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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521169-28-00 | EU Trial (CTIS) Number |
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The purpose of this first time in humans trial is to evaluate the safety, reactogenicity and immunogenicity of repeated administrations of AVX70371 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVX70371 | Experimental | Participants in this arm receive administrations of AVX70371 |
|
| Placebo | Placebo Comparator | Participants in this arm receive administrations of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVX70371 | Biological | AstriVax Therapeutics' HBV immunotherapeutic |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of solicited adverse events | During a 14-day follow-up period after each administration | |
| Occurrence of unsolicited adverse events | From Day 1 up to 1 month after the last administration | |
| Occurrence of hematological and biochemical laboratory abnormalities | From Day 1 up to 1 month after the last administration | |
| Occurrence of adverse events of special interest | From Day 1 up to 1 year after the last administration | |
| Occurrence of serious adverse events | From Day 1 up to 1 year after the last administration |
| Measure | Description | Time Frame |
|---|---|---|
| Cellular immune response following administrations of AVX70371, as measured by Intracellular Cytokine Staining (ICS) | From Day 1 up to 1 year after the last administration | |
| Humoral immune response following administrations of AVX70371, as measured by enzyme-linked immunosorbent assay (ELISA) |
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Inclusion Criteria:
Exclusion Criteria:
Note: other protocol-defined inclusion / exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent - Centrum voor Vaccinologie (CEVAC) | Ghent | Belgium |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Placebo |
| Other |
Placebo |
|
| From Day 1 up to 1 year after the last administration |
| 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 |