NCT00480792

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
437

participants targeted

Target at P50-P75 for phase_3 hiv-infections

Timeline
Completed

Started Jun 2007

Longer than P75 for phase_3 hiv-infections

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

May 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2007

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

July 23, 2013

Status Verified

July 1, 2013

Enrollment Period

1.5 years

First QC Date

May 30, 2007

Last Update Submit

July 22, 2013

Conditions

HIV Infections

Keywords

Hepatitis B vaccinationGenHevac-B PasteurHIV Infections

Outcome Measures

Primary Outcomes (1)

  • 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.

    two months after the last injection;week 28, month 18, month 30 and month 42

Secondary Outcomes (1)

  • 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

    two months after the last injection; week 28, month 18, month 30 and month 42

Study Arms (3)

A

ACTIVE COMPARATOR

GenHevac-B 20 microgramme Intramuscular use at M0, M1, M6

Biological: GenHevac B Pasteur

B

EXPERIMENTAL

GenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6

Biological: GenHevac B Pasteur

C

EXPERIMENTAL

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

Biological: GenHevac B Pasteur

Interventions

GenHevac B PasteurBIOLOGICAL

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

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:

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

You may not qualify if:

  • 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
  • History of intolerance to any component of GenHevac-B
  • Evolutive opportunistic infection treated the month before the screening visit
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Cochin CIC de vaccinologie

Paris, 75014, France

Location

Related Publications (2)

  • Launay O, Rosenberg AR, Rey D, Pouget N, Michel ML, Reynes J, Neau D, Raffi F, Piroth L, Carrat F; ANRS HB03 VIHVAC-B (Trial Comparing 3 Strategies of Vaccination Against the Virus of Hepatitis B in HIV-Infected Patients) Group. Long-term Immune Response to Hepatitis B Virus Vaccination Regimens in Adults With Human Immunodeficiency Virus 1: Secondary Analysis of a Randomized Clinical Trial. JAMA Intern Med. 2016 May 1;176(5):603-10. doi: 10.1001/jamainternmed.2016.0741.

    PMID: 27064975DERIVED

  • Launay O, van der Vliet D, Rosenberg AR, Michel ML, Piroth L, Rey D, Colin de Verdiere N, Slama L, Martin K, Lortholary O, Carrat F; ANRS HB03 VIHVAC-B Trial. Safety and immunogenicity of 4 intramuscular double doses and 4 intradermal low doses vs standard hepatitis B vaccine regimen in adults with HIV-1: a randomized controlled trial. JAMA. 2011 Apr 13;305(14):1432-40. doi: 10.1001/jama.2011.351.

    PMID: 21486976DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

GenHevac B Pasteur

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Odile Launay, MD

    CIC de vaccinologie Cochin-Pasteur 27, rue du Fb Saint Jacques 75014 Paris Fr

    PRINCIPAL INVESTIGATOR

  • Fabrice Carrat, MD

    Inserm U707 27, rue de Chaligny 75571 Paris cedex 12 Fr

    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

May 30, 2007

First Posted

May 31, 2007

Study Start

June 1, 2007

Primary Completion

December 1, 2008

Study Completion

September 1, 2012

Last Updated

July 23, 2013

Record last verified: 2013-07

Locations

FR(1)