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

HIV Infections Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480792
• Other study ID #: 2006-003940-50
• Secondary ID: ANRS HB 03 VIHVA
• Status: Completed
• Phase: Phase 3
• First received: May 30, 2007
• Last updated: July 22, 2013
• Start date: June 2007
• Est. completion date: September 2012

Study information

• Verified date: July 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: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 437
• Est. completion date: September 2012
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hepatitis B
• HIV Infections

Intervention

Biological:
• GenHevac B Pasteur
Intra-muscular injection 20 microgramme Intramuscular use at M0, M1, M6
• GenHevac B Pasteur
Intra-muscular injection 40 microgramme intramuscular use at M0, M1,M2, M6
• GenHevac B Pasteur
GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6

Locations

Country	Name	City	State
France	Hopital Cochin CIC de vaccinologie	Paris

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	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.		two months after the last injection;week 28, month 18, month 30 and month 42	Yes
Secondary	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		two months after the last injection; week 28, month 18, month 30 and month 42	Yes