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Chronic Hepatitis BPhase 1NCT06070051

Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nucleos(t)Ide Therapy

A Phase 1 study testing VRON-0200-AdC6, VRON-0200-AdC7 and VIR-2218 in people with Chronic Hepatitis B, run by Virion Therapeutics at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This Phase 1b clinical study is a multi-center, open-label, dose escalation, prime only, and prime plus boost therapeutic vaccination study of 2 distinct chimpanzee adenoviral vectors (AdC6 and AdC7), containing parts of hepatitis B virus (HBV) core and polymerase antigens fused within glycoprotein D in a cohort of… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Chronic Hepatitis B
What is being tested?
VRON-0200-AdC6, VRON-0200-AdC7 and VIR-2218
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
3 sitesin 2 countries
Study dates
26 Sep 2023to 31 Mar 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 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Documented chronic HBV infection (eg, HBsAg+ ≥ 6 months with detectable HBsAg at screening)
  • Receipt of either entecavir, tenofovir (tenofovir alafenamide fumarate or tenofovir disoproxil fumarate), or lamivudine for at least 12 months before screening with no reported antiviral resistance during this time; still on treatment at screening and expected to stay on therapy during the study period
  • Virally suppressed for > 12 months (HBV DNA < 40 IU/mL)
  • No clinical diagnosis of advanced liver fibrosis and/or cirrhosis

Who cannot join

  • History of hepatic decompensation, advanced fibrosis, or liver transplantation
  • History of hepatocellular carcinoma
  • History of risk factors for thrombosis and thrombocytopenia
  • Documented hepatitis A, hepatitis C, hepatitis D, hepatitis E, or HIV (or history of prior active disease)
  • Pregnant, nursing, or planning a pregnancy during the trial

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

New Zealand2 sites

  • Aotearoa Clinical Trials, Middlemore Hospital

    Auckland

  • Auckland City Hospital

    Auckland

Other trials in New Zealand

Hong Kong1 site

  • Chinese University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Phase 1b Multi-Center, Open-Label, Dose-Escalation, Prime And Boost Vaccination Evaluation of VRON-0200 Using Two Chimpanzee Adenoviral Vectors in Adult Participants With Chronic HBV Infection Who Are Currently Receiving HBV Nucleos(t)Ide Reverse Transcriptase Inhibitors

This Phase 1b clinical study is a multi-center, open-label, dose escalation, prime only, and prime plus boost therapeutic vaccination study of 2 distinct chimpanzee adenoviral vectors (AdC6 and AdC7), containing parts of hepatitis B virus (HBV) core and polymerase antigens fused within glycoprotein D in a cohort of chronic hepatitis B (CHB)-infected adult participants who are currently receiving entecavir, tenofovir (tenofovir alafenamide fumarate or tenofovir disoproxil fumarate), or lamivudine, with documented HBV viral load suppression for at least 12 months.

Approximately 24 participants will be enrolled in Group 1 and randomized to Cohort 1a or Cohort 1b. Those assigned to Cohort 1a will receive a low dose prime therapeutic vaccination of vector AdC7 on Day 1, followed by a booster vaccination on Day 91 using vector AdC6. Those assigned to Cohort 1b will receive a low dose prime therapeutic vaccination of vector AdC6 on Day 1, and will not receive a booster vaccination.

Read more

Group 2 will then enroll approximately 24 participants randomized to Cohort 2a or Cohort 2b. Those assigned to Cohort 2a will receive a high dose prime therapeutic vaccination of vector AdC7 on Day 1, followed by a booster vaccination on Day 91 using vector AdC6. Those assigned to Cohort 2b will receive a high dose prime therapeutic vaccination of vector AdC6 on Day 1, and will not receive a booster vaccination.

Group 3 will enroll approximately 8 participants randomized into Cohort 3a or Cohort 3b. Cohort 3a will receive the high dose prime VRON-0200 vaccination of vector AdC7 on Day 1, followed by doses of VIR-2218 plus VIR-3434 on Days 28, 56, 84, 112, 140 and 168, and then a booster using a high dose VRON-0200 vaccination of vector AdC6 on Day 196. Cohort 3b will receive the same high dose prime VRON-0200 vaccination of vector AdC7 followed by 6 doses of VIR-2218 plus VIR-3434 at the same timepoints as Cohort 3a, but will not receive the booster dose on Day 196.

VRON-0200 vaccine doses will be administered by intramuscular (IM) injection. VIR-2218 and VIR-3434 will be administered subcutaneously.

All study participants will be followed for a total of 1 year post-prime vaccination.

