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

Study Overview
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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

Official Title
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Study of Immunogenicity of Anti-HAV Immunisation in HIV-1 Infected Patients, Co-infected or Not With HBV and/or HCV. HEP.A.VAC Study.

Conditions
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HIV Infection

Intervention / Treatment
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* Drug: group1
* Drug: group2


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group1:3 administrations of Havrix<br>group 1 received immunisation with Havrix (1440IU) at weeks S0, S4, S24 | Drug: group1<br>* Havrix at 1440IU was administrated à weeks S0, S4 and S24<br>|
| Active Comparator: group2: 2 administrations of Havrix<br>group 2 received usual immunisation with Havrix (1440IU) at weeks S0 and S24 | Drug: group2<br>* Havrix (1440IU) was administrated at weeks S0 and S24 according to RECOMMANDATIONS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients with anti-HAV antibodies superior 20 mUI/ml 7 months after the first vaccination | percentage of patients with anti-HAV antibodies superior 20 mUI/ml 7 months after the first vaccination | during de study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti-HAV antibodies mean geometric titers 7 months after the first vaccination | anti-HAV antibodies mean geometric titers 7 months after the first vaccination | during the study | 
| durability of seroprotection 1 year after the end of vaccination | durability of seroprotection 1 year after the end of vaccination | during the study | 
| safety | safety | during the study | 
| predictive factors of vaccinal response | predictive factors of vaccinal response | during the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, hepatitis A, vaccine, HBV and/or HCV co-infection