ISRCTN34192276进行中（未招募）4 期
The immunogenicity of Shingrix vaccination in people living with HIV at risk of shingles infection (SAGE)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Able and willing to comply with the requirements of the protocol
- •2. Able and willing to provide fully informed consent
- •3. Male or non-pregnant, non-lactating females
- •4. People living with HIV >50 years and over OR have perinatally acquired HIV (any CD4) and are aged 18 years and over
- •5. If female, of child-bearing age, not sterilised and participating in sexual intercourse that could result in pregnancy, using at least one acceptable method of contraception when engaging in sexual activities that can result in pregnancy, beginning at screening through month 4. Acceptable methods of contraception include the following:
- •5.1. Hormonal contraception
- •5.2. Male or female condom
- •5.3. Diaphragm or cervical cap with a spermicide
- •5.4. Intrauterine device
排除标准
- •1. Active herpes zoster disease in past 6 months preceding the first dose of study vaccine
- •2. If female, planning to get pregnant, currently pregnant (evidence from positive serum or urine pregnancy test), or breastfeeding
- •3. Used any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine or planned use during the study period
- •4. Vaccinated within the 12 months preceding the first dose of study vaccine or planned to be vaccinated during the study with a (non-study) vaccine against herpes zoster or varicella zoster virus
- •5. History of any reaction or hypersensitivity likely to be exacerbated by any vaccine component
- •6. Received or planned to receive a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine or had received or planned to receive a non-replicating vaccine within 8 days before or within 14 days after either dose of study vaccine
- •7. Acute disease and/or fever at the time of enrolment. Fever is defined as temperature = 37.5°C (99.5°F) on oral, axillary or tympanic setting. The preferred route for recording temperature in this study will be oral. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
- •8. Chronic administration (defined as more than 15 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone < 20 mg/day, or equivalent, is allowed. Inhaled and topical steroids are allowed. Drugs include: chemotherapeutic drugs, immunomodulators and systemic immunosuppressive treatments, oral glucocorticoids >20 mg/day, cyclosporine, methotrexate, interleukins and/or cytokines, immunotherapies (including TNF blockers).
- •9. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study
- •10. History of potential immune-mediated disease (pIMD). Note: If the subject has any condition on the list of pIMDs specified in the protocol, they must be excluded unless the aetiology is clearly documented to be non-immune mediated
研究者
相似试验
招募中
1 期
Safety and immunologic response of SHIngrix VAccination in patients suffering from Psoriasis or Psoriatic arthritis (SHIVAP)Psoriasis vulgaris and/or psoriatric arthritisMedDRA version: 20.0Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2022-003477-36-DEJustus-Liebig University Giessen - KKS Marburg-Giessen336
进行中（未招募）
1 期
Safety and efficiacy of a new chickenpox and shingles vaccine in patients who have undergone kidney transplantatioEUCTR2019-002529-31-NOOslo University Hospital50
进行中（未招募）
3 期
A clinical study to evaluate immune responses and adverse events of the 6-in-one SHAN6® vaccine in childreCTRI/2020/04/024843Sanofi Healthcare India Pvt Ltd formerly known as Shantha Biotechnics Pvt Ltd
进行中（未招募）
不适用
A study of the immune response to vaccination in MS patients treated with alemtuzumab - CAM-VACThe vaccinations are being used to investigate immunological memory following treatment of multiple sclerosis with the lympho-depleting humanised monoclonal antibody alemtuzumab.MedDRA version: 9.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisMedDRA version: 9.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisMedDRA version: 9.1Level: LLTClassification code 10046859Term: VaccinationEUCTR2009-011523-31-GBR & D, Cambridge University Hospitals60
已完成
不适用
Response to routine immunisations in human immunodeficiency virus (HIV) infected adultsISRCTN95588307niversity of Birmingham (UK)1,115