Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00190242
Status:
COMPLETED
Last Update Posted:
2011-12-16
First Post:
2005-09-13
Brief Title:
Immunogenicity and Tolerance of Two Strategies of Anti-HAV Vaccination in HIV-infected Patients
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Study of Immunogenicity of Anti-HAV Immunisation in HIV-1 Infected Patients Co-infected or Not With HBV andor HCV HEPAVAC Study
Status:
COMPLETED
Status Verified Date:
2005-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEPAVAC
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 andor 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 mUIml at month 7 of 2 strategies 2 doses at months 1 and 6 versus 3 doses at months 1 2 and 6of anti-HAV vaccine in HIV-1 infected patients co-infected with HBV andor HCV with CD4 cell count between 200 and 500mm3 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None