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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
HIV Infections

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Trial Information

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


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


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

- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Odile Launay, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CIC de vaccinologie Cochin-Pasteur 27, rue du Fb Saint Jacques 75014 Paris Fr

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2006-003940-50

NCT ID:

NCT00480792

Start Date:

June 2007

Completion Date:

December 2008

Related Keywords:

  • HIV Infections
  • Hepatitis B vaccination
  • GenHevac-B Pasteur
  • HIV Infections
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Hepatitis
  • Hepatitis A
  • Hepatitis B

Name

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