The Yellow Fever Vaccine Immunity in HIV Infected Patients : Development of New Assays for Virological and Immunological Monitoring in HIV Infected Patient
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Immuno-virologic criterion
研究概览
简要总结
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-negative individuals who had not been given YFV before.
Secondary objectives :
- To develop and assess ELISPOT technology for yellow fever and to measure the response within 7, 14, 28, 90 and 365 days of administration of YFV in 30 HIV negative subjects and 40 HIV positive subjects (CD4 > 350/mm3 under Highly Active Antiretroviral Therapy (HAART) for at least one year, with a viral load < 50 copies/mL since at least 6 months) in terms of : (1) seroconversion by fluorescence, (2) cytotoxic response in ELISPOT, (3) neutralizing antibody levels in Plaque reduction neutralization test (PRNT:reference method) and a new pseudotype based method, (4) post-vaccination viremia and (5) diversity of viral quasi-species.
- To assess the impact of YFV on the T-lymphocyte response against HIV by ELISPOT and viral load.
详细描述
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 : Yellow fever vaccination (STAMARIL)
Criterion :
Immuno-virologic: At J-7, J7, J28, M3 and M12 will be determined the levels of antibodies by fluorescence, at J0, J7, J28, M3 and M12 titles and neutralization with Prnt pseudotypes, the ELISPOT response anti-yellow fever, viremia with quantitative analysis and nucleotide sequences on phylogenetic strains of viremia. Titles and Amariles kinetics of viremia, neutralizing antibodies and ELISPOT will be considered as surrogate markers of response in terms of groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1: Voluntary HIV positive subjects
- •Inclusion Criteria:
- •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.
排除标准
- •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-CCR
- •Group 2: HIV negative subjects
- •Inclusion Criteria:
- •HIV and HCV negatives
- •Exclusion Criteria:
- •Previous vaccination against yellow fever or yellow fever Fluorescence anti-IgG positive.
- •Administration of immunoglobulins < 3 months or any vaccine <1 month.
- •Other vaccinations should be deferred beyond M
- •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, coinfection with HCV virus untreated
结局指标
主要结局
Immuno-virologic criterion
时间窗: Day 7
At Day 7 will be determined titles and neutralization with Prnt pseudotypes, the ELISPOT response anti-yellow fever, viremia with quantitative analysis and nucleotide sequences on phylogenetic strains of viremia
次要结局
- Clinical and biological tolerance(day -7)
- clinical and biological tolerance(month 12)