Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV Infected Patients (VIHVAC-B)

April 1, 2026 updated by: ANRS, Emerging Infectious Diseases

Open-label, Randomized, and Multicentric Phase III Clinical Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV-1-infected Patients With CD4-positive T-lymphocytes Counts Above 200 permm3 ANRS HB 03 VIHVAC-B

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Comparison of 3 vaccination strategy against Hepatitis B in patients with HIV infection T CD4 above 200 per mm3

Intervention:

  1. Arm A: GenHevac-B 20 microgramme Intramuscular use at M0, M1, M6
  2. Arm B: GenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6
  3. Arm C: GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6

Study Type

Interventional

Enrollment (Actual)

437

Phase

  • Phase 3

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, 75014
        • Hopital Cochin CIC de vaccinologie

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Age Eligible for Study: 18 years - NA, Genders Eligible for Study: Both

Criteria

Inclusion criteria:

  • HIV infection
  • T CD4 count cell level above 200 per mm3
  • Serology Hepatitis B negative (AgHBs, AbHBs and AbHBc negative)
  • unchanged ARV for the last 3 months for patients who are receiving ARV at the screening visit
  • Undetectable for the last 6 months with ARV for any patient with T CD4 level below 350 per mm3
  • Pregnancy test negative at the screening and inclusion visits

Exclusion Criteria:

  • Any injection of the vaccine against Hepatitis B in the medical history
  • Acute cytolysis in the last 3 months with transaminases equal or above 5 times the upper normal range for HIV-HCV coinfected patients, or transaminases equal or above 2 times the upper normal for non coinfected patients
  • Any vaccine received one month before the inclusion
  • History of intolerance to any component of GenHevac-B
  • Evolutive opportunistic infection treated the month before the screening visit
  • Severe and acute pyretic infection or unexplained fever the week before inclusion
  • Evolutive hemopathy or solid-organ cancer
  • Prothrombin factor equal or below 50 percent and/or platelets equal or below 50 000 per mm3
  • Immunosuppressive treatment or general corticotherapy (equal or above 0,5 mg per kg per day during above 7 days) in the last 6 months before the screening visit
  • Previous Immunomodulating treatment (interferon, interleukin-2,etc) or plan in the next 6 months
  • Splenectomy
  • Decompensated cirrhosis (Child Pugh B or C)
  • Kidney deficient function (creatinine clearance below 50 ml per mn)
  • Other immunocompromised condition not related to HIV infection (solid-organ transplantation, chemotherapy in the last 6 months)
  • Any participation to another clinical trial plan until Week 28

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
GenHevac-B 20 microgramme Intramuscular use at M0, M1, M6
Biological: GenHevac B Pasteur
Intra-muscular injection 20 microgramme Intramuscular use at M0, M1, M6
Other Names:
  • Sanofi Pasteur MSD
Biological: GenHevac B Pasteur
Intra-muscular injection 40 microgramme intramuscular use at M0, M1,M2, M6
Other Names:
  • Sanofi Pasteur MSD
Biological: GenHevac B Pasteur
GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6
Other Names:
  • Sanofi Pasteur MSD
Experimental: B
GenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6
Biological: GenHevac B Pasteur
Intra-muscular injection 20 microgramme Intramuscular use at M0, M1, M6
Other Names:
  • Sanofi Pasteur MSD
Biological: GenHevac B Pasteur
Intra-muscular injection 40 microgramme intramuscular use at M0, M1,M2, M6
Other Names:
  • Sanofi Pasteur MSD
Biological: GenHevac B Pasteur
GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6
Other Names:
  • Sanofi Pasteur MSD
Experimental: C
GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6
Biological: GenHevac B Pasteur
Intra-muscular injection 20 microgramme Intramuscular use at M0, M1, M6
Other Names:
  • Sanofi Pasteur MSD
Biological: GenHevac B Pasteur
Intra-muscular injection 40 microgramme intramuscular use at M0, M1,M2, M6
Other Names:
  • Sanofi Pasteur MSD
Biological: GenHevac B Pasteur
GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6
Other Names:
  • Sanofi Pasteur MSD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HIV-infected patients who seroconvert in the first two months after the last vaccination. Seroconversion is defined as antibodies AbHBs titers equal or above 10 mUI per ml.
Time Frame: two months after the last injection;week 28, month 18, month 30 and month 42
two months after the last injection;week 28, month 18, month 30 and month 42

Secondary Outcome Measures

Outcome Measure
Time Frame
According to the vaccine administration (IM or ID) comparison of AbHBs titers,permanence of the humoral response,intensity of clinical and biological events and predicting factors related to seroconversion
Time Frame: two months after the last injection; week 28, month 18, month 30 and month 42
two months after the last injection; week 28, month 18, month 30 and month 42

Collaborators and Investigators

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

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

MCM Vaccines B.V.

Investigators

  • Principal Investigator: Odile Launay, MD, CIC de vaccinologie Cochin-Pasteur 27, rue du Fb Saint Jacques 75014 Paris Fr
  • Study Chair: Fabrice Carrat, MD, Inserm U707 27, rue de Chaligny 75571 Paris cedex 12 Fr

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

June 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

May 30, 2007

First Submitted That Met QC Criteria

May 30, 2007

First Posted (Estimated)

May 31, 2007

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS HB 03 VIHVAC-B
  • 2006-003940-50 (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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