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

This study has been completed.
Sponsor:
Collaborators:
Ensemble contre le SIDA
GlaxoSmithKline
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00190242
First received: September 13, 2005
Last updated: December 15, 2011
Last verified: June 2005
History of Changes

September 13, 2005
December 15, 2011
June 2003
October 2006   (final data collection date for primary outcome measure)
percentage of patients with anti-HAV antibodies superior 20 mUI/ml 7 months after the first vaccination [ Time Frame: during de study ] [ Designated as safety issue: Yes ]
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
Complete list of historical versions of study NCT00190242 on ClinicalTrials.gov Archive Site
  • anti-HAV antibodies mean geometric titers 7 months after the first vaccination [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    anti-HAV antibodies mean geometric titers 7 months after the first vaccination
  • durability of seroprotection 1 year after the end of vaccination [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    durability of seroprotection 1 year after the end of vaccination
  • safety [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    safety
  • predictive factors of vaccinal response [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    predictive factors of vaccinal response
  • anti-HAV antibodies mean geometric titers 7 months after the first vaccination
  • durability of seroprotection 1 year after the end of vaccination
  • safety
  • predictive factors of vaccinal response
Not Provided
Not Provided
 
Immunogenicity and Tolerance of Two Strategies of Anti-HAV Vaccination in HIV-infected Patients
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.
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.

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
  • Drug: group1
    Havrix at 1440IU was administrated à weeks S0, S4 and S24
  • Drug: group2
    Havrix (1440IU) was administrated at weeks S0 and S24 according to RECOMMANDATIONS
  • Experimental: group1:3 administrations of Havrix
    group 1 received immunisation with Havrix (1440IU) at weeks S0, S4, S24
    Intervention: Drug: group1
  • Active Comparator: group2: 2 administrations of Havrix
    group 2 received usual immunisation with Havrix (1440IU) at weeks S0 and S24
    Intervention: Drug: group2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
October 2009
October 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00190242
P050706
No
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
  • Ensemble contre le SIDA
  • GlaxoSmithKline
Principal Investigator: Odile Launay, MD Assistance Publique - Hôpitaux de Paris
Study Chair: Sophie GRABAR, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP