Study to Evaluate Immunogenicity and Safety of TVAX-008 Injection in Non/Treated Chronic Hepatitis B Patients With HBsAg≤20IU/ml or HBsAg Negative Without Serological Conversion
The objective of this study is to assess the immunogenicity and safety of TVAX-008 injection in antiviral untreated/untreated chronic hepatitis B patients with HBsAg≤20 IU/mL, or HBsAg negative and no seroconversion through an investigator-initiated clinical study.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Male or female, aged 18-65 years (inclusive);
2. Chronic hepatitis B patients with HBsAg\<20 IU/mL without/on antiviral therapy; or HBsAg negative and no seroconversion population (HBsAg \<20 IU/mL;HBVDNA\<20 IU/mL; ）
3. HBsAg \<10mIU/mL detected at least 4 weeks
Exclusion Criteria:
1. Use of immunosuppressants within 6 months prior to first dose:
2. Use of c1orticosteroids (other than topical or inhaled corticosteroids) for 1 week or more within 6 months prior to the first dose;
3. Hepatitis C virus (HCV), hepatitis D virus (HDV), Treponema pallidum (TP) antibody or human immunodeficiency virus (HIV) antibody positive:
Primary outcome measure(s)
Change from baseline in HBSAb levels after end of treatment — week24 Change from baseline in HBSAb levels after end of treatment
Trial sites (1)
Facility
City
Region
Status
Shandong Province Public Health Clinical Center
Jinan
Shandong
More Grand Theravac Life Sciences (Nanjing) Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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