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
  Purpose

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.


Condition Intervention Phase
HIV Infection
Drug: group1
Drug: group2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 99
Study Start Date: June 2003
Study Completion Date: October 2009
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group1:3 administrations of Havrix
group 1 received immunisation with Havrix (1440IU) at weeks S0, S4, S24
Drug: group1
Havrix at 1440IU was administrated à weeks S0, S4 and S24
Active Comparator: group2: 2 administrations of Havrix
group 2 received usual immunisation with Havrix (1440IU) at weeks S0 and S24
Drug: group2
Havrix (1440IU) was administrated at weeks S0 and S24 according to RECOMMANDATIONS

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190242

Locations
France
CIC de vaccinologie Cochin Pasteur, Service de médecine interne, hôpital Cochin
Paris, France, 75014
CISIH, Hôpital de Strasbourg
Strasbourg, France, 67091
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ensemble contre le SIDA
GlaxoSmithKline
Investigators
Principal Investigator: Odile Launay, MD Assistance Publique - Hôpitaux de Paris
Study Chair: Sophie GRABAR, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00190242     History of Changes
Other Study ID Numbers: P050706
Study First Received: September 13, 2005
Last Updated: December 15, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique - Hôpitaux de Paris:
HIV
hepatitis A
vaccine
HBV and/or HCV co-infection

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014