Efficacy and Tolerance of Naked DNA Vaccine in Patients With Chronic B Hepatitis (VAC-ADN)

April 1, 2026 updated by: French National Agency for Research on AIDS and Viral Hepatitis

Randomised, Opened, Multicentre Phase I/II Trial in Patients With Chronic Hepatitis B With HBV VL < 12 IU/ml and Under Treatment With NRTI, Which Evaluated Efficacy and Tolerance of Vaccination With Naked DNA on Viral Replication After Analogs' Treatment Interruption. ANRS HB02 VAC-ADN

The purpose of this study is to determine if DNA vaccination of chronic HBV patients under treatment with NRTI can restore T-cell responsiveness and delay virologic reactivation after treatment discontinuation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite the availability of effective vaccines against hepatitis B, over 370 million people worldwide remain persistently infected with HBV. Persistent infection is associated with chronic liver disease that can lead to the developement of cirrhosis and hepatocellular carcinoma in two-third of persons. Treatment of chronic hepatitis B relies on the use of analogs such as lamivudine, adefovir, entecavir or immunostimulators such as interferons. Although analogs are efficient, genotypic resistance occurs after one year of treatment and the rate of virologic relapse is high after treatment discontinuation.

HBV is a non cytopathic virus and liver damage is caused by immune response against infected hepatocytes and to a non specific inflammatory response. Immune response contributes to the virus clearance. In acute hepatitis B infection, T cell response is polyclonal, specific and vigorous, whereas in patients with chronic infection, responses remain weak, less specific and hardly detectable in peripheral blood.

T cell responses could be induced or restored by antigenic stimulation such as vaccination. In a previous phase I clinical trial, we showed that DNA vaccination with plasmid pCMVS2.S is safe and can specifically, but transiently activate T-cell responses in chronic HBV-carriers not responding to current antiviral therapies.

Analogs such as lamivudine and adefovir were shown to enhance T cell responses concomitantly with viral load decrease. In this phase I/II clinical trial, we would like to determine if DNA vaccination of chronic HBV patients under treatment with NRTI can restore T-cell responsiveness and delay virologic reactivation after treatment discontinuation.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • FONTAINE Hélène

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • chronic hepatitis B with or without AgHBe
  • no cirrhosis and no hepatocellular carcinoma
  • treatment with NRTI unchanged for at least 3 months
  • undetectable HBV viral load for 12 months
  • HBV viral load < 12 IU/ml at screening
  • sGPT < 5N
  • tetanus immunization or booster dose for less than 8 years
  • accurate birth control or menopausal women or sterility
  • sickness insurance
  • signed informed consent

Exclusion Criteria:

  • HLA-DR 15/16
  • coinfections with HDV, HCV and/or HIV
  • treatment with immunomodulators
  • immunosuppressors
  • long-term corticotherapy (over 4 weeks)
  • active intravenous drug-users
  • prolonged and excessive consumption of alcohol (men > 40g/day ; women > 30g/day ; for more than 5 years)
  • medical history of autoimmune disease or presence of autoantibodies
  • previous immunization by HBV vaccine of less than 5 years
  • previous immunization by DNA vaccine against HBV
  • personal or family medical history of demyelinising diseases
  • uncontrolled hypophosphatemia
  • renal failure, renal transplantation, haemodialysis
  • pregnancy, breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2
Experimental: 1
Patients will receive 5 injections of DNA vaccine at weeks 0, 8, 16, 40, 44.
Biological: DNA vaccine pCMVS2.S
Patients will receive injections of 1 ml of vaccine (1 mg/ml) at weeks 0, 8, 16, 40 and 44

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary endpoint is virologic failure defined by 1) reactivation after analogs' treatment interruption, 2) virologic breakthrough during treatment with analogs, 3) the impossibility for the patients to interrupt treatment at week 48
Time Frame: at week 72
at week 72

Secondary Outcome Measures

Outcome Measure
Time Frame
Delay of appearance of virologic failure
Time Frame: at Week 72
at Week 72
Biological and clinical tolerance of DNA vaccine
Time Frame: all along the trial
all along the trial
Immunological responses
Time Frame: At weeks 18, 40, 46, 60, 72
At weeks 18, 40, 46, 60, 72
Clinical progression of hepatitis B
Time Frame: all along the trial
all along the trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Investigators

  • Principal Investigator: Hélène FONTAINE, MD, Pôle d'Hépatologie, Hôpital COCHIN, PARIS, FRANCE
  • Study Chair: Jean-Pierre ABOULKER, MD, INSERM SC-10, VILLEJUIF, FRANCE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

September 26, 2007

First Submitted That Met QC Criteria

September 27, 2007

First Posted (Estimated)

September 28, 2007

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS HB02 VAC-ADN
  • 2007-001682-15 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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