NCT01008813已完成2 期
A Randomized Phase II Trial to Evaluate the Immunogenicity and Safety of an Adjuvanted A(H1N1)v Influenza Vaccine and a Non-adjuvanted A(H1N1)v Influenza Vaccine in HIV-infected Patients (ANRS 151 Hifluvac)
French National Agency for Research on AIDS and Viral Hepatitis12 个研究点 分布在 1 个国家目标入组 306 人开始时间: 2009年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 306
- 试验地点
- 12
- 主要终点
- To evaluate the immunogenicity and safety of a A(H1N1)v influenza vaccine, administered with or without adjuvant, in HIV-infected patients after two injections.
研究概览
简要总结
A 1-year multicenter, randomized, single-blinded, phase II trial, stratified on HAART. The purpose of this trial is to evaluate the immunogenicity and safety of a A(H1N1)French National Agency for Research on AIDS and Viral Hepatitis influenza vaccine, administered with or without adjuvant, in HIV-infected patients after one or two injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Able to give written consent
- •Covered by French Social Security
- •HIV-infected (infection attested by the patient's chart)
- •Patients treated by HAART for at least 6 months, with a viral load inferior to 50 copies/mL on at least 2 last visits
- •Patients without any treatment for HIV for at least 6 months and without any indication to start a treatment in the following 3 months
- •Patients followed for their HIV-infection in an ANRS center and whose home is close to the center in case of influenza-like illness, consultation and hospitalization in the center where he is followed if necessary
- •For women with childbearing potential, using an effective method of contraception, and willing to undergo urine pregnancy tests prior to each vaccination.
排除标准
- •Pregnancy
- •Receipt of chemotherapy, immunotherapy (IL2, IL7, IV Ig), or corticosteroids within 3 months prior to enrolment
- •Thrombopenia inferior to 20 000/mm3
- •Febrile episode (at least 38°C rectal or if at least 37,5°C measured orally) within one week prior to vaccination
- •Opportunistic infection (treated for less than 1 month)
- •Co-infection with HCV and treated with IFNa
- •Influenza (clinically or virologically documented) in the last 6 months
- •History of documented auto-immune disease (lupus, systemic inflammatory disease, ...)
- •Child C cirrhosis
- •Solid organ transplant recipient
- •Intolerance to 1 component of the vaccine
- •Other immunization received within 3 weeks prior to inclusion or planned until after the last vaccine injection.
研究组 & 干预措施
non-adjuvanted A(H1N1)v influenza vaccine
Experimental
Two injection at day 0 and day 21
干预措施: non-adjuvanted A(H1N1)v influenza vaccine (Biological)
adjuvanted A(H1N1)v influenza vaccine
Experimental
Two injections at day 0 and day 21
干预措施: adjuvanted A(H1N1)v influenza vaccine (Biological)
结局指标
主要结局
To evaluate the immunogenicity and safety of a A(H1N1)v influenza vaccine, administered with or without adjuvant, in HIV-infected patients after two injections.
时间窗: Day 42
次要结局
- To evaluate the safety (local and general adverse events) between the two study vaccines(From week 0 to week 48)
- To evaluate the immunogenicity of a A(H1N1)v influenza vaccine, administered with or without adjuvant, in HIV-infected patients receiving antiretroviral therapy or not(Day 21 and Day 42)
- To describe the factors influencing the response to the vaccine (such as age, sex, tobacco use, HAART, CD4 count and nadir, HIV viral load, ...)(From week 0 to week 48)
- To compare the sustainability of the immune response induced by two injections of the study(Day 21 and Day 42)
- To explore the post-vaccinal cellular immune response of the two study vaccines(Day 42)
- To compare the consequences of the A(H1N1)v influenza vaccine, with or without adjuvant, on the HIV infection parameters (CD4 count, HIV viral load)(Week 48)
- To assess vaccination failures and describe the clinical presentation of influenza in the study population(Week 48)
研究者
研究点 (12)
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