Chronic Hepatitis bPhase 1RUBYNCT06989788
A Study to Evaluate the Safety and Immunogenicity of an Investigational Vaccine for Chronic Hepatitis B Virus Infection, in Healthy Adults
A Phase 1 study testing AVX70371 in people with Chronic Hepatitis b, run by AstriVax Therapeutics at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- AVX70371
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- 6 May 2025to 10 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
- Pregnant or lactating woman
- Woman of childbearing potential who is not utilizing a highly effective birth control method for at least 1 month prior to the first study vaccination, or who is planning to discontinue highly effective contraception prior to 2 months following the last study vaccination
- Employed by the Sponsor, by the contract research organisations working on behalf of the Sponsor, by the Investigator or the study site, or close relatives of research staff working on this study
- Medical condition or use of medication(s) that can increase the risk of bleeding or haematoma
- Any other condition or finding that the Investigator judges may interfere with study procedures or study results, or renders the participant unsuitable for the study
- Note: other protocol-defined inclusion / exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
University Hospital Ghent - Centrum voor Vaccinologie (CEVAC)
Ghent
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Single Centre, Phase I Study to Evaluate the Safety, Reactogenicity and Immunogenicity of AstriVax' Investigational Therapeutic Hepatitis B Virus (HBV) Vaccine (AVX70371) in Healthy Adults Aged 18 to 40 Years
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
- Being tested
- AVX70371, Placebo
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVX70371Biological
AstriVax Therapeutics' HBV immunotherapeutic
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| AVX70371 | Experimental | Participants in this arm receive administrations of AVX70371 Receives: Biological: AVX70371 |
| Placebo | Placebo comparator | Participants in this arm receive administrations of placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of solicited adverse events
Measured: During a 14-day follow-up period after each administration
Occurrence of unsolicited adverse events
Measured: From Day 1 up to 1 month after the last administration
Occurrence of hematological and biochemical laboratory abnormalities
Measured: From Day 1 up to 1 month after the last administration
Occurrence of adverse events of special interest
Measured: From Day 1 up to 1 year after the last administration
Occurrence of serious adverse events
Measured: 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)
Measured: 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)
Measured: From Day 1 up to 1 year after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start6 May 2025
- Primary completion10 Aug 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstriVax Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989788
- Sponsor's protocol ID
- AVX37-102
- Other IDs
- 2025-521169-28-00, 2025
- Acronym
- RUBY
- Status last verified
- Oct 2026
- First submitted
- 16 May 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Single Centre, Phase I Study to Evaluate the Safety, Reactogenicity and Immunogenicity of AstriVax' Investigational Therapeutic Hepatitis B Virus (HBV) Vaccine (AVX70371) in Healthy Adults Aged 18 to 40 Years
- ClinicalTrials.gov ID
- NCT06989788
- Acronym / sponsor ID
- RUBY / AVX37-102
- Conditions
- Chronic Hepatitis b
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AstriVax TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 6 May 2025 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AVX70371 | Experimental | Biological: AVX70371Participants in this arm receive administrations of AVX70371 |
| Placebo | Placebo comparator | Other: PlaceboParticipants in this arm receive administrations of placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVX70371AstriVax Therapeutics' HBV immunotherapeutic | Biological | AVX70371 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Occurrence of solicited adverse events
Time frame: During a 14-day follow-up period after each administration
Occurrence of unsolicited adverse events
Time frame: From Day 1 up to 1 month after the last administration
Occurrence of hematological and biochemical laboratory abnormalities
Time frame: From Day 1 up to 1 month after the last administration
Occurrence of adverse events of special interest
Time frame: From Day 1 up to 1 year after the last administration
Occurrence of serious adverse events
Time frame: From Day 1 up to 1 year after the last administration
2 secondary outcomes
Cellular immune response following administrations of AVX70371, as measured by Intracellular Cytokine Staining (ICS)
Time frame: 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)
Time frame: From Day 1 up to 1 year after the last administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AVX70371 in people with Chronic Hepatitis b, run by AstriVax Therapeutics at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of solicited adverse events (time frame: During a 14-day follow-up period after each administration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.