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Active, Not Recruiting

NCT Number: NCT06070051

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

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.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chinese University of Hong Kong, Hong Kong

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

VRON-0200-AdC6

Biological

VRON-0200 chimpanzee adenovirus serotype 6 vaccine vector

VRON-0200-AdC7

Biological

VRON-0200 chimpanzee adenovirus serotype 7 vaccine vector

VIR-2218

Drug

VIR-2218 given by subcutaneous injection

Other names: elebsiran

VIR-3434

Drug

VIR-3434 given by subcutaneous injection

Other names: tobevibart, BRII-877

Primary outcomes

  1. Treatment Emergent Adverse Events

    Time frame: 28 days

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

  2. Grade 3 Adverse Events

    Time frame: 28 days

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

  3. Clinically Significant Changes in Lab Values

    Time frame: 28 days

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

  4. Serious Adverse Events

    Time frame: 6 months

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

  5. Medically Attended Adverse Events

    Time frame: 6 months

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

Secondary outcomes

  1. Adverse Events

    Time frame: 360 days

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

  2. T Cell Frequencies

    Time frame: 360 days

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

Other outcomes

  1. Hepatitis B Virus DNA

    Time frame: 360 days

    Quantitative changes from baseline over time in HBV DNA

  2. Hepatitis B Virus Pregenomic RNA

    Time frame: 360 days

    Quantitative changes from baseline over time in HBV pgRNA

  3. Hepatitis B Surface Antigen

    Time frame: 360 days

    Quantitative changes from baseline over time in HBsAg

Sponsors and collaborators

Lead sponsor

Virion Therapeutics

Industry

Collaborators

  • Vir Biotechnology, Inc.

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 6, 2023
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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