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

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

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: TVAX-008

Study type: Interventional

Funder types: Industry

Identifiers

NCT07204236

YDSWX(TVAX-008)-004(IIT)

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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:

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

TVAX-008

Experimental group

Description:

TVAX-008

Treatment:

Drug: TVAX-008