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
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Completed
First Posted
: September 19, 2005
Last Update Posted
: December 16, 2011
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Tracking Information | |||||||
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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 |
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
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Original Primary Outcome Measures ICMJE |
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 |
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Original Secondary Outcome Measures ICMJE |
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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 |
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Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | HIV Infection | ||||||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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Investigators ICMJE |
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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 |