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| Name | Class |
|---|---|
| Ensemble contre le SIDA | UNKNOWN |
| GlaxoSmithKline | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group1:3 administrations of Havrix | Experimental | group 1 received immunisation with Havrix (1440IU) at weeks S0, S4, S24 |
|
| group2: 2 administrations of Havrix | Active Comparator | group 2 received usual immunisation with Havrix (1440IU) at weeks S0 and S24 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| group1 | Drug | Havrix at 1440IU was administrated à weeks S0, S4 and S24 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | during de study |
| Measure | Description | Time Frame |
|---|---|---|
| anti-HAV antibodies mean geometric titers 7 months after the first vaccination | anti-HAV antibodies mean geometric titers 7 months after the first vaccination | during the study |
| durability of seroprotection 1 year after the end of vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Odile Launay, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Sophie GRABAR, MD | Assistance Publique - Hôpitaux de Paris | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIC de vaccinologie Cochin Pasteur, Service de médecine interne, hôpital Cochin | Paris | 75014 | France | |||
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006506 | Hepatitis A |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| group2 | Drug | Havrix (1440IU) was administrated at weeks S0 and S24 according to RECOMMANDATIONS |
|
durability of seroprotection 1 year after the end of vaccination
| during the study |
| safety | safety | during the study |
| predictive factors of vaccinal response | predictive factors of vaccinal response | during the study |
| CISIH, Hôpital de Strasbourg |
| Strasbourg |
| 67091 |
| France |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006525 | Hepatitis, Viral, Human |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |