- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00190242
Immunogenicity and Tolerance of Two Strategies of Anti-HAV Vaccination in HIV-infected Patients (HEPAVAC)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
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-
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Paris, Frankrike, 75014
- CIC de vaccinologie Cochin Pasteur, Service de médecine interne, hôpital Cochin
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Strasbourg, Frankrike, 67091
- CISIH, Hôpital de Strasbourg
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: group1:3 administrations of Havrix
group 1 received immunisation with Havrix (1440IU) at weeks S0, S4, S24
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Havrix at 1440IU was administrated à weeks S0, S4 and S24
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Aktiv komparator: group2: 2 administrations of Havrix
group 2 received usual immunisation with Havrix (1440IU) at weeks S0 and S24
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Havrix (1440IU) was administrated at weeks S0 and S24 according to RECOMMANDATIONS
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
percentage of patients with anti-HAV antibodies superior 20 mUI/ml 7 months after the first vaccination
Tidsram: during de study
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percentage of patients with anti-HAV antibodies superior 20 mUI/ml 7 months after the first vaccination
|
during de study
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
anti-HAV antibodies mean geometric titers 7 months after the first vaccination
Tidsram: during the study
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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
Tidsram: during the study
|
durability of seroprotection 1 year after the end of vaccination
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during the study
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safety
Tidsram: during the study
|
safety
|
during the study
|
predictive factors of vaccinal response
Tidsram: during the study
|
predictive factors of vaccinal response
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during the study
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Odile Launay, MD, Assistance Publique - Hôpitaux de Paris
- Studiestol: Sophie GRABAR, MD, Assistance Publique - Hôpitaux de Paris
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P050706
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