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Efficacy and Tolerance of Naked DNA Vaccine in Patients With Chronic B Hepatitis

NCT00536627 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-04-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • French National Agency for Research on AIDS and Viral Hepatitis

    lead OTHER_GOV

Principal Investigators

  • Hélène FONTAINE, MD · Pôle d'Hépatologie, Hôpital COCHIN, PARIS, FRANCE

  • Jean-Pierre ABOULKER, MD · INSERM SC-10, VILLEJUIF, FRANCE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00536627 on ClinicalTrials.gov