A Phase II, Randomized, Placebo-controlled Study to Evaluate the Immunogenicity and the Safety of 2 Schedules of an Homologous Prime-boost With the ALVAC-HIV vCP1452 in Chronically HIV-Infected Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 10
- 主要终点
- Change from baseline of the frequency of HIV-specific PBMC (CD4/CD8) at W24 (4 weeks after the last immunization)
研究概览
简要总结
Prior pilot studies have shown that four monthly injections of ALVAC-HIV (vCP1433) are immunogenic in 60% HIV-infected patients with a boosting effect obtained after 1 or 2 injections followed by a plateau or a decrease of these responses prior to interrupting therapy. The goal of the present study is to look for an improved vaccination schedule in terms of strength and duration of the HIV-specific immunity induced by the HIV-recombinant canary pox vector ALVAC-HIV (vCP1452) by testing a strategy of immunization involving a first series of two versus three monthly injections followed by a boost three months later.
详细描述
Manon 02 is a phase II, multicentre, randomized, placebo-controlled study with 3 arms comprising 2 steps:
Step I : Immunization phase from W0 to W24, on HAART
The immunization will be administered by intramuscular injection :
Arm A: one injection of vCP1452 at W0, W4, W8 and W20 + HAART, for a total of 4 injections Arm B: one injection of vCP1452 at W4, W8 and W20 + HAART, for a total of 3 injections Arm C: one injection of placebo at W0, W4, W8 and W20 + HAART, for a total of 4 injections or at W4, W8 and W20 + HAART, for a total of 3 injections
Step II: Post immunization phase from W24 to W48, off HAART
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Documented HIV infection
- •under potent antiretroviral therapy for more than 6 months
- •with entry CD4+ counts > 350 cells/mm3 for at least 1 year
- •plasma HIV RNA < 400 cp/ml for at least the last 6 months
- •Contraception needed for women
排除标准
- •Antiretroviral therapy started with CD4 cell count > 400/mm3
- •Patients treated at time of primary HIV infection
- •Patient with past AIDS defining event
结局指标
主要结局
Change from baseline of the frequency of HIV-specific PBMC (CD4/CD8) at W24 (4 weeks after the last immunization)
次要结局
- - Percentage of responders as defined by an increase of at least 0.7 log10 from baseline of the frequencies of HIV-specific PBMC and/or CD4 and/or CD8 T cells four weeks after the last immunization(W24) as measured by ELISpot IFNγ
- - Change from baseline of the frequency of HIV-specific PBMC and/or CD4 and/or CD8 T cells at week 4, 6, 8, 12, 20 and 24 in the study arms as measured by ELISpot IFNγ
- - Evaluation of the magnitude of CD4 and CD8 T cell response at W4, W6, W8, W12, W20, W24 in the study arms
- - Evaluation of the immune responses, HIV-specific PBMC and/or CD4 and/or CD8 T cells at W48
- - Percentage of patients who generate a primary immune response against the artificial pol/nef sequences present in the vaccine but not in the HIV strain
- - Evaluation of the immune responses directed to vCP1452 in the study arms at all study point during the immunization phase
- - Percentage of patients who do not reach the restart therapy criteria from W24 to W48
- - Percentage of patients who remain off therapy at W48
- - Evaluation of the safety and tolerability of the vCP1452