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

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ClinicalTrials.gov Identifier: NCT00480792
Recruitment Status : Completed
First Posted : May 31, 2007
Last Update Posted : July 23, 2013
Sponsor:
Collaborator:
MCM Vaccines B.V.
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

Tracking Information
First Submitted Date  ICMJE May 30, 2007
First Posted Date  ICMJE May 31, 2007
Last Update Posted Date July 23, 2013
Study Start Date  ICMJE June 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2007)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV Infected Patients
Official Title  ICMJE 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
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.

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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2013)
437
Original Estimated Enrollment  ICMJE
 (submitted: May 30, 2007)
420
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00480792
Other Study ID Numbers  ICMJE 2006-003940-50
ANRS HB 03 VIHVAC-B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ANRS, Emerging Infectious Diseases
Study Sponsor  ICMJE ANRS, Emerging Infectious Diseases
Collaborators  ICMJE MCM Vaccines B.V.
Investigators  ICMJE
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
PRS Account ANRS, Emerging Infectious Diseases
Verification Date July 2013

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