NCT00670839

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2008

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2008

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

August 12, 2013

Status Verified

August 1, 2013

Enrollment Period

3.6 years

First QC Date

April 29, 2008

Last Update Submit

August 8, 2013

Conditions

Hepatitis BHIV Infection

Keywords

Hepatitis B vaccinationGenHevac-B PasteurHIV infection

Outcome Measures

Primary Outcomes (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

    one month after the last vaccination (week 28)

Secondary Outcomes (2)

  • 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

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

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

    at D0

Study Arms (2)

A

ACTIVE COMPARATOR

GenHevac-B 20 microgram intramuscular use at M0, M1 and M6

Biological: GenHevac-B

B

EXPERIMENTAL

GenHevac-B 40 microgram intramuscular use at M0, M1 and M6

Biological: GenHevac-B

Interventions

GenHevac-BBIOLOGICAL

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

Also known as: Sanofi Pasteur MSD
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • History of hypersensitivity to any component of GenHevac-B
  • acute opportunistic infection treated the month before the screening visit
  • Hemopathy or solid-organ cancer
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Strasbourg, 67091 Cedex, France

Location

Related Publications (1)

  • 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.

    PMID: 26257021DERIVED

Related Links

MeSH Terms

Conditions

Hepatitis BHIV Infections

Interventions

GenHevac B Pasteur

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • David Rey, MD

    Hôpital civil, Strasbourg, France

    PRINCIPAL INVESTIGATOR

  • Fabrice Carrat, MD

    Inserm U707 Paris France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2008

First Posted

May 2, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2011

Study Completion

February 1, 2013

Last Updated

August 12, 2013

Record last verified: 2013-08

Locations

FR(1)