ISRCTN10482904已完成未知
Population differences in vaccine response: the role, reversibility and mediators of immunomodulation by chronic infections in the tropics (POPVAC). Trial protocol C: The impact of BCG pre-immunisation” on the response to vaccines among Ugandan adolescents participating in the Entebbe Mother and Baby Study
ondon School of Hygiene and Tropical Medicine0 个研究点目标入组 300 人开始时间: 2019年4月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33593770/ (added 05/05/2022) 2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33593767/ (added 03/05/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Participants must meet all of the following criteria to enter the trial:
- •1. A participant in the Entebbe Mother and Baby Study. Participants will be aged 13-17 years of age.
- •2. Written informed consent by parent or guardian
- •3. Written informed assent by participant
- •4. Willing to remain in the study area for the duration of the study
- •5. Willing to provide locator information and to be contacted during the course of the trial
- •6. Agree to avoid pregnancy for the duration of the trial (female only)
- •7. Able and willing (in the investigator's opinion) to comply with all the study requirements
排除标准
- •1. Concurrent enrolment into another clinical trial. Of note, EMaBS participants enrolled into trial TB042 Open label, dose escalation and age de-escalation for ChAdOx1 85A in Ugandan adults and adolescents, followed by a Phase IIa randomised, open-label trial among adolescents comparing ChAdOx1 85A prime followed by MVA85A boost versus BCG re-vaccination” will not be eligible to enrol into this study. If they have not already received the vaccines offered in this study, they will be given the opportunity to receive them, as a service (not as part of a study) once TB042 follow up has been completed.
- •2. Clinically significant history of immunodeficiency (including HIV), cancer, cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness
- •3. History of serious psychiatric condition or disorder
- •4. Previous immunisation with YF, oral typhoid or HPV vaccine; previous immunisation with BCG or Td at age >5 years
- •5. Concurrent oral or systemic steroid medication or the concurrent use of other
- •immunosuppressive agents within 2 months prior to enrolment
- •6. History of allergic reaction to immunisation or any allergy likely to be exacerbated by any
- •component of the study vaccines including egg or chicken proteins
- •7. Tendency to develop keloid scars
- •8. Positive HIV serology
- •9. Positive pregnancy test
- •10. Female currently lactating, confirmed pregnancy or intention to become pregnant during the trial period
- •11. Use of an investigational medicinal product or non-registered drug, live vaccine, or medical device other than the study vaccines for 30 days prior to dosing with the study vaccine, or planned use during the study period
- •12. Administration of immunoglobulins and/or any blood products within the three months
- •preceding the planned trial immunisation date
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