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Trial Comparing Two Strategies of Vaccination Against Hepatitis B in HIV-infected Patients Non Responding to Primary Immunization (B-BOOST) (B-BOOST)

Primary Purpose

Hepatitis B, HIV Infection

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

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • HIV-1 infection
  • T CD4 cell count number above 200 /mm3
  • History of 2 to 4 injections of Hepatitis B vaccine, at any time in the past
  • No history of Hepatitis B vaccination with a double-dose schedule
  • No response to Hepatitis B vaccination: serology Hepatitis B negative (AgHBs, AbHBs and AbHBc negative) the previous twelve months and at the screening visit
  • AbHBs titers below 10 IU/ml four weeks after the boost of Genhevac-B® 20μg preceding the randomization
  • unchanged ARV treatment for the last 2 months for patients who are receiving ARV at the screening visit
  • Undetectable HIV RNA for the last 6 months and on-going ARV for any patients with T CD4 cell level below 350/mm3
  • HIV-1 plasma load below 100 000 copies per ml for patients without ARV
  • Negative pregnancy test at the screening visit, and immediately before the Genhevac-B® 20 µg boost injection preceding the randomization

Exclusion Criteria:

  • Acute cytolysis in the last 3 months with transaminases equal or above 5 times the upper limit of normal for HIV-HCV coinfected patients, or transaminases equal or above 2 times the upper limit of normal for non coinfected patients
  • Any vaccine received during the month preceding the inclusion
  • History of hypersensitivity to any component of GenHevac-B
  • acute opportunistic infection treated the month before the screening visit
  • Severe and acute pyretic infection or unexplained fever the week before inclusion
  • Hemopathy or solid-organ cancer
  • Prothrombin factor equal or below 50% 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 at least 7 days) in the last 6 months before the screening visit
  • Immunomodulating treatment (interferon, interleukine-2,…) in the last 6 months before the screening visit
  • Splenectomy
  • Decompensated cirrhosis (Child Pugh B or C)
  • Renal failure (creatinine clearance below 50 ml/mn)
  • Other severe 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

  • Centre de Soins de l'Infection par le VIH NHC, Hôpitaux Universitaires Strasbourg, 1 place de l'hôpital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

GenHevac-B 20 microgram intramuscular use at M0, M1 and M6

GenHevac-B 40 microgram intramuscular use at M0, M1 and M6

Outcomes

Primary Outcome Measures

rate of HIV-infected patients who seroconvert one month after the last vaccination. Seroconversion is defined as anti-HBs titers equal or above 10 mUI per ml

Secondary Outcome Measures

According to the vaccine strategy (single-dose or double-dose), comparison of AbHBs titers, permanence of humoral response, intensity of clinical and biological events, and predicting factors related to seroconversion
immunological substudy: to understand genetic link between some alleles of HLA-DR and non-response to immunization

Full Information

First Posted
April 29, 2008
Last Updated
August 8, 2013
Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
MCM Vaccines B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT00670839
Brief Title
Trial Comparing Two Strategies of Vaccination Against Hepatitis B in HIV-infected Patients Non Responding to Primary Immunization (B-BOOST)
Acronym
B-BOOST
Official Title
Open-label, Randomized, and Multicenter Phase III Clinical Trial Comparing Immunogenicity of Double-dose (40 µg at S0, S4 and S24), Versus Standard Dose Vaccination (20 µg at S0, S4 and S24), Against Hepatitis B Virus in HIV-1-infected Patients Without Any Previous Immune Response After Primary Immunization Plus One Single Boost
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
February 2013 (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
HIV infected patients exposed to Hepatitis B virus are more susceptible to develop a chronic and severe liver disease, with a major risk of cirrhosis and liver cancer. However, immune response to standard Hepatitis B vaccination is decreased in HIV-infected patients, compared to non HIV-infected individuals, and, in case of response, its durability has to be carefully followed up. This study compares the efficacy of two strategies of revaccination in HIV-infected patients who didn't respond to previous hepatitis B vaccination. Failure is defined by two conditions: non response to the primary immunization (2 to 4 single-dose injections received before the screening visit) and failure to a single 20 µg boost before being included in the study.
Detailed Description
Comparison of 2 revaccination strategies in randomized HIV-infected patients with T CD4 cell count above 200/mm3 Intervention: Arm A: GenHevac-B® 20μg IM at M0, M1, M6 Arm B: GenHevac-B® 40μg IM at M0, M1, M6

