Active — Not RecruitingEarly Phase 1

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

China20 participantsStarted 2024-01-18

Plain-language 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 seroconversion through an investigator-initiated clinical study.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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:

What they're measuring

Change from baseline in HBSAb levels after end of treatment

Timeframe: week24

Trial details

NCT IDNCT07204236

SponsorGrand Theravac Life Sciences (Nanjing) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-01

View on ClinicalTrials.gov More Chronic Hepatitis B trials