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

Phase 3

Completed

• Conditions: HIV Infection
• Interventions: Drug: group1; Drug: group2

• Registration Number: NCT00190242
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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

Study Timeline

• Study Start: 2003-06
• Status Verified: 2005-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Primary Completion: 2006-10
• Study Completion: 2009-10
• Last Update Submitted: 2011-12-15
• Last Update Posted: 2011-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group1:3 administrations of Havrix	group1	group 1 received immunisation with Havrix (1440IU) at weeks S0, S4, S24
group2: 2 administrations of Havrix	group2	group 2 received usual immunisation with Havrix (1440IU) at weeks S0 and S24

Primary Outcome Measures

Name	Time	Method
percentage of patients with anti-HAV antibodies superior 20 mUI/ml 7 months after the first vaccination	during de study	percentage of patients with anti-HAV antibodies superior 20 mUI/ml 7 months after the first vaccination

Secondary Outcome Measures

Name	Time	Method
anti-HAV antibodies mean geometric titers 7 months after the first vaccination	during the study	anti-HAV antibodies mean geometric titers 7 months after the first vaccination
durability of seroprotection 1 year after the end of vaccination	during the study	durability of seroprotection 1 year after the end of vaccination
safety	during the study	safety
predictive factors of vaccinal response	during the study	predictive factors of vaccinal response

Trial Locations

Locations (2)

CIC de vaccinologie Cochin Pasteur, Service de médecine interne, hôpital Cochin; 🇫🇷 Paris, France

CISIH, Hôpital de Strasbourg; 🇫🇷 Strasbourg, France