Being tested
VRON-0200-AdC6, VRON-0200-AdC7, VIR-2218, VIR-3434
Keywords
Hep B, Chronic Hep B, HBV, Hepatitis B Virus, Chronic Hepatitis B Virus, CHB, VRON-0200, Virion, therapeutic vaccine, VIR-2218, VIR-3434, Functional cure, Hepatitis B, Chronic Hepatitis B
Medical subject headings
Hepatitis B, Chronic, Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VRON-0200-AdC6Biological

    VRON-0200 chimpanzee adenovirus serotype 6 vaccine vector

  • VRON-0200-AdC7Biological

    VRON-0200 chimpanzee adenovirus serotype 7 vaccine vector

  • VIR-2218Drug

    Also called elebsiran

    VIR-2218 given by subcutaneous injection

  • VIR-3434Drug

    Also called tobevibart, BRII-877

    VIR-3434 given by subcutaneous injection

Study groups in NCT06070051
Study groupRoleWhat they receive
Cohort 1a: Low Dose VRON-0200-AdC7 Prime, VRON-0200-AdC6 BoostExperimentalParticipants assigned to Cohort 1a will receive a low dose prime vaccination of AdC7 vector on Day 1. They will receive a low dose boost vaccination of vector AdC6 on Day 91.
Receives: Biological: VRON-0200-AdC6; Biological: VRON-0200-AdC7
Cohort 1b: Low Dose VRON-0200-AdC6 Prime, No BoostExperimentalParticipants assigned to Cohort 1b will receive a low dose prime vaccination of AdC6 vector on Day 1. They will not receive a booster vaccination.
Receives: Biological: VRON-0200-AdC6
Cohort 2a: High Dose VRON-0200-AdC7 Prime, VRON-0200-AdC6 BoostExperimentalParticipants assigned to Cohort 2a will receive a high dose prime vaccination of AdC7 vector on Day 1. They will receive a high dose boost vaccination of AdC6 vector on Day 91.
Receives: Biological: VRON-0200-AdC6; Biological: VRON-0200-AdC7
Cohort 2b: High Dose VRON-0200-AdC6 Prime, No BoostExperimentalParticipants assigned to Cohort 2b will receive a high dose prime vaccination of AdC6 vector on Day 1. They will not receive a booster vaccination.
Receives: Biological: VRON-0200-AdC6
Cohort 3a: High Dose VRON-0200-AdC7 Prime, 6 Doses VIR-2218 + VIR-3434, VRON-0200-AdC6 BoostExperimentalParticipants assigned to Cohort 3a will receive a high dose prime vaccination of AdC7 vector on Day 1. They will receive VIR-2218 and VIR-3434 on Days 28, 56, 84, 112, 140, and 168. They will receive a high dose boost vaccination of AdC6 vector on Day 91.
Receives: Biological: VRON-0200-AdC6; Biological: VRON-0200-AdC7; Drug: VIR-2218; Drug: VIR-3434
Cohort 3b: High Dose VRON-0200-AdC7 Prime, 6 Doses VIR-2218 + VIR-3434, No BoostExperimentalParticipants assigned to Cohort 3a will receive a high dose prime vaccination of AdC7 vector on Day 1. They will receive VIR-2218 and VIR-3434 on Days 28, 56, 84, 112, 140, and 168. They will not receive a boost vaccination.
Receives: Biological: VRON-0200-AdC7; Drug: VIR-2218; Drug: VIR-3434

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment Emergent Adverse Events

    Number and percent of participants with 1 or more treatment-emergent adverse events within 28 days after the last dose by cohort.

    Measured: 28 days

  2. Grade 3 Adverse Events

    Number and percent of participants with Grade 3 or higher local and/or systemic reactions within 28 days after the last dose by cohort.

    Measured: 28 days

  3. Clinically Significant Changes in Lab Values

    Number and percent of participants with clinically significant changes from pre-vaccination laboratory values within 28 days after the last dose by cohort.

    Measured: 28 days

  4. Serious Adverse Events

    Number and percent of participants with serious adverse events within 6 months after the last dose by cohort.

    Measured: 6 months

  5. Medically Attended Adverse Events

    Number and percent of participants with medically attended adverse events within 6 months after the last dose by cohort.

    Measured: 6 months

Secondary outcomes (2)

  1. Adverse Events

    Number and percentage of adverse events for all participants through Day 360.

    Measured: 360 days

  2. T Cell Frequencies

    Change from baseline in vaccine-induced CD8+ T cell frequencies in the blood.

    Measured: 360 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2023
  2. Study start26 Sep 2023
  3. Primary completion31 Mar 2026
  4. Study completion31 Mar 2026

Resources

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
Sequential
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06070051
Sponsor's protocol ID
21-0200-101
Status last verified
May 2025
First submitted
20 Sep 2023
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gane E, Wong GL, Currie S, Luber A, MacDonald P, Bonhomme M, Lim TH. VRON-0200 alone and in combination with investigational antivirals for participants with chronic hepatitis B virus infection receiving stable nucleos(t)ide therapy: a phase 1b, randomised, open-label, multicentre trial. Lancet Microbe. 2026 Jul;7(7):101448. doi: 10.1016/j.lanmic.2026.101448. Epub 2026 May 29.

    PubMed 42214405

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VRON-0200-AdC6, VRON-0200-AdC7 and VIR-2218 in people with Chronic Hepatitis B, run by Virion Therapeutics at 3 sites in 2 countries.

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 4 inclusion and 5 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in New Zealand, Hong Kong. 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. 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?

Treatment Emergent Adverse Events (time frame: 28 days). 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?

On the ClinicalTrials.gov record for NCT06070051, which also lists 1 linked publication.

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 19 Aug 2026.

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