Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nucleos(t)Ide Therapy
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
1 other identifier
interventional
56
2 countries
3
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2023
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2023
CompletedStudy Start
First participant enrolled
September 26, 2023
CompletedFirst Posted
Study publicly available on registry
October 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedMay 30, 2025
May 1, 2025
2.5 years
September 20, 2023
May 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
28 days
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.
28 days
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.
28 days
Serious Adverse Events
Number and percent of participants with serious adverse events within 6 months after the last dose by cohort.
6 months
Medically Attended Adverse Events
Number and percent of participants with medically attended adverse events within 6 months after the last dose by cohort.
6 months
Secondary Outcomes (2)
Adverse Events
360 days
T Cell Frequencies
360 days
Other Outcomes (3)
Hepatitis B Virus DNA
360 days
Hepatitis B Virus Pregenomic RNA
360 days
Hepatitis B Surface Antigen
360 days
Study Arms (6)
Cohort 1a: Low Dose VRON-0200-AdC7 Prime, VRON-0200-AdC6 Boost
EXPERIMENTALParticipants 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.
Cohort 1b: Low Dose VRON-0200-AdC6 Prime, No Boost
EXPERIMENTALParticipants assigned to Cohort 1b will receive a low dose prime vaccination of AdC6 vector on Day 1. They will not receive a booster vaccination.
Cohort 2a: High Dose VRON-0200-AdC7 Prime, VRON-0200-AdC6 Boost
EXPERIMENTALParticipants 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.
Cohort 2b: High Dose VRON-0200-AdC6 Prime, No Boost
EXPERIMENTALParticipants assigned to Cohort 2b will receive a high dose prime vaccination of AdC6 vector on Day 1. They will not receive a booster vaccination.
Cohort 3a: High Dose VRON-0200-AdC7 Prime, 6 Doses VIR-2218 + VIR-3434, VRON-0200-AdC6 Boost
EXPERIMENTALParticipants 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.
Cohort 3b: High Dose VRON-0200-AdC7 Prime, 6 Doses VIR-2218 + VIR-3434, No Boost
EXPERIMENTALParticipants 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.
Interventions
VRON-0200 chimpanzee adenovirus serotype 6 vaccine vector
VRON-0200 chimpanzee adenovirus serotype 7 vaccine vector
VIR-2218 given by subcutaneous injection
VIR-3434 given by subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Virion Therapeuticslead
- Vir Biotechnology, Inc.collaborator
Study Sites (3)
Chinese University of Hong Kong
Hong Kong, Hong Kong
Aotearoa Clinical Trials, Middlemore Hospital
Auckland, New Zealand
Auckland City Hospital
Auckland, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sue Currie, PhD
Virion Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2023
First Posted
October 6, 2023
Study Start
September 26, 2023
Primary Completion
March 31, 2026
Study Completion
March 31, 2026
Last Updated
May 30, 2025
Record last verified: 2025-05