Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV Infected Patients (VIHVAC-B)

ANRS, Emerging Infectious Diseases

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Biological: GenHevac B Pasteur

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00480792

ANRS HB 03 VIHVAC-B

2006-003940-50

Details and patient eligibility

About

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.

Full 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

Enrollment: 437 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

437 participants in 3 patient groups

A

Active Comparator group

Description:

GenHevac-B 20 microgramme Intramuscular use at M0, M1, M6

Treatment:

Biological: GenHevac B Pasteur

Biological: GenHevac B Pasteur

Biological: GenHevac B Pasteur

B

Experimental group

Description:

GenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6

Treatment:

Biological: GenHevac B Pasteur

Biological: GenHevac B Pasteur

Biological: GenHevac B Pasteur

C

Experimental group

Description:

GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6

Treatment:

Biological: GenHevac B Pasteur

Biological: GenHevac B Pasteur

Biological: GenHevac B Pasteur