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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Biological: GenHevac B Pasteur
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 437
Study Start Date: June 2007
Study Completion Date: September 2012
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Sanofi Pasteur MSD
Experimental: B
GenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6
Biological: GenHevac B Pasteur
Intra-muscular injection 40 microgramme intramuscular use at M0, M1,M2, M6
Other Name: Sanofi Pasteur MSD
Experimental: C
GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6
Biological: GenHevac B Pasteur
GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6
Other Name: Sanofi Pasteur MSD

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480792

Locations
France
Hopital Cochin CIC de vaccinologie
Paris, France, 75014
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sanofi Pasteur MSD
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
  More Information

No publications provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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     History of Changes
Other Study ID Numbers: 2006-003940-50, ANRS HB 03 VIHVAC-B
Study First Received: May 30, 2007
Last Updated: July 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Hepatitis B vaccination
GenHevac-B Pasteur
HIV Infections

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Hepatitis B
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on July 23, 2014