Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Grand Theravac Life Sciences (Nanjing) Co., Ltd.
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- Male or female, aged 18-65 years (inclusive);
- 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; ）
- HBsAg \<10mIU/mL detected at least 4 weeks
Exclusion
- Use of immunosuppressants within 6 months prior to first dose:
- Use of c1orticosteroids (other than topical or inhaled corticosteroids) for 1 week or more within 6 months prior to the first dose;
- Hepatitis C virus (HCV), hepatitis D virus (HDV), Treponema pallidum (TP) antibody or human immunodeficiency virus (HIV) antibody positive:
Key Trial Info
Start Date :
January 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07204236
Start Date
January 18 2024
End Date
March 1 2026
Last Update
October 2 2025
Active Locations (1)
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1
Shandong Province Public Health Clinical Center
Jinan, Shandong, China, 250000