NCT07204236Active, 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
Source: ClinicalTrials.gov · Last updated 2 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 24 Sept 2025
- Start date
- Jan 2024
- Primary completion date
- Mar 2025
- Lead sponsor
- Grand Theravac Life Sciences (Nanjing) Co., Ltd.
- Diseases
- Hepatitis B
- NCT number
- NCT07204236
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 20
- From Jan 2024 to the primary completion date, Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Hepatitis C virus (HCV), hepatitis D virus (HDV), Treponema pallidum (TP) antibody or human immunodeficiency virus (HIV) antibody positive:
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shandong Province Public Health Clinical Center Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.