Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV Infected Patients - Full Text View

Sponsors and Collaborators:	French National Agency for Research on AIDS and Viral Hepatitis Sanofi Pasteur MSD
Information provided by:	French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:	NCT00480792

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Biological: GenHevac B Pasteur	Phase III

MedlinePlus related topics: AIDS Hepatitis Hepatitis B

Drug Information available for: Hepatitis B Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	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

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:

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. [ Time Frame: two months after the last injection;week 28, month 18, month 30 and month 42 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

According to the vaccine administration (IM or ID) comparison of AbHBs titers,permanence of the humoral response,intensity of clinical and biological events and predicting factors related to seroconversion [ Time Frame: two months after the last injection; week 28, month 18, month 30 and month 42 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	420
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator GenHevac-B 20 microgramme Intramuscular use at M0, M1, M6	Biological: GenHevac B Pasteur Intra-muscular injection 20 microgramme Intramuscular use at M0, M1, M6
B: Experimental GenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6	Biological: GenHevac B Pasteur Intra-muscular injection 40 microgramme intramuscular use at M0, M1,M2, M6
C: Experimental GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6	Biological: GenHevac B Pasteur GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6

Detailed Description:

Comparison of 3 vaccination strategy against Hepatitis B in patients with HIV infection T CD4 above 200 per mm3

Intervention:

Arm A: GenHevac-B 20 microgramme Intramuscular use at M0, M1, M6
Arm B: GenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6
Arm C: GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480792

Contacts

Contact: Odile Launay, MD	+33 1 43 25 38 67	odile.launay@cch.aphp.fr
Contact: Diane Van Der Vliet, MD	+33 1 58 41 28 60	diane.vandervliet@cch.aphp.fr

Locations

France
Hopital Cochin CIC de vaccinologie	Recruiting
Paris, France, 75014
Contact: Odile Launay, MD +33 1 43 25 38 67 odile.launay@cch.aphp.fr

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis

Sanofi Pasteur MSD

Investigators

Principal Investigator:	Odile Launay, MD	CIC de vaccinologie Cochin-Pasteur 27, rue du Fb Saint Jacques 75014 Paris Fr
Study Chair:	Fabrice Carrat, MD	Inserm U707 27, rue de Chaligny 75571 Paris cedex 12 Fr

More Information

Responsible Party:	ANRS ( Nadia Squalli )
Study ID Numbers:	2006-003940-50, ANRS HB 03 VIHVAC-B
Study First Received:	May 30, 2007
Last Updated:	December 24, 2007
ClinicalTrials.gov Identifier:	NCT00480792
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

Hepatitis B vaccination
GenHevac-B Pasteur
HIV Infections

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Liver Diseases
Acquired Immunodeficiency Syndrome
Hepatitis, Viral, Human
Immunologic Deficiency Syndromes
Hepatitis
Virus Diseases

Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Hepatitis B
DNA Virus Infections
Retroviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases

Lentivirus Infections
Infection
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 13, 2009