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

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ClinicalTrials.gov Identifier: NCT00190242
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : December 16, 2011
Sponsor:
Collaborators:
Ensemble contre le SIDA
GlaxoSmithKline
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 19, 2005
Last Update Posted Date December 16, 2011
Study Start Date  ICMJE June 2003
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2011)
percentage of patients with anti-HAV antibodies superior 20 mUI/ml 7 months after the first vaccination [ Time Frame: during de study ]
percentage of patients with anti-HAV antibodies superior 20 mUI/ml 7 months after the first vaccination
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
percentage of patients with anti-HAV antibodies superior 20 mUI/ml 7 months after the first vaccination
Change History Complete list of historical versions of study NCT00190242 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2011)
  • anti-HAV antibodies mean geometric titers 7 months after the first vaccination [ Time Frame: 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 [ Time Frame: during the study ]
    durability of seroprotection 1 year after the end of vaccination
  • safety [ Time Frame: during the study ]
    safety
  • predictive factors of vaccinal response [ Time Frame: during the study ]
    predictive factors of vaccinal response
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity and Tolerance of Two Strategies of Anti-HAV Vaccination in HIV-infected Patients
Official Title  ICMJE 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infection
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2005)
99
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00190242
Other Study ID Numbers  ICMJE P050706
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE
  • Ensemble contre le SIDA
  • GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Odile Launay, MD Assistance Publique - Hôpitaux de Paris
Study Chair: Sophie GRABAR, MD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date June 2005

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