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Hepatitis BPhase 3B-BOOSTNCT00670839

Trial Comparing Two Strategies of Vaccination Against Hepatitis B in HIV-infected Patients Non Responding to Primary Immunization (B-BOOST)

A Phase 3 study testing GenHevac-B in people with Hepatitis B and HIV Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

HIV infected patients exposed to Hepatitis B virus are more susceptible to develop a chronic and severe liver disease, with a major risk of cirrhosis and liver cancer. However, immune response to standard Hepatitis B vaccination is decreased in HIV-infected patients, compared to non HIV-infected individuals, and, in… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis B, HIV Infection
What is being tested?
GenHevac-B
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
1 siteFrance
Study dates
May 2008to Feb 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HIV-1 infection
  • T CD4 cell count number above 200 /mm3
  • History of 2 to 4 injections of Hepatitis B vaccine, at any time in the past
  • No history of Hepatitis B vaccination with a double-dose schedule
  • No response to Hepatitis B vaccination: serology Hepatitis B negative (AgHBs, AbHBs and AbHBc negative) the previous twelve months and at the screening visit
  • AbHBs titers below 10 IU/ml four weeks after the boost of Genhevac-B® 20μg preceding the randomization
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  • unchanged ARV treatment for the last 2 months for patients who are receiving ARV at the screening visit
  • Undetectable HIV RNA for the last 6 months and on-going ARV for any patients with T CD4 cell level below 350/mm3
  • HIV-1 plasma load below 100 000 copies per ml for patients without ARV
  • Negative pregnancy test at the screening visit, and immediately before the Genhevac-B® 20 µg boost injection preceding the randomization

Who cannot join

  • Acute cytolysis in the last 3 months with transaminases equal or above 5 times the upper limit of normal for HIV-HCV coinfected patients, or transaminases equal or above 2 times the upper limit of normal for non coinfected patients
  • Any vaccine received during the month preceding the inclusion
  • History of hypersensitivity to any component of GenHevac-B
  • acute opportunistic infection treated the month before the screening visit
  • Severe and acute pyretic infection or unexplained fever the week before inclusion
  • Hemopathy or solid-organ cancer
Show all 14Show fewer
  • Prothrombin factor equal or below 50% 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 at least 7 days) in the last 6 months before the screening visit
  • Immunomodulating treatment (interferon, interleukine-2,…) in the last 6 months before the screening visit
  • Splenectomy
  • Decompensated cirrhosis (Child Pugh B or C)
  • Renal failure (creatinine clearance below 50 ml/mn)
  • Other severe 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre de Soins de l'Infection par le VIH NHC, Hôpitaux Universitaires Strasbourg, 1 place de l'hôpital

    Strasbourg, 67091 Cedex

Other trials in France

About this study

Official title: Open-label, Randomized, and Multicenter Phase III Clinical Trial Comparing Immunogenicity of Double-dose (40 µg at S0, S4 and S24), Versus Standard Dose Vaccination (20 µg at S0, S4 and S24), Against Hepatitis B Virus in HIV-1-infected Patients Without Any Previous Immune Response After Primary Immunization Plus One Single Boost

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

However, immune response to standard Hepatitis B vaccination is decreased in HIV-infected patients, compared to non HIV-infected individuals, and, in case of response, its durability has to be carefully followed up. This study compares the efficacy of two strategies of revaccination in HIV-infected patients who didn't respond to previous hepatitis B vaccination. Failure is defined by two conditions: non response to the primary immunization (2 to 4 single-dose injections received before the screening visit) and failure to a single 20 µg boost before being included in the study.

Read the detailed description

Comparison of 2 revaccination strategies in randomized HIV-infected patients with T CD4 cell count above 200/mm3

Intervention:

  1. Arm A: GenHevac-B® 20μg IM at M0, M1, M6
  2. Arm B: GenHevac-B® 40μg IM at M0, M1, M6
Being tested
GenHevac-B
Keywords
Hepatitis B vaccination, GenHevac-B Pasteur, HIV infection
Medical subject headings
Hepatitis B, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GenHevac-BBiological

    Also called Sanofi Pasteur MSD

    1 intramuscular injection of Genhevac-B® 20μg on day zero, month 1,and month 6

  • GenHevac-BBiological

    Also called Sanofi Pasteur MSD

    2 intramuscular injections of Genhevac-B® 20μg on day zero, month 1,and month 6

Study groups in NCT00670839
Study groupRoleWhat they receive
AActive comparatorGenHevac-B 20 microgram intramuscular use at M0, M1 and M6
Receives: Biological: GenHevac-B
BExperimentalGenHevac-B 40 microgram intramuscular use at M0, M1 and M6
Receives: Biological: GenHevac-B

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. rate of HIV-infected patients who seroconvert one month after the last vaccination. Seroconversion is defined as anti-HBs titers equal or above 10 mUI per ml

    Measured: one month after the last vaccination (week 28)

Secondary outcomes (2)

  1. According to the vaccine strategy (single-dose or double-dose), comparison of AbHBs titers, permanence of humoral response, intensity of clinical and biological events, and predicting factors related to seroconversion

    Measured: one month after the last injection ( week 28) and month 18

  2. immunological substudy: to understand genetic link between some alleles of HLA-DR and non-response to immunization

    Measured: at D0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionDec 2011
  4. Study completionFeb 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00670839
Sponsor's protocol ID
ANRS HB04 B-BOOST
Other IDs
2007-005023-15
Acronym
B-BOOST
Status last verified
Aug 2013
First submitted
29 Apr 2008
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Rey D, Piroth L, Wendling MJ, Miailhes P, Michel ML, Dufour C, Haour G, Sogni P, Rohel A, Ajana F, Billaud E, Molina JM, Launay O, Carrat F; ANRS HB04 B-BOOST study group. Safety and immunogenicity of double-dose versus standard-dose hepatitis B revaccination in non-responding adults with HIV-1 (ANRS HB04 B-BOOST): a multicentre, open-label, randomised controlled trial. Lancet Infect Dis. 2015 Nov;15(11):1283-91. doi: 10.1016/S1473-3099(15)00220-0. Epub 2015 Aug 6.

    PubMed 26257021

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GenHevac-B in people with Hepatitis B and HIV Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rate of HIV-infected patients who seroconvert one month after the last vaccination. Seroconversion is defined as anti-HBs titers equal or above 10 mUI per ml (time frame: one month after the last vaccination (week 28)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00670839, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.

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