Status:
COMPLETED
The Yellow Fever Vaccine Immunity in HIV Infected Patients : Development of New Assays for Virological and Immunological Monitoring in HIV Infected Patient.
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Conditions:
HIV Infection
Yellow Fever
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
Main objective : To develop the tools for evaluation of humoral and cell-mediated immunity after Yellow Fever Vaccine (YFV) and compare virological and immune responses in HIV-positive and HIV-negati...
Detailed Description
Method : Clinical Trial Phase III, Multicentre protocol at Saint-Louis hospital, Bichat hospital and Cochin-Pasteur hospital, with CERVI, INSERM U 941 and SC10 collaboration. Trial treatment : Yello...
Eligibility Criteria
Inclusion
- Group 1: Voluntary HIV positive subjects
- Adults under HAART for at least one year (and stable on treatment for at least 3 months prior to enrolment)
- \> 350 CD4/mm3 (with half of them a nadir \< 200 CD4/mm3) and a viral load \< 50 copies/mL for at least 6 months.
- Patients were HCV negative or non-replicative and treated for at least 2 years with normal ALT and negative HBs antigen.
Exclusion
- Previous vaccination against yellow fever or yellow fever Fluorescence anti-IgG positive.
- Administration of immunoglobulins \< 3 months or any vaccine \<1 month.
- Pregnancy ongoing or planned during the study.
- Coinfection with HCV virus untreated.
- HBs Ag positive.
- Hypersensitivity reaction to eggs / chicken protein; hereditary fructose intolerance.
- Immunosuppression, whether congenital, idiopathic or as a result of corticosteroids systemically (at doses ≥ 20mg/d of prednisone), or due to radiation or antineoplastic older than 6 months.
- History of thymic dysfunction (including thymoma and thymectomy).
- For HIV + subjects: ART Celsentri or by other anti-CCR5.
- Group 2: HIV negative subjects
- Inclusion Criteria:
- HIV and HCV negatives
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01426243
Start Date
July 1 2011
End Date
December 1 2017
Last Update
January 18 2019
Active Locations (1)
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1
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Paris, France