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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS Hepatitis Hepatitis B

Drug Information available for: Hepatitis B Vaccines

U.S. FDA Resources

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

No publications provided

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 History of Changes
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:

Liver Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Hepatitis, Viral, Human
Infection
Hepadnaviridae Infections
Immunologic Deficiency Syndromes

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

ClinicalTrials.gov processed this record on September 11, 2009