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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TVAX-008 | Experimental | TVAX-008 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TVAX-008 | Drug | TVAX-008 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HBSAb levels after end of treatment | Change from baseline in HBSAb levels after end of treatment | week24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Province Public Health Clinical Center | Jinan | Shandong | 250000 | China |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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