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
GenHevac-B 20 microgram intramuscular use at M0, M1 and M6
Arm Title
B
Arm Type
Experimental
Arm Description
GenHevac-B 40 microgram intramuscular use at M0, M1 and M6
Intervention Type
Biological
Intervention Name(s)
GenHevac-B
Other Intervention Name(s)
Sanofi Pasteur MSD
Intervention Description
1 intramuscular injection of Genhevac-B® 20μg on day zero, month 1,and month 6
Intervention Type
Biological
Intervention Name(s)
GenHevac-B
Other Intervention Name(s)
Sanofi Pasteur MSD
Intervention Description
2 intramuscular injections of Genhevac-B® 20μg on day zero, month 1,and month 6
Primary Outcome Measure Information:
Title
rate of HIV-infected patients who seroconvert one month after the last vaccination. Seroconversion is defined as anti-HBs titers equal or above 10 mUI per ml
Time Frame
one month after the last vaccination (week 28)
Secondary Outcome Measure Information:
Title
According to the vaccine strategy (single-dose or double-dose), comparison of AbHBs titers, permanence of humoral response, intensity of clinical and biological events, and predicting factors related to seroconversion
Time Frame
one month after the last injection ( week 28) and month 18
Title
immunological substudy: to understand genetic link between some alleles of HLA-DR and non-response to immunization
Time Frame
at D0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-1 infection T CD4 cell count number above 200 /mm3 History of 2 to 4 injections of Hepatitis B vaccine, at any time in the past No history of Hepatitis B vaccination with a double-dose schedule No response to Hepatitis B vaccination: serology Hepatitis B negative (AgHBs, AbHBs and AbHBc negative) the previous twelve months and at the screening visit AbHBs titers below 10 IU/ml four weeks after the boost of Genhevac-B® 20μg preceding the randomization unchanged ARV treatment for the last 2 months for patients who are receiving ARV at the screening visit Undetectable HIV RNA for the last 6 months and on-going ARV for any patients with T CD4 cell level below 350/mm3 HIV-1 plasma load below 100 000 copies per ml for patients without ARV Negative pregnancy test at the screening visit, and immediately before the Genhevac-B® 20 µg boost injection preceding the randomization Exclusion Criteria: Acute cytolysis in the last 3 months with transaminases equal or above 5 times the upper limit of normal for HIV-HCV coinfected patients, or transaminases equal or above 2 times the upper limit of normal for non coinfected patients Any vaccine received during the month preceding the inclusion History of hypersensitivity to any component of GenHevac-B acute opportunistic infection treated the month before the screening visit Severe and acute pyretic infection or unexplained fever the week before inclusion Hemopathy or solid-organ cancer Prothrombin factor equal or below 50% 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 at least 7 days) in the last 6 months before the screening visit Immunomodulating treatment (interferon, interleukine-2,…) in the last 6 months before the screening visit Splenectomy Decompensated cirrhosis (Child Pugh B or C) Renal failure (creatinine clearance below 50 ml/mn) Other severe 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
David Rey, MD
Organizational Affiliation
Hôpital civil, Strasbourg, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fabrice Carrat, MD
Organizational Affiliation
Inserm U707 Paris France
Official's Role
Study Chair
Facility Information:
Facility Name
Centre de Soins de l'Infection par le VIH NHC, Hôpitaux Universitaires Strasbourg, 1 place de l'hôpital
City
Strasbourg
ZIP/Postal Code
67091 Cedex
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26257021
Citation
Rey D, Piroth L, Wendling MJ, Miailhes P, Michel ML, Dufour C, Haour G, Sogni P, Rohel A, Ajana F, Billaud E, Molina JM, Launay O, Carrat F; ANRS HB04 B-BOOST study group. Safety and immunogenicity of double-dose versus standard-dose hepatitis B revaccination in non-responding adults with HIV-1 (ANRS HB04 B-BOOST): a multicentre, open-label, randomised controlled trial. Lancet Infect Dis. 2015 Nov;15(11):1283-91. doi: 10.1016/S1473-3099(15)00220-0. Epub 2015 Aug 6.
Results Reference
derived
Links:
URL
http://www.anrs.fr
Description
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Trial Comparing Two Strategies of Vaccination Against Hepatitis B in HIV-infected Patients Non Responding to Primary Immunization (B-BOOST)

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