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

HIV Infection Clinical Trial

— HEPAVAC  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190242
• Other study ID #: P050706
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: December 15, 2011
• Start date: June 2003
• Est. completion date: October 2009

Study information

• Verified date: June 2005
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: October 2009
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection

Intervention

Drug:
• group1
Havrix at 1440IU was administrated à weeks S0, S4 and S24
• group2
Havrix (1440IU) was administrated at weeks S0 and S24 according to RECOMMANDATIONS

Locations

Country	Name	City	State
France	CIC de vaccinologie Cochin Pasteur, Service de médecine interne, hôpital Cochin	Paris
France	CISIH, Hôpital de Strasbourg	Strasbourg

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ensemble contre le SIDA, GlaxoSmithKline

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	durability of seroprotection 1 year after the end of vaccination	durability of seroprotection 1 year after the end of vaccination	during the study	Yes
Secondary	safety	safety	during the study	Yes
Secondary	predictive factors of vaccinal response	predictive factors of vaccinal response	during the study	Yes