ISRCTN62041885已完成未知
The effect of intermittent preventive treatment for malaria with dihydroartemisinin-piperaquine on response to vaccines among rural Ugandan adolescents
ondon School of Hygiene and Tropical Medicine0 个研究点目标入组 341 人开始时间: 2019年8月23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
- 341
研究概览
简要总结
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33593769/ (added 16/08/2022) 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
- •1. Attending the selected school and planning to continue to attend the school for the duration of the study
- •2. Aged 9 to 17 years and enrolled in primary 1 to 6
- •3. Written informed assent by participant and consent by parent or guardian
- •4. Agree to avoid pregnancy for the duration of the trial (female only)
- •5. Willing to provide locator information and to be contacted during the course of the trial
- •6. Able and willing (in the investigator’s opinion) to comply with all the study requirements
排除标准
- •1. Clinically significant history of immunodeficiency (including HIV), cancer, cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illnesses.
- •2. Moderate or severe acute illness characterised any of the following symptoms: fever, impaired consciousness, convulsions, difficulty in breathing, vomiting; or as determined by the attending project clinician.
- •3. Family history of sudden death attributable to a heart condition in a first-degree relative
- •4. Family history of long QT syndrome
- •5. Know congenital prolongation of the QTc interval
- •6. History of known heart disease or fainting
- •7. Known allergy or history of adverse reaction to DP or to artemether-lumefantrine
- •8. History of serious psychiatric condition or disorder
- •9. Previous immunisation with Yellow Fever (YF), oral typhoid or Human Papillomavirus (HPV) vaccine; previous immunisation with BCG or Tetanus and diphtheria vaccine (Td) at age >5 years
- •10. Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents within 2 months prior to enrolment
- •11. Current use of medications known to prolong the QT interval (Table 2)
- •12. History of an allergic reaction to immunisation or any allergy likely to be exacerbated by any component of the study vaccines including egg or chicken proteins
- •13. Tendency to develop keloid scars
- •14. Haemoglobin less than 80g/L
- •15. Positive HIV serology
- •16. Positive pregnancy test
- •17. Female currently lactating, confirmed pregnancy or intention to become pregnant during the trial period
- •18. 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
- •19. Administration of immunoglobulins and/or any blood products within the three months preceding the planned trial immunisation date.
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