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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
GenHevac B Pasteur
GenHevac B Pasteur
GenHevac B Pasteur
Sponsored by
ANRS, Emerging Infectious Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Hepatitis B vaccination, GenHevac-B Pasteur, HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Cochin CIC de vaccinologie

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

A

B

C

Arm Description

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

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

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

Outcomes

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.

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

Full Information

First Posted
May 30, 2007
Last Updated
July 22, 2013
Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
MCM Vaccines B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT00480792
Brief Title
Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV Infected Patients
Acronym
VIHVAC-B
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
MCM Vaccines B.V.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: Arm A: GenHevac-B 20 microgramme Intramuscular use at M0, M1, M6 Arm B: GenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6 Arm C: GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Hepatitis B vaccination, GenHevac-B Pasteur, HIV Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
437 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
GenHevac-B 20 microgramme Intramuscular use at M0, M1, M6
Arm Title
B
Arm Type
Experimental
Arm Description
GenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6
Arm Title
C
Arm Type
Experimental
Arm Description
GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6
Intervention Type
Biological
Intervention Name(s)
GenHevac B Pasteur
Other Intervention Name(s)
Sanofi Pasteur MSD
Intervention Description
Intra-muscular injection 20 microgramme Intramuscular use at M0, M1, M6
Intervention Type
Biological
Intervention Name(s)
GenHevac B Pasteur
Other Intervention Name(s)
Sanofi Pasteur MSD
Intervention Description
Intra-muscular injection 40 microgramme intramuscular use at M0, M1,M2, M6
Intervention Type
Biological
Intervention Name(s)
GenHevac B Pasteur
Other Intervention Name(s)
Sanofi Pasteur MSD
Intervention Description
GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Odile Launay, MD
Organizational Affiliation
CIC de vaccinologie Cochin-Pasteur 27, rue du Fb Saint Jacques 75014 Paris Fr
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fabrice Carrat, MD
Organizational Affiliation
Inserm U707 27, rue de Chaligny 75571 Paris cedex 12 Fr
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital Cochin CIC de vaccinologie
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27064975
Citation
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.
Results Reference
derived
PubMed Identifier
21486976
Citation
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.
Results Reference
derived

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Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV Infected Patients

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