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

HIV Infection Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00670839
• Other study ID #: 2007-005023-15
• Secondary ID: ANRS HB04 B-BOOS
• Status: Completed
• Phase: Phase 3
• First received: April 29, 2008
• Last updated: August 8, 2013
• Start date: May 2008
• Est. completion date: February 2013

Study information

• Verified date: August 2013
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Description:

Comparison of 2 revaccination strategies in randomized HIV-infected patients with T CD4 cell count above 200/mm3

Intervention:

1. Arm A: GenHevac-B® 20μg IM at M0, M1, M6

2. Arm B: GenHevac-B® 40μg IM at M0, M1, M6

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: February 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• HIV Infection
• HIV Infections

Intervention

Biological:
• GenHevac-B
1 intramuscular injection of Genhevac-B® 20µg on day zero, month 1,and month 6
• GenHevac-B
2 intramuscular injections of Genhevac-B® 20µg on day zero, month 1,and month 6

Locations

Country	Name	City	State
France	Centre de Soins de l'Infection par le VIH NHC, Hôpitaux Universitaires Strasbourg, 1 place de l'hôpital	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	Sanofi Pasteur MSD

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		one month after the last vaccination (week 28)	Yes
Secondary	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		one month after the last injection ( week 28) and month 18	Yes
Secondary	immunological substudy: to understand genetic link between some alleles of HLA-DR and non-response to immunization		at D0	No

External Links

•   Link