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Immunogenicity and Tolerance of Two Strategies of Anti-HAV Vaccination in HIV-infected Patients

NCT ID: NCT00190242

Last Updated: 2011-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2009-10-31

Brief Summary

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Immunogenicity is reduced in immunocompromised patients. The aim of this prospective randomized study is to evaluate tolerance and immunogenicity of 2 doses versus 3 doses of anti-HAV vaccine in HIV-1 infected patients with CD4 count between 200 and 500 per mm3, co-infected or not with HBV and/or HCV. The factors influencing vaccine immunogenicity will be evaluate.

Detailed Description

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RECOMMANDATIONS for hepatitis A vaccination is the same for HIV-infected patients than for general population. However, immunogenicity induced with 2 doses of anti-HAV vaccine is lower in HIV-infected patients. The primary objective of the study is to compare the immunogenicity (percentage of patients with anti-HAV antibodies \> 20 mUI/ml at month 7) of 2 strategies (2 doses at months 1 and 6, versus 3 doses at months 1, 2 and 6)of anti-HAV vaccine in HIV-1 infected patients co-infected with HBV and/or HCV with CD4 cell count between 200 and 500/mm3. The second objectives are to compare mean anti-HAV antibodies titers obtained with the 2 strategies, the durability of the seroprotection 12 months after the end of vaccination, and the safety. The PARAMATERS than may have an effect on the immune response will be evaluated.

This open, prospective, study have included 99 patients, aged from 18 to 55 years old. Patients were randomized to receive 2 or 3 doses of HAVRIX 1440 UI intramuscularly at week O, 4, and 24 or week 0, and 24. Clinical and biological safety is evaluated after each immunisation and blood samples for serological evaluation taken at week -4, 4, 8, 24 and 28 for immunogenicity and week 72 for long term analysis

Conditions

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HIV Infection

Keywords

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HIV hepatitis A vaccine HBV and/or HCV co-infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group1:3 administrations of Havrix

group 1 received immunisation with Havrix (1440IU) at weeks S0, S4, S24

Group Type EXPERIMENTAL

group1

Intervention Type DRUG

Havrix at 1440IU was administrated à weeks S0, S4 and S24

group2: 2 administrations of Havrix

group 2 received usual immunisation with Havrix (1440IU) at weeks S0 and S24

Group Type ACTIVE_COMPARATOR

group2

Intervention Type DRUG

Havrix (1440IU) was administrated at weeks S0 and S24 according to RECOMMANDATIONS

Interventions

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group1

Havrix at 1440IU was administrated à weeks S0, S4 and S24

Intervention Type DRUG

group2

Havrix (1440IU) was administrated at weeks S0 and S24 according to RECOMMANDATIONS

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* VIH-1 infection, aged 18-55 years negative anti-HAV IgG CD4 cell count between 200 and 500/mm3

Exclusion Criteria

* prior anti-HAV vaccination immunosuppressive treatment splenectomy Prothrombin time \< 50%, platelets\< 50 000/mm3 fever serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) activity \> 2 ULN for non co-infected patients, \> 5 ULN for co-infected patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ensemble contre le SIDA

UNKNOWN

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Odile Launay, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Sophie GRABAR, MD

Role: STUDY_CHAIR

Assistance Publique - Hôpitaux de Paris

Locations

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CIC de vaccinologie Cochin Pasteur, Service de médecine interne, hôpital Cochin

Paris, , France

Site Status

CISIH, Hôpital de Strasbourg

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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P050706

Identifier Type: -

Identifier Source: org_study_id