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

Primary Purpose

HIV Infection

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
group1
group2
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring HIV, hepatitis A, vaccine, HBV and/or HCV co-infection

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CIC de vaccinologie Cochin Pasteur, Service de médecine interne, hôpital Cochin
  • CISIH, Hôpital de Strasbourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group1:3 administrations of Havrix

group2: 2 administrations of Havrix

Arm Description

group 1 received immunisation with Havrix (1440IU) at weeks S0, S4, S24

group 2 received usual immunisation with Havrix (1440IU) at weeks S0 and S24

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

anti-HAV antibodies mean geometric titers 7 months after the first vaccination
anti-HAV antibodies mean geometric titers 7 months after the first vaccination
durability of seroprotection 1 year after the end of vaccination
durability of seroprotection 1 year after the end of vaccination
safety
safety
predictive factors of vaccinal response
predictive factors of vaccinal response

Full Information

First Posted
September 13, 2005
Last Updated
December 15, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ensemble contre le SIDA, GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00190242
Brief Title
Immunogenicity and Tolerance of Two Strategies of Anti-HAV Vaccination in HIV-infected Patients
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ensemble contre le SIDA, GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV, hepatitis A, vaccine, HBV and/or HCV co-infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group1:3 administrations of Havrix
Arm Type
Experimental
Arm Description
group 1 received immunisation with Havrix (1440IU) at weeks S0, S4, S24
Arm Title
group2: 2 administrations of Havrix
Arm Type
Active Comparator
Arm Description
group 2 received usual immunisation with Havrix (1440IU) at weeks S0 and S24
Intervention Type
Drug
Intervention Name(s)
group1
Intervention Description
Havrix at 1440IU was administrated à weeks S0, S4 and S24
Intervention Type
Drug
Intervention Name(s)
group2
Intervention Description
Havrix (1440IU) was administrated at weeks S0 and S24 according to RECOMMANDATIONS
Primary Outcome Measure Information:
Title
percentage of patients with anti-HAV antibodies superior 20 mUI/ml 7 months after the first vaccination
Description
percentage of patients with anti-HAV antibodies superior 20 mUI/ml 7 months after the first vaccination
Time Frame
during de study
Secondary Outcome Measure Information:
Title
anti-HAV antibodies mean geometric titers 7 months after the first vaccination
Description
anti-HAV antibodies mean geometric titers 7 months after the first vaccination
Time Frame
during the study
Title
durability of seroprotection 1 year after the end of vaccination
Description
durability of seroprotection 1 year after the end of vaccination
Time Frame
during the study
Title
safety
Description
safety
Time Frame
during the study
Title
predictive factors of vaccinal response
Description
predictive factors of vaccinal response
Time Frame
during the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Odile Launay, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sophie GRABAR, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Chair
Facility Information:
Facility Name
CIC de vaccinologie Cochin Pasteur, Service de médecine interne, hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
CISIH, Hôpital de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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