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
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
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
NCT ID
NCT00480792
First Posted
May 30, 2007
Last Updated
July 22, 2013
Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
MCM Vaccines B.V.
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
Learn more about this trial
Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV Infected Patients
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