Trials Sponsors Conditions Drugs Pricing

Conditions

Hepatitis B HIV Infection

Keywords

Hepatitis B vaccinationGenHevac-B PasteurHIV infection

Outcome Measures

Primary Outcomes (1)

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
one month after the last vaccination (week 28)

Secondary Outcomes (2)

According to the vaccine strategy (single-dose or double-dose), comparison of AbHBs titers, permanence of humoral response, intensity of clinical and biological events, and predicting factors related to seroconversion
one month after the last injection ( week 28) and month 18
immunological substudy: to understand genetic link between some alleles of HLA-DR and non-response to immunization
at D0

Study Arms (2)

A

ACTIVE COMPARATOR

GenHevac-B 20 microgram intramuscular use at M0, M1 and M6

Biological: GenHevac-B

B

EXPERIMENTAL

GenHevac-B 40 microgram intramuscular use at M0, M1 and M6

Biological: GenHevac-B

Interventions

GenHevac-BBiological

1 intramuscular injection of Genhevac-B® 20μg on day zero, month 1,and month 6

Also known as: Sanofi Pasteur MSD

GenHevac-BBiological

2 intramuscular injections of Genhevac-B® 20μg on day zero, month 1,and month 6

Also known as:

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

HIV-1 infection
T CD4 cell count number above 200 /mm3

Sponsors & Collaborators

MCM Vaccines B.V.
Industrycollaborator
ANRS, Emerging Infectious Diseases
Governmentlead

Study Sites (1)

Centre de Soins de l'Infection par le VIH NHC, Hôpitaux Universitaires Strasbourg, 1 place de l'hôpital

Strasbourg, 67091 Cedex, France

Related Publications (1)

Rey D, Piroth L, Wendling MJ, Miailhes P, Michel ML, Dufour C, Haour G, Sogni P, Rohel A, Ajana F, Billaud E, Molina JM, Launay O, Carrat F; ANRS HB04 B-BOOST study group. Safety and immunogenicity of double-dose versus standard-dose hepatitis B revaccination in non-responding adults with HIV-1 (ANRS HB04 B-BOOST): a multicentre, open-label, randomised controlled trial. Lancet Infect Dis. 2015 Nov;15(11):1283-91. doi: 10.1016/S1473-3099(15)00220-0. Epub 2015 Aug 6.
PMID: 26257021DERIVED

MeSH Terms

Conditions

Hepatitis BHIV Infections

Interventions

GenHevac B Pasteur

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesSexually Transmitted Diseases, Viral

Study Officials

David Rey, MD
Hôpital civil, Strasbourg, France
PRINCIPAL INVESTIGATOR
Fabrice Carrat, MD
Inserm U707 Paris France
STUDY CHAIR

Enrollment

178 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER GOV
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 29, 2008

First Posted

May 2, 2008

Study Start

May 2008

Date type not reported

This date has not been verified as actual or estimated.

Trial Comparing Two Strategies of Vaccination Against Hepatitis B in HIV-infected Patients Non Responding to Primary Immunization (B-BOOST)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations