Hepatitis B vaccination in patients with chronic hepatitis B

Completed

• Conditions: Patients with occult hepatitis B (OBI) as defined by chronic hepatitis B carrier, with documented loss of HBsAg, negative anti-HBs, positive anti-HBc and negative HBV DNA.; Infections and Infestations

• Registration Number: ISRCTN47278669
• Lead Sponsor: niversity of Hong Kong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-27
• Last Update Posted: 20 November 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Subjects recruited have to be aged =18 years with no history of previous hepatitis B vaccination, with documentation of loss of HBsAg without anti-HBs production during follow-up of the chronic hepatitis B infection, with normal liver function tests and negative HBV DNA
2. Subjects have to give written informed consent
3. Subjects must be available to complete the study and comply with study procedures

Exclusion Criteria

1. Subjects with a history or any illness that might interfere with the results of the study or participation in the study may pose additional risk to the subjects
2. Subjects have a recent history (documented, confirmed or suspected) of a flu-like disease within a week of vaccination
3. Subjects have a known allergy to components of the study vaccine Sci-B-Vac™
4. Subjects have a positive urine or serum pregnancy test within 24 hours prior to vaccination, or women who are breastfeeding
5. Subjects have an active neoplastic disease or a history of any hematologic malignancy
6. Subjects have known chronic active hepatitis C (anti-HCV+ve), autoimmune hepatitis or cirrhosis
7. Subjects have known active human immunodeficiency virus infection (anti-HIV+ve)
8. Subjects have received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study
9. Subjects participate in another clinical study during the current study
10. Subjects have axillary temperature =38°C or oral temperature =38.5°C within 3 days of intended study vaccination
11. Subjects have a history of alcohol or drug abuse in the last 5 years
12. Subjects have any condition that the investigator believes may interfere with successful completion of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified