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

Phase 3

Completed

• Conditions: HIV Infections
• Interventions: Biological: GenHevac B Pasteur

• Registration Number: NCT00480792
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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:

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

Study Timeline

• Study First Submitted: 2007-05-30
• Study First Submitted QC: 2007-05-30
• Study First Posted: 2007-05-31
• Study Start: 2007-06
• Primary Completion: 2008-12
• Study Completion: 2012-09
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-22
• Last Update Posted: 2013-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 437

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	GenHevac B Pasteur	GenHevac-B 20 microgramme Intramuscular use at M0, M1, M6
B	GenHevac B Pasteur	GenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6
C	GenHevac B Pasteur	GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hopital Cochin CIC de vaccinologie; 🇫🇷 Paris, France