Immunogenicity and Tolerance of Two Strategies of Anti-HAV Vaccination in HIV-infected Patients (HEPAVAC)
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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. |
- 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
- 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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00190242
| France | |
| CIC de vaccinologie Cochin Pasteur, Service de médecine interne, hôpital Cochin | |
| Paris, France, 75014 | |
| CISIH, Hôpital de Strasbourg | |
| Strasbourg, France, 67091 | |
| 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 |
ClinicalTrials.gov processed this record on March 03, 2015