Status:
ACTIVE_NOT_RECRUITING
Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nucleos(t)Ide Therapy
Lead Sponsor:
Virion Therapeutics
Collaborating Sponsors:
Vir Biotechnology, Inc.
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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),...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06070051
Start Date
September 26 2023
End Date
March 31 2026
Last Update
May 30 2025
Active Locations (3)
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1
Chinese University of Hong Kong
Hong Kong, Hong Kong
2
Aotearoa Clinical Trials, Middlemore Hospital
Auckland, New Zealand
3
Auckland City Hospital
Auckland, New Zealand