ISRCTN94098600进行中（未招募）Unknown
A feasibility study of controlled human infection with intradermal Bacillus Calmette–Guérin injection
iverpool School of Tropical Medicine0 个研究点目标入组 30 人开始时间: 2023年3月29日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39219857/ (added 02/09/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy adults aged 18-50 years (inclusive)
- •2. Resident near Liverpool School of Tropical Medicine (LSTM) (<1 h drive) for the duration of the study period
- •3. Allows the investigators to discuss the volunteer’s medical history with their GP
- •4. Females of childbearing potential with a negative urine pregnancy test at screening and willing to practice adequate birth control measures during the study.
- •5. Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement
- •6. Capacity to provide written informed consent
- •7. Able and willing (in the investigator's opinion) to comply with all the study requirements
排除标准
- •1. Laboratory evidence at screening of latent M. tb infection as indicated by a positive ELISPOT response to ESAT6 or CFP10 antigens
- •2. Clinical, radiological, or laboratory evidence of current active TB disease
- •3. Previous vaccination with BCG, or any candidate TB vaccine
- •4. Within the last year had close household contact with an individual with smear-positive pulmonary tuberculosis
- •5. Clinically significant history of skin disorder, allergy, immunodeficiency (including HIV), cancer, cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness or psychiatric disorder
- •6. Current medical issues:
- •6.1. Acute respiratory tract infection in the 4 weeks preceding recruitment
- •6.2. Any uncontrolled medical or surgical condition at the discretion of the study doctor
- •7. Maternal:
- •7.1. Female participants who are pregnant
- •7.2. Female participants who are lactating
- •7.3. Female participants who intend to become pregnant during the study
- •7.4. Female participants who are unable to take contraception measures during the study
- •8. Smoking:
- •8.1. Current (defined as =5/week) or ex-smoker (cigarettes/cigars/e-cigarette /vaping/smoking of recreational drugs) in the last 6 months
- •8.2. Previous significant smoking history (more than 20 cigarettes per day for 20 years or the equivalent [>20 pack years])
- •9. Current alcohol and recreational drug use
- •9.1. Regularly drinks =3 units/day (male) or =2 units/day (female)
- •9.2. Uses recreational drugs
- •9.3. Participants may be excluded at the discretion of the research clinician
- •10. Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents
- •11. History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the challenge agent
- •12. Has received any vaccination within one month of the screening visit
- •13. Has not completed at least two COVID-19 vaccination doses
- •14. Any abnormality of screening blood or urine tests that is deemed to be clinically significant or that may compromise the safety of the volunteer in the study
- •15. Positive HBsAg, HCV or HIV antibodies
- •16. Current involvement in another trial that involves regular blood tests or an investigational medicinal product
- •17. Use of an investigational medicinal product or non-registered drug, live vaccine, or investigational medical device for 4 weeks prior to dosing with the study challenge agent
- •18. Administration of immunoglobulins and/or any blood products within the three months preceding the planned challenge date
- •19. Participants who meet STOP criteria at the time of screening
- •20. Any other issue which, in the opinion of the study staff, may:
- •20.1. Put the participant or their contacts at risk because of participation in the study
- •20.2. Adversely affect the interpretation of the study results
- •20.3. Impair the participant’s ability to participate in the study
研究者
相似试验
已完成
不适用
Trial of a group programme intervention for men who are concerned about their behaviourISRCTN71797549niversity of Bristol51
进行中（未招募）
3 期
Comparing x-ray to artificial intelligence guidance in keyhole aortic aneurysm surgeryCirculatory SystemAbdominal aortic aneurysm, without mention of ruptureAbdominal aortic aneurysmISRCTN13832085King's College London364
进行中（未招募）
Unknown
Timing an intervention for aortic stenosis with remote patient monitoringRemote monitoring of patients with aortic stenosisCirculatory SystemISRCTN19413194niversity of Birmingham66
已完成
Unknown
A clinical trial to find out the optimal oral iron dosing schedule for the prevention of anaemia in pregnant women (PANDA-Dose study)Iron supplementation in pregnant womenPregnancy and ChildbirthISRCTN12911644HS Blood and Transplant300
进行中（未招募）
不适用
Developing and testing a strategy to prevent involuntary psychiatric hospital admissionsMental healthMental and Behavioural DisordersISRCTN11627644niversity College London80