A Study to Evaluate the Safety and Immunogenicity of an Investigational Vaccine for Chronic Hepatitis B Virus Infection, in Healthy Adults

NCT06989788 | Active Not Recruiting Phase 1

• 2 other identifiers: AVX37-1022025-521169-28-00
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Hepatitis b

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (2)

• 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)

  From Day 1 up to 1 year after the last administration

Study Arms (2)

AVX70371

EXPERIMENTAL

Participants in this arm receive administrations of AVX70371

Biological: AVX70371

Placebo

PLACEBO COMPARATOR

Participants in this arm receive administrations of placebo

Other: Placebo

Interventions

AVX70371 BIOLOGICAL

AstriVax Therapeutics' HBV immunotherapeutic

AVX70371

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female assigned at birth, inclusive of all gender identities
• Between, and including, 18 and 40 years of age on the day of the Screening Visit
• Healthy individual, as established by the Investigator
• Able to read and understand the informed consent form, and written informed consent obtained from the participant
• Participants who, in the opinion of the Investigator, can and will comply with the requirements of the protocol

You may not qualify if:

• Body Mass Index \< 18.0 or \> 32.0 kg/m2
• Use of any investigational or non-registered product other than the study vaccination within 1 month preceding study entry, or concurrent participation in another clinical study in which the participant has been or will be exposed to an investigational or non-registered product, at any time during the study period
• Administration / planned administration of any vaccine not foreseen by the study protocol within 1 month preceding the first study vaccination and up to 1 month after the last study vaccination
• Presence of serologic marker of acute, chronic or past HBV infection
• Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months preceding first study vaccination, or planned chronic administration at any time during the study period
• Administration of long-acting immune-modifying drugs within 6 months or 5 half-lives (whichever is longer) preceding first study vaccination, or planned administration at any time during the study period
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history, family history or physical examination
• Administration of immunoglobulins and / or any blood or blood-derived products within 3 months preceding the first study vaccination, or planned administration during the study period
• History of or current autoimmune disease
• Malignancies or lymphoproliferative disorders within previous 5 years
• Personal or family history of thymic pathology
• History of any neurological disorders or seizures
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the investigational vaccine
• Moderate or severe acute disease in the opinion of the Investigator, and / or fever, on Day 1
• Alcohol, prescription drug, or substance (ab)use that, in the opinion of the Investigator, might interfere with the study conduct and / or participant safety

Sponsors & Collaborators

• AstriVax Therapeutics: lead

Study Sites (1)

University Hospital Ghent - Centrum voor Vaccinologie (CEVAC)

Ghent, Belgium

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 25, 2025
• Study Start: May 6, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

BE (1)