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

2014-08-27 03:30:54 | BioPortfolio

Summary

HIV infected patients exposed to Hepatitis B virus are more susceptible to develop a chronic and severe liver disease, with a major risk of cirrhosis and liver cancer.

However, immune response to standard Hepatitis B vaccination is decreased in HIV-infected patients, compared to non HIV-infected individuals, and, in case of response, its durability has to be carefully followed up. This study compares the efficacy of two strategies of revaccination in HIV-infected patients who didn't respond to previous hepatitis B vaccination. Failure is defined by two conditions: non response to the primary immunization (2 to 4 single-dose injections received before the screening visit) and failure to a single 20 µg boost before being included in the study.

Description

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

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Hepatitis B

Intervention

GenHevac-B, GenHevac-B

Location

Hôpital de Jour COREVIH - Clinique médicale A, Hôpital civil, 1 place de l'hôpital
Strasbourg
France
67091 Cedex

Status

Recruiting

Source

French National Agency for Research on AIDS and Viral Hepatitis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:30:54-0400

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Medical and Biotech [MESH] Definitions

INFLAMMATION of the LIVER in humans due to infection by VIRUSES. There are several significant types of human viral hepatitis with infection caused by enteric-transmission (HEPATITIS A; HEPATITIS E) or blood transfusion (HEPATITIS B; HEPATITIS C; and HEPATITIS D).

A family of hepatotropic DNA viruses which contains double-stranded DNA genomes and causes hepatitis in humans and animals. There are two genera: AVIHEPADNAVIRUS and ORTHOHEPADNAVIRUS. Hepadnaviruses include HEPATITIS B VIRUS, duck hepatitis B virus (HEPATITIS B VIRUS, DUCK), heron hepatitis B virus, ground squirrel hepatitis virus, and woodchuck hepatitis B virus (HEPATITIS B VIRUS, WOODCHUCK).

A species in the genus HEPATOVIRUS containing one serotype and two strains: HUMAN HEPATITIS A VIRUS and Simian hepatitis A virus causing hepatitis in humans (HEPATITIS A) and primates, respectively.

INFLAMMATION of the LIVER in humans caused by HEPATITIS DELTA VIRUS, a defective RNA virus that can only infect HEPATITIS B patients. For its viral coating, hepatitis delta virus requires the HEPATITIS B SURFACE ANTIGENS produced by these patients. Hepatitis D can occur either concomitantly with (coinfection) or subsequent to (superinfection) hepatitis B infection. Similar to hepatitis B, it is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact.

INFLAMMATION of the LIVER in humans caused by HEPATITIS C VIRUS, a single-stranded RNA virus. Its incubation period is 30-90 days. Hepatitis C is transmitted primarily by contaminated blood parenterally, and is often associated with transfusion and intravenous drug abuse. However, in a significant number of cases, the source of hepatitis C infection is unknown.

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