Population differences in vaccine response: the role, reversibility and mediators of immunomodulation by chronic infections in the tropics (POPVAC). Trial Protocol A: the effect of intensive treatment for schistosomiasis on response to vaccines among island adolescents in Uganda

ondon School of Hygiene and Tropical Medicine0 个研究点目标入组 479 人开始时间: 2019年5月1日最近更新: 2024年7月22日

适应症

试验速览

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33593768/ (added 05/05/2022) 2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33593767/ scientific rationale and cross-cutting analyses (added 26/10/2022)

•1. Attending the selected school and planning to continue to attend the school for the duration of the study
•2. Aged 9 to 17 year and enrolled in primary 4, 5 or 6
•3. Written informed consent by parent or guardian
•4. Written informed assent by participant
•5. Agree to avoid pregnancy for the duration of the trial (female only)
•6. Willing to provide locator information and to be contacted during the course of the trial
•7. Able and willing (in the investigator's opinion) to comply with all the study requirements

•1. Clinically significant history of immunodeficiency (including HIV), cancer, cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness
•2. History of serious psychiatric condition or disorder
•3. Concurrent oral or systemic steroid medication or the concurrent use of other
•immunosuppressive agents within 2 months prior to enrolment
•4. 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
•5. History of previous immunisation with YF, oral typhoid or HPV vaccine; previous immunisation with BCG or Td at age >5 years
•6. Tendency to develop keloid scars
•7. Haemoglobin less than 82g/L
•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

发起方

ondon School of Hygiene and Tropical Medicine