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Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV Infected Patients

NCT00480792 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 437

Last updated 2026-04-06

No results posted yet for this study

Summary

In HIV infected patients, individuals exposed to the virus of Hepatitis B are more susceptible to develop a chronic and severe liver disease with a major risk of cirrhosis and liver cancer.

However, the existing protocol of vaccination against Hepatitis B is less efficient in HIV-infected patients than in non HIV-infected-patients, and, in case of response, its longevity has to be followed up carefully. This study compares the efficacy of the standard protocol vaccination with GenHevac-B and 2 other protocols, a double-dose of GenHevac-B and a set of intradermal injections of Genhevac-B, in HIV-infected patients with lymphocytes T CD4 level above 200 permm3.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

GenHevac B Pasteur

Intra-muscular injection 20 microgramme Intramuscular use at M0, M1, M6

BIOLOGICAL

GenHevac B Pasteur

Intra-muscular injection 40 microgramme intramuscular use at M0, M1,M2, M6

BIOLOGICAL

GenHevac B Pasteur

GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6

Sponsors & Collaborators

  • MCM Vaccines B.V.

    collaborator INDUSTRY

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Odile Launay, MD · CIC de vaccinologie Cochin-Pasteur 27, rue du Fb Saint Jacques 75014 Paris Fr

  • Fabrice Carrat, MD · Inserm U707 27, rue de Chaligny 75571 Paris cedex 12 Fr

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-12-31
Completion
2012-09-30

Countries

  • France

Study Locations

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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 NCT00480792 on ClinicalTrials.gov