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

NCT ID: NCT00480792

Last Updated: 2013-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 437 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2012-09-30

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

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

A

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

Group Type: ACTIVE_COMPARATOR

GenHevac B Pasteur

Intervention Type: BIOLOGICAL

Intra-muscular injection 20 microgramme Intramuscular use at M0, M1, M6

B

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

Group Type: EXPERIMENTAL

GenHevac B Pasteur

Intervention Type: BIOLOGICAL

Intra-muscular injection 40 microgramme intramuscular use at M0, M1,M2, M6

C

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

Group Type: EXPERIMENTAL

GenHevac B Pasteur

Intervention Type: BIOLOGICAL

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

Interventions

GenHevac B Pasteur

Intra-muscular injection 20 microgramme Intramuscular use at M0, M1, M6

Intervention Type: BIOLOGICAL

GenHevac B Pasteur

Intra-muscular injection 40 microgramme intramuscular use at M0, M1,M2, M6

Intervention Type: BIOLOGICAL

GenHevac B Pasteur

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Sanofi Pasteur MSD; Sanofi Pasteur MSD; Sanofi Pasteur MSD

Eligibility Criteria

Inclusion Criteria

Age Eligible for Study: 18 years - NA, Genders Eligible for Study: Both

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MCM Vaccines B.V.

INDUSTRY

Sponsor Role: collaborator

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Odile Launay, MD

Role: PRINCIPAL_INVESTIGATOR

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

Fabrice Carrat, MD

Role: STUDY_CHAIR

Inserm U707 27, rue de Chaligny 75571 Paris cedex 12 Fr

Locations

Hopital Cochin CIC de vaccinologie

Paris, , France

Countries

France

References

Launay O, Rosenberg AR, Rey D, Pouget N, Michel ML, Reynes J, Neau D, Raffi F, Piroth L, Carrat F; ANRS HB03 VIHVAC-B (Trial Comparing 3 Strategies of Vaccination Against the Virus of Hepatitis B in HIV-Infected Patients) Group. Long-term Immune Response to Hepatitis B Virus Vaccination Regimens in Adults With Human Immunodeficiency Virus 1: Secondary Analysis of a Randomized Clinical Trial. JAMA Intern Med. 2016 May 1;176(5):603-10. doi: 10.1001/jamainternmed.2016.0741.

Reference Type: DERIVED

PMID: 27064975 (View on PubMed)

Launay O, van der Vliet D, Rosenberg AR, Michel ML, Piroth L, Rey D, Colin de Verdiere N, Slama L, Martin K, Lortholary O, Carrat F; ANRS HB03 VIHVAC-B Trial. Safety and immunogenicity of 4 intramuscular double doses and 4 intradermal low doses vs standard hepatitis B vaccine regimen in adults with HIV-1: a randomized controlled trial. JAMA. 2011 Apr 13;305(14):1432-40. doi: 10.1001/jama.2011.351.

Reference Type: DERIVED

PMID: 21486976 (View on PubMed)

Other Identifiers

ANRS HB 03 VIHVAC-B

Identifier Type: -

Identifier Source: secondary_id

2006-003940-50

Identifier Type: -

Identifier Source: org_study_id