial Hepatitis B vaccine

Standard treatment

Outcomes

Primary Outcome Measures

HBsAb level at 4 weeks after complete vaccine injection

HBsAb level more than 10 mIU/ml at 7 months

Secondary Outcome Measures

HBsAb level at 6 months after complete vaccine injection

HBsAb level more than 10 mIU/ml at 6 months

Adverse event from HBV vaccine

Any adverse event from HBV vaccine by CTCAE v4.0

Factors associated with HBV vaccine response

Factors associated with HBV vaccine response at 12 months

Full Information

NCT ID

NCT03405597

First Posted

January 4, 2018

Last Updated

January 12, 2018

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT03405597

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 30, 2017 (Actual)

Primary Completion Date

February 28, 2018 (Anticipated)

Study Completion Date

June 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

97 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy control

Arm Type

Experimental

Arm Description

Commercial Hepatitis B vaccine

Arm Title

Chronic hepatitis B with vaccination

Arm Type

Experimental

Arm Description

Commercial Hepatitis B vaccine

Arm Title

Chronic hepatitis B without vaccination

Arm Type

Active Comparator

Arm Description

Standard treatment

Intervention Type

Drug

Intervention Name(s)

Commercial Hepatitis B vaccine

Other Intervention Name(s)

Engerix B

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Standard Treatment

Intervention Description

HBsAg, HBsAb test Ultrasound upper abdomen every 6 months

Primary Outcome Measure Information:

Title

HBsAb level at 4 weeks after complete vaccine injection

Description

HBsAb level more than 10 mIU/ml at 7 months

Time Frame

an average of 7 months

Secondary Outcome Measure Information:

Title

HBsAb level at 6 months after complete vaccine injection

Description

HBsAb level more than 10 mIU/ml at 6 months

Time Frame

an average of 1 year

Title

Adverse event from HBV vaccine

Description

Any adverse event from HBV vaccine by CTCAE v4.0

Time Frame

an average of 1 year

Title

Factors associated with HBV vaccine response

Description

Factors associated with HBV vaccine response at 12 months

Time Frame

an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Suppawat Jiraphairot

Phone

+66 877116517

suppawat_tu@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Tawesak Tanwandee

Phone

+66 24197281

Ext

102

tawesak@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tawesak Tanwandee

Organizational Affiliation

Department of Medicine, Faculty of medicine Siriraj Hospital, Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine Siriraj Hospital

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chairat Shayakul

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

22087128

Citation

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.

Results Reference

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

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