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

CompletedPhase 3

Sponsor: ANRS, Emerging Infectious Diseases

Conditions: HIV Infections

Interventions: GenHevac B Pasteur, GenHevac B Pasteur, GenHevac B Pasteur

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Paris, France