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

Primary Purpose

Chronic Hepatitis B

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABX203 therapeutic Hepatitis B vaccine treatment arm
Sponsored by
Abivax S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Royal Prince Alfred Hospital
  • Monash Medical Centre Clayton
  • St Vincent's Hospital Melbourne
  • Austin Hospital
  • Liverpool Hospital
  • The Alfred Hospital
  • Royal Melbourne Hospital
  • Royal Perth Hospital
  • Westmead Hospital
  • Auckland City Hospital
  • Waikato Hospital
  • Wellington Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group 1 - ABX203 therapeutic Hepatitis B vaccine treatment arm

Group 2 - Control arm

Arm Description

ABX203 therapeutic vaccine in addition to NUCs background therapy

NUCs background therapy only

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical response defined as changes in viral load, liver function, time to relapse
Immune response defined as T-cell response by ICS (CD4 and CD8 to HBcAg and HBsAg)
Safety assessment will be conducted throughout the study and will include physical examinations, vital signs, clinical laboratory évaluations, and the recording of AEs

Full Information

First Posted
September 19, 2014
Last Updated
January 23, 2017
Sponsor
Abivax S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02249988
Brief Title
Clinical Efficacy of ABX203 Therapeutic Vaccine in HBeAg Negative Patients With Chronic Hepatitis B
Official Title
Phase IIB-III Efficacy Study of ABX203 Vaccine as an Adjunct Therapy to Nucleos(t)Ide Analogs to Maintain Control of HBV Replication After Cessation of Treatment in HBeAg Negative Patients With Chronic Hepatitis B
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abivax S.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - ABX203 therapeutic Hepatitis B vaccine treatment arm
Arm Type
Experimental
Arm Description
ABX203 therapeutic vaccine in addition to NUCs background therapy
Arm Title
Group 2 - Control arm
Arm Type
No Intervention
Arm Description
NUCs background therapy only
Intervention Type
Drug
Intervention Name(s)
ABX203 therapeutic Hepatitis B vaccine treatment arm
Primary Outcome Measure Information:
Title
Percentage of subjects with viral load < 40 IU/mL at Week 48.
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Clinical response defined as changes in viral load, liver function, time to relapse
Time Frame
Week 48 and Week 96
Title
Immune response defined as T-cell response by ICS (CD4 and CD8 to HBcAg and HBsAg)
Time Frame
Week 48
Title
Safety assessment will be conducted throughout the study and will include physical examinations, vital signs, clinical laboratory évaluations, and the recording of AEs
Time Frame
Participants will be followed for the duration of their study participation up to 96 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Facility Name
Monash Medical Centre Clayton
City
Clayton
ZIP/Postal Code
3168
Country
Australia
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
ZIP/Postal Code
2170
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
ZIP/Postal Code
3050
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
ZIP/Postal Code
6000
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton West
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
33437904
Citation
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. Erratum In: Hepatol Commun. 2022 Nov;6(11):3284.
Results Reference
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Clinical Efficacy of ABX203 Therapeutic Vaccine in HBeAg Negative Patients With Chronic Hepatitis B

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