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

This study has been completed.
Sponsor:
Collaborator:
Sanofi Pasteur MSD
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT00480792
First received: May 30, 2007
Last updated: July 22, 2013
Last verified: July 2013

May 30, 2007
July 22, 2013
June 2007
December 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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 ]
Complete list of historical versions of study NCT00480792 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
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 ]
Not Provided
Not Provided
 
Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV Infected Patients
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.

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • Biological: GenHevac B Pasteur
    Intra-muscular injection 20 microgramme Intramuscular use at M0, M1, M6
    Other Name: Sanofi Pasteur MSD
  • Biological: GenHevac B Pasteur
    Intra-muscular injection 40 microgramme intramuscular use at M0, M1,M2, M6
    Other Name: Sanofi Pasteur MSD
  • Biological: GenHevac B Pasteur
    GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6
    Other Name: Sanofi Pasteur MSD
  • Active Comparator: A
    GenHevac-B 20 microgramme Intramuscular use at M0, M1, M6
    Intervention: Biological: GenHevac B Pasteur
  • Experimental: B
    GenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6
    Intervention: Biological: GenHevac B Pasteur
  • Experimental: C
    GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6
    Intervention: Biological: GenHevac B Pasteur
Launay O, van der Vliet D, Rosenberg AR, Michel ML, Piroth L, Rey D, Colin de Verdière 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
437
September 2012
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00480792
2006-003940-50, ANRS HB 03 VIHVAC-B
Yes
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sanofi Pasteur MSD
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
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP