NCT05575830进行中（未招募）4 期
Immune Response to the Recombinant Zoster Vaccine in People Living With HIV Over 50 Years of Age Compared to Non-HIV Age- and Gender-matched Controls - The Shingr'HIV Phase IV Multicenter Study
Calmy Alexandra10 个研究点 分布在 2 个国家目标入组 225 人开始时间: 2022年12月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 225
- 试验地点
- 10
- 主要终点
- Geometric mean titer (GMT) of gE-specific total IgG
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of the adjuvanted recombinant Zoster vaccine (RZV, or Shingrix®) in older people (> 50 years) living with HIV (PLWH) compared to age-matched healthy adults over a 1-year period.
详细描述
This is a prospective multicentric phase IV study, aiming at evaluating the immunogenicity and safety profile of RZV in PLWH over 50 years of age (YOA) on long term antiretroviral therapy (ART) (>10 years) compared to non-HIV age-matched adult controls to address the combined effect of aging and immunosuppression from HIV disease.
Inclusion will be stratified as follow:
HIV+ groups:
- Group 1: PLWH registered in the SHCS or ANRS CO3, >75 YOA and under cART for more than 10 years - N=50
- Group 2: PLWH patients registered in the SHCS, aged between 60 and 75 and under cART for more than 10 years - N=50
- Group 3: PLWH patients registered in the SHCS, aged between 50 and 59 and under cART for more than 10 years - N=50
Control groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be registered in the SHCS or in the ANRS CO3 Aquitaine Cohort
- •Age >50 YOA
- •Time since cART initiation > 10 years
- •Not already vaccinated with RZV
- •HIV viral load <50 copies/ml (within 6 months from the last blood sampling)
- •Informed consent as documented by signature
- •(France) : Person affiliated with or beneficiary of the French social security scheme
- •For aged/gender-matched controls
- •Age >50 YOA
- •Not already vaccinated with RZV
- •Informed consent as documented by signature
- •(France) Not HIV infected
- •(France) Person affiliated with or beneficiary of the French social security scheme
排除标准
- •Ongoing signs of febrile or non-febrile infection at the time of the first vaccination
- •Immunosuppression from the following:
- •Current malignant neoplasm;
- •primary immunodeficiency;
- •recent (<2 years) solid or bone-marrow transplant or any transplant still requiring immunosuppressive therapy
- •Intake of drugs which suppress the immune system (e.g. glucocorticoids for a long time [an equivalent dose of prednisolone >20 mg/day > 3 months], monoclonal antibodies, cytostatics, biological products, etc.) within 6 months before screening.
- •Administration of immunoglobulins or any blood products within 3 months preceding the first dose of vaccine or planned administration during the study period
- •Having received a vaccine in the last month or is expected to receive a vaccine in the next month
- •Having received a shingles vaccine within one year
- •Presented with herpes zoster in the previous year
- •Contra-indication to RZV
- •Hospitalized patients
- •Unable to provide informed consent or inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •Participation in another study with investigational drug within the 30 days preceding and during the present study.
- •(France) Pregnant or breastfeeding woman
- •(France) Patient governed by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)
研究组 & 干预措施
RZV or Shingrix®)
Experimental
Recombinant Zoster Vaccine
干预措施: Recombinant Zoster Vaccine (Biological)
结局指标
主要结局
Geometric mean titer (GMT) of gE-specific total IgG
时间窗: Day 90
gE-specific total IgG titers is determined by gE-specific ELISA from sera samples
次要结局
- Vaccine safety - AESI 7 days(7 days)
- Vaccine safety - PLWH(Day 90)
- Vaccine immunogenicity - CD4+ T cells(Day 90)
- Vaccine safety - SAE 360 days(360 days)
- Vaccine safety -pIMDs(360 days)
研究者
Calmy Alexandra
Prof
University Hospital, Geneva
研究点 (10)
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