Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT03307902
Eligibility Criteria:
Inclusion Criteria:
* Subjects recruited have to be aged ≥27 years (born before the universal hepatitis B immunization program for newborns introduced in Hong Kong in 1988), with documentation of loss of HBsAg without anti-HBs production during follow-up of the chronic hepatitis B infection in our clinics in Queen Mary Hospital. These patients should have normal liver function tests.
* Subjects have to give written informed consent.
* Subjects must be available to complete the study and comply with study procedures.
* Subjects are willing to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
Exclusion Criteria:
* 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.
* Subjects have a recent history (documented, confirmed or suspected) of a flu-like disease within a week of vaccination.
* Subjects have a known allergy to components of the study vaccine Sci-B-Vac™.
* Subjects have a positive urine or serum pregnancy test within 24 hours prior to vaccination, or women who are breastfeeding.
* Subjects have an active neoplastic disease or a history of any hematologic malignancy.
* Subjects have known chronic active hepatitis C (anti-HCV+ve), autoimmune hepatitis or cirrhosis.
* Subjects have known active human immunodeficiency virus infection (anti-HIV+ve).
* Subjects have known chronic liver disease due to primary biliary cirrhosis, metabolic or hereditary causes.
* 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.
* Subjects participate in another clinical study during the current study.
* Subjects have axillary temperature ≥38°C or oral temperature ≥38.5°C within 3 days of intended study vaccination
* Subjects have a history of alcohol or drug abuse in the last 5 years.
* Subjects have any condition that the investigator believes may interfere with successful completion of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
27 Years
Study:
NCT03307902
Study Brief:
Protocol Section:
NCT03307902