Clinical Efficacy of ABX203 Therapeutic Vaccine in HBeAg Negative Patients With Chronic Hepatitis B

NCT02249988 | Completed Phase 2 DMC

• 1 other identifier: ABX203-002
• Study Type: interventional
• Target: 261
• Locations: 2 countries
• Sites: 12

Brief Summary

The study is an open-label, randomized, comparative, multicenter clinical trial. The purpose of this study is to assess the efficacy of ABX203, a new chronic hepatitis B therapeutic vaccine administered as an adjunct therapy to nucleos(t)ide analogs (NUCs), in maintaining control of Hepatitis B disease after cessation of treatment with NUCs in subjects with HBeAg negative chronic Hepatitis B.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with viral load < 40 IU/mL at Week 48.

  Week 48

Secondary Outcomes (3)

• Clinical response defined as changes in viral load, liver function, time to relapse

  Week 48 and Week 96

• Immune response defined as T-cell response by ICS (CD4 and CD8 to HBcAg and HBsAg)

  Week 48

• Safety assessment will be conducted throughout the study and will include physical examinations, vital signs, clinical laboratory évaluations, and the recording of AEs

  Participants will be followed for the duration of their study participation up to 96 weeks

Study Arms (2)

Group 1 - ABX203 therapeutic Hepatitis B vaccine treatment arm

EXPERIMENTAL

ABX203 therapeutic vaccine in addition to NUCs background therapy

Drug: ABX203 therapeutic Hepatitis B vaccine treatment arm

Group 2 - Control arm

NO INTERVENTION

NUCs background therapy only

Interventions

ABX203 therapeutic Hepatitis B vaccine treatment arm DRUG

Group 1 - ABX203 therapeutic Hepatitis B vaccine treatment arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject between 18 and 65 years of age at the time of randomization.
• Must be HBeAg negative and anti-HBe Abs positive for at least 1 year prior to screening and at screening.
• Has HBV DNA \< 40 IU/mL for at least 1 year prior to screening and at screening
• Has both ALT and AST levels ≤ ULN for at least 1 year prior to screening and at screening.
• Must be HBsAg positive at screening.
• Has been treated with NUCs for at least 2 years prior to screening.
• Has not been treated with PEG-IFN or IFN for at least 1 year prior to screening.
• For all females, must have a negative serum pregnancy test at screening. For female of childbearing potential, must have been using adequate contraception and must agree to continue to use it during all study period and for 6 months after completion of the study product administration.
• Has provided written informed consent.

You may not qualify if:

• Has elevated blood levels of alpha-fetoprotein (AFP) (\> 500 ng/mL).
• Has cirrhosis, defined as
• platelet count \< 150,000/mm3, with esophageal varices on imaging and spleen size \> 12, or
• liver stiffness of 11 kilopascal \[kPa\] as measured by elastography using FibroScan® or .an AST to Platelet Ratio Index (APRI) \> 2).
• Has hepatocellular carcinoma (HCC) (diagnosed by ultrasonography).
• Has liver decompensation (albumin \< 3.5 g/dL and bilirubin ≥1.3 mg/dL).
• Is Hepatitis C virus (HCV) Ab positive at screening.
• Is Hepatitis delta virus (HDV) Ab positive at screening.
• Is Human Immunodeficiency Virus (HIV) Ab positive at screening.
• Has an immune suppressive disorder or treatment with immunosuppressive drugs.
• Has been treated with corticosteroids within 12 weeks prior to the first administration of study product, with the exception of topical or inhaled corticosteroids.
• Has been treated with rituximab.
• Has other hepatic diseases of different etiology (such as auto-immune hepatitis, toxic hepatitis, Wilson disease, alcoholic or hemochromatosis).
• Has a history of allergic disease or reactions likely to be exacerbated by any component of the study products.
• Has a history of a substance abuse (drug or alcohol) problem within the previous 3 years.

Sponsors & Collaborators

• Abivax S.A.: lead

Study Sites (12)

Royal Prince Alfred Hospital

Camperdown, 2050, Australia

Location

Monash Medical Centre Clayton

Clayton, 3168, Australia

Location

St Vincent's Hospital Melbourne

Fitzroy, 3065, Australia

Location

Austin Hospital

Heidelberg, 3084, Australia

Location

Liverpool Hospital

Liverpool, 2170, Australia

Location

The Alfred Hospital

Melbourne, 3004, Australia

Location

Royal Melbourne Hospital

Parkville, 3050, Australia

Location

Royal Perth Hospital

Perth, 6000, Australia

Location

Westmead Hospital

Westmead, 2145, Australia

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Waikato Hospital

Hamilton West, 3240, New Zealand

Location

Wellington Hospital

Wellington, 6021, New Zealand

Location

Related Publications (2)

• Ohlendorf V, Wubbolding M, Honer Zu Siederdissen C, Bremer B, Deterding K, Wedemeyer H, Cornberg M, Maasoumy B. Limited Value of HBV-RNA for Relapse Prediction After Nucleos(t)ide Analogue Withdrawal in HBeAg-negative Hepatitis B Patients. J Viral Hepat. 2025 Apr;32(4):e14026. doi: 10.1111/jvh.14026. Epub 2024 Oct 19.

  PMID: 39425534 DERIVED

• Wubbolding M, Lopez Alfonso JC, Lin CY, Binder S, Falk C, Debarry J, Gineste P, Kraft ARM, Chien RN, Maasoumy B, Wedemeyer H, Jeng WJ, Meyer Hermann M, Cornberg M, Honer Zu Siederdissen C. Pilot Study Using Machine Learning to Identify Immune Profiles for the Prediction of Early Virological Relapse After Stopping Nucleos(t)ide Analogues in HBeAg-Negative CHB. Hepatol Commun. 2020 Nov 5;5(1):97-111. doi: 10.1002/hep4.1626. eCollection 2021 Jan.

  PMID: 33437904 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: September 26, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 24, 2017

Record last verified: 2015-09

Locations

NZ (3); AU (9)