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

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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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	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	Sexes Eligible for Study: All
Ages	18 Years to 55 Years (Adult)
Accepts Healthy Volunteers	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	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