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Open-label, Randomized, and Multicenter Phase III Clinical Trial Comparing Immunogenicity of Double-dose (40 µg at S0, S4 and S24), Versus Standard Dose Vaccination (20 µg at S0, S4 and S24), Against Hepatitis B Virus in HIV-1-infected Patients Without Any Previous Immune Response After Primary Immunization Plus One Single Boost


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Hepatitis B, HIV Infection

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Trial Information

Open-label, Randomized, and Multicenter Phase III Clinical Trial Comparing Immunogenicity of Double-dose (40 µg at S0, S4 and S24), Versus Standard Dose Vaccination (20 µg at S0, S4 and S24), Against Hepatitis B Virus in HIV-1-infected Patients Without Any Previous Immune Response After Primary Immunization Plus One Single Boost


Comparison of 2 revaccination strategies in randomized HIV-infected patients with T CD4 cell
count above 200/mm3

Intervention:

1. Arm A: GenHevac-B® 20μg IM at M0, M1, M6

2. Arm B: GenHevac-B® 40μg IM at M0, M1, M6


Inclusion Criteria:



- HIV-1 infection

- T CD4 cell count number above 200 /mm3

- History of 2 to 4 injections of Hepatitis B vaccine, at any time in the past

- No history of Hepatitis B vaccination with a double-dose schedule

- No response to Hepatitis B vaccination: serology Hepatitis B negative (AgHBs, AbHBs
and AbHBc negative) the previous twelve months and at the screening visit

- AbHBs titers below 10 IU/ml four weeks after the boost of Genhevac-B® 20μg preceding
the randomization

- unchanged ARV treatment for the last 2 months for patients who are receiving ARV at
the screening visit

- Undetectable HIV RNA for the last 6 months and on-going ARV for any patients with T
CD4 cell level below 350/mm3

- HIV-1 plasma load below 100 000 copies per ml for patients without ARV

- Negative pregnancy test at the screening visit, and immediately before the
Genhevac-B® 20 µg boost injection preceding the randomization

Exclusion Criteria:

- Acute cytolysis in the last 3 months with transaminases equal or above 5 times the
upper limit of normal for HIV-HCV coinfected patients, or transaminases equal or
above 2 times the upper limit of normal for non coinfected patients

- Any vaccine received during the month preceding the inclusion

- History of hypersensitivity to any component of GenHevac-B

- acute opportunistic infection treated the month before the screening visit

- Severe and acute pyretic infection or unexplained fever the week before inclusion

- Hemopathy or solid-organ cancer

- Prothrombin factor equal or below 50% 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 at least 7 days) in the last 6 months before the screening visit

- Immunomodulating treatment (interferon, interleukine-2,…) in the last 6 months before
the screening visit

- Splenectomy

- Decompensated cirrhosis (Child Pugh B or C)

- Renal failure (creatinine clearance below 50 ml/mn)

- Other severe 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:

rate of HIV-infected patients who seroconvert one month after the last vaccination. Seroconversion is defined as anti-HBs titers equal or above 10 mUI per ml

Outcome Time Frame:

one month after the last vaccination,; week 28, month 18

Safety Issue:

Yes

Principal Investigator

David Rey, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpital civil, Strasbourg, France

Authority:

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

Study ID:

2007-005023-15

NCT ID:

NCT00670839

Start Date:

May 2008

Completion Date:

February 2013

Related Keywords:

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